Joint Appendix — Watson v. Philip Morris Companies, Inc.

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Supreme Court, US.

FILED

(a FEB 2 3 2007

No-05-1284 OFFICE OF THE CLERK

IN THE

Supreme Court of the United States

LISA WATSON AND LORETTA LAWSON, INDIVIDUALLY

AND ON BEHALF OF ALL OTHERS SIMILARLY SITUATED.

Petitioners.

Vv.

PHILIP MORRIS COMPANIES, INC., A CORPORATION:

AND PHILIP MORRIS, INCORPORATED, A CORPORATION,

Respondents.

On Writ of Certiorari

to the United States Court of Appeals

=lal<tities a — Eighth Circuit

st * EO IQINT APPENDIX

t / |

L_SUPSENE COURT US. |

DAVID C, FREDERICK THEODORE B. OLSON

Counsel of Record Counsel of Record

MARK L. EVANS MARK A. PERRY

KELLY P. DUNBAR AMIR C. TAYRANI

KELLOGG, HUBER, HANSEN, GIBSON, DUNN & CRUTCHER

TODD, EVANS & FIGEL. LLP

pat a 1050 Connecticut Avenue, N.W.

1615 M Street, N.W. Washington, D.C. 20036

Suite 400 (202) 955-8500

Washington, D.C. 20036 Counsel for Respondents

(202) 326-7900

Counsel for Petitroners February 23, 2007

Seed

PETITION FOR A WRIT OF CERTIORARI FILED: APRIL 7. 2006

CERTIORARI GRANTED: JANUARY 12, 2007

TABLE OF CONTENTS

Relevant Docket Entries:

Circuit Court of Pulaski County, Arkansas,

RR, ee ITED tiatiesinsinctecsinihoassecniniabiasonisisbiechentan

United States District Court for the Eastern

District of Arkansas, No. 03-CV-00519-GTE..........

United States Court of Appeals for the Eighth

EERE SEN on SEIS OS ere ea Te

Defendants’ Memorandum in Opposition to Plain-

tiffs’ Motion for Remand, Watson, et al. Philip

Morris Cos., Inc., et al., No. 03-CV-00519-GTE

(E.D. Ark. filed Aug. 22, 2003):

Exhibit 2 (Letter from W.H. Brain to J. Hewitt

(Dec. 17, 1959)) (Appellee’s CA App. DA-004).....

Exhibit 7 (Excerpt from FTC Report to Con-

gress Pursuant to the Federal Cigarette Labeling

and Advertisitfg Act (June 30, 1968)) (Appel-

re Fe, Fe ectitvtinesinniccnemiititaneczcantsinte

Exhibit 8 (FTC News Release (Mar. 25, 1966))

(Appellee’s CA App. DA-037)..............cccceceeeeeeeeees

Exhibit 9 (Public Health Service Technical Re-

port on ‘Tar’ & Nicotine, reprinted in Review-

ing Progress Made Toward the Development

and Marketing of a Less Hazardous Cigarette:

Hearings Before the Consumer Subcomm. of the

Senate Comm. on Commerce, 90th Cong. 7

(1967)) (Appellee’s CA App. DA-038-40) ..............

Exhibit 11 (Methods To Be Employed in De-

termining Tar and Nicotine Content; Notice of

Public Hearing, 31 Fed. Reg. 14,278 (Nov. 4,

1966)) (Appellee’s CA App. DA-048-49)...000000....

Page

seeee —

ine 22

Exhibit 14 (Philip Morris Incorporated, e7 a/.,

Supplemental Observations Following Nov. 30.

1966 Hearing (Dec. 20, 1966) (Industry Sub-

mission)) (Appellee’s CA App. DA-233-46)............

Exhibit 16 (Cigarettes, Testing for Tar and

Nicotine Content, 32 Fed. Reg. 11,178 (Aug. 1.

1967)) (Appellee’s CA App. DA-247-48)...00....0.0.....

Exhibit 20 (Excerpt from Tar, Nicotine and

Carbon Monoxide of the Smoke of 1206 Varie-

ties of Domestic Cigarettes for the Year 1994

(1997)) (Appellee’s CA App. DA-290-93) ...............

Exhibit 21 (FTC News Release, FTC to Begin

Cigarette Testing (Aug. |, 1967)) (Appellee’s

Be I icecactinersnieriimiieunnidiaindnnienvndevite

Exhibit 22 (Letter from J.W. Shea. Secretary.

FTC, to H.H. Bell (Oct. 25, 1967)) (Appellee’s

ae pe O MIE caniiariccncnssssiciniesinlgneiititipidepmnbestions

Exhibit 23 (Excerpt from National Institutes of

Health. National Cancer Institute, Monograph

7: The FTC Cigarette Test Method for Deter-

mining Tar, Nicotine and Carbon Monoxide

Yields of U.S. Cigarettes (1994)) (Appellee’s

ee 8. oie eee

Exhibit 24 (FTC Nicotine Program: Hearing

Betore the Subcomm. on Transportation, Tour-

ism, and Hazardous Materials of the House

Comm. on Energy and Commerce, 100th Cong.

3 (1987). Excerpt from Testimony of FTC

Chairman D. Oliver) (Appellees CA App. DA-

ITE wibiisiccenethteidunscinicusisineaisitaneesiaaliisnaiaestgaaniipiiainiminiaiat

Exhibit 27 (Cigarette Testing, Tar and Nicotine

Content Results, 42 Fed. Reg. 21,155 (Apr. 25,

—_ 30

sinha 57

— 66

1977)) (Appellee’s CA App. DA-352)..................00. 127

Exhibit 36 (Commission Determination Re Bar-

clay Cigarettes; Amendment of Report of “Tar,”

Nicotine. and Carbon Monoxide Content of 208

Varieties of Cigarettes; Request for Comment

on Possible Testing Modifications, 48 Fed. Reg.

15.953 (Apr. 13, 1983)) (Appellee’s CA App.

STITT siiskocisisncislagdsicehideaichailunissdasnittinpaniintatoiiatalonsis

Exhibit 40 (Advertising of Cigarettes. Notice of

Public Hearing and Opportunity To Submit

Data, Views, or Arguments Regarding Proposed

Trade Regulation Rule, 35 Fed. Reg. 12,671

(Aug. 8, 1970)) (Appellee’s CA App. DA-445)........

Exhibit 41 (Nomination of Miles W. Kirkpatrick

to be Chairman of the FTC: Hearing Before the

Senate Comm. on Commerce, 9\st Cong. 172

(1970)) (Appellee’s CA App. DA-446-49) ooo...

Exhibit 42 (FTC News Release. FTC Directs

Tobacco Industry to Submit Specifics on Dis-

closing Tar and Nicotine Content (Oct. 1,

1970)) (Appellee’s CA App. DA-450)......................

Exhibit 43 (FTC News Release, FTC Suspends

Proceeding to Require Disclosure of Tar and

Nicotine Content in Cigarette Advertising After

Industry Amends Voluntary Plan (Dec. 23,

1970)) (Appellee’s CA App. DA-451-52).......0.0000.-«

Exhibit 45 (Memo from A.F. Brauninger to FTC

(Nov. 9, 1970)) (Appellee’s CA App. DA-456-

—_,_ a Se RE a 7 REN Ee TE

Exhibit 46 (Memo from FTC Chairman M.W.

Kirkpatrick to FTC (Nov. 24. 1970)) (Appel-

Be et I TI icici sniseehdactiatitiiebiediniehaontde

Exhibit 49 (Memo from A.F. Brauninger to FTC

(Dec. 21, 1970)) (Appellee’s CA App. DA-487-

tae

von Va

... 138

... 146

... 148

... 159

Exhibit 50 (Memo from J.W. Shea (Dec. 22,

1970)) (Appellee’s CA App. DA-521-22)...........00000-. 194

Exhibit 51 (Letter from H.R. Kornegay to M.W.

Kerkpatrick (Sept. 11, 1970)) (Appellee’s CA

UE sii stpitstialeadtncenitiniinshictibaintiiductatitinoomeioniein 196

Exhibit 52 (Letter from J.W. Shea to H.R.

Kornegay (Sept. 16, 1970)) (Appellee’s CA

Ss EIT viteisiaiiteecontincihisiabicietsainnspmcineininmeniinbateine 199

Exhibit 53 (/n re Lorillard, 92 F.T.C. 1035

(1978)) (Appellee’s CA App. DA-527-29) ................. 201

Exhibit 54 (/n the Matter of American Brands,

79 F.T.C. 255 (1971)) (Appellee’s CA App. -

TED icik cichiicienielineditbiclambiihdibcasccsduisledaaiaisei aiaadli 203

Exhibit 55 (Report to Congress Pursuant to the

Federal Cigarette Labeling and Advertising Act

for the Year 1979) (Appellee’s CA App. DA-

IU viclccvatpinidinhibsdidliiadbbiititpntictnadienititapionieainniaseniints 209

Exhibit 56 (Report to Congress Pursuant to the

Federal Cigarette Labeling and Advertising Act

for the Year 1980 (Nov. 15, 1982)) (Appellee’s

Se EIDE icsiiiscnisiecectsidentnteadeiiceddadinnsioateniedsipnees SE

Exhibit 66 {The American Tobacco Company;

Proposed Consent Agreement With Analysis To

Aid Public Comment, 59 Fed. Reg. 51,980 (Oct.

13, 1994)) (Appellee’s CA App. DA-624-26)......«.......214

Defendants’ Supplemental Memorandum of Addi-

tional Authority Regarding Plaintiffs’ Motion To

Remand, Watson, et al. Philip Morris Cos., Inc., et

al., No. 03-CV-00519-GTE (E.D. Ark. filed Nov.

18, 2003):

Exhibit 66 (Letter from H.R. Kornegay to FTC

(Dec. 17, 1970)) (Appellee’s CA App. DA-639-

Exhibit 69 (Letter from FTC Chairman D.

Oliver to Hon. T.A. Luken) (Appellee’s CA

RD. DRAG TED ..ccsecsnsccvnistenssnensiiiniainguiaiaimamamall

Exhibit 70 (Selected Pages from Deposition of

C.L. Peeler in United States v. Philip Morris,

Inc., No. 99-CV-02496 (GK) (July 30 & 31,

2002)) (Appellee’s CA App. DA-672-707)..................

Order of the United States Court of Appeals Grant-

ing Petition for Interlocutory Appeal, Watson, et al.

v. Philip Morris Cos., Inc., et al., No. 03-

SOZSEALR, CFUR, FB, BOD ccccccsnsscseninsessincicensnatelsimenanianin

NOTICE

The following documents have been omitted in the printing

of this Joint Appendix but may be found in the appendix to

the petition for a writ of certiorari filed im this case:

Opinion of the United States Court of Appeals for

the Eighth Circuit, Watson, et al. v. Philip Morris

Cos., Inc., et al., No. 04-1225 (Aug. 25, 2005)... cece. la

Order of the United States District Court for the

Eastern District of Arkansas, Watson. et al. v. Philip

Morris Cos., Inc., et al., No. 4:03-CV-519-GTE

ESR SEER is ee 20a

Order Denying Petition for Rehearing of the United

States Court of Appeals for the Eighth Circuit,

Watson, et al. v. Philip Morris Cos., Inc., et al.,

| > —_ | nena 6la

First Amended Class Action Complaint, Watson, et

al. v. Philip Morris Cos., Inc., et al., Case No.

CV03-4661 (Pulaski Cty., Ark. Cir. Ct. filed May

a acl eaticcnmnnsncnmabeannceasnte 62a

Notice of Removal, Watson, et al. v. Philip Morris

Cos., Inc., et al., No. 4:03-CV-519-GTE (E.D. Ark.

I TTT coals ina daesintnenotennenanennnanmenseenannenenséees 74a

Statutory Provisions Involved .................cccccececeeeeeeeeeeeeeeees 98a

Letter from Supreme Court Clerk regarding ex-

tension request for filing a petition for a writ of

RETIN LE 100a

Letter from Supreme Court Clerk regarding second

extension request for filing a petition for a writ of

ET a 10la

CIRCUIT COURT OF PULASKI COUNTY, ARKANSAS

No. CV 2003 004661

LORETTA LAWSON AND LISA WATSON,

Plaintiffs,

Vv.

PHILIP MORRIS COMPANIES, INC., A CORPORATION;

AND PHILIP MORRIS, INCORPORATED, A CORPORATION,

Defendants.

APPEARANCE AND EXECUTION DOCKET

DATE DOCKET ENTRY

4/18/03 Complaint (Civil Cases) 100.00Pd

5/29/03 Amended Complaint

xe KK

7/2/03 _ Notice of Removal: Philip Morris USA Inc.

7/22/04 Notice of Withdrawal of Lead PIf Loretta

Lawson: PIf Loretta Lawson

7/22/04 Motion to Dismiss Loretta Lawson

S Gene Cauley

UNITED STATES DISTRICT COURT

FOR THE EASTERN DISTRICT OF ARKANSAS

LITTLE ROCK DIVISION

Case No. 4:03-CV-00519-GTE

LISA WATSON AND LORETTA LAWSON, INDIVIDUALLY

AND ON BEHALF OF ALL OTHERS SIMILARLY SITUATED,

Plaintiffs,

PHILIP MORRIS COMPANIES, INC., AND

DATE 5

7/2/03 l

7/2/03

7/10/03 2

PHILIP MORRIS, INCORPORATED,

Defendants.

DOCKET PROCEEDINGS

DOCKET ENTRY

NOTICE of Petition for Removal from

Pulaski County Circuit Court; Case

Number: CV03-4661; filing fee of $150.00

pd, receipt #108478 (kjp) (Entered:

07/03/2003)

COMPLAINT (kjp) (Entered: 07/03/2003)

FIRST AMENDED CLASS ACTION

complaint with jury demand [0-1] by

plaintiff, adding Lisa Watson (kjp)

(Entered: 07/03/2003)

ANSWER of Philip Morris USA Inc. to

plaintiffs’ first amended class action com-

plaint with jury demand (rjh) (Entered:

07/11/2003)

8/1/03

8/22/03

9/12/03

11/10/03

11/18/03

11/20/03

*e ee *

MOTION by pltfs for remand to Circuit

Court of Pulaski County (rjh) Modified on —

08/04/2003 (Entered: 08/04/2003)

MEMORANDUM OF LAW by piltfs in

support of motion for remand to Circuit

Court of Pulaski County [4-1] (rh)

(Entered: 08/04/2003)

x*eE*

MEMORANDUM IN OPPOSITION TO

PLTFS’ MOTION FOR REMAND by

defts [4-1] (exhb attached) (rh)

(Entered: 08/25/2003)

*e*£ ee €

REPLY memorandum of law in support of

pitfs’ motion to remand to the Circuit

Court of Pulaski County, Arkansas [4-1]

by pltfs (rjh) (Entered: 09/15/2003)

MOTION by plitfs for class certification

(rjh) (Entered: 11/12/2003)

MEMORANDUM OF LAW by pltfs in

support of motion for class certification

{1 1-1] (jh) (Entered: 11/12/2003)

DEFENDANTS’ SUPPLEMENTAL

MEMORANDUM OF ADDITIONAL

Authority regarding plitfs’ motion to re-

mand [4-1] (rjh) (Entered: 11/19/2003)

*e EK *

CLERK’S MINUTES: ORAL ARGU-

MENT before Judge G. Thomas Eisele on

Motion to Remand. Court takes under

advisement. (Court reporter, Elaine

Hinson) (cyw) (Entered: | 1/20/2003)

12/11/03 19

12/12/03 20

12/30/03 21

12/30/03 22

ADDENDUM & additional documenta-

tion regarding the voluntary agreement in

support of defts’ memorandum in opposi-

tion to pltfs’ motion for remand (exhibits

#66 «through #71) (rh) (Entered:

12/11/2003)

MEMORANDUM OPINION AND OR-

DER by Judge G. T. Eisele for the reasons

& findings stated herein, pltfs’ motion for

remand to Circuit Court of Pulaski County

[4-1] is denied; pltfs’ request (contained in

Doc #2) for costs & fees is denied; ordered

that the controlling question on this case is .

designated for interlocutory appeal under

1292(b) & pltfs shall have 10 days to file

an applic for interlocutory review with

USCA; upon filing applic, proceedings in

this Ct will be stayed; the date on which

defts’ resp to pltfs’ mot for class cert is

due shall be extended; if stay comes into

effect, defts’ resp to mot for class cert

need not be filed until 14 days after Eighth

Circuit final action upon pltfs’ applic; if

pitfs do not seek interlocutory appeal,

defts’ resp is due no later than 14 days af-

ter expiration of the ten day penod in

_ which pltfs have to file an applic for inter-

locutory review (cc: all counsel) (rh)

(Entered: 12/15/2003)

NOTICE by plaintiffs of filing petition

for interlocutory appeal (dac) (Entered:

12/31/2003)

TRANSCRIPT (| volumes)- of proceed-

ings for the following date: 11/20/03 oral

argument on motion to remand (dac)

(Entered: 12/31/2003)

1/5/04 =———DOCKETING LETTER: 8 USCA Number

03-8023; petition for permission to appeal

pursuant to 28USC section 1292(b) has

been filed (dac) (Entered: 01/05/2004)

2/2/04 DOCKETING LETTER: 8 USCA Number

04-1225; petition for permission of Lisa

Watson, et a] to take an interlocutory ap-

peal is granted (dac) (Entered: 02/02/2004)

x*e*K K *

12/5/05 24 MANDATE USCA8 re 1292(b) appeal of

20 Order on Motion for Relief is affirmed

in accordance with the opinion of this

Court (Attachment: # 1 Opinion) (dac)

(Entered: 12/08/2005)

*eKK *

1/18/06 = 36 MOTION to Stay Proceedings Pending

Supreme Court Resolution of Plaintiffs’

Petition for Certiorari 25 by Plaintiffs (rjh)

(Entered: 01/18/2006)

1/18/06 = 37 MEMORANDUM IN SUPPORT filed by

Plaintiffs of their 36 Motion to Stay Pro-

ceedings Pending Supreme Court Resolu-

tion of Plaintiffs’ Petition for Certiorari.

(rjh) (Entered: 01/18/2006)

1/30/06 =38 ORDER IMPOSING STAY that Plain-

tiffs’ Motion 36 is GRANTED and all

proceedings in this case are stayed until

directed otherwise by this Court; parties

are directed to notify the Court upon

resolution by the U. S. Supreme Court of

the pending Petition for Certiorari. Signed

by Judge G. Thomas Eisele on 1/30/06.

(rjh) (Entered: 01/30/2006)

** KK *

1/30/06

4/24/06

4/26/06

1/17/07

1/29/07

CERTIFICATE OF MAILING by the

Clerk re 38 Order Staying Case (rjh)

(Entered: 01/30/2006)

Letter from U. S. Supreme Court, petition

for a writ of certiorari was filed on 4/7/06

and placed on the docket 4/10/06 as

No. 05-1284 (dac) (Modified entry on

4/26/2006 to correct the placed on docket

date to 4/10/06) (bfw). (Entered:

04/26/2006)

NOTICE OF DOCKET CORRECTION:

40 Letter — (modified entry to correct the

placed on docket date to 4/10/06) (bfw)

(Entered: 04/26/2006)

LETTER RESPONSE re 38 Order Staying

Case filed by Philip Morris Companies,

Inc. and Philip Morris Incorporated. (thd)

(Entered: 01/17/2007)

NOTICE of Action on Plaintiffs’ Petition

for Certiorari in Response to 38 Order

Staying Case filed by Loretta Lawson and

Lisa Watson. (thd) (Entered: 01/17/2007)

WRIT of Certiorari is granted by the Su-

preme Court (dac,) (Entered: 01/30/2007)

UNITED STATES COURT OF APPEALS

FOR THE EIGHTH CIRCUIT

No. 04-1225

LISA WATSON AND LORETTA LAWSON, INDIVIDUALLY

AND ON BEHALF OF ALL OTHERS SIMILARLY SITUATED,

Plaintifjs-Appellants,

PHILIP MORRIS COMPANIES, INC., A CORPORATION,

AND PHILIP MORRIS, INCORPORATED, A CORPORATION,

DATE

1/28/04

3/22/04

4/19/04

Defendants-Appellees.

DOCKET PROCEEDINGS

DOCKET ENTRY

Civil Case Docketed. Dist. Ct. Office:

Little Rock, Arkansas

CASE TRANSFERRED - Petition for

interlocutory appeal and _ respondent’s

answer.

**e KE *

BRIEF FILED — Brief of Appellant-

Loretta Lawson 25 pages w/addendum 10

copies — w/service 3/19/04. [04-1225]

[1749375]

**e# kK *

BRIEF FILED Brief of Appellee —

Philip Morris. 13,719 words w/addendum

5/4/04

11/15/04

2/25/05

8/25/05

— 10 copies — w/service 4/19/04. w/disk

[04-1225] [1758605]

*e *e* *

BRIEF FILED — Reply bref ~ Lisa Wat-

son, Loretta Lawson. 6 pages 10 copies —

w/service 5/3/04. w/diskette [04-1225]

[1763671]

** * * *

ARGUED AND SUBMITTED IN ST.

LOUIS TO JUDGES William J. Riley,

Circuit Judge, John R. Gibson, Circuit

Judge, Raymond W. Gruender, Circuit

Judge. Marcus Neil Bozeman for Appel-

lants Loretta Lawson, Appellants Lisa

Watson. Amy Phillips Rosenthal for Ap-

pellees Philip Morns, Appellees Philip

Morris. Rebuttal by: Marcus Bozeman.

RECORDED. [04-1225]

KERR |

28(j) citation received and filed from

Appellees Philip Morris, Appellees Philip

Morris TO COURT [04-1225] [1872104]

THE COURT: William J. Riley, John.

R. Gibson, Raymond W. Gruender.

OPINION FILED by John R. Gibson,

Authoring Judge CONCUR by Raymond

W. Gruender, PUBLISHED. [04-1225]

[1944316]

JUDGMENT: William J. Riley, John

R. Gibson, Raymond W. Gruender.

The judgment of the lower court is

AFFIRMED in accordance with the opin-

ion. [04-1225] [1944318]

9/22/05

9/29/05

10/3/05

10/7/05

10/13/05

**e Ee * *

PETITION for REHEARING with petition

for rehearing en banc. Filed by Appellants

Lisa Watson, Appellants Loretta Lawson,

w/service 9/21/05. TO COURT [04-1225]

MOTION of amicus curiae, Public Citizen

Inc. and AARP, for leave to file brief in

support of appellants’ petition for rehear-

ing. [04-1225] [1958002], TO COURT

w/service 9/28/05

MOTION of amici curiae, Campaign

for Tobacco-Free Kids, American Lung

Association, American Heart Association,

American Cancer Society, and Michael

Pertschuk, for leave to file brief in sup-

port of petition for rehearing en banc.

[04-1225] [1960363], TO COURT

w/service 9/29/05

Clerk letter sent notifying that party has

an Opportunity to respond to petition for

Rehearing with petition for rehearing en

banc filed by Lisa Watson, Loretta Law-

son [1955145-1] [04-1225] Response due

by 10/13/05

MOTION of aplee, Philip Morris, to strike

amici curiae’s reliance on extra-record evi-

dence [04-1225] [1961429], TO COURT

w/service 10/7/05

RESPONSE to petition for Rehearing with

petition for rehearing en banc filed by Lisa

Watson, Loretta Lawson [1955145-1]

[1963028]. Response filed by Philip

Morris. w/service 10/13/05 TO COURT

[04-1225]

10/21/05

10/24/05

11/2/05

RESPONSE of amicus curiae, Public

Citizen, Inc., and AARP, in opposition to

appellee motion to strike amici curiae’s

reliance on extra-record evidence filed by

Philip Morris [1961429-1] [04-1225]

[1966230]. TO COURT

RESPONSE of amici curiae, Campaign

for Tobacco-Free Kids, American Lung

Assoc., American Heart Assoc., American

Cancer Society, and Michael Pertschuk in

opposition to appellee motion to strike

amici curiae’s reliance on extra-record evi-

dence filed by Philip Morris [1961429-1]

[04-1225] [1967595]. TO COURT

JUDGE ORDER: granting amicus motion

filed by Public Citizen and AARP for

leave to file brief in support of appellant’s

petition for rehearing [1958002-1] [04-

1225] [1970311], denying amicus motion

filed by Tobacco-Free Kids, American

Lung Assoc., American Heart Assoc.,

American Cancer Society and Michael

Pertschuk for leave to file a brief in sup-

port of petition for rehearing [1960363-1]

filed [04-1225] [1970311] The brief of

amici curiae Public Citizen and AARP is

redacted to excise references to briefs filed

in other cases which were not included in

the record on appeal.

ADDITIONAL PETITION for REHEAR-

ING with petition for rehearing en banc.

Filed by Amici on behalf of Appellant

Public Citizen, Amici on behalf of Appel-

lant AARP, w/service 9/28/05. [1970426],

TO COURT [04-1225]

11/18/05

12/2/05

2/27/06

3/20/06

4/14/06

1/16/07

JUDGE ORDER: denying petition for Re-

hearing with petition for rehearing en banc

[1955145-1] filed by Lisa Watson, Loretta

Lawson. Petition for panel Rehearing is

also denied. [04-1225] Judge Armold and

Judge Bye would grant the petition for re-

hearing en banc. [1976549] — Published

Order.

MANDATE ISSUED [04-1225]

** eK *

Supreme Court notice received extending

time to file petition for writ of certiorari

until March 20, 2006. [04-1225]

Supreme Court notice received extending

time to file petition for writ of certiorari

until 4/17/06. [04-1225]

U.S. Supreme Court notice filed. Petition

for writ of certiorari filed in the Supreme

Court on April 7, 2006. Supreme Ct. Case

No.: 05-1284 [04-1225] [2035669]

SUPREME COURT order filed granting

cert petition. Order filed on 01/12/2007.

[3272613] [04-1225]

FEDERAL TRADE COMMISSION

WASHINGTON 25

Bureau of Consultation

DEC 17 1959

Mr. John Vance Hewitt,

Conboy, Hewitt, O’Brien & Boardman,

39 Broadway,

New York 6, N.Y.

Re: ‘Tar and Nicotine Claims

Dear Mr. Hewitt:

To confirm my telephone call of December 15, we wish

to advise that all representations of low or reduced tar or

nicotine, whether by filtration or otherwise, will be construed

as health claims. No hedging statements, such as taste or

sales volume qualifications, will be considered as changing

the character of reduction claims. Our purpose is to eliminate

from cigarette advertising representations which in any way

imply health benefit.

This advice is being disseminated on an industry-wide

basis and prompt, simultaneous compliance is urgently re-

quested. Any advertising which is not promptly brought into

conformance with this request will be forwarded to other Bu-

reaus looking forward to mandatory procedures. As always,

the services of this Bureau are available to cigarette advertis-

ers to confer on proposed advertising.

Please advise this office at the earlicst possible time of

your client's willingness to make necessary changes in the

present advertising of any and all of its brands to comply

with this request.

Very truly yours,

/s/

William H. Brain,

Attorney.

FEDERAL TRADE COMMISSION

REPORT TO CONGRESS

Pursuant To The

Federal Cigarette Labeling and Advertising Act

June 30, 1968

The 1967 Cigarette Report noted the possibility that

cigarette advertisers play important roles as social arbiters.

32/ Exposition if not outright espousal of values has become

a prominent feature in current cigarette advertising. Thus,

Be up-to-date: “You're a part of the right now

. everything about True says right now”.

Avoid Alienation: “don’t go out without your

Lark pack ... if you’re ready to show your

pack, the Lark truck will see you” and “you

too, join the crowd that smokes the number

one in ‘good taste’ ... Winston”. Persevere:

“not long ago if you smoked a reduced tar and

nicotine cigarette you were pretty much alone

in the world ... you’re not alone anymore”

(True).

Be aristocratic: with a connoisseur’s eye, Sir

Arthur Smith trades his Rolls Royce for a pack

of Newports, “The smoothest (taste) that’s

ever been bred”. Chesterfield filters are sa-

vored by a wine taster who pronounces their

taste “suave, aristocratic, great finesse”. Be

patriotic (and egalitarian): “afterall, in this

country, it’s what you are, not who you are

that counts” (Century 100s). Be cosmopoli-

tan: “the first filter cigarette to combine rich

American taste with handsome European styl-

ing” (Half and Half).

Presumably not all the values depicted represent those of

the advertisers, e.g. “I bold, brawny, Bob Bevans am a flavor

grabber” (L&M). In an L&M commercial taking place

aboard ship, the object is to ‘see how many [L.&M’s] are

grabbed in the next 50 seconds”. In one commercial, the

taste of Kents drives a man to larceny but in another delivers

him from a career of gambling.

Certain commercials seek to associate their product with

a mood. There is the “male whimsy” of Camel advertising,

in which men with wondering souls travel from Kilimanjaro

to Maine, a mile and yet a mile and a half onward, buying

Camels and displaying holes in their soles.

As has been duly noted, cigarette advertising can lend it-

self to flights from reality.

Marlboro Country continues “traditional male heroic”

and moored to the range—‘“you know when one’s missin!

Without countin’, you know ... this 1s Marlboro Country.

Where a good colt is as important today as it was a hundred

years ago”.

There was a time when tribulations befell Salem Coun-

try. Replaced by appeals to urbanites (“you can take Salem

out of the country ...”) and invaded by the hard sell (“that

last cigarette was pretty tasteless—try Salem—taste now—

talk later”), Salem Country when last sighted recommenced a

definite bucolic upbeat, replete with jodhpur clad damsels

with beaux and sorrels.

The Parliament Night People started the year characteris-

tically (“let’s find a new place for dinner, OK? ... Meet the

Night People ... This is their style. They look for atmos-

phere”), but in the end gave way to sardonic Englishmen,

given to having the last word over the mainstream of Parlia-

ment cigarettes.

Assuaging Anxiety

For good reason, there is concern that cigarettes are haz-

ardous to health. 33/ Consequently, it is important to adver-

tisers of cigarettes that this concern be allayed. Attempts by

cigarette advertisers to dispel worry or anxiety over the

health consequences of smoking have met with considerable

success. 34/

While recognizing that smoking any cigarette is hazard-

ous, the Surgeon General of the United States has clearly in-

dicated that some cigarettes may be less hazardous than oth-

ers. Thus, he has stated that “in recent years, the harmful ef-

fects of tar and nicotine in cigarette smoke have been the sub-

ject of intensive scientific research here and abroad.” There is

evidence that tar . . . is many times more potent in its cancer-

producing properties than any of the substances isolated from

it.” 35/ A committee appointed by the Surgeon General has

concluded that “the preponderance of scientific evidence

strongly suggests that the lower the ‘tar’ and nicotine content

of cigarette smokc, the less harmful are the effects.” 36/

Based upon the proposition that lower yield cigarettes

present a lessened hazard to the American public, the Com-

mission has acted within the past year to (1) augment infor-

mation available to the public on the tar and nicotine content

of cigarettes and (2) prompt cigarette manufacturers to de-

velop less hazardous cigarettes.

On May 15, 1967, Chairman Paul Rand Dixon an-

nounced the activation of a Commission cigarette testing

laboratory. Testing procedures to be utilized by the labora-

tory were announced on August |, 1967. On October 26,

1967, the Commission issued a policy statement which indi-

cated that as a general rule the Commission would not chal-

lenge statements or representations of or relating to tar and

nicotine content or cigarettes “where they are shown to be

accurately and fully substantiated by tests conducted in ac-

cordance with the standardized testing methods and proce-

dures used by the Federal Trade Commission”.

Shortly thereafter, on November 22, 1967, the Commis-

sion published test results on the tar and nicotine yields of 59

varieties of cigarettes—these included varieties having the

greatest sales at the time and those whose labeling or adver-

tising contained tar or nicotine yield statements. Only two

varieties made yield claims lower than those published by the

Commission and in both instances, the advertisers voluntarily

corrected the situation. Unofficial information has been re-

ceived that the November 22, 1967 test results were carried

on the front pages of three out of four of all major daily

newspapers in the United States. Many hundreds of thou-

sands of copies were reproduced and distributed by the Pub-

lic Health Service, the American Cancer Society and other

health agencies.

As recently as mid-June of 1968 the Commission re-

leased test results of the tar and nicotine yields of virtually all

brands marketed domestically, 127 in number. Advertisers

now have available for use in their advertising, information

concerning the tar and nicotine levels of their and competi-

tive brands. Their use of this information must be factual,

fair and not misleading. The ORC-ACS Survey indicated

that 62% of all interviewees think that the amount of tar and

nicotine should appear both on the cigarette pack and in ad-

vertising; an additional 14% think that such information

should appear on the pack only. 37/ Since the establishment

of the Commission’s laboratory, cigarette manufacturers have

changed thirty-eight 38/ different varieties of cigarettes with

respect to filters, filter overwraps, blends, etc., in an effort to

lower tar and nicotine yields. We know of no attempts to

produce cigarettes with higher yields.

An analysis of sales data provided by cigarette manufac-

turers indicates that sales of comparatively low yield ciga-

rettes, e.g., for purposes of this report only, those having 15

milligrams (mg.) of tar or less, have not been extensive thus

far. Three categories of cigarettes, classified according to tar

yields, divided the market in 1967 as follows: 15 mg. and

under ~— 2%; 16 - 21 mg. — 59%; 22 mg. and over — 39%.

In promoting the above-noted 2% of the market, ciga-

rette advertisers spent 5.5% of their total 1967 advertising

budget. During the first two months of 1968, cigarettes with

tar content of 15 mg. and under accounted for 2.4% of the

market and 7.8% of total advertising expenditures. Perhaps

the trend noted in connection with filter and 100 millimeter

cigarettes has commenced with respect to low yield ciga-

rettes—-manufacturers are spending disproportionately large

amounts to promote them with the result that their market

share increases each year.

There is every reason to believe that the promotion of

low tar and nicotine yield cigarettes can be profitable. As

indicated, the Commission released tar and nicotine figures

for 59 varieties of cigarettes in late November 1967. These

figures indicated that regular and king-sized filter Marvels

were lowest in tar and nicotine of the 59. They also indicated

that Cascade was lowest among menthol cigarettes. The

sales of these three brands rose respectively 382%, 570% and

200% in December 1967, despite the fact that overall ciga-

rette sales declined in December (from November) in 1967,

1966 and 1965. Furthermore, both True and Carlton ciga-

rettes, two well advertised low yield cigarettes, each in-

creased sales 20% that December following publication of

Commission figures.

The only brands making tar or nicotine content disclo-

sures in advertising or labeling at the time of the 1967 Ciga-

rette Report were Carlton, True, Marvels, Cascade, King

Sano, and Duke of Durham filters. 39/ To these may now be

added Domino menthols, Montclair, Silva Thins, and Tryon

filters.

As noted in the 1967 Cigarette Report, rather than alert

smokers to less hazardous low yield cigarettes, advertisers

sought for the most part to allay smoker anxiety by proclaim-

ing the wonders of their filters. 40/ The PHS Survey revealed

a plausible reason for this—the belief is widely held that fil-

ter cigarettes are less hazardous to health than nonfilter ciga-

rettes. 41/ -

Now that the Commission has tested nearly every. ciga-

rette on the market, an evaluation of this belief is possible.

Concerning the 127 varieties tested, the lowest 34 in tar con-

tent are all filter cigarettes and the highest six are all nonfilter

cigarettes. However, the nonfilter cigarette ranking 35th

lowest in tar is lower in tar than no fewer than 62 other filter

cigarettes. Furthermore, it would appear that 95 millimeter,

filter Pall Mall spews slightly more tar than king size, nonfil-

ter Pall Mall and that regular size, nonfilter Chesterfield

spews slightly less tar than 101 millimeter, filter Chester-

fields. 42/ Obviously, the consumer cannot rely on the filter

alone.

Nevertheless, the implied safety of a filter (“the mere

addition of a filter to a cigarette is, in and of itself, some kind

of claim or assurance relating to the health aspects of smok-

ing” 43/) and the miraculous way in which it delivers taste

continue to be the advertisers’ principal palliative against

smoker misgivings. Examples include:

“the flavor of the world’s finest tobaccos

through the Kent filter”; “the charcoal gran-

ules make the taste better” (Lark); “white filter

flavor” (L&M); “a filter cigarette blended with

natural flavor fresheners” (Viceroy); “Kool’s

white filter... menthol through a filter.”

Some filters are tasty enough to do without tobacco (“You

don’t even have to light it to like it”-—Lucky Strike 100s).

The implication that “filter” equals “comparative safety”

can be made more express through depictions of the compli-

cated inner workings of the filter (True, Tempo, Lark, Lucky

Strike 100s) or by euphemisms such as “mild”, “soft”, e.g.

“flavor comes through filtered mild” and “charcoal to soften

the taste” (Lucky Strike 100s), “the charcoal filter smoothes

the taste” (Tareyton), “air cooled filter, a great light taste”

(Carlton).

The Pall Mall advertisements, “Look! it’s extra long at

both ends. More fine tobacco at one end. And an extra long

filter at the other. So it travels the smoke further for greater

mildness” and “filter[s] further for a milder smoke”, combine

several approaches. The implicit assurance of the word “fil-

ter” is there, made more exp/icit, by “an extra long filter” and

through the euphemism “travels the smoke further for greater

mildness” (emphasis added). The further thought is projected

that such euphemistic mildness comes from the longer filter

and more tobacco, i.c. “extra long at both ends .. . filter{s]

further for greater mildness”.

News Release

Federal Trade Commission

Washington, D.C. 20580

OFFICE OF INFORMATION 393-6800 Ext. 197

For RELEASE: IMMEDIATE, Friday, March 25, 1966

The Federal Trade Commission today announced that it

has sent identical letters to each of the nation’s major ciga-

rette manufacturers and to Mr. Robert B. Meyner, Adminis-

trator of The Cigarette Advertising Code, Inc., in regard to

factual statements of tar and nicotine content on labels and in

advertising of cigarettes. The text of the letter is as follows:

Gent!emen:

The Cigarette Advertising Guides

promulgated by the Commission in September

1955 provided that no representation should

be made that “any brand of cigarette or the

smoke therefrom is low in nicotine or tars

*** when it has not been established by

competent scientific proof applicable at the

time of dissemination that the claim is true,

and if true, that such difference or differences

are significant.” On the basis of the facts now

available to it, the Commission has deter-

mined that a factual statement of the tar and

nicotine content (expressed in milligrams) of

the mainstream smoke from a cigarette would

not be in violation of such Guides, or of any of

the provisions of law administered by the

Commission so long as (1) no collateral repre-

sentations (other than factual statements of tar

and nicotine contents of cigarettes offered for

sale to the public) are madc, expressly or by

implication, as to reduction or elimination of

health hazards, and (2) the statement of tar and

nicotine content is supported by adequate re-

cords of tests conducted in accordance with

the Cambridge Filter Method, as described in

ar. article entitled “Determination of Particu-

late Matter and Alkaloids (as Nicotine) in

Cigarette Smoke,” by C.L. Ogg, which ap-

peared in the Journal of the Association of Of-

ficial Agricultural Chemists, Vol. 47, No. 2,

1964. It 1s the Commission’s position that it is

in the public interest to promote the dissemi-

nation of truthful information concerning ciga-

rettes which may be material and desired by

the consuming public.

By direction of the Commission.

Joseph W. Shea,

Secretary.

REVIEWING PROGRESS MADE TOWARD

THE DEVELOPMENT AND MARKETING OF A

LESS HAZARDOUS CIGARETTE

HEARINGS

BEFORE THE

CONSUMER SUBCOMMITTEE

OF THE

COMMITTEE ON COMMERCE

UNITED STATES SENATE

NINETIETH CONGRESS

FIRST SESSION

August 23, 24, and 25, 1967

Serial No. 90-52

* * *

THE SECRETARY OF HEALTH,

EDUCATION, AND WELFARE

Washington, January 10, 1967

HON. WARREN G. MAGNUSON,

U.S. Senate, Washington, D.C.

DEAR SENATOR MAGNUSON: In response to your letter

of November 9, 1964, | am pleased to forward to you a copy

of a technical report by the Public Health Service reviewing

the significance of the “tar” and nicotine content of cigarette

smoke. This report was in the process of preparation at the

time of my last letter to you in July and | regret this long de-

lay in putting it in your hands. The report reflects the general

considerations which went into the thinking of the committee

whose recommendations to the Surgeon General were trans-

mitted to you earlier.

In our opinion, requiring the identification of “tar” and

nicotine levels on packages and in advertising, as you have

proposed, would be an important step and would result in the

progressive reduction of “tar” and nicotine levels because of

public demand.

On the basis of available evidence regarding the effects

of individual constituents of cigarette smoke, their relation-

ship to the overall hazards of cigarette smoking, and the rela-

tive precision regarding measurement techniques, the identi-

fication of “tar” and nicotine levels can provide valuable in-

formation on overall dosage. In considering any labeling re-

quirement, it would be important that such requirement allow

for the addition of other components of cigarette smoke as

they are identified as a hazard and when agreement is reached

On appropriate measurements to be used.

I strongly support your view that these steps reiating to

the measurement and labeling of “tar” and nicotine in ciga-

rette smoke are only part of our overall] approach to this prob-

lem. As you have pointed out, until hazardous substances

can be removed from cigarette smoke, the only effective

means available to eliminate the health hazards associated

with smoking is an educational program designed to inform

people of the hazard and encourage people to stop or not to

start smoking.

| hope that this letter and the attached technical report

will prove helpful.

Sincerely,

JOHN W. CLAIBORNE,

Secretary.

“Public Health Service Technical Report on ‘Tar’

and Nicotine

“It 1s clear that the overall risk associated with cigarette

smoking increases as the average number of cigarettes con-

sumed per day increases (1). In the studies which have re-

ported other measures of exposure such as pack years, degree

of inhalation, and maximum level of cigarette consumption,

the same type of relationship holds.

“Hammond (2) has shown that users of high ‘tar’ and

nicotine cigarettes report significantly more of the symptoms

that are characteristic of cigarette smokers in general. Grati-

ani et al (3) have shown that appreciable variations in ‘tar’

yield of cigarettes may be achieved by changing the pattern

of smoking with maximum yield being obtained when puff-

ing is concentrated toward the end of the cigarettes. The ef-

fect of tobacco smoke condensate on the mouse skin has been

shown by numerous investigators to be dependent on the

dose of tar applied to the skin.

“These findings support the existence of a dose-response

relationship between exposure to cigarette smoke and the

risks most clearly associated with cigarette smoking—lung

cancer, chronic obstructive pulmonary diseases, and cardio-

vascular diseases. Among the factors which may enter into

the total exposure are numbers of cigarettes consumed, length

of cigarette consumed, pattern of smoking (relative concen-

tration of puffing at beginning, middle, or end of cigarette),

frequency and depth of inhalation, and concentration of to-

bacco smoke which enters the smoker’s mouth. The concen-

tration of particulate matter in the mainstream of smoke is

reflected in the measurement of the so-called ‘tars’ in tobacco

smoke.

“The epidemiologic evidence on the effect of cigarette

smoking on health is based largely on numbers of cigarettes

consumed daily as the measure of exposure. That the degree

of risk correlates as high as it does with numbers of cigarettes

probably reflect the fact that the various measures of expo-

sure noted above tend to be positively later correlated. Those

individuals who smoke many cigarettes, and also, who inhale

frequently and deeply, take more puffs, use higher ‘tar’ and

nicotine content cigarettes, and so on.

“Wynder and Hoffmann (4) have shown that the tumori-

genicity of cigarette smoke can be reduced by alternation in

the cigarette which reduces the ‘tar’ and nicotine content.

They use the term ‘indicator’ for ‘tar’ and nicotine content or

other measures which reflect this type of gross relationship

lacking the identification of specific agents which are respon-

sible for the effect. Bock, Mourn, and Clark (5) have inde-

pendently shown a similar variation in carcinogenic activity

of tobacco ‘tar’ obtained from different types of cigarettes.

“The ad-hoc group of scientists which reviewed and dis-

cussed these data recently at the invitation of the Surgeon

General concluded that:

“|. The preponderance of scientific evidence strongly

suggests that the lower the ‘tar’ and nicotine content of ciga-

rette smoke, the less harmful would be the effect.

“2. We recommend to the Surgeon General that action

be encouraged which will result in the progressive reduction

of the ‘tar’ and nicotine content of cigarette smoke.

“This judgment was arrived at with full recognition of

the following:

“1. It is possible for a cigarette to be altered in such a

way that its ‘tar’ and nicotine content is reduced but certain

other harmful effects, for example, the effect of the gaseous

phase may be increased. Although this is a theoretical possi-

bility, there is no evidence that this has occurred to any seri-

ous degree.

“2. The potential benefit to the individual consumer who

might shift to a Jower tar and nicotine cigarette would be ne-

gated if this shift were accompanied by an increase in the

number of cigarettes consumed, or in the length of each ciga-

rette used. There is evidence that, by-and-large, this does not

occur, that the shift to low ‘tar’ and nicotine cigarettes tends

to be accompanied by the same level of consumption or an

even lower level rather than by an increased consumption

(0.7).

“3. Promotion of a low ‘tar’ and nicotine cigarette might

lull the consumer into believing that he could smoke this kind

of cigarette without any accompanying risk. The presence of

the warning label] on the package, control over the advertising

statements which are permitted, and the continuing educa-

tional efforts of public health agencies on this subject should

minimize this likelihood.”

FEDERAL REGISTER

VOLUME 31 NUMBER 215

Friday, November 4, 1966 Washington, D.C.

Pages 14105-14291

* * *

FEDERAL TRADE COMMISSION

CIGARETTES AND RELATED MATTERS

Methods To Be Employed in Determining Tar and Nico-

tine Content; Notice of Public Hearing

Notice 1s hereby given that the Federal Trade Commis-

sion will hold a public hearing before the full Commission on

November 30, 1968, commencing at 10 a.m., e.s.t. in Room

532, Federal Trade Commission Building, Sixth Street and

Pennsylvania Avenue NW., Washington, D.C., at which time

and place all interested and affected parties may verbally pre-

sent data, views, arguments and suggestions relevant to the

- manner of testing cigarettes to determine their tar and_nico-

tine content and the reporting of the results of such tests.

Written data, views, arguments and suggestions will also be

made a part of the public record and considered if mailed to

Mr. Joseph W. Shea, Secretary, Federal Trade Commission,

Sixth Street and Pennsylvania Avenue N.W., Washington,

D.C. 20580, on or before November 30, 1968. Persons sub-

mitting written presentations exceeding two pages should file

12 copies thereof, and any person desiring to make oral pres-

entation at the hearing on November 30, 1968, should notify

the Secretary of the Commission to this effect, with an esti-

mate of the time required for his presentation, not later than

November 21, 1968.

The purpose of this hearing is to establish a public record

to assist the Commission in.determining what action, if any

should be taken in the public interest with respect to modify-

ing or amplifying the Cambridge Filter Method, as described

in an article entitled “Determination of Particulate Matter and

Alkaloids (as Nicotine) in Cigarette Smoke,” by C.L. Ogg,

which appeared in the Journal of the Association of Official

Agricultural Chemists, Vol. 47, No. 2, 1964, to determine tar

and nicotine yields of cigarette smoke, and the form in which

such results should be expressed in the public interest. This

method was specified by the Commission on March 25,

1966, as that to be used to support any factual statements of

tar and nicotine content of the mainstream smoke of ciga-

rettes. The public record to be established will assist the

Commission in reaching informed determinations with re-

spect to the manner in which its laboratory will be operated,

and related questions.

The Commission solicits information and suggestions on

the following questions:

1. Whether the butt-length to which test cigarettes are

smoked should be 23 mm for nonfilter cigarettes, and the

length of the filter and overwrap plus 3 mm for filter ciga-

rettes if such combined length is more than 23 mm;

2. Whether the total particulate matter should be reported

on a “wet” or “dry” basis, and if the latter whether the gas

chromatography method published by C.H. Sloan and B.J.

Sublett, “Moisture Content of the Particulate Phase of Smoke

from Filter and Nonfilter Cigarettes.” in Tobacco Science 9,

page 70, 1965, as modified by F.J. Schultz and A.W. Spears

report “Determination of Moisture in Total Particulate Mat-

ter” published in Tobacco Vol. 162, No. 24, page 32, dated

17 June 1966, should be employed to determine the moisture

content;

3. Whether test results should be reported in terms of

whole numbers or whole numbers and fractions of milli-

grams, or a range, or a figure accompanied by the standard

deviation with an explanation; and

4. The number of cigarettes to be smoked necessary to

produce reliable results, and the size and geographic distribu-

tion of the sample from which such test cigarettes are se-

lected.

Interested persons are invited to submit any information

pertinent to these questions or other aspects of the subject.

The data, views, or arguments presented orally or in

writing will be available for examination by interested parties

at the Federal Trade Commission, Washington, D.C.

Issued: November 3, 1966

By the Commission

[SEAL] JOSEPH W. SHEA

Secretary.

Before the

Federal Trade Commission

CIGARETTES AND RELATED MATTERS

Methods To Be Employed in Determining

Tar and Nicotine Content

SUPPLEMENTARY OBSERVATIONS FOLLOWING

NOVEMBER 30, 1966 HEARING

The written submissions and oral discussions at the No-

vember 30, 1966 Hearing, indicate that many of those con-

cerned had wholly different approaches, technical under-

standing, working knowledge of the actual use or inherent

limitations or required laboratory equipment, or appreciation

of the scientific predicates underlying the Cambridge Filter

Method whose modification or amplification was being con- -

sidered.

This Memorandum endeavors in simple form to expose

and to clarify the complex technological procedures involved

in testing the amount of particulate matter (PM) and nicotine

in cigarette smoke. That background must be appreciated by

anyone responsible for resolving the various points relating to

testing which the Commission has under consideration.

What Is Being Measured?

Whether you call it “tar” or particulate matter (PM), the

so-called Ogg Method, cmploying the Cambridge filter, sceks

to determine the non-vapor material in cigarette s as

generated in the automatic standardized smoking of a ciga-

rette by a machine, not by a human being, according to nec-

essary prescribed standard technical directions.

The weight of the material so drawr in the machine

smoking of the cigarette is calculated by prescribed proce-

dures, and the weight of the nicotine in that material is de-

termined.

The amounts of PM and nicotine (per filter pad, with

each pad collecting the smoke of five cigarettes, as described

later), being measured either absolutely or relatively, are min-

iscule. They are weight determined from each filter pad to

the nearest 0.1 milligram.

A gram is about one twenty-eighth of an ounce. A mil-

ligram is one-thousandth of a gram. Put another way, a mil-

ligram is 1/28,000 of an ounce. The weighing of the filter

pad, which collects PM from five machine-smoked ciga-

rettes, to 0.1 mulligram, 1s a determination to one ten-

thousandth of a gram.

To visualize the quantities and the possible weight dif-

ferences sought to be determined, one might consider a milli-

gram to be equivalent to a barely visible particle of sugar

which when dissolved in a quart of water—could not be

tasted. A like comparison of a tenth of a milligram to an

ounce would be to compare the apparent size of a period sign

on a page of the Federal Register to the entire page.

What Is Not Being Measured?

The Ogg Method in fact does not, and cannot, measure

either all of the particulate matter (PM), or the total nicotine,

from any cigarette. It measures only the PM and nicotine in

the volume of smoke puffed through a machine on the stan-

dardized method. It does not measure the PM or nicotine in

all of the smoke that any cigarette might produce when to-

tally smoked under any and all conditions.

The Ogg Method does not measure the volume of

smoke-—or the PM or nicotine in the volume of smoke—that

any human being will draw from smoking any particular

cigarette. Each smoking characteristic is leveled or averaged

out by the standard method.

No two human smokers smoke in the same way. No in-

dividual smoker always smokes in the same fashion. The

speed at which one smokes varies both among smokers, and

usually also varies with the same individual under different

circumstances even within the same day. Some take long

puffs (or draws); some take short puffs. That variation af-

fects the PM quantity in the smoke generated.

Even with the same type of cigarette, individual smokers

take a different number of puffs per cigarette depending upon

the circumstances. When concentrating, or talking, the num-

ber of puffs is usually less. When listening, or required to

listen, to another person talking, the number of puffs per

cigarette, as well as the duration of cach puff, usually in-

creases. Smoking rates while reading a book may differ from

smoking rates while viewing a television program. The

number of puffs and puff duration (as well as butt length)

will vary according to emotional state. Some smokers cus-

tomarily put their cigarette down in an ashtray where they

burn between puffs; other smokers constantly hold cigarettes

in their mouths; others hold them between their fingers.

As to butt length to which individuals smoke various

types of cigarettes, as will be seen the average is over 30 mi-

limeters, except where the filter prevents smoking down to

that length, or where the rapidity of smoking generates a high

heat zone or a change in taste, and causes the smoker to dis-

card the cigarette. But, here again. there are no constants,

and there is no relationship between standardized machine

smoking of cigarettes and the volume of smoke which any

smoker will get in smoking down to any selected butt length.

About all that is known is that tobacco itself has some filter

effect.

The Ogg Method does not and cannot measure these

many variations in human smoking habits. It does not meas--

ure PM or nicotine in the smoke generated while the cigarette

is not being puffed. It does not measure all of the PM or

nicotine in any cigarette, but only that in the smoke drawn in

the standardized machine smoking according to the pre-

scribed method.

These basic standardizations are well understood by all

technologists in talking about any testing method.

Standardization Required And

Embodied In The Ogg Method

Because of the minute quantities of PM present in smoke

and the difficulties in impounding it on a filter pad and meas-

uring these minute ievels, the Ogg Method, or indeed any

other scientific testing method, must attempt to reduce all

possible variations that will substantially affect the determi-

nations of PM and nicotine.

No standardizatron of technique can eliminate human er-

ror or ineptitude. No method designed can remedy the limi-

tations in a testing method derived from the available equip-

ment, the precision possible in its use, or its inability to se-

cure reproducible results.

What the Ogg Method does standardize are a few of the

factors—puff frequency, puff duration, and the puff volume

through the filter pad—that affect the burning rate and the

amount of PM and nicotine deposited.

Puff Frequency. One puff each 60 seconds, = one sec-

ond is essential to the method. Two factors flow from that

clement of standardization. The first is that whatever smok-

ing machine is uscd must precisely meet this basic time re-

quirement. The second ts a reminder that this puff frequency

does not reflect widely varying smoking habits, and is an av-

erage.

Puff Duration. The puff is drawn for two seconds, again

within a narrow tolerance of two-tenths of a second either

way. If any results are to be accurate or remotely compara-

ble, this duration factor must be constantly watched, timed

with accurate devices, and rigidly maintained by the machine.

Puff Volume. The Ogg Method standardizes this volume

at 35 milliliters. Again, the permitted tolerance is = 0.5 milli-

liters. Obviously, puff volume is a basic controlling factor in

the determination. There are various smoking machines that

control puff volume, within the duration of each puff, in dif-

ferent ways. Once again, constant careful recalibration is es-

sential. Once again, it must be remembered that the standard-

ized puff volume may bear no direct relation to how any par-

_ ticular individual smokes, and is essentially an average.

Tne point to be remembered is that all of the difficulties

and disclosed limitations in the Ogg Method exist even when

these factors are carefully standardized. The Ogg Method of

machine smoking was evolved on uniform specially prepared

cigarettes. Its published description tells nothing about its

use in the comparative testing of cigarettes of different

brands which have varying construction, burning rate, and

other variations. The Method as published discloses its vari-

ability, e.g., its limits of reproducibility, only on weight-

selected cigarettes. (Compare Table | in the published Ogg

Method.) It tells nothing about smoke volume or PM or nico-

tine in market-derived brands of cigarettes. For example, in

smoking the same brand of conditioned cigarettes, under

carefully controlled conditions with experienced technicians,

the number of puffs in smoking a cigarette to a specified butt

length can vary from seven to ten puffs in a single run of a

machine.

How Does A Smoking Machine

Collect PM And Nicotine?

For non-scientists to comprehend how a smoking ma-

chine works and the difficulties in any method employing

smoking machines, there is no substitute for seeing smoking

machines in operation in the hands of trained technicians.

Nevertheless, the published Ogg Mehod indicates—and even

cursory viewing would confirm—~a few of the key unavoid-

able operating problems. These can be easily visualized by a

brief description of how the job must be done.

First, 1t is essential to equilibrate or condition the sam-

ples of each brand of cigarettes being tested because humid-

ity conditions at the various pickup points vary so widely.

The relative humidity encountered in New Orleans may be 90

percent, whereas in Phoenix it may be only 20 percent. In

placing cigarettes on the conditioning screens, care must be

exercised not to damage or fragment or spill tobacco from,

the individual cigarettes.

Each filter pad is assembled in a plastic filter holder, the

parts of which must be tightly screwed together, to be leak

proof. .

To one side there is next attached a piece of rubber

membrane with a hole cut in it. This rubber membrane must

be tightly locked on with a solid rubber ring.

Each assembled filter unit must then be separately tested

for leaks.

Each filter assembly must next be conditioned in the cor-

rect humidity and temperature for a sufficient period.

Each unit assembly is then separately weighed and re-

corded to the nearest one-tenth of a milligram.

The asseinbled filter units are then placed in the smoking

machine ports.

Some of the precise controls in placement and smoking

may be indicated. The failure to exercise these will markedly

affect the results.

To begin with, the smoking machine room _must be pre-

cisely air conditioned for temperature and humidity control.

Automatic controls for temperature and humidity must in turn

be regularly verified with manual temperature and humidity

checking devices.

The air flow in the machine, both at the top vents and at

the smoking ports, must be checked each day with precise

instruments because such air flow directly affects the burning

rate of the cigarette between puffs and can materially affect

the quantity of PM deposited. Absent proper venting, the

machine and the room would accumulate smoke and distort

the results.

Cardinally, the timing controls must be checked regu-

larly, and on some type of machines even daily.

The entire machine assembly must be regularly checked

to insure that it is leak proof throughout.

Even where the smoking machines are fully calibrated,

the human factors in their operation are highly variable.

When inserting the cigarette in the filter holder, the ends

should not be bruised or broken. Where cigarettes are elec-

-trically ignited, the lighters should not be permitted to push

the cigarettes against the filter pad. As Ogg notes, “Take

care that butt end does not come in contact with [the Cam-

bridge} filter disc.”

Unless automatic cut-off devices are included in the

smoking machine, the problem of watching and remembering

“unders” and “overs” of butt length introduces large factors

of human error. An operator has to watch, stop, and clear a

number of ports within brief periods. Where automatic cut-

offs are provided, carelessness in adjusting the burning

threads or the springs can likewise affect the results.

For PM weighing and water and nicotine determination,

other human manipulations are necessary which must be per-

formed with both a high degree of skill and constant alert

care.

The tare and second weighing of the filter unit must be

performed with a chemical balance. preferably a refined,

closed-chamber precision balance, within the same air-

conditioned room.

In the removal of the filter pad from the smoking holder,

the pad must be-manually folded over with a large tweezer

which is then used to rub all of the remaining PM from the

holder onto the filter pad. Unless this pad folding and rub-

bing operation is performed carefully and completely, there

may be marked variations in the latter determinations.

Unless the manual wiping of the smoking holder is properly

performed, as much as an entire milligram difference in the

PM carried forward for the determinations can be here intro-

duced by inexperience or ineptitude.

For water and nicotine determinations, each filter pad is

next placed into a separate small flask which is then stop-

pered. These flasks must be carefully washed and oven dried

after each use.

Thereafter cach flask containing the separate filter pad

must be thoroughly shaken with the precisely measured

amount of solvent for up to an hour to get the water and nico-

tine into the solution. This must be accomplished by shaking

machines or more rapidly by a spinning agitator.

Experience demonstrates that in the chromatographic de-

termination of water variations can occur among different

operators in the amount of solvent drawn and in the manner

of its mjection into these machines, which again requires

constant calibration.

In nicotine determination, precise dilutions are neces-

sary. In virtual mass production cigarette testing, that factor

may readily become a source of human error.

The calculation of results-requires the use of calculating

machines and necessarily skilled operatives. Approximately

two calculating machines are required in a laboratory utiliz-

ing about 40 ports.

These requirements of refined equipment and experi-

enced personnel, and the basic limitations in the Ogg

Method, underlie the necessity for the suggested period of

training for any personnel given the responsibility for operat-

ing a testing laboratory. Even Dr. Hammond found it neces-

sary to offer that caution. (See Hammond Tr. 18-19.) They

dictate further that adequate personne! must be provided.

Laboratory determinations of this nature cannot be

speeded up to accommodate extraneously determined dates.

At the outset, there must be at least one operator for each

smoking machine, one for water determination, and two for

nicotine determinations if these are to be kept in balance with

the smoking machines. Additional personnel are required for

calculation and recording, and for filter unst assembly and

cleaning of laboratory flasks, and maintenance.

Limits Of Measurements Obtainable

In Ogg Method

Even assuming adequate equipment and thoroughly ex-

perienced trained personnel, the available data makes clear

the inherent limits in the Ogg Method. These can be talked

about either as the limits of reproducibility of results within a

single laboratory or as the variances in results found in the

testing of identical cigarettes by the Ogg method among dif-

ferent laboratories.

These inescapable variances are in the Ogg Method it-

self, and have nothing to do with any variations in the popu-

lation of cigarettes being tested. (That factor will be exam-

ined later.)

It can never be forgotten that the Ogg Method was

evolved on a specially prepared uniform lot of cigarettes.

Even so, the percentage coefficients of variance within single

laboratories ranged between |.2 percent and 5.9 percent. Be-

tween laboratories they were never lower than 9.8 percent.

The mean standard deviation ranged as high as 3.19 milli-

grams PM for non-filter cigarettes and 2.48 milligrams PM

for filtered cigarettes.

Industry testing of various brands of cigarettes, e.g., not

a uniform specially prepared lot, has shown standard devia-

tions as high as 2.8 milligrams per cigarette determined per

port.

In short, even with the most accurate refined equipment

and experienced personnel, the same laboratory cannot

achieve reproducible results on all brands beyond these lim-

its, and if the results of two laboratories are to be compared

the spreads are greater. The significance of the variations in

the method alone will be considered in discussing sample

size and reporting.

Against this summary description of the machine smok-

ing of cigarettes and what is involved in determining and re-

porting PM and nicotine, some additional comments may be

offered on the four questions on which the Commission has

invited comment.

Butt Length

Insofar as possible, the butt length to which cigarettes

should ve smoked in the smoking machine should be based

on some rational criteria.

In any method employing machine smoking of cigarettes

to determine PM and nicotine there must be standardization

of puff frequency, puff duration, and buff volume. These ba-

sic_factors nonetheless bear no rclation to individual smoking

by any human being. In that respect, as noted, these factors

are when standardized initially averaged.

Because different people smoke to different butt lengths,

and even the same individual will smoke to varying butt

lengths depending upon the circumstances in which he ts en-

gaged, the use of an average butt length is the only rational

basis to employ. To utilize predetermined average puff dura-

tion, puff volume, and puff frequency, and not to use an aver-

age butt length, creates both an illogical and unwarranted dis-

tortion in both the testing and reporting.

The recorded data makes it clear that the average butt

length to which individuals smoke is somewhat in excess of

30 millimeters. No witness testified to an average of less

than 30 millimeters.” Those who suggest a shorter butt

length, and a different butt length for filtered cigarettes, are

not unaware that doing so basically biases the comparative

results under the Ogg Method largely in favor of filtered

cigarettes.

It may be granted that there are presently no comprehen-

sive studies of butt lengths, and indeed all such studies have

inherent weaknesses. Butts obtained from ashtrays invariably

indicate a lower average than the true length to which a ciga-

rette is smoked because a great many smokers do not wholly

extinguish cigarettes, and others exert varying degrees of

pressure in attempting to extinguish them. Moreover, there 1s

evidence that most smokers cannot smoke to less than 30 mil-

limeters without burning their fingers. (See Hobbs Tr. 57)

If 23 millimeters were selected, 90 percent of the filter

cigarettes cannot in fact be smoked to that length. Scientifi-

cally, it is not rational to adopt a standard butt length which is

* Dr. Hammond testified that his study showed an average of “ap-

proximately 30” millimeters in the United States. (Tr. 33) Dr. Ogg testi-

fied that data available to members of the committee at the time of his

study “indicated the average butt-length in this country at that time was

approximately 30 millimeters,” and that in a study Dr. Ogg had recently

conducted “the averages came out for non-filter cigarettes was 30.2 mil-

limeters and for filter cigarettes was 33.2.” (Tr. 38-39.) Dr. Hobbs testi-

fied that a butt length of no shorter than 30 to 33 millimeters “does ap-

proximate average smoking habits.” (Tr. 57.) See also the Recommenda-

tions Submitted by Tennessee Eastman Company stating that the results of

its study “indicated that the average butt length was at least 30 mm.” (p.

1) See also the various studies referred to on pages 5-6 of the Statement

to the Federal Trade Commission on Cigarette Smoking Techniques by

the Celanese Corporation all of which showed an average butt length of

at least 30 millimeters.

not applicable to 90 percent of that group of cigarettes.

About 99 percent of all cigarettes, both filtered and non-

filtered, can be smoked to 30 millimeters.

Finally, there is no way of knowing what additional vari-

ances in the Ogg Method, which utilized a butt length of 30

millimeters, would be introduced by adopting a shorter butt

length. In addition, any shorter butt length necessarily in-

creases the difficulties for the operator in positioning the

cigarettes in the smoking machine. This is a difficult and te-

dious task even for the most highly skilled operator having

great dexterity. Moreover, the problems of terminating the

machine smoking, either by observation and withdrawal, or

by automatic means, make it clear that additional variances

would be introduced. Reducing the butt length would require

measurable increases in sample size.

Wet Or Dry Basis

Little need be added to this point. For most cigarettes,

water content ranges from 62 to 13 percent of PM collected

on the Cambridge Filter. Water content among brands like-

wise varies even after conditioning. If the Commission is to

test and record PM among brands, the failure to determine

and report on a dry basis will be highly misleading.

Experience has demonstrated that test results on a dry

basis contribute greater precision. As Dr. Ogg testified (Tr.

40) if the modern gas chromatographic method had been

available at the time of his study, those methods would

probably have been originally included to permit reporting on

a dry basis.

Reporting Of Test Results

There is no challenge that results cannot be reported be-

yond the precision of the testing method. A spring bathroom

scale, accurate only to a pound, cannot give a person’s weight

in ounces or fractions of an ounce.

As to particulate matter, the errors in the Ogg procedures

permit accuracy only to the nearest milligram and not to any

more finite values. What has already been noted with respect

to the variances in the Ogg Method and the possibilities of

human error in the mass testing of cigarettes makes it abun-

dantly clear that any effort to report comparable PM results

among different brands of cigarettes to less than the nearest

whole milligram would be both unfounded and substantially

misleading.

By the same token, the record makes clear that the fail-

ure to report results both on an average per puff and average

per cigarette basis would create bias and have unwarranted

adverse competitive effects.

Sampling Procedures and Number

of Cigarettes To Be Smoked

There is no need for elaborate additional statistical

analysis for the consideration of sample size.

To begin with it may be assumed that picking up sam-

ples of each brand at 50 market points will permit the market

sample to approach a true probability sample—to which con-

ventional statistical formulas may be applied. Such a market

sample will not be a true probability sample, but for practical

purposes, considering the other variances which must be

dealt with, it may be considered sufficiently randomized to be

utilized as though it were a true probability sample.

Next, there appears to be no disagreement that a confi-

dence level of 95 percent will afford a reasonable criterion.

The determination of the number of cigarettes of each

brand to be smoked to afford a pragmatically acceptable es-

timate for the entire population of a particular brand therefore

turns on conventional statistical formulas that will adequately

reflect the variations both in the method and in the cigarettes.

The most conservative figure advarced, developed from re-

ported industry experience, employs a standard deviation of

1.6 milligrams and yields a required sample size to be

smoked of 205 cigarettes.

Statistical experts, invited carefully’ to study the data and

make recommendations to the Commission, were in accord in

advising that this suggested sample size would have to be re-

garded as the absolute minimum. As Dr. Herbert Arkin (an

outstanding authority as indicated by his qualifications)

pointed out, the variations in cigarettes within the same brand

as well as the variations inherent in the Ogg Method makes it

clear that the use of a standard deviation of 1.6 milligrams

tends to understate the required sample size. His recommen-

dation is that the highest reported standard deviation, rather

than a value nearer the lowest, found in previous testing

work, should be used, to avoid sampling and other errors.

(Arkin Letter, pages 4-6.) He also notes that in most of the

previous testing, cigarettes were weight selected rather than

tested as they are found on the market and smoked by con-

sumers, a factor that reduces the standard deviation, and

therefore should be considered. In his judgment, therefore, a

much larger sample would be appropriate, certainly at the

outset and until a standard deviation for each brand has been

determined.

On the basis of his conclusion that a sample size, deter-

mined by employing a standard deviation of 2.2 to 2.6 milli-

grams would be appropriate, a sample size of 307 to 519

cigarettes to be smoked would be required. (See Arkin Let-

ter, pages 4-5, Appendix A.)

Mr. Hendricks, speaking for both himself and Dr. Alva

L. Finkner, of the Research Triangle Institute, emphasized

that in the application of conventional statistical formulas to

the current problem, the fact that the percentage differences

in PM and nicotine may lie within very narrow limits, to

achieve the desired precision in reporting test results would

call for about 350 cigarettes of each brand to be tested. This

would be essential where these percentage differences be-

tween brands were 25 percent of the comparative PM values

being reported. (Hendricks Statement, pages |2-14.)

Moreover, utilizing the published Reader's Digest com-

parative PM and nicotine values for a number of different

market brands, he found that the percentage of difference was

very small indeed and that if in the brands tested by the

Commission comparable small percentages of differences

turned up, far larger samples would be required to be tested.

(Hendricks Statement, page 14.)

No valid basis was offered at the hearing for reducing

the sample size to be tested below the absolute minimum

level of 205 advanced by the research scientists of the five

cigarette companies.

The suggestion that sample size or butt length can some-

how be related to a small fraction of the population of smok-

ers is about as valid as suggesting that average weight esti-

mates can be developed by limiting the observations to the

skinniest people in the population and drawing a small

enough sample to eliminate the contributions to the average

made by the heavier or even obese people.

The only remaining point of apparent confusion resides

in the failure to understand that (in addition to the disclosed

variations inherent in the use of the Ogg Method by thor-

oughly experienced tobacco technologists) there are inescap-

able natural variations in cigarettes. Despite recognized close

quality control in their manufacture, the tobacco in cigarettes

is a natural product, cigarettes are mass produced on fast ma-

chinery, and they are distributed under highly varying cli-

matic conditions and periods of storage. In addition, the re-

quired handling in conditioning prior to testing, and in the

testing procedure itself, occasions further variations. The

plain fact is that in the standardized machine smoking of the

same brand of cigarettes, randomly selected from a market

purchase, the rate of burning causes a difference in the num-

ber of puffs ranging from seven to ten puffs per cigarette.

This in turn causes variations in the PM and nicotine depos-

ited on the filter, and results more from the variations among

cigarettes than from the limits of the method.

In short, any suggestion that every cigarette 1s precisely

and minutely identical to every other cigarette within the

same brand is fallacious. No processed natural product can

be manufactured to such precise limits. Recognition of the

variation in any processed agricultural product is reflected in

every governmental or commercially developed grading

standard.

It is perhaps unnecessary to repeat that no factual scien-

tific data exists as to the relevance of PM or so-called “tar” or

nicotine content in terms of health.

Respectfully submitted,

THE AMERICAN TOBACCO COMPANY

/s/ CYRIL F. HETSKO

BROWN & WILLIAMSON TOBACCO

CORPORATION

/S/ ADDISON YEAMAN

LIGGETT & MEYERS TOBACCO COMPANY

/S/ FREDERICK P. HAAS

PHILIP MORRIS INCORPORATED

/S/ PAUL D. SMITH

R. J. REYNOLDS TOBACCO COMPANY

/S/ H. HENRY RAMM

December 20, 1966

FEDERAL REGISTER

VOLUME 32 NUMBER 147

Tuesday, August |, 1967 Washington, D.C.

Pages 11107-11197

* * *

FEDERAL TRADE COMMISSION

CIGARETTES

Testing for Tar and Nicotine Content

The Federal Trade Commission, having been advised by

the staff that the cigarette testing laboratory has satisfactorily

completed its trial tests, hereby issues directions to its staff to

commence the first formal test, under the following condi-

tions:

1. Smoke cigarettes to a 23 mm. butt length, or to the

length of the filter and overwrap plus 3 mim. if in excess of 33

mm.

2. Base result on a test of 100 cigarettes per brand, or

type.

3. Cigarettes to be treated will be selected on a random

basis, as opposed to “weight selection”.

4. Determine particulate matter on a “dry” basis em-

ployment the gas chromatography method published by C.M.

Sloan and B.J. Sublett in Tobacco Science 9, page 70, 1965,

as modified by F.J. Schultz’ and A.W. Spears’ report pub-

lished in Tobacco Vol. 102, No. 24. page 32, dated June 17,

1965, to determine the moisture content.

5. Determine and report the “tar” content after subtract-

ing moisture and alkaloids (as nicotine) from particulate mat-

ter.

6. Report tar content to the nearest whole milligram and

nicotine content to the nearest 1/10 milligrams.

The Commission directs that the test cover approxi-

mately 50 of the major brands and types (many brands are

sold as regular, and king size, or filter, etc.) and all brands -for

which any tar or nicotine statement appears on the label or in

the advertising. With respect to the latter, one purpose of the

test will be to determine the accuracy of such statement.

Cigarettes for testing will be purchased on the open market in

50 localities throughout the United States.

Issued: July 31, 1967

By the Commission.

JOSEPH W. SHEA,

Secretary.

Federal Trade Commission

TAR, NICOTINE, AND CARBON MONOXIDE

OF THE SMOKE OF 1206 VARIETIES

OF DOMESTIC CIGARETTES

FOR THE YEAR 1994

1997

Report of “Tar,” Nicotine, and Carbon Monoxide of the

Smoke of 1206 Varieties of Domestic Cigarettes

For the Year 1994

This report contains data on the “tar,” nicotine, and car-

bon monoxide yields of 1206 varieties of cigarettes manufac-

tured and sold in the United States in 1994. The Federal

Trade Commission (FTC) obtained the test results from the

five largest cigarette manufacturers in the United States.

These companies are: Brown & Williamson Tobacco Corpo-

ration; Liggett Group, Inc.; Lorillard, Inc.; Philip Morris,

Inc.; and R.J. Reynolds Tobacco Company, Inc.!

The Tobacco Institute Testing Laboratory (TITL), a pri-

vate laboratory operated by the cigarette industry, conducted

most the “tar,” nicotine, and carbon monoxide tests for these

varietics. The Commission collected the results of the TITL

testing directly from the individual companies under compul-

sory process. Generic, private label, and other brands not

widely available were not tested by TITL. The Commission

obtained the information on these other brands directly from

| The number of major domestic cigarette manufacturers went from six

to five in April 1995, when the Commission approved B.A.T. Industries’

acquisition of The American Tobacco Company after B.A.T., the parent

company of Brown & Williamson, agreed to divest itself of certain assets

it proposed to acquire from American Tobacco. In October 1996, the

Commission approved B.A.T.’s application to divest six brands, a manu-

facturing plant, and certain related assets to Commonwealth Tobacco

LLC.

the manufacturers, pursuant to compulsory process: Results

of such non-TITL testing are indicated by asterisks. The

methodology, processes, and procedures that the five ciga-

rette companies and TITL employ are identical to those the

Commission, in its own testing lab, had followed in the past.

Harold Pillsbury, the former director of the FTC laboratory

and currently a contractor to the Commission had unrestricted

access to the TITL laboratory to review TITL’s testing meth-

odology and protocols and to monitor the actual testing proc-

ess. TITL provided the results to the respective cigarette

companies, which then provided TITL’s data regarding their

own brands to the FTC in response to compulsory process.

The cigarettes were tested using the Cambridge Method.

The FTC approved this methodology, and it has been the

standard for cigarette testing since 1966. The testing was

subjected to the conditions prescribed by the FTC in-Federal

gust 1, 1967. With regard to the testing of carbon monoxide

yield, the conditions are specified in Federal Register, Vol-

ume 45, Number 134, Page 46,483, dated July 10, 1980. The

conditions prescribed in the FTC’s 1967 announcement are

the following:

2 The Commission determined in early 1987 to close its laboratory.

The Commission found that closing the laboratory was necessary for sev-

eral reasons, chiefly, the cost of the laboratory was significant, and the

Commission would have had to commit significant additional funds to

continue the program. The Commission was also persuaded that the in-

formation could be obtained from other sources, and other means were

available to verify the accuracy of industry testing results.

Smoke cigarettes to a 23mm. butt length, or to the

length of the filter and overwrap plus 3mm. if in ex-

cess of 23mm.;

Base results on a test of 100 cigarettes per brand, or

type;

Cigarettes to be tested will be selected on a random

basis, as opposed to “weight selection”;

Determine particulate matter on a “dry” basis em-

ploying the gas chromatography method published

by C.H. Sloan and B.J. Sublett in Tobacco Science

9, page 70, 1965, as modified by F.J. Schultz’ and

A.W Spears’ report published in Tobacco Vol. 162,

No. 24, page 32, dated-June 17, 1966, to determine

the moisture content;

Determine and report the “tar” yield after subtract-

ing moisture and alkaloids (as nicotine) from par-

ticulate matter;

Report “tar” yield to the nearest whole milligram

and nicotine yield to the nearest 1/10 milligram (32

Fed. Reg. 11,178 (1967)).

The 1980 FTC announcement contained specifications

regarding a new testing methodology to determine the carbon

monoxide (CO) and nicotine yield of cigarettes. These speci-

fications are the following:

Determine CO concentration using a 20-port se-

quential smoking machine described by H.C. Pills-

bury and G. Merfeld at the 32nd Tobacco Chemists

Research Conference, October 1978;

The concentration of CO will be reported as millt-

grams per cigarettc;

The present method for “tar” and nicotine determi-

nation will be modified to use the method described

in an article entitled, “Gas Chromatographic Deter-

mination of Nicotine Contained on Cambridge Filter

Pads,” by John R. Wagner et al., as presented at the

annual meeting of the Association of Official Ana-

lytical Chemists, October 1978 (45 Fed. Reg. 46,483

(1980)).

- ————

NEWS RELEASE

FEDERAL TRADE COMMISSION

Washington, D.C. 20580

OFFICE OF INFORMATION 393-6800 Ext. 197

For RELEASE: A.M., Tuesday, August |, 1967

FTC TO BEGIN CIGARETTE TESTING

The Federal Trade Commission, having been advised by

the staff that the cigarette testing laboratory has satisfactorily

completed its trial tests, has now issued directions to com-

mence the first formal test, under the following conditions:

Smoke cigarettes to a 23 mm. butt length, or to the

length of the filter and overwrap plus 3 mm. if in

excess Of 23 mm.,

Base results on a test of 100 cigarettes per brand, or

type, |

Cigarettes to be tested will be selected on a random

basis, as opposed to “weight selection,”

Determine particulate matter on a “dry” basis em-

ploying the gas chromatography method published

by C.H. Sloan and B.J. Sublett in Tobacco Science

9, page 70, 1965, as modified by F.J. Schultz’ and

A.W. Spears’ report published in Tobacco Vol. 162, _

No. 24, page 32, dated June 17, 1966, to determine

the moisture content,

Determine and report the “tar” content after sub-

tracting moisture and alkaloids (as nicotine) from

particulate matter,

6. Report tar content to the nearest whole milligram

and nicotine content to the nearest 1/10 milligrams.

The Commission directed that the test cover approxi-

mately 50 of the major brands and types (many brands are

sold as regular, and king size, or filter, etc.) and all brands for

which any tar or nicotine statement appears on the label or in

the advertising. With respect to the latter, one purpose of the

test will be to determine the accuracy of such statement.

Cigarettes for testing will be purchased on the open market in

50 localities throughout the United States.

In determining the foregoing procedures, the Commis-

sion relied substantially upon a record including written pres-

entation by interested persons and oral testimony offered at a

public hearing on November 30, 1966, which was held “to

assist the Commission in determining what action, if any,

should be taken in the public interest with respect to modify-

ing or amplifying the Cambridge Filter Method ... and the

form in which test results should be expressed.” At the hear-

ing the Commission received numerous submissions reflect-

ing a variety of modifications of the Cambridge Filter Meth-

ods that have been adopted by different groups engaged in

testing cigarettes. No test can precisely duplicate conditions

of actual human smoking and, within fairly wide limits, no

one method can be said to be either “right” or “wrong.” The

Commission considers it most important that the test results

be based on a reasonable standardized method and that they

be capable of being presented to the public in a manner that is

readily understandable. Although minor variations may not

make one testing method “better” than another, the public

interest requires that all test results presented to the public be

based on a uniform method used by all laboratories. Use of

more than one testing method would produce different results

which would only serve to confuse or mislead the public.

In determining the testing method, the Commission has

not attempted to gauge the test to the amount of smoke, or tar

and nicotine, which the “average” smoker will draw from any

particular cigarette.

No two human smokers smoke in the same way. No in-

dividual smoker always smokes in the same fashion. The

speed at which one smokes varies both among smokers, and

usually also varies with the same individual under different

circumstances even within the same day. Some take long

puffs (or draws); some take short puffs. That variation ef-

fects the tar and nicotine quantity in the smoke generated.

Even with the same type of cigarette, individual smokers

take a different number of puffs per cigarette depending upon

the circumstances. When concentrating, or talking, the num-

ber of puffs is usually less. When listening, or required to

listen to another person talking, the number of puffs per ciga-

rette, as well as the duration of each puff, usually increases.

Smoking rates while reading a book may differ from smoking

rates while viewing a television program. The number of

puffs and puff duration (as well as butt length) will vary ac-

cording to emotional state. Some smokers customarily put

their cigarettes down in an ashtray where they burn between

puffs; other smokers constantly hold cigarettes in their

mouths; others hold them between their fingers.

The Cambridge Filter Method does not and cannot

measure these many variations in human smoking habits. It

does not measure tar or nicotine in the smoke generated while

the cigarette is not being puffed. It does not measure all of

the tar and nicotine in any cigarette, but only that in the

smoke drawn in the standardized machine smoking according

to the prescribed method. Thus, the purpose of testing is not

to determine the amount of tar and nicotine inhaled by any

human smokcr, but rather to determine the amount of tar and

nicotine generated when a cigarette is smoked by machine in

accordance with the prescribed method.

Accordingly, the testing methed should not be consid-

ered defective because it does not rely on “averages.” There

are too many variables as to both smokers and smoking con-

ditions for any average to be meaningful. Test results

phrased in terms of an “average” smoker could be misleading

to the public, because a smoker has no way of knowing how

closely his smoking habits conform to those of the purport-

edly “average” smoker. It should be emphasized that the

Cambridge Filter Method itself did not purport to duplicate

an “average” smokcr. Rather, it was an amalgam of many

choices-—-some of them arbitrary. For example, the tempera-

ture and humidity specified in that method was not deter-

mined by reference to the “average” temperature or the “av-

erage” humidity at which people smoke cigarettes. There is

no human smoker who smokes, and no cigarette that is

smoked, under conditions that precisely duplicate either the

Cambridge Filter Method in its original form or as modified

by the Commission. Thus, to reiterate, the uniform method

determined by the Commission has as its purpose measure-

ment of the tar and nicotine generated by cigarettes when

smoked according to that procedure.

There has been a wide variation among testing groups on

the question of how many cigarettes of each brand to test.

Recommendations were made to the Commission to test as

few as 60 cigarettes per brand and as many as 200. After

studying the record and its laboratory’s preliminary test re-

sults, the Commission has determined that testing 100 ciga-

rettes per brand will provide valid and reliable results. How-

ever, the Commission intends to continue evaluating its test

results, and on that basis may determine in the future to

change the number of cigarettes tested or any other testing

procedures as may be found necessary.

Chairman Dixon dissents from that part of the majority's

direction on-testing procedures with respect to butt length and

has filed a separate statement which ts attached.

. Commissioner MacIntyre did not participate in the

Commission’s vote on this matter for the reason that he did

not consider that the Commission’s cigarette testing labora-

tory had satisfactorily completed its trial test so as to suffi-

ciently and adequately advise the Commission regarding

what ts required in this respect.

Attached is: Separate Statement of Chairman Dixon.

FEDERAL TRADE COMMISSION

WASIIINGTON, D.C. 20580

JOSEPH W. SHEA

Secretary October 25, 1967

Mr. Howard H. Bell, Director,

The Code Authority,

National Association of Broadcasters,

1771 N Street, N.W.,

Washington, D.C. 20036

Dear Mr. Bell:

This will reply to your letter of September 20, 1967, in

which you inquire as to the Commission’s current policy re-

garding (1) statements im cigarette advertising relating to

health implications of tar and nicotine content of cigarettes,

and (2) utilization in advertising of the official FTC tar and

nicotine yield data. Your letter requests any guidance that

the Commission could provide your organization in adminis-

tering Radio and Television Code policies pertaining to ciga-

rette advertising.

Any discussion of this subject at the present time must

begin with the premise, which is correctly stated in your let-

ter, that “the government would like to stress the relative ad-

vantages of low tar and nicotine yield cigarettes”. In the Re-

port to Congress on Smoking and Health, submitted on July

12, 1967, the Secretary of Health, Education, and Welfare

stated that “the accumulated evidence strongly suggests that

the lower the ‘tar’ and nicotine content of cigarette smoke,

the lower the harmful effect. * * * The cigarette package

label and advertising should be required to contain informa-

tron on the ‘tar’ and nicotine levels in the smoke of the ciga-

rette, and the identity and quantity of such other substances

or agents in the smoke as may subsequently be found by the

appropriate Federal agency to contnbute to the health hazards

of smoking.”

To the same effect, the Surgeon General of the U.S. Pub-

lic Health Service testified before the Senate Commerce

Committee on August 25, 1967, as follows:

“| believe that disclosure of tar and nico-

tine on cigarette packages and in advertise-

ments, and the responsible promotion of those

cigarettes low in tar and nicotine would be

constructive and helpful steps to the extent

they provide the smoker with as much infor-

mation as possible on the risks of smoking and

enables him to make his own decision as to

the amount of dosage he will accept. Public

opinion backs such action. A Public Health

Service survey shows that 77 percent of peo-

ple who were interviewed felt that cigarette

companies should be required to list tar and

nicotine content on packages; among cigarctte

smokers, 71 percent favored such action. As

other substances are found in the cigarette

smoke which contribute to the health hazard

of smoking, the identity and quantity of such

substances, should be included along with tar

and nicotine in the package labeling and in

advertising.

“The question is: will tar and nicotine dis-

closure on cigarette packages and in adver-

~ tisements encourage wider use of the brands

with lower levels? I believe that a progressive

reduction of tar and nicotine levels will result

from such action because of public demand.”

In its Report to Congress under the Federal Cigarette La-

beling and Advertising Act, transmitted June 30, 1967, the

Federal Trade Commission stated: “For the information of

cigarette smokers, the Commission favors mandatory label-

ing of tar and nicotine content on cigarette packages and in

cigarette advertisements and other measures that will prompt

cigarette manufacturers to develop less hazardous cigarettes.

* * * It appears to the Commission, from the switch toward

filter cigarettes and the popularity of low tar and nicotine

cigarettes, that a substantial segment of the public is most

concerned about the health hazards of cigarette smoking.

Many smokers would like to give up the habit, but don’t and

won't. Some of these have switched to brands that they be-

lieve, often erroneously, to be less hazardous. The Commis-

sion favors giving smokers as much information about the

risks involved in smoking as is possible and to that end fa-

vors mandatory disclosure of tar and nicotire content, as

measured by a standard test.” (Pp. 8, 28.)

After review and reexamination in the light of the fore-

going, the Commission’s current enforcement policy in re-

gard to statements of, and representations relating to, tar and

nicotine content of cigarettes may be formulated as follows:

As a general rule, the Commission will not challenge such

statements or representations where they are shown to be ac-

curate and fully substantiated by tests conducted m accor-

dance with the standardized testing methods and procedures

used by the Federal Trade Commission, as described in its

release issued August |, 1967. Advertisements which cor-

rectly report official FTC tar and nicotine yield data are

within this category. On the other hand, statements or repre-

sentations based on non-standardized tests having no official

or governmental sanction would tend to confuse and mislead

the public.

_ Where comparisons of tar and nicotine content with

other brands of cigarettes are made, the advertising should be

factual, fair, and not misleading. For example, a cigarette

testing relatively high or not among the lowest in tar and

nicotine yield should not be represented to be otherwise, e1-

ther expressly or by innuendo. By the same token, a cigarette

testing relatively low, or among the lowest, in comparison

with other brands may be so represented in advertising it to

the public, provided that the basis for comparison ts fully and

60.

fairly stated. It must also be borne in mind that, while pres-

ently available scientific data indicate that a substantial re-

duction of tar and nicotine intake may lower the harmful ef-

fects, there is no reliable evidence that the health hazards of

cigarette smoking are thereby eliminated or avoided. Hence,

no matter how relatively low its tar and nicotine content, no

cigarette may truthfully be advertised or represented to the

public, expressly or by implication, as “safe” or “safer”.

The Commission recognizes that this statement of en-

forcement policy is necessarily cast in general terms, and that

questions will inevitably arise concerning its application to

particular cases. In facilitating the. resolution of such prob-

lems, the Commission’s advisory opinion procedure will be

available to you and to members of the broadcasting and

cigarette industries.

In view of the substantial public interest of the subject

matter, the Commission is making public this exchange of

correspondence.

By direction of the Commission.

Chairman Dixon and Commissioner Maclntyre dis-

sented. Their separate statement is attached. Also attached is

the separate statement of Commissioner Elman.

/s/ JOSEPH W. SHEA,

Joseph W. Shea

Secretary.

SEPARATE STATEMENT OF CHAIRMAN DIXON

AND COMMISSIONER MacINTY RE

In response to the inquiry from the National Association

Broadcasters, the Commission has set forth its current en-

forcement policy in regard to statements of, and representa-

tions relating to, tar and nicotine content of cigarettes. In

substance, the policy statement is to the effect that the Com-

mission will not challenge representations as to tar and nico-

tine content of cigarettes when the representations are sub-

stantiated by .tests conduc.ed in accordance with testing

methods used by the Commission. Moreover, the policy

statement asserts that representations based on tests not per-

formed in accordance with the methods set down by the

Commission would tend to confuse and mislead the public.

Thus, by implication, it is the stated policy of the Commis-

sion to challenge such representations.

Prior to the establishment of testing procedures by the

Commission, various manufacturers had made representa-

tions as to tar and nicotine content of their individual ciga-

rettes, based on the Cambridge Filter Method of testing,

which tested cigarettes to a 30 mm. butt length. The Com-

mission, however, in establishing its testing procedures, did

not adopt the 30 mm. butt length of the Cambridge method

but set 23 mm. as the standard for testing. This is the shortest

butt length to which a cigarette can be tested in the Commis-

sion’s testing machine. All that will be shown as the result of

this standard is the maximum amount of tar and nicotine that

a smoker may inhale.

Certainly, we would agree to the use of the 23 mm. butt

length for testing purposes if it were established that this is

the average length to which all smokers smoke their ciga-

rettes. Unfortunately, however, this is far from being the

fact. In the first place, it is physically impossible to smoke

most filter brands of cigarettes to a 23 mm. butt length. As

has been pointed out in a previous statement on this issue, of

approximately 120 brands of cigarettes on the market, only

49 can be smoked to 23 mm. Secondly, it is agreed that be-

cause smoking habits vary greatly, smokers of nonfilter as

well as filter brands smoke their cigarettes to varying butt

lengths, either shorter or longer than a 23 mm. butt length.

It is generally agreed that the shorter the butt length of a

cigarette, the more tar and nicotine are generated in the main-

stream smoke of the cigarette. In other words, the yield of tar

and nicotine is not uniform for the entire length of the ciga-

rette. Thus, the mainstream smoke of a cigarette at, for ex-

ample, a 23 mm. butt length will yield more tar and nicotine

than the mainstream smoke at 30 mm. Tests performed to a

23 mm. butt length, while giving the maximum tar and nico-

tine content, will not be a true indication as to the tar and

nicotine content of the same cigarette at 30 mm.

It is our belief that one of the purposes in establishing

cigarette testing procedures was to afford smokers a mean-

ingful way of comparing the amount of tar and nicotine

yields as between brands. Under the foregoing circum-

stances, we do not see how the Commission’s standards will

accomplish this purpose. In our view, it is misleading to re-

quire that tests be performed to a butt length which gives a

maximum yield of tar and nicotine in nonfilter cigarettes

when, in fact, it has not been established that this is an aver-

age butt length for smokers, and it is not possible to smoke

certain filter brands to that butt length.

We would not challenge representations based on tests

performed to a 30 mm. butt length. Since most brands of

cigarettes can be tested to that length, the smoker would have

a meaningful way of comparing tar and nicotine content re-

gardless of the overall length of the cigarettes. We realize, of

course, that there are possibly five brands of cigarettes which

cannot be smoked even to 30 mm_ However, the 30 mm.

standard would serve to minimize the disadvantages inherent

in the 23 mm. standard which, in effect, precludes a meaning-

ful comparison between a majority of the brands now on the

market.

SEPARATE STATEMENT OF

COMMISSIONER ELMAN

it is true, as Chairman Dixon points out, that the Com-

mission’s tests will show the maximum amount of tar and

nicotine that a smoker of a particular brand will inhale. It is

also true, as he notes, that brands of cigarettes on the market

vary in length. Thus, if Brand A is 100 min. long and Brand

B, made of the same tobacco, is 85 mm. long, the tests will

show Brand A as containing more tar and nicotine than Brand

B. According to Chairman Dixon, this is “misleading”. I do

not agree.

Suppose, for example, that one were to test the caloric

content of chocolate bars. Brand A is sold in a 4 oz. size, and

Brand B, made of the same ingredients, is sold in a 3 oz. size.

One who eats a Brand A bar will consume substantially more

calories than Brand B. Is it “misleading” to report that Brand

A contains more calories than Brand B? Chairman Dixon

would answer “yes”, because it is “not established” that the

“average person” will eat the whole bar. Conceivably, he

might eat only half of a Brand A bar—in which case he

would be consuming fewer calories than if he ate all of Brand

B. The Chairman applies the same reasoning to the testing of

cigarette brands for tar and nicotine content.

Moreover, even he does not propose that the testing pro-

cedure should be to smoke a uniform length (say, 50 mm.) of

every cigarette regardless of its actual size. His proposal

was, and is, that all cigarettes, regardless of size, be smoked

down to a butt length of 30 mm. Thus, if the Chairman’s

testing procedure were to be used, the machine would smoke

70 mm. of Brand A, 100 mm. long, and 55 mm. of Brand B,

made with the same tobacco but 85 mm. long. The Chair-

man’s test results would be just as “misleading” in showing

Brand A as containing more tar and nicotine than Brand B.

The Chairman also points out that many filter brands

cannot be smoked down to a butt length of 23 mm. Taking

that fact into account, the Commission’s testing procedure

provides that all such cigarettes shall be tested to a butt

length of “the filter and overwrap plus 3 mm.” In this respect

the Commission adopted the proposal made not only by the

health and medical organizations but also by industry repre-

sentatives. This testing procedure clearly affords a sensible

and meaningful basis for comparing the maximum tar and

nicotine yields as between brands of cigarettes; and it is nei-

ther accurate nor fair to suggest otherwise.

The fact of the matter ts that there is nothing “mislead-

ing” in the testing procedure adopted by the Commission.

The difference between the Chairman and the majority of the

Commission is quite simple. He would test a cigarette for

only part of its tar and nicotine content. We would test for all

of it. By analogy, the Chairman would determine the-alcoho!

content of a martini by testing the vermouth but not the gin.

Query: who is “misleading” whom?*/

*/ Since the Chairman has seen fit to rehash the arguments considered

and rejected by the Commission before adopting its testing procedure, it

is appropriate to repeat the following excerpts from the Commission’s

release of August 1, 1967:

“No test can precisely duplicate conditions of actual human smoking

and, within fairly wide limits, no one method can be said to be either

‘right’ or ‘wrong.’ The Commission considers it most important that

the test results be based on a reasonable standardized method and that

they be capable of being presented to the public in a manner that is

readily understandable. Although minor variations may not make

one testing method ‘better’ than another, the public interest requires

that all test results presented to the public be based on a uniform

method used by all laboratories. Use of more than one testing

method would produce different resulis which would only serve to

confuse or mislead the public.

“In determining the testing method, the Commission has not at-

tempted to gauge the test to the amount of smoke, or tar and nicotine,

which the ‘average’ smoker will draw from any particular cigarette.

[Footnote continued on next page]

[Footnote continued from previous page|

“No two human smokers smoke in the same way. No individual

smoker always smokes in the same fashion. The speed at which one

smokes varices both among smokers, and usually also varies with the

same individual under different circumstances even within the same

day. Some take long puffs (or draws); some take short puffs. That

variation affects the tar and nicotine quantity in the smoke gencrated.

“Even with the same type of cigarette, individual smokers take a

different number of puffs per cigarette depending upon the circum-

stances. When concentrating, or talking, the number of puffs is usu-

ally less. When listening, or required to listen to another person talk-

ing, the number of puffs per cigarette, as well as the duration of cach

puff, usually increases. Smoking rates while reading a book may dif-

fer from smoking rates while viewing a television program. The

number of puffs and puff duration (as well as butt length) will vary

according to emotional state. Some smokers customarily put their

cigarettes down in an ashtray where they bur between puffs; other

smokers constantly hold cigarettes in their mouths; others hold them

between their fingers.

“The Cambridge Filter Method does not and cannot measure

these many variations in human smoking habits. It does not measure

tar or nicotine in the smoke generated while the cigarette is not being

puffed. 11 does not measure all of the tar and nicotine in any ciga-

rette, but only that in the smoke drawn in the standardized machine

smoking according to the prescribed method. Thus, the purpose of

testing is not to determine the amount of tar and nicotine inhaled by

any human smoker. but-rather to determine the amount of tar and

nicotine generated when a cigarette is smoked by machine in accor-

dance with the prescribed method.

“Accordingly, the testing method should not be considered de-

fective because it does not rely on ‘averages.’ There are too many

variables as to both smokers and smoking conditions for any average

to be meaningful. Test results phrased in terms of an ‘average’

smoker could be misleading to the public, because a smoker has no

way of knowing how closely his smoking habits conform to those of

the purportedly ‘average’ smoker.”

Smoking and Tobacco Control

Monograph 7

The FTC Cigarette Test Method for Determining Tar,

Nicotine, and Carbon Monoxide Yields of U.S. Cigarettes

Report of the NCI Expert Committee

NATIONAL INSTITUTES OF HEALTH

National Cancer Institute

Foreword

In response to the emerging scientific evidence that ciga-

rette smoking posed a significant health risk to the user, in

the early 1950’s the major cigarette manufacturers began

widespread promotion of filtered cigarettes to reassure smok-

ers that, regardless of whatever unhealthy constituents were

in cigarette smoke, filters were a “scientific” breakthrough.

Advertisements for Viceroy’s “health guard filter”

stated, “DENTISTS ADVISE—Smoke VICEROYS—The

Nicotine and Tars Trapped by The Viceroy Filter CAN

NEVER STAIN YOUR TEETH!” and “Leading N.Y. Doctor

Tells His Patients What to Smoke-—--Filtered Cigarette Smoke

Is Better For Health. The Nicotine and Tars Trapped .. .

Cannot Reach Mouth, Throat Or Lungs.” Chesterfield was

“Best for you-—/ow in nicotine, highest in quality,” while

L&M’s were “Just What the Doctor Ordered.” Lorillard To-

bacco Company stressed its science-based Kent micronite

tilter (the original micronite filter was made of asbestos) and

claimed it removed seven times more tar and nicotine than

any other cigarette, which “put Kent in a class all by itself

where health protection is concerned.” Of course, we know

today that not only were these claims patently false, but the

cigarette companies knew it.

In the early 1950's the Federal Trade Commission (FTC)

challenged a variety of health claims made for cigarettes in

their advertising, including claims about tar and nicotine. In

1955 FTC published advertising guidelines that, among other

things, prohibited claims by cigarette manufacturers that a

particular brand of cigarettes was low in tar and nicotine or

lower than other brands, when it had not been established by

competent scientific proof that the claim was true and the dif-

ference was significant. Cigarette manufactures, however,

continued to advertise tar numbers. In the absence of a stan-

dardized test methodology, this resulted in what is referred to

as a “tar derby”—a multitude of inconsistent, noncomparable

claims that did not give consumers a meaningful opportunity

to assess the relative tar delivery of competing brands. The

tar derby ended in 1960 when discussions with FTC culmi-

nated in an industry agreement to refrain from tar and nico-

tine advertising.

In 1966, however, the U.S. Public Health Service (PHS)

prepared a technical report on “tar” and nicotine that con-

cluded, “The preponderance of scientific evidence strongly

suggests that the lower the ‘tar’ and nicotine content of ciga-

rette smoke, the less harmful would be the effect.” In reach-

ing this conclusion, the report noted the clear relationship be-

tween dose of cigarette smoke received by the smoker and

disease risk. Regardless of how dose was calculated——by

number of cigarettes smoked per day, age of initiation, total

number of years one smoked, or depth of inhalation, mortal-

ity rates among smokers increased. When smokers quit

smoking, their risk was reduced in proportion to the length of

time off cigarettes.

Subsequent to the PHS statement, FTC reversed its deci-

sion banning tar and nicotine claims in advertising and estab-

lished a standardized testing protocol for assessing tar and

nicotine yields. Today that protocol is widely known as the

FTC test method. In 1980 the protocol was broadened to in-

clude measurement of the carbon monoxide yields of ciga-

rettes as well.

The initial protocol adopted by FTC was largely based

on the work of U.S. Department of Agriculture chemist C.L.

Ogg, as published in the Journal of the Association of Offi-

cial Agricultural Chemists in 1964. it appears, however, that

this protocol was based on one person’s observations about

how people smoked.

Much the same protocol] had been proposed by American

Tobacco Company researchers in 1936. Writing in the July

Issue of Industrial and Engineering Chemistry, J.A. Bradford

and colleagues noted, “The present writer’s arbitrarily se-

lected rate is a 35-cc puff of 2-second duration taken once a

minute.”

However, cigarettes consumed at that time were vastly

different from those manufactured and marketed later. In

fact, tar and nicotine levels began to decline during the

1950’s, concurrent with the mass marketing of filter ciga-

rettes. Market share of filter cigarettes increased from almost

zero in 1950 (0.6 percent of the market) to 50 percent by dec-

ade’s end. Total cigarette sales, which had begun to decline

after the first public statements about the hazards of smoking

in the early 1950’s, rebounded to new highs.

Although filter efficiency may have contributed to some

of the reduction in tar/nicotine yields in the 1950's, the de-

cline resulted mostly from less tobacco being used to make

filtered as opposed to unfiltered cigarettes. However, during

the 1960’s and 1970’s major cigarette design changes re-

sulted in significantly lower machine-measured cigarette

yields. The changes included increased use of ventilated to-

bacco rods and filters, use of more porous cigarette papers,

and increased use of expanded and reconstituted tobacco.

Concurrent with these modifications in cigarette design, ciga-

rette manufacturers increasingly made use of additives in

manufacturing. Today about 600 different compounds are

routinely added to domestic cigarette brands, yet no routine

testing is performed to determine whether these compounds

pose any additional health risk to the smoker when they are

burned in a cigarette.

U.S. market share of cigarettes yielding 15 mg tar or less

went from 3.6 percent in 1970 to 44.8 percent by 1980. The

sales-weighted average tar and nicotine yields of all U.S.

cigarettes are now approximately 12 mg tar and 0.9 mg nico-

tine. By comparison, sales-weighted yields in the early

1950’s were 35 mg tar and 2.5 mg nicotine.

As consumption of low-yield cigarettes began to prolif-

crate, the public health community became concerned that

these products were not what they seemed. Increasingly, sci-

entific studies documented that smokers who switched to

these low-yield products smoked them differently, thus ne-

gating the reason many of them changed in the first place—to

lower their health risk.

The U.S. Congress also voiced its concern in 1978 when

it enacted the Health Services and Centers Act. Section 403

of that legislation directed the U.S. Department of Health and

Human Services (DHHS) to conduct a “study or studies of

(1) the relative health risks associated with smoking ciga-

rettes of varying levels of tar, nicotine, and carbon monoxide;

and (2) the health risks associated with smoking cigarettes

containing any substances commonly added to commercially

manufactured cigarettes.” The Secretary of the Department

of Health and Human Services addressed this issue as part of

the 1981 Surgeon General's report, The Health Consequences

of Smoking: The Changing Cigarette. The overall conclu-

sion of that report was clear: There is no safe cigarette and

no safe level of consumption.” Although the report did note

that smoking cigarettes with lower yields of tar and nicotine

reduces the risk of lung cancer to some extent, the benefits

are minimal in comparison with giving up cigarettes entirely.

Evidence relating to heart disease, other cancers, or chronic

obstructive lung disease was not sufficient to permit conclu-

sions to be drawn. As to the accuracy of the FTC test

method, the report stated: “The ‘tar’ and nicotine yields ob-

tained by present testing methods do not correspond to the

dosages that the individual smokers receive: In some cases

they may seriously underestimate these dosages.” |

Growing numbers of questions were raised about the ac-

curacy of the FTC test protocol to measure tar, nicotine, and

carbon monoxide levels from low-yield cigarettes—-questions

raised not just by the public health community but also within

the tobacco industry. Competitors complained to FTC that

Brown and Williamson’s (B&W) Barclay brand cigarette did

not test accurately with the FTC test method. They argued

that the brand was designed with unique air ventilation chan-

nels that caused it to test low on the FTC method. The venti-

lation channels, which remained open when Barclays were

smoked on the FTC machine, were rendered inoperable when

a human being smoked the cigarettes. In April 1983 FTC

announced that its testing method understated values for con-

stituents in Barclay cigarettes, and as a result, until new test-

ing methods were developed, FTC would no longer report an

official rating for Barclay cigarettes. Later, FTC took similar

steps with respect to other B&W cigarette varieties that used

a filter design similar to Barclay’s.

Eventually FTC closed its cigarette testing laboratory, in

part because of insufficient expertise within the agency to

carry out an increasingly complex and costly testing program.

Since 1987, constituent levels for domestic cigarette brands

have been determined for the manufacturers by the Tobacco

Institute Testing Laboratory with oversight by FTC. The To-

bacco Institute serves as a trade organization as well as the

information and lobbying arm of the tobacco industry.

In June 1994 the Chairman of the House Subcommittee

or Health and the Environment wrote the Director of the Na-

tional Cancer Institute (NCI), asking him to convene a meet-

ing of experts to“... review and make recommendations on

the accuracy and appropriateness of the Federal Trade Com-

mission’s method for determining the relative ‘tar’ and nico-

tine content of cigarettes.” A similar request was received

from the FTC Chairman asking that NCI convene a consen-

sus conference on the topic and outlining several areas it

wished to be considered.

On December 5 and 6, 1994, a meeting of the NCI ad

hoc expert committee was convened under the aegis of the

President’s Cancer Panel to examine this issue. The commit-

tee consisted of || individuals from diverse scientific back-

grounds and experience. The committee had the benefit of

excellent presentations from 14 experts whose professional

careers were not only involved in research on smoking, but

who have been active contributors to this field of scientific

inquiry. Two of the individual participants were cigarette

industry scientists, who participated in all discussions.

From the outset of the committee’s deliberations, it was

clear that the intent of the meeting was not to redesign the

FTC testing protocol but, rather, to examine the protocol and

make suggestions for improvement, if warranted. To provide

a framework for discussion, the committee was asked to con-

sider three basic questions:

1. Does the evidence presented clearly demonstrate

that changes are needed in the current FTC pro-

tocol for measuring tar, nicotine, and carbon

monoxide? If yes, what changes are required?

2. Should constituents other than tar, nicotine, and

carbon monoxide be added to the protocol?

3. Does the FTC protocol provide information use-

ful to smokers in making decisions about their

health?

1. The committee reached the following conclusions with

respect to the first question.

A. The smoking of cigarettes with lower machine-

measured yields has a small effect in reducing the

risk of cancer caused by smoking, no effect on the

risk of cardiovascular diseases, and an uncertain ef-

fect on the risk of pulmonary disease. A reduction

in machine-measured tar yield from 15 mg tar to |

mg tar does not reduce relative risk from 15 to |.

.. The FTC test protocol was based on cursory obser-

vations of human smoking behavior. Actual human

smoking behavior is characterized by wide varia-

tions in smoking patterns, which result in wide

variations in tar and nicotine exposure. Smokers

who switch to lower tar and nicotine cigarettes fre-

quently change their smoking behavior, which may

negate potential health benefits.

Accordingly, the committee recommends the fol-

lowing changes to the FTC protocol:

1. This system should also measure and publish

information on the range of tar, nicotine, and

carbon monoxide yields that most smokers

should expect from each cigarette sold in the

United States.

2. This information should be clearly communi-

cated to smokers.

3. A simple graphic representation should be pro-

vided with each pack of cigarettes sold in the

United States and in all advertisements. The

representation should not imply a one-to-one re-

lationship between measurements and disease

risk.

4. The system must be accompanied by public

education to make smokers aware that individ-

ual exposure depends on how the cigarette 1s

smoked and that the benefits of switching to

lower yicld cigarettes are small compared with

quitting.

There should be Federal oversight of cigarette test-

ing, but such testing should continue to be per-

Il.

formed by the tobacco industry and at industry ex-

pense.

E. The questions involved in the purpose, methodol-

ogy, and utility of the FTC protocol are complex

medical and scientific issues that require ongoing

involvement of Federal health agencies; including

the National Institutes of Health, the Food and Drug

Administration, and the Centers for Disease Control

and Prevention.

F. The system should be reexamined at least every 5

years to evaluate whether the protocol is maintain-

ing its utility to the smoker.

G. When a cigarette manufacturer makes significant

changes in cigarette design that affect yields, it

should notify the appropriate Federal agency.

With regard to the second question, the committee rec-

ommends that to avoid confusing smokers, no smoke

constituents other than tar, nicotine, and carbon monox-

ide be measured and published at the present time.

Smokers should be informed of the presence of other

hazardous smoke constituents with each package and

with all advertisements. These constituents should be

classified by toxic effects.

In considering the third question, the committee reached

the following conclusions:

A. Information from the testing system is useless to

smokers unless they have ready access to it. The in-

formation from the testing system should be made

available to all smokers, including those who smoke

generic brands and other brands not widely adver-

tised.

B. Brand names and brand classifications such as

“light” and “ultralight” represent health claims and

should be regulated and accompanied, in fair bal-

ance, with an appropriate disclaimer.

C. The available data suggest that smokers misunder-

stand the FTC test data. This underscores the need

for an extensive public education effort.

As Chairman of the President’s Cancer Panel under

whose aegis this meeting was convened, | would like to ex-

press here my admiration and deep appreciation to the mem-

bers of the NCI ad hoc committee and its expert consultants

for a job well done. In transmitting this report to both the

U.S. Congress and the Federal Trade Commission, it is my

sincere hope that the recommendations contained herein will

receive the serious and thoughtful consideration they deserve.

Harold P. Freeman, M.D.

Chairman, President’s Cancer Panel

Chapter 1

Cigarette Testing and the Federal Trade

Commission: A Historical Overview!

C. Lee Peeler

Cigarette manufacturers began advertising their prod-

ucts’ tar and nicotine content before there was a standardized

procedure for testing cigarette output. In 1955, after a series

of cases challenging a variety of claims made for cigarettes

(including tar and nicotine claims),? the Federal Trade Com-

mission (Commission or FTC) published cigarette advertising

guides. Among other things, the guides prohibited claims

that a particular brand of cigarettes was low in tar and nico-

tine or lower than other brands “when it has not been estab-

lished by competent scientific proof... that the claim is true,

and if true, that such difference or differences are significant”

(Federal Trade Commission, 1 988a).

However, cigarette manufacturers continued to advertise

tar numbers. In the absence of a standardized testing meth-

odology, their claims resulted in what is often referred to as

the “tar derby”——a multitude of inconsistent, noncomparable

1 These remarks are the views of the staff of the Bureau of Consumer

Protection. They do not necessarily represent the view of the Commis-

sion or any individual commissioner.

2 See, e.g., Reynolds Tobacco Co. v. FTC, 192 F.2d 535 7th Cir. (1951)

(claims that Camel does not impair the physical condition of athletes and

aids digestion); American Tohacco Co., 47 F.T.C. 1393 (1951) (Lucky

Strike cigarettes advertised as less irritating to the throat than competing

brands and containing less tar than four other leading brands); P. Lori/-

lard Co., 46 F.T.C. 735 (1950) (Old Gold cigarettes advertised as lowest

of seven leading brands tn nicotine and throat irritating tars, and Beech-

Nut cigarettes as providing “definite defense against throat irritation’).

See also, e.g . Leighton Tobacco Co. 46 F.T.C. 1230 (1950) (Phantom

cigarettes represented as causing no irritation of any kind).

claims that did not give consumers a meaningful opportunity

to assess the relative tar delivery of competing brands. The

tar derby ended in 1960, when discussions with the Commis-

sion culminated in an agreement by the industry to refrain

from tar and nicotine advertising (Federal Trade Commis-

sion, 1988b).

In 1964 the first Surgeon General’s report on the health

risks of smoking concluded that cigarette smoking was a

cause of lung cancer in men (U.S. Department of Health and

Human Services, 1964). In 1966 the Public Health Service

stated that“The preponderance of scientific evidence

strongly suggests that the lower the tar and nicotine content

of cigarette smoke, the less harmful would be the effect”

(U.S. Department of Health and Human Services, 1981, p. v).

It was in this environment that the Commission initiated

two major steps in 1966 to encourage cigarette manufacturers

to provide consumers with comparative information about

their products’ tar and nicotine.yields. First, it ended the ban

on tar and nicotine advertising by announcing that factual

statements of the tar and nicotine content of mainstream ciga-

rette smoke could be made if they were supported by tests

conducted in accordance with the so-called “Cambridge Fil-

ter method” and if they were not accompanied by claims

about reduced health hazards (Federal Trade Commission,

1988a). Second, it authorized establishment of a laboratory

to analyze cigarette smoke and invited public comment on

what modifications, if any, should be made to the Cambridge

Filter method for purposes of the laboratory’s procedures and

how the test results should be expressed (Federal Register,

1966). The modified Cambridge Filter method ultimately

adopted by the Commission is often referred to as the “FTC

method.”

By mid-1967 the laboratory was ready to begin testing

cigarettes (Federal Register, 1967).5 The Commission

agreed, pursuant to Senator Warren Magnuson’s request,’ to

report the test results to Congress periodically, a process that

continues today.

From the outset, the testing was intended to obtain uni-

form, standardized data about the tar and nicotine yield of

mainstream cigarette smoke, nof to replicate actual human

smoking. The Commission recognized that individual smok-

ing behavior was just that—too individual to gauge what a

hypothetical “average” smoker would get from any particular

cigarette: “No two human smokers smoke in the same way.

No individual smoker always smokes in the same fashion”

(Federal Trade Commission, 1967). The purpose of the test-

ing was “not to determine the amount of ‘tar’ and nicotine

inhaled by any human smoker. but rather to determine the

amount of tar and nicotine generated when a cigarette is

smoked by machine in accordance with the prescribed

method” (Federal Trade Commission, 1967). Indeed, the

Cambridge Filter method did not attempt to duplicate an “av-

3 For the first dozen years of its existence, the laboratory tested only

for tar and nicotine. In 1980 the protocol was modified to add testing for

carbon monoxide.

4 Expressing the opinion held at that time by many people in the Fed-

eral Government, Senator Magnuson stated that “By encouraging smok-

ers to switch to low tar/micotine cigaretics, we can contribute meaning-

fully to the physical health of our nation. Publication of the Commis-

sion’s testing results is one important facet.

The Commission expressed its views concerming dissemination of tar

and nicotine figures in an October 1967 letter to the National Association

of Broadcasters: “The Commission favors giving smokers as much in-

formation about the risks involved in smoking as ts possible and to that

end favors mandatory disclosure of tar and nicotine content, as measured

by a standard test.” P

erage” smoker but was “an amalgam of many choices” (Fed-

eral Trade Commission, 1967). Because no test could accu-

rately duplicate human smoking, the Commission believed

that the most important thing was to make certain the results

presented to the public were based un a reasonable, standard-

ized method and could be presented to consumers in an un-

derstandable manner.

The Commission next attempted to increase consumer

awareness of the ratings produced by its laboratory. In 1970

it proposed a trade regulation rule that would have required

disclosure of tar and nicotine ratings in all cigarette advertis-

ing (Federal Register, 1970). The rulemaking was suspended

indefinitely a short time later, when five of the major ciga-

rette manufacturers and three small companies agreed volun-

tarily among themselves to include the ratings produced by

the Commission’s protocol in their advertisements. That

agreement, modified to reflect the discontinuance of the

Commission’s laboratory, remains in effect today.>

There are a number of ways to lower a cigarette’s tar and

nicotine rating, including adding filters that literally trap

some of the constituents of the tobacco smoke before they

reach the machine, wrapping the tobacco plug in paper that

burns relatively quickly, and placing ventilation holes around

the circumference of the filter so that when a smoker or

smoking machine puffs on the cigarette, air is drawn into the

filter and the resulting diluted mixture of air and smoke

yields lower tar and nicotine ratings than the undiluted puff

of smoke would yield. The last technique is often referred to

as “aeration.”

> The American Tobacco Company did sign the voluntary agreement,

but similar disclosures have been contained in tts advertisements, pursu-

ant to a 1971 consent agreement with the Commission. [/n re American

Brands, Inc., 79 F.T.C. 255 (1971).]

These types of changes in cigarette technology have fo-

cused the Commission’s attention on its protocol on two

separate occasions since 1970. In both cases, the Commis-

sion has solicited public comments on certain aspects of the

FTC method. However, in neither instance dtd the informa-

tion received by the Commission form a sufficient basis for

changing the protocol, even though the limitations on the

predictiveness of the FTC method caused by compensatory

smoking were clearly recognized by the mid-1980’s. (“Com-

pensatory behavior” is the tendency of consumers to offset

the benefits of a positive change in their behavior by making

a second, negative change. For example, a smoker who

switches to a brand with lower tar and nicotine ratings might

smoke more cigarettes cach day or smoke cach one more in-

tensively, that 1s, inhale more deeply and/or take more puffs

per cigarette.) Following is a review of the two events re-

ferred to above.

Aeration first became an issue for the Commission in

1977, when Lonillard, Inc., suggested that the depth to which

Cigarettes were inserted in the Commission’s smoking ma-

chine be decreased when the standard dept would block some

of a cigarette’s ventilation holes, thereby impairing its filtra-

tion system and resulting in higher ratings than if the holes

were open. The Commission solicited public comments on

this question and also on whether the insertion depth should

be decreased beyond the point where consumers cover the

cigarette with their fingers or lips (Federal Register, 1977).

Of the seven cigarette companies that commented, only

Lorillard supported varying the standard insertion depth.

However, none of the responders addressed the question of

whether the new insertion depth would be more consistent

with actual smoking practices. After reviewing the com-

ments, the Commission noted that the development of ciga-

rettes with ventilation holes near the tip had complicated the

comparability of its tar and nicotine ratings.° but “that a

change in the insertion depth would cause a lack of continuity

with previous test results” (Federal Register, 1978, pp.

11856, 11857). The Commission decided not to modify the

protocol “in the absence of information indicating that a new

insertion depth would be more consistent with the manner in

which smokers insert cigarettes in actual use” (Federal Reg-

ister, 1978, p. 11857).

Another controversy concerning the test method arose in

the early 1980’s and involved the Brown & Williamson To-

bacco Corporation’s (B&W) Barclay cigarette, which was

designed with a channel ventilation system rather than air

holes.’ Competitors claimed that Barclay, which had re-

6 Quoting its 1967 statement that the purpose of testing was not to de-

termine the amount of constituents inhaled by a human smoker but to

determine the amount generated when a cigarette was smoked by a ma-

chine in accordance with a prescribed protocol (see above), the Commis-

sion noted that:

The point of this statement was that the FTC’s “tar” and nicotine val-

ues represented valid standards for making comparisons among dif-

ferent cigarettes. Thus, if the consumer smoked each different ciga-

rette the same way, he would inhale “tar” and nicotine in amounts

proportional to the relative values of the FTC figures. A person who

smoked a 10 mg “tar” cigarette would ingest half the “tar” he would

by smoking a 20 mg “tar” cigarette providing he smoked the same

way. The development of cigarettes with ventilation areas within | 1

mm of the tip has complicated this simple relationship. (Federal

7 In conventional aerated cigarettes, air and smoke mixed togetner as

they passed through the filter. Outside air drawn into Barclay’s channels,

however. went directly into the smoker’s mouth before first mixing with

any smoke; dilution was supposed to occur in the mouth, not in the filter.

Competitors alleged that because the exit holes for the channels were

close to the smoker’s lips, they were crushed or covered by lips, thus re-

ducing dilution.

ceived an official FTC rating of | mg tar in 1981, did not test

accurately on the FTC smoking machine because the chan-

nels remained open during testing but were rendered inoper-

able in practice. After careful consideration, the Commission

determined that its present test method did not accurately

measure Barclay’s tar, nicotine, and carbon monoxide. It re-

voked the I-mg rating, estimating that Barclay should be

rated between 3 and 7 mg of tar (based on testing by inde-

pendent consultants) and invited comments on a number of

issues relating to possible modification of its testing method,

including using new cigarette holders on the smoking ma-

chine that would simulate the reduction in ventilation that

occurred when people smoked Barclay (Federal Register,

1983). The Commission asked which modifications would

yield the most appropriate results for all cigarettes and

whether modification of the cigarette testing method would

result in unintended consequences and affect possible innova-

tion in cigarettes design (Federal Register, 1983).

The Commission also took this opportunity to reiterate

that its ratings were relative; that the amount of tar, nicotine,

and carbon monoxide any particular cigarette delivered de-

pended on how it was smoked; and that in the case of venti-

lated filter cigarettes, delivery would be increased if ventila-

tion holes were blocked (Federal Register, 1983). It then in-

vited comments on a wide range of issues concerning com-

pensatory smoking behavior.

Should the Commission further examine the

implications for its testing program of the is-

sues raised by compensatory smoking behav-

ior, including hole blocking, when consumers

- smoke lower “tar” cigarettes? What is the evi-

dence that smokers use higher “tar” cigarettes

differently than lower “tar” cigarettes? What

is the evidence regarding the extent of hole

blocking by smokers of different ventilated fil-

ter cigarettes? Are there problems regarding

compensatory smoking behavior which are

significant enough to warrant further explora-

tion of changes in the method, beyond those

necessitated by the Commnission’s findings

concerning Barclay? What lines of inquiry

would gencrate the most useful information if

such an examination is undertaken? For ex-

ample, should the Commission explore a sys-

tem of categories or “bands” of “tar” content

rather than specific numerical estimates?

Also, should consumers be advised that the

cigarettes’ actual “tar” delivery depends on

how it is smoked? (Federal Register, 1983)

Shortly after the initial comment period closed,® a Fed-

eral district court issued an opinion in the Commission’s ac-

tion against B&W over advertisements that continued to de-

scribe Barclay as a |-mg tar cigarette, despite the Commis-

sion’s revocation of Barclay’s |-mg rating [F7C v. Brown &

Williamson Tobacco Corp., 580 F. Supp. 981 (D.D.C. 1983),

aff'd in part, remanded in part, 778 F.2d 35 (D.C. Cir.

1985)]. During that litigation, B&W contended that “recent

scientific evidence demonstrates that the FTC system is so

flawed that it is itself deceptive” [580 F. Supp. at 984].9 The

8 Comments responsive to the April 13, 1983, Federal Register notice

were originally due by June 30, 1983. On June 4, 1984, however, the

Commission reopened the comment period because certain information

that was relevant to the questions addressed in that notice, but had been

previously under a court-ordered seal, was now publiciy available (Fed-

eral Register, 1984).

9 B&W argued that all cigarettes were subject to compensatory smok-

ing behavior and thus all tar numbers were “soft.” The Commission ac-

knowledged that low-yield cigarettes were subject to substantial varia-

tions in actual smoker intake but contended that Barclay tested differently

on the machine from other cigarettes. The Commission’s position was

that the tar ratings provided a rough comparative scale; that is, a ]-mg

{Footnote continued on next page]

court recognized that compensatory smoking behavior com-

plicated the ratings question but rejected B& W’s contention

that the system provided no benefit to consumers:

The FTC system attempts only to determine

how much relative tar and nicotine a smoker

would get in his mouth were he to smoke two

cigarettes in the same manner. B&W has ut-

terly failed to show that the system does not

do this. Nor has it shown that a better method

for determining the relative health hazards of

the many different varieties of cigarettes on

the market is currently feasible [580 F. we 8

at 985].

The comments ultimately submitted in pom to the

Commission’s questions about compensatory smoking re-

flected sharply disparate views. On the one hand, the Ameri-

can Heart Association (AHA), American Lung Association

(ALA), and American Cancer Society (ACS) identified prov-

lems with the existing methodology, expressed concern over

the impact of compensatory smoking behavior, and suggested

extensive research to improve the current testing and report-

ing procedures. !0

[Footnote continued from previous page]

cigarette should be comparable to all other !-mg cigarettes, if all are

smoked in an identical manner.

10 The ALA stated that given the reality of compensatory smoking, low-

tar cigarettes might not be as safe as some consumers were being led to

believe and that the Commission’s testing and reporting procedures were

contributing to questionable advertisements for “safe” cigarettes. The

ACS stated that the Commission's test method should be modified to re-

flect current understanding of compensatory smoking behavior. The

AHA expressed its view that the Commission's testing and reporting pro-

cedures fostered the belief among consumers that low-tar cigarettes were

safer than high-tar brands. However, epidemiological evidence showing a

[Footnote continued on next page]

On the other hand, Philip Morris, R.J. Reynolds Tobacco

Company, and American Brands asserted that compensatory

smoking behavior was not relevant to the testing methodol-

ogy and that devising a protocol that accounted for compen-

satory smoking would require establishing a profile of the

average smoker, something the Commission had previously

declined to do because of the impossibility of accounting for

all the relevant variables. Lorillard stated that data on com-

pensatory smoking were very limited and therefore recom-

mended that the existing system be kept intact. Liggett &

Myers suggested that perhaps all cigarette testing should be

abolished because smoking behavior could seriously affect

tar and nicotine yields and smokers could not be taught to

change their behavior.

In response to the Commission's question about possible

implementation of a “banding” system for its tar and nicotine

ratings, B&W (which had just had Barclay’s rating revoked)

argued that the current system caused manufacturers to em-

phasize small differences that might not exist, given the reali-

ties of compensatory smoking, and that it should be replaced

with a system that would group products into high-tar, me-

dium-tar, low-tar, and ultra low-tar “bands.” Philip Morris

and American Brands argued that banding would lead to a

[Footnote continued from previous page]

correlation between the risk of coronary heart disease and the number of

cigarettes smoked per day, but not a reduced rate of such disease among

low-tar smokers, suggested that smokers cf those cigareties might be en-

gaging in compensatory smoking.

The ALA and ACS recommended that research be conducted to de-

termine how actual intake of tar and other smoke constituents by smokers

related to the FTC's ratings; following completion of this research, the

Commission should test each cigarette under a range of conditions repli-

cating actual smoking behavior and report those results with a warning

that individual yield depends on individual smoking patterns.

concentration of brands at the upper limit of each category (in

contrast to the existing system, which encouraged reductions

across the board). American Brands also contended that

banding would confuse consumers, whereas Philip Morris

noted that it would substitute the Government’s judgment

about the significance of differences in tar ratings for that of

the individual consumer:

In short, there was no clear consensus as to specific ac-

tion the Commission could (or should) take to eliminate the

limitations of the test method. At the same time, abandoning

the testing system without instituting another method of tar

testing would have been premature because then-current epi-

demiological evidence suggested that there had been a reduc-

tion in lung cancer deaths that might be attributable to de-

clines in average tar levels that had occurred since the 1950's

(U.S. Department of Health and Human Services, 1981).!!

Accordingly, at that time the Commission made no changes

to its cigarette test method to address compensatory smoking.

In early 1987 the Commission decided to close its ciga-

rette testing laboratory. The Commission found that closing

the laboratory was necessary for several reasons, chiefly be-

cause the cost of the laboratory was significant and the

Commission would have had to commit significant additional

funds to continue its operation. The Commission also was

persuaded that the same information could be obtained from

other sources and that other means were available to verify

the accuracy of industry testing results. In fact, the Commis-

sion’s operation of a testing system for the industry at tax-

payer expense was highly unusual. The common scenario is

11 tn 1954 the tar yicld of the sales-weighted average cigarette was 37

mg (U.S. Department of Health and Human Services, 1981). By 1981

cigarettes yielding 15 mg of tar or less had 56 percent of the domestic

market (Federal Trade Commission, 1984).

for the industry to conduct its own testing under Govern-

ment-specified testing protocols.

Since 1987 the Tobacco Institute Testing Laboratory

(TITL) has continued to test most cigarettes, using the Com-

mission’s approved methodology; the companics report the

results to the Commission pursuant to a compulsory request,

and the Commission publishes the results. TITL keeps the

Commission informed of proposed changes in the testing

procedure and solicits Commission approval for all signifi-

cant changes. TITL’s work is regularly monitored by the

Commission’s contractor, Harold Pillsbury, Jr. (this volume),

who has virtually unrestricted access to the laboratory and

makes unannounced visits to inspect it and check the testing

process. Mr. Pillsbury also checks the data for consistency

from run to run and from year to year. Most industry mem-

bers also have testing facilities; however, the numbers pub-

lished by the Commission are primarily TITL numbers. (Ge-

neric and private label brands, as well as new cigarettes and

cigarettes that are not widely available, are not tested by

TITL.)

Since the closing of its laboratory, the Commission has

continued to review advertising for today’s low- and ul-

tralow-yield cigarettes for deceptive claims. In January 1995

the Commission approved a consent agreement with the

American Tobacco Company, settling charges over adver-

tisements that allegedly misused the Commission's tar and

nicotine ratings by stating that consumers would get less tar

by smoking 10 packs of Carlton brand cigarettes (which are

rated as having | mg of tar per cigarette) than by smoking a

single pack of certain other brands of cigarettes (rated as hav-

ing more than 10 mg of tar per cigarette).

The Commission's desire to ensure that smokers have

accurate and useful information about their cigarettes led to

its request for the conference, whose reports are contained in

this monograph.

FTC NICOTINE PROGRAM

HEARING

Before The

SUBCOMMITTEE ON

TRANSPORTATION, TOURISM, AND HAZARDOUS

MATERIALS

Of The

COMMITTEE ON

ENERGY AND COMMERCE

HOUSE OF REPRESENTATIVES

ONE HUNDREDTH CONGRESS

FIRST SESSION

May 7, 1987

Serial No. 100-42

* * *

Mr. LUKEN. The gentleman from Kansas.

Mr. WHITTAKER. Thank you, Mr. Chairman.

The testimony that we receive today will help us review

the FTC decision to close its cigarette testing laboratory. |

regret, however, that the final decision to focus this hearing

on this issue was only made recently, resulting in somewhat

rushed preparations by both the witnesses and the members

of this subcommittee. Perhaps we can work together to avoid

this type of situation in the future.

Last month, the FTC pulled the plugs on their smoking

machines used to test tar and nicotine levels in cigarettes.

ers should continue to pay for these smoking 1ron lungs.

The purpose of the FTC laboratories was to ensure the

manufacturers truthfully advertisedthe levels of tar and nico-

tine in their cigarettes. Cigarette manufacturers also test their

own as well as their competitor’s products and we are told

they uniformly use the FTC testing procedure. Therefore, the

manufacturers’ results have consistently been the same as the

FTC’s. The FTC believes it can depend upon the industry

test results in conjunction with the competitive spirit between

the individual manufacturers to ensure truth in advertising.

Some health organizations, however, question whether

the tobacco industry can be trusted to issue correct measure-

ments on its own products. They assert that there will be an

inherent conflict of interest. Today’s hearing will enable us

to test the FTC’s faith in the industry’s tests and its enforce-

ment of truthful advertising.

Mr. Chairman, | for one believe that too many people

endanger t..cir health by smoking. It is important that the

public be fully informed about the content of tar and nicotine

in cigarettes which cause serious health consequences.

| commend you very strongly for calling this hearing and

| look forward to the witnesses’ testimony which will help us

determine if the FTC’s laboratory is necessary to fully inform

the public.

Thank you.

Mr. LUKEN. The gentleman from NJ, Mr. Florio.

Mr. FLORIO. Thank you very much, Mr. Chairman. I,

too, am pleased to be here and commend you for calling these

hearings.

This, | think, is the first hearing that we have had with

regard to the FTC. I assume at some point before too long

we will be going into reauthorization hearings for this

Agency that some of us regard as a less than aggressive

Agency over the last number of years, that has had its trou-

bles. The jurisdiction of the Agency, of course, falls into two

areas, the anti-trust area and the consumer protection area,

which in a sense we are dealing with today. | can’t but notice

in today’s New York Times on the anti-trust side, on the

business first page, the suggestion that the General Mo-

tors/Toyota agreement, which some of us were not enthusias-

tic about the FTC approving in a very cursory way years ago,

that in a sense didn’t pay a lot of attention to the traditional

anti-trust standards and justified the merger going forward or

the joint venture going forward on the basis of efficiencies,

and apparently the reports today indicate General Motors has

not been the big beneficiary of the efficiencies that some sug-

gested were going to result from this somewhat strange joint

venture being allowed between the number one and number

three car manufacturers in the world.

Today’s hearing, of course, goes to the second part of the

jurisdiction, consumer protection. | think we are talking

about the specific problem today but it is also an aspect of the

ad substantiation responsibilities of the FTC, going into the

responsibilities of the FTC in ensuring that we have nonde-

ceptive and fair advertising.

I hope that through the course of the morning we will

talk a little bit about the general approach that the commis-

sion is taking towards that area of its jurisdiction, this piece

of it being of course the ability of the commission to deter-

mine whether advertising is deceptive, whether it is fair and

whether it is substantiated by the facts, when claims are

made.

Mr. Chairman, | commend you for these hearings and

look forward to taking part in them today.

Mr. LUKEN. The gentleman from Tennessee.

Mr. CooPer. I have no opening statement, Mr. Chair-

man.

Mr. LUKEN. Anything further from the members?

{No response. }

Mr. LUKEN. If not, we will proceed with the first wit-

nesses, Mr. Daniel Oliver, Chairman of the Federal Trade

Commission, whom we welcome this morning. Mr. William

MacLeod, who is the Director of the Bureau of Consumer

Protection.

Mr. Oliver, you have submitted a statement which with-

out objection will be admitted into the record. You and Mr.

MacLeod may proceed to acquaint the subcommittee in any

way you see fit with your views on the issues that have been

raised this morning.

STATEMENT OF HON. DANIEL OLIVER,

CHAIRMAN, FEDERAL TRADE COMMISSION,

ACCOMPANIED BY WILLIAM C. MacLEOD,

DIRECTOR, BUREAU OF CONSUMER PROTECTION

Mr. OLIVER. Thank you, Mr. Chairman, members of the

committee. We were originally asked to be here today to dis-

cuss authorization of the Federal Trade Commission. | think

it is unfortunate that consideration of authorization has been

postponed in order to discuss the unanimous decision the

commission made almost 3 months ago to close the cigarette

laboratory.

The commission has provided the subcommittee with a

statement on this subject. In addition, we have provided both

responsive documents and written answers to the questions

presented to us as late as last Friday.

Mr. LUKEN. Did you submit anything to the committee

before last Friday?

Mr. OLIVER. I believe we have submitted reports on

why the cigarette laboratory was closed; yes.

Mr..LUKEN. When was that?

Mr. OLIVER. We received the request for documents on

Friday. ,

Mr. LUKEN. Pardon me for interrupting.

Mr. OLIVER. I believe the documents have been submit-

ted.

Mr. LUKEN. In your presentation, | thought there was an

inference that the subcommittee had been advised some time

ago as to the closing of the lab.

Mr. OLIVER. I believe Congress was made aware 3

months ago, roughly 3 months that the laboratory had been

closed.

Mr. LUKEN. I apologize. We will go into that in the

questioning. If there is some notice here, | would like to be

looking at it while you are testifying.

Mr. OLIVER. As those materials show, on February 13,

1987, the commission voted unanimously to terminate the

cigarette testing laboratory. The information produced by the

laboratory duplicates data obtainable from other sources.

Government facilities are available to verify that information.

In addition, the cigarette companies themselves have every

incentive to test their rivals’ products to ensure their adver-

tised claims are accurate.

The commission saw no benefit to consumers in continu-

ing to expend taxpayer dollars on the laboratory. Those tax-

payer dollars can be deployed more effectively in other law

enforcement activities.

The FTC notified the appropriate committees and Mem-

bers of the Congress after the commission’s decision was

made, and the House and Senate Appropriation Committees

approved the commission's action. The cigarette laboratory

has since been closed.

As | have already said, I regret that this smal! matter, un-

dertaken without controversy and without objection has dis-

placed discussion of the FTC’s authorization, which was

supposed to take place today.

Mr. William MacLeod, on my left, the Director of the

Bureau of Consumer Protection, is very familiar with the de-

tails of the former laboratory’s operation. If there are any

questions, we will attempt to answer them.

{The prepared statement of Mr. Oliver follows: ]

STATEMENT OF FEDERAL TRADE COMMISSION

| am happy to be here today to present the commission‘s

statement regarding its decision to terminate its in-house

cigarette program. The commission staff's review of the con-

tinuing need for our facilities began in 1982. During its re-

view, staff consulted with representatives from the Surgeon

General’s Office, the Office of Smoking and Health, the Na-

tional Cancer Institute, the major health groups, the tobacco

industry and Congressional staff members.

The commission unanimously voted to close the Ciga-

rette Testing Laboratory on February 13, 1987. That decision

was based not only on the present costs of running the labora-

tory and the additional funds that would be required in order

to update and maintain the laboratory, but on the fact that

those costs would be incurred even though the same informa-

tion is currently being generated by the cigarette industry and

can be obtained from it at little additional cost to the govern-

ment. On February 19, the commission sent letters to the

Chairmen of the Senate and House Appropriations Commit-

tees notifying them of its decision. On March 27, the Senate

Appropriations Committee orally notified the commission

that it had no objections to the closing of the laboratory. By

letter of April 9, the Chairman of the House Appropriations

Committee notified the Commission that he also had no ob-

jections. After receiving these approvals, the commission

formally announced the closing of the laboratory on April 15,

1987.

In 1966, the commission initiated several actions for the

purpose of cncouraging cigarette manufacturers to provide

consumers with accurate comparative information concerning

the tar and nicotine content of the cigarettes that they smoke.

In that year, the commission ended a 6 year ban on tar and

nicotine advertising, adopted a uniform testing system meas-

uring tar and nicotine content, and sent a letter to the domes-

tic manufacturers approving their dissemination of tar and

nicotine claims, if such claims were supported by tests con-

ducted in accordance with the approved method. In 1966, the

commission also created the Cigarette Testing Laboratory to

facilitate the dissemination of tar and nicotine information

pursuant to this uniform testing standard, and begin to pro-

vide the results of its testing periodically to Congress. Since

1971, the cigarette industry has included tar and nicotine rat-

ings in all advertising companies. The current voluntary

agreement among the companies requires the companies to

test new and reformulated cigarettes for tar and nicotine be-

tween commission testing periods using the Commission

standards. In addition, the companies often test each others

brands for accuracy.

Each of the major cigarette companies either has a labo-

ratory of its own or has access to a laboratory to do tar and

nicotine assays. In addition, the Tobacco Institute Testing

Laboratory (TITL), a private laboratory run by the cigarette

industry, does tar and nicotine testing. The methodology,

procedures and processes that the companies and TITL use

are identical to those that the commission has followed. The

equipment used by TITL 1s practically identical to the

equipment that the commission has used, except that in many

cases the equipment is newer or is automated.

| wish to emphasize that the closing of our in-house fa-

cilities will not significantly affect our ability to ensure the

accuracy of tar and nicotine claims. Indeed, the commission

has only recently completed a vigorously contested litigation

involving the accuracy of tar and nicotine claims made by a

major manufacturer. Importantly, that case arose not as a re-

sult of commission testing or monitoring but because of a

competitor’s compl

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