Regulations Restricting the Sale and Distribution of Cigarettes and Smokeless Tobacco to Protect Children and Adolescents
Federal RegisterAug 28, 1996
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SUMMARY: The Food and Drug Administration (FDA) is issuing regulations
governing access to and promotion of nicotine-containing cigarettes and
smokeless tobacco to children and adolescents.
The regulations prohibit the sale of nicotine-containing cigarettes
and smokeless tobacco to individuals under the age of 18; require
manufacturers, distributors, and retailers to comply with certain
conditions regarding the sale and distribution of these products;
require retailers to verify a purchaser's age by photographic
identification; prohibit all free samples and prohibit the sale of
these products through vending machines and self-service displays
except in facilities where individuals under the age of 18 are not
present or permitted at any time; limit the advertising and labeling to
which children and adolescents are exposed to a black-and-white, text-
only format; prohibit the sale or distribution of brand-identified
promotional nontobacco items such as hats and tee shirts; prohibit
sponsorship of sporting and other events, teams, and entries in a brand
name of a tobacco product, but permit such sponsorship in a corporate
name; and require manufacturers to provide intended use information on
all cigarette and smokeless tobacco product labels and in cigarette
advertising.
These regulations will address the serious public health problems
caused by cigarettes and smokeless tobacco products. They will reduce
children's and adolescents' easy access to cigarettes and smokeless
tobacco and will significantly decrease the amount of positive imagery
that makes these products so appealing to that age group.
The regulations are predicated on the agency's assertion of
jurisdiction under the Federal Food, Drug, and Cosmetic Act over
cigarettes and smokeless tobacco as delivery devices for nicotine,
incorporated as part of the regulations for purposes of, and to
facilitate, congressional review under the Small Business Regulatory
Enforcement Fairness Act of 1996.
DATES: Effective date. The regulation is effective August 28, 1997,
except that Sec. 897.14(a) and (b) are effective February 28, 1997 and
Sec. 897.34(c) is effective February 28, 1998.
Compliance dates. Manufacturers and distributors are required to
comply with the requirements of 21 CFR parts 803 and 804 August 28,
1997; manufacturers are required to comply with the requirements of 21
CFR parts 807 and 820 February 28, 1998.
ADDRESSES: References listed in the footnotes of this document have
been placed on public display at the Dockets Management Branch (HFA-
305), Food and Drug Administration, 12420 Parklawn Dr., rm. 1-23,
Rockville, MD 20857, and may be seen by interested persons between 9
a.m. and 4 p.m., Monday through Friday.
FOR FURTHER INFORMATION CONTACT: Nancy Yeates, Office of Policy (HF-
26), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD
20857, 301-827-0867.
SUPPLEMENTARY INFORMATION:
Preamble Outline
I. Introduction
A. Purpose and Overview of the Rule
B. Background
C. Provisions of the Rule
II. Legal Authority
A. Legal Principles Applicable to Combination Drug/Device
Products
1. The SMDA Recognized Combination Products for the First Time
2. The SMDA Leaves to FDA's Discretion the Determination of
Which Regulatory Authorities to Apply to Particular Combination
Products
3. Interpreting the SMDA to Allow the Agency to Determine
Which Regulatory Scheme Best Serves the Public Health is Consistent
With 50 Years of Case Law
4. The Implementing Regulations and the Delegations of
Authority Reflect FDA's Interpretation That Section 503(g) of the
Act Authorizes the Agency to Determine the Appropriate Regulatory
Authorities
5. The Intercenter Agreements and Administrative Precedent
Recognize That FDA May Determine Which Regulatory Authority to Apply
to a Particular Product
B. Cigarettes and Smokeless Tobacco Have Both a Drug and a
Device Component and Are Therefore Combination Products
C. FDA's Choice of Legal Authorities
1. FDA Will Regulate Cigarettes and Smokeless Tobacco Under
the Act's Device Authorities
2. Cigarettes and Smokeless Tobacco Will be Subject to the
Full Range of Device Authorities
3. The Restricted Device Provision Authorizes FDA to Establish
Access and Advertising Restrictions
4. Application of Other Device Authorities
5. FDA Will Classify Cigarettes and Smokeless Tobacco Under
Section 513 of the Act
D. The Fact That the Act's Drug Authorities Authorize the
Imposition of Similar Restrictions Supports the Reasonableness of
the Restrictions That the Agency Has Imposed
E. Constitutional Issues Regarding Authority
1. Separation of Powers
2. Nondelegation Doctrine
III. Overview of Comments, Smoking Prevalence Rates Among Minors,
Scope, Purpose, and Definitions
A. Overview of Comments
B. Smoking Prevalence Rates Among Minors
C. Scope
D. Purpose (Sec. 897.2)
E. Definitions (Sec. 897.3)
IV. Access
A. General Comments
B. General Responsibilities of Manufacturers, Distributors, and
Retailers (Sec. 897.10)
C. Additional Responsibilities of Manufacturers (Sec. 897.12)
1. Removal of Manufacturer-Supplied or Manufacturer-Owned
Items That Do Not Comply With the Regulations
2. Visual Inspections by a Manufacturer's Representative at
Each Point of Sale
D. Additional Responsibilities of Retailers (Sec. 897.14)
1. Use of Photographic Identification to Verify Age
2. Minimum Age
3. Restrictions Against ``Impersonal'' Modes of Sale
4. Restrictions Against the Sale of Individual Cigarettes
5. Additional Comments
E. Conditions of Manufacture, Sale, and Distribution
(Sec. 897.16)
1. Restrictions on Nontobacco Trade Names on Tobacco Products
2. Minimum Package Size
3. Maximum Package Size
4. Impersonal Modes of Sale
V. Label
A. Established Name (Sec. 897.24)
B. Package Design
C. Ingredient Labeling
D. Labeling for Intended Use
E. Adequate Directions for Use and Warnings Against Use (Section
502(f) of the act)
F. Package Inserts
VI. Advertising
A. Subpart D--Restrictions on Advertising and Labeling of
Tobacco Products
B. The Need for Advertising Restrictions
1. Advertising and Young People
2. Advertising and Adults
C. The Regulations Under the First Amendment
1. Introduction
[[Page 44397]]
2. The Central Hudson Test
3. Is Cigarette and Smokeless Tobacco Advertising Misleading,
or Does It Relate to Unlawful Activity?
4. Is the Asserted Government Interest Substantial?
D. Evidence Supporting FDA's Advertising Restrictions
1. Introduction
2. Do the Regulations Directly Advance the Governmental
Interest Asserted?
3. Is There Harm? Does Advertising Affect the Decision by
Young People to Use Tobacco Products?
4. Why Young People Use Tobacco and the Role of Advertising in
That Process
5. Has The Agency Met Its Burden?
6. The Efficacy of the Restrictions; Empirical Evidence
Concerning Advertising Restrictions
E. Provisions of the Final Rule
1. Are FDA's Regulations Narrowly Drawn?
2. Section 897.30(a)--Permissible Forms of Labeling and
Advertising
3. Section 897.30(b)--Billboards
4. Section 897.32(a)--Text-Only Format
5. Section 897.32(a)--Definition of ``Adult Publication''
6. Advertising--Sec. 897.32 Requirements for Disclosure of
Important Information
7. Section 897.34(a) and (b)--Promotions, Nontobacco Items,
and Contests and Games of Chance
8. Section 897.34(c)--Sponsorship of Events
9. Proposed Sec. 897.36--False or Misleading Statements
F. Additional First Amendment Issues
VII. Education Campaign
VIII. Additional Regulatory Requirements
IX. Implementation Dates
X. Relationship Between the Rule and Other Federal and State Laws
A. The Federal Cigarette Labeling and Advertising Act
B. The Comprehensive Smokeless Tobacco Health Education Act
C. Conflict with Congressional Purpose Behind Current Regulatory
Scheme for Tobacco Products
1. The Cigarette Act and the Smokeless Act
2. The PHS Act
D. Occupation of the Field
E. Preemption of State and Local Requirements Under Section
521(a) of the Act
F. Preemption of State Product Liability Claims Under Section
521(a) of the Act
XI. Miscellaneous Constitutional Issues
A. Takings Under the Fifth Amendment
1. The Interests at Issue
2. The Takings Analysis
3. The Character of the Governmental Action
4. The Economic Impact of the Governmental Action
5. Interference with Reasonable Investment-backed Expectations
6. Summary
B. Substantive Due Process, Equal Protection, and Restrictions
on Use of Trade Names
C. Procedural Due Process Under the Fifth Amendment
XII. Procedural Issues
A. Introduction
B. Adequacy of the Record
1. The Administrative Record
2. The Agency's Use of Confidential Documents
3. The Claim that FDA Relied on ``Unknown'' Undisclosed Data
4. The Claim that FDA Failed to Include in the Record New Drug
Application (NDA) Data on Which it Relied
5. The Agency's Reliance in the Final Rulemaking on New
Materials
C. Adequacy of the Notice
1. The Agency Provided Adequate Notice of the Key Legal and
Factual Issues
2. The Agency Provided a ``Reasoned Explanation'' for its
Current Position
D. Adequacy of the Comment Period
E. Conclusion
XIII. Executive Orders
A. Executive Order 12606: The Family
B. Executive Order 12612: Federalism
C. Executive Order 12630: Governmental Actions and Interference
with Constitutionally Protected Property Rights
XIV. Environmental Impact
XV. Analysis of Impacts
A. Introduction and Summary
B. Statement of Need for Action
C. Regulatory Benefits
1. Prevalence-Based Studies
2. FDA's Methodology
3. Reduced Incidence of New Young Smokers
4. Reduced Number of Adult Smokers
5. Lives Saved
6. Life-Years Saved
7. Monetized Benefits of Reduced Tobacco Use
8. Reduced Medical Costs
9. Reduced Morbidity Costs
10. Benefits of Reduced Mortality Rates
11. Reduced Fire Costs
12. Smokeless Tobacco
13. Summary of Benefits
D. Regulatory Costs
1. Number of Affected Retail Establishments
2. Removing Self-Service and Other Prohibited Retail Displays
3. Label Changes
4. Educational Program
5. Restricted Advertising and Promotional Activities
6. Training
7. Access Restrictions
8. I.D. Checks
9. Vending Machines
10. Readership Surveys
11. Records and Reports
12. Government Enforcement
13. Comparison of Benefits to Cost
E. Distributional Effects
1. Tobacco Manufacturers and Distributors
2. Tobacco Growers
3. Vending Machine Operators
4. Advertising Sector
5. Retail Sector
6. Other Private Sectors
7. Excise Tax Revenues
F. Small Business Impacts
G. Other Alternatives
H. Unfunded Mandates Reform Act of 1995
XVI. Paperwork Reduction Act of 1995
A. Comments on the Paperwork Reduction Act Statement
B. Information Collection Provisions in the Final Rule
XVII. Congressional Review
Codified Language
I. Introduction
A. Purpose and Overview of the Rule
This rule establishes regulations restricting the sale and
distribution of cigarettes and smokeless tobacco to children and
adolescents, implementing FDA's determination that it has jurisdiction
over these products under the Federal Food, Drug, and Cosmetic Act (the
act). As described in ``Nicotine in Cigarettes and Smokeless Tobacco Is
a Drug and These Products Are Nicotine Delivery Devices Under the
Federal Food, Drug, and Cosmetic Act: Jurisdictional Determination''
(the 1996 Jurisdictional Determination), annexed hereto, FDA has
determined that cigarettes and smokeless tobacco are intended to affect
the structure or function of the body, within the meaning of the act's
definitions of ``drug'' and ``device.'' The nicotine in cigarettes and
smokeless tobacco is a ``drug,'' which produces significant
pharmacological effects in consumers, including satisfaction of
addiction, stimulation, sedation, and weight control. Cigarettes and
smokeless tobacco are combination products consisting of the drug
nicotine and device components intended to deliver nicotine to the
body.
FDA has chosen to regulate cigarettes and smokeless tobacco under
the act's device authorities. This rule allows the continued marketing
of these products, while employing measures to prevent future
generations of Americans from becoming addicted to them. As discussed
in section I.B. of this document, most people who use cigarettes and
smokeless tobacco begin their use before the age of 18 and, therefore,
before they fully understand the addictive nature and serious health
risks of these products. Even though the sale of tobacco products to
minors is illegal in 50 States, the tobacco industry has adopted
extensive marketing campaigns which appeal to children and adolescents.
Therefore, the rule effects measures that would both complement the
existing State restrictions on access and prevent
[[Page 44398]]
tobacco companies from marketing their products to children and
adolescents.
In determining the best course of action, the agency considered the
highly addictive nature of cigarettes and smokeless tobacco and the
fact that these products have previously been lawfully marketed to
millions of adult Americans. The agency has determined that the
approach outlined in this document--restrictions to reduce the use of
cigarettes and smokeless tobacco by individuals under the age of 18
while leaving these products on the market for adults--is the available
option that is the most consistent with both the act and the agency's
mission to protect the public health.
The agency intends to assist affected entities, including
retailers, distributors, and manufacturers, in complying with the rule.
The agency also will issue a small entities guide in easy to understand
language. In addition, the agency will conduct workshops throughout the
country to assist affected entities in complying with the rule.
B. Background
Approximately 50 million Americans currently smoke cigarettes and
another 6 million use smokeless tobacco. \1\ In the Federal Register of
August 11, 1995 (60 FR 41314), FDA published a proposed rule entitled
``Regulations Restricting the Sale and Distribution of Cigarettes and
Smokeless Tobacco Products to Protect Children and Adolescents'' (the
1995 proposed rule). As stated in the preamble to the 1995 proposed
rule, tobacco use is the single leading cause of preventable death in
the United States. \2\ More than 400,000 people die each year from
tobacco-related illnesses, such as cancer, respiratory illnesses, and
heart disease, often suffering long and painful deaths. \3\ Tobacco
alone kills more people each year in the United States than acquired
immunodeficiency syndrome (AIDS), car accidents, alcohol, homicides,
illegal drugs, suicides, and fires, combined. \4\
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\1\ ``National Household Survey on Drug Abuse: Population
Estimate 1993, Department of Health and Human Services (DHHS),
Public Health Service (PHS), Substance and Mental Health Services
Administration (SAMHSA), Office of Applied Studies, Rockville, MD,
Pub. No. (SMA) 94-3017, pp. 89 and 95, 1994.
\2\ ``Cigarette Smoking--Attributable Mortality and Years of
Potential Life Lost--United States, 1990,'' Mortality and Morbidity
Weekly Report, (MMWR) CDC, DHHS, vol. 42, No. 33, pp. 645-649, 1993;
Lynch, B. S., and R. J. Bonnie, editors, Growing Up Tobacco Free--
Preventing Nicotine Addiction in Children and Youths, Committee on
Preventing Nicotine Addiction in Children and Youths, Division of
Biobehavioral Sciences and Mental Disorders, Institute of Medicine,
National Academy Press, Washington, DC, p.3, 1994, (hereinafter
cited as ``IOM Report'').
\3\ ``Cigarette Smoking--Attributable Mortality and Years of
Potential Life Lost--United States, 1990,'' MMWR, CDC, DHHS, vol.
42, No. 33, pp. 645-649, 1993.
\4\ IOM Report, pp. 3-4.
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Tobacco products have historically been legal and widely available
in this country. It was only after millions of people became addicted
to the nicotine in cigarettes and smokeless tobacco that health experts
became fully aware of the extraordinary health risks involved in the
consumption of these products. Consequently, tobacco use has become one
of the most serious public health problems facing the United States
today. Because of the grave health consequences of the use of tobacco
products, some have argued that they should be removed from the market.
However, a ban would have adverse health consequences and would not
be likely to prevent individuals from gaining access to these products.
Of the 50 million people who use cigarettes, 77 to 92 percent are
addicted. \5\ Data suggest that almost as many smokeless tobacco users
may be addicted. \6\ Adverse health consequences could result if these
people were suddenly deprived of the nicotine these products deliver.
As stated in the preamble to the 1995 proposed rule:
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\5\ See authorities cited at 1996 Jurisdictional Determination,
Section II(B)(2)(a).
\6\ Id.
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Because of the high addiction rates and the difficulties smokers
experience when they attempt to quit, there may be adverse health
consequences for many individuals if the products were to be
withdrawn suddenly from the marketplace. Our current health care
system and available pharmaceuticals may not be able to provide
adequate or sufficiently safe treatment for such a precipitous
withdrawal.
(60 FR 41314 at 41348)
A similar situation would exist for addicted smokeless tobacco users.
It is probable also that a black market and smuggling would develop
to supply addicted users with these products. As stated in the preamble
to the 1995 proposed rule, and discussed further in section II.C.5. of
this document, ``[t]he products that would be available through a black
market could very well be more dangerous (e.g., cigarettes containing
more tar or nicotine, or more toxic additives) than products currently
on the market'' (60 FR 41314 at 41349). Thus, the agency has concluded
that, while taking cigarettes and smokeless tobacco off the market
could prevent some people from becoming addicted and reduce death and
disease for others, the record does not establish that such a ban is
the appropriate public health response under the act.
To effectively address the death and disease caused by tobacco
products, addiction to cigarettes and smokeless tobacco must be
eliminated or substantially reduced. The evidence demonstrates that
this can be achieved only by preventing children and adolescents from
starting to use tobacco. Most people who suffer the adverse health
consequences of using cigarettes and smokeless tobacco begin their use
before they reach the age of 18, an age when they are not prepared for,
or equipped to, make a decision that, for many, will have lifelong
consequences. These young people do not fully understand the serious
health risks of these products or do not believe that those risks apply
to them. They are also very impressionable and therefore vulnerable to
the sophisticated marketing techniques employed by the tobacco
industry, techniques that associate the use of tobacco products with
excitement, glamour, and independence. When cigarette and smokeless
tobacco use by children and adolescents results in addiction, as it so
often does, these youths lose their freedom to choose whether or not to
use the products as adults.
The facts on underage use confirm this pattern. As stated in the
preamble to the 1995 proposed rule, approximately 3 million American
adolescents currently smoke and an additional 1 million adolescent
males use smokeless tobacco. \7\ Eighty-two percent of adults who ever
smoked had their first cigarette before the age of 18, and more than
half of them had already become regular smokers by that age. \8\ Among
smokers ages 12 to 17 years, 70 percent already regret their decision
to smoke and 66 percent say that they want to quit. \9\
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\7\ ``Preventing Tobacco Use Among Young People: A Report of the
Surgeon General,'' DHHS, PHS, CDC, National Center for Chronic
Disease Prevention and Health Promotion, the Office on Smoking and
Health (OSH), Atlanta, GA, p. 5, 1994, (hereinafter cited as ``1994
SGR'').
\8\ 1994 SGR, p. 65.
\9\ ``Teen-Age Attitudes and Behavior Concerning Tobacco,'' The
George H. Gallup International Institute, p. 54, September 1992.
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Moreover, children and adolescents are beginning to smoke at
younger ages than ever before. Despite a decline in smoking rates in
most segments of the American adult population, the rates among
children and adolescents have recently begun to rise. \10\ Data
reported
[[Page 44399]]
in December 1995, after publication of the 1995 proposed rule, showed
increases in 30-day prevalence rates of cigarette smoking for 4
consecutive years for 8th- and 10th-graders, and 3 consecutive years
for high school seniors. \11\ Daily use of cigarettes by 8th-, 10th-,
and 12th-graders has also increased in each of the last 3 years. \12\
The percentage of 8th- and 10th-graders who reported smoking in the 30
days before the survey had risen by one-third since 1991 to about 19
percent and 28 percent, respectively. \13\ Similarly, the percentage of
high school seniors saying that they had smoked in the 30 days before
the survey had increased by more than one-fifth since 1991, to about
33.5 percent or one in three. \14\
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\10\ ``Cigarette Smoking Among Adults--United States, 1991,''
MMWR, DHHS, CDC, vol. 42, No. 12, pp. 230-233, 1993; Johnston, L.
D., P. M. O'Malley, and J. G. Bachman, ``National Survey Results on
Drug Use from the Monitoring the Future Study 1975-1993, vol. I:
Secondary School Students,'' Rockville, MD, DHHS, PHS, National
Institutes of Health (NIH), National Institute on Drug Abuse (NIDA),
NIH Pub. No. 94-3809, pp. 9 and 19, 79, 80, and 101, 1994; ``Smoking
Rates Climb Among American Teen-agers, Who Find Smoking Increasingly
Acceptable and Seriously Underestimate the Risks,'' The University
of Michigan News and Information Service, Table 1., July 17, 1995.
\11\ ``Results from the 1995 Monitoring the Future Survey,''
National Institute on Drug Abuse Briefing for Donna E. Shalala,
Ph.D., Secretary of Health and Human Services, December 13, 1995.
\12\ Id.
\13\ Id.
\14\ Id.
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An adolescent whose cigarette use continues into adulthood
increases his or her risk of dying from cancer, cardiovascular disease,
or lung disease. \15\ Moreover, the earlier a young person's smoking
habit begins, the more likely he or she will become a heavy smoker and
therefore suffer a greater risk of diseases caused by smoking. \16\
Approximately one out of every three young people who become regular
smokers each day will die prematurely as a result. \17\
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\15\ McGinnis, J. M., and W. H. Foege, ``Actual Causes of Death
in the United States,'' Journal of the American Medical Association
(JAMA), vol. 270, No. 18, pp. 2207-2212, 1993; ``Reducing Health
Consequences of Smoking: 25 Years of Progress, A Report of the
Surgeon General,'' DHHS, PHS, CDC, National Center for Chronic
Disease Prevention and Health Promotion (NCCDPHP), OSH, DHHS Pub.
No. 89-8411, p. 5, 1989, (hereinafter cited as ``1989 SGR''); See
generally ``The Health Consequences of Smoking: Chronic Obstructive
Lung Disease: A Report of the Surgeon General,'' DHHS, PHS, OSH,
1984, (hereinafter cited as ``1984 SGR''); ``The Health Consequences
of Smoking: Cardiovascular Disease--A Report of the Surgeon
General,'' DHHS, PHS, OSH, 1983 (hereinafter cited as ``1983 SGR'');
``The Health Consequences of Smoking: Cancer--A Report of the
Surgeon General,'' DHHS, PHS, OSH, 1982, (hereinafter cited as
``1982 SGR'').
\16\ Taioli, E., and E. L. Wynder, ``Effect of the Age at Which
Smoking Begins on Frequency of Smoking in Adulthood,'' The New
England Journal of Medicine, vol. 325, No. 13, pp. 968-969, 1991;
Escobedo, L. G., et al. ``Sports Participation, Age at Smoking
Initiation, and the Risk of Smoking Among U.S. High School
Students,'' JAMA, vol. 269, No. 11, pp. 1391-1395, 1993; see also
1994 SGR, p. 65.
\17\ Memorandum from Michael P. Eriksen (CDC) to Catherine
Lorraine (FDA) August 7, 1995 and CDC Fact Sheet (based on J. P.
Pierce, M. C. Fiore, T. E. Novotny, E. J. Hatziandreu, and R. M.
Davis, ``Trends in Cigarette Smoking in the United States:
Projections to the Year 2000,'' JAMA, vol. 261, pp. 61-65, 1989;
Unpublished data from the 1986 National Mortality Followback Survey,
CDC, OSH; Peto, R., A. D. Lopez, J. Boreham, M. Thun, and C. Heath,
Jr., ``Mortality from Smoking in Developed Countries, 1950-2000:
Indirect Estimates from National Vital Statistics,'' Oxford
University Press, Oxford, 1994).
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Similar problems exist with underage use of smokeless tobacco. As
stated in the 1995 proposed rule, the market for smokeless tobacco has
shifted dramatically toward young people since 1970 (60 FR 41314 at
41317). School-based surveys in 1991 estimated that 19.2 percent of 9th
to 12th-grade boys use smokeless tobacco. \18\ Among high school
seniors who had ever tried smokeless tobacco, 73 percent did so by the
9th grade. \19\
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\18\ Kann, L., W. Warren, J. L. Collins, J. Ross, B. Collins,
and L. J. Kolbe, ``Results from the National School-Based 1991 Youth
Risk Behavior Survey and Progress Toward Achieving Related Health
Objectives for the Nation,'' Public Health Reports, vol. 108, (Supp.
1), pp. 47-54, 1993.
\19\ 1994 SGR, p. 101.
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As long as children and adolescents become addicted to cigarette
and smokeless tobacco use in these numbers, there is little chance that
society will be able reduce the toll of tobacco-related illnesses. If,
however, the number of children and adolescents who begin tobacco use
can be substantially diminished, tobacco-related illness can be
correspondingly reduced because data suggest that anyone who does not
begin smoking in childhood or adolescence is unlikely to ever begin.
\20\
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\20\ Id., pp. 5, 58, and 65-67.
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On the basis of this evidence, the agency has determined that
establishing restrictions to substantially reduce the number of
children and adolescents who become addicted to cigarettes and
smokeless tobacco best serves its public health obligations. Because
such a small percentage of the U.S. population begins tobacco use after
the age of 18, limiting the use of these products to the adult
population would substantially reduce the principal source of new
users. Thus, the appropriate emphasis is on reducing the use of tobacco
products by children and adolescents.
Evidence in the administrative record demonstrates that the most
effective way to achieve such a reduction is by limiting the access to,
and attractiveness of, cigarettes and smokeless tobacco to young
people. FDA concludes that the act provides sufficient authority to
issue regulations that, while leaving these products on the market for
adult use, restrict access to and promotion of cigarettes and smokeless
tobacco to those under 18 years of age.
C. Provisions of the Rule
After considering numerous comments submitted in response to the
1995 proposed rule, the agency is adopting the rule in modified form.
New part 897 is being added to Title 21 of the Code of Federal
Regulations and contains the regulations governing the labeling,
advertising, sale, and distribution of cigarettes and smokeless tobacco
to children and adolescents.
FDA is regulating nicotine-containing cigarettes and smokeless
tobacco as restricted devices within the meaning of the section 520(e)
of the act (21 U.S.C. 360j(e)). While leaving these products on the
market for adults, the final rule prohibits the sale of nicotine-
containing cigarettes and smokeless tobacco to individuals under the
age of 18 and requires manufacturers, distributors, and retailers to
comply with certain conditions regarding access to, and promotion of,
these products. Among other things, the final rule requires retailers
to verify a purchaser's age by photographic identification. It also
prohibits all free samples and prohibits the sale of these products
through vending machines and self-service displays except in facilities
where individuals under the age of 18 are not present or permitted at
any time. The rule also limits the advertising and labeling to which
children and adolescents are exposed. The rule accomplishes this by
generally restricting advertising to which children and adolescents are
exposed to a black-and-white, text-only format. In addition, billboards
and other outdoor advertising are prohibited within 1,000 feet of
schools and public playgrounds. The rule also prohibits the sale or
distribution of brand-identified promotional, nontobacco items such as
hats and tee shirts. Furthermore, the rule prohibits sponsorship of
sporting and other events, teams, and entries in a brand name of a
tobacco product, but permits such sponsorship in a corporate name. This
rule is intended to complement the regulations issued by SAMHSA
implementing section 1926 of the Public Health Service Act (42 U.S.C.
300x-26) regarding the sale and
[[Page 44400]]
distribution of tobacco products to individuals under the age of 18
(the SAMHSA rule).
In this document, FDA: (1) Presents its analysis of its authority
to issue regulations that impose the enumerated restrictions on the
sale and promotion of cigarettes and smokeless tobacco to those under
the age of 18, while leaving cigarettes and smokeless tobacco on the
market for adults; and (2) responds to comments on the proposed rule.
II. Legal Authority
In the 1996 Jurisdictional Determination, annexed hereto, the Food
and Drug Administration (FDA) \21\ has determined that cigarettes and
smokeless tobacco are combination products consisting of a drug
(nicotine) and device components intended to deliver nicotine to the
body. The agency may regulate a drug/device combination product using
the Federal Food, Drug, and Cosmetic Act's (the act's) drug
authorities, device authorities, or both. The agency exercises its
discretion to determine which authorities to apply in the regulation of
combination products to provide the most effective protection to the
public health. FDA has determined that tobacco products are most
appropriately regulated under the device provisions of the act,
including the restricted device authority in section 520(e) of the act
(21 U.S.C. 360j(e)).
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\21\ The Secretary of the Department of Health and Human
Services (DHHS) (the Secretary) has the authority to carry out
functions under the act through the Commissioner of Food and Drugs
(the Commissioner). (See section 903 of the act (21 U.S.C. 393); 21
CFR 5.10 and 5.11.) Throughout this document, references to FDA
include the Secretary and the Commissioner.
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A. Legal Principles Applicable to Combination Drug/Device Products
The agency's discretion to choose the appropriate regulatory tools
under the act is based, in part, on the authority provided under the
Safe Medical Devices Act of 1990 (the SMDA). FDA's interpretation,
supported by the language of the statute and its legislative history,
is embodied in the agency's implementing regulations codified at part 3
(21 CFR part 3), the delegations of premarket approval authority to
FDA's Center for Drug Evaluation and Research (CDER), Center for
Devices and Radiological Health (CDRH), and Center for Biologics
Evaluation and Research (CBER) that enable all three Centers to
administer statutory authority for drugs, devices, and biologics (56 FR
58758, November 21, 1991), and the ``intercenter agreements'' that
guide the agency in allocating Center responsibility for various
categories of combination products (56 FR 58760, November 21, 1991). In
addition to the authority provided by the SMDA, the agency's discretion
is also based on the principles recognized by the Supreme Court in
cases such as United States v. An Article of Drug * * * Bacto-Unidisk,
394 U.S. 784 (1969). In Bacto-Unidisk, for example, the Supreme Court
upheld the agency's decision to regulate a diagnostic test kit under
its drug authorities on the grounds that ``[i]t is enough for us that
the expert agency charged with the enforcement of remedial legislation
has determined that such regulation is desirable for the public health
* * *.'' (Bacto-Unidisk 394 U.S. at 791-792.)
The discussion that follows describes in more detail FDA's
interpretation of the combination product provisions of the SMDA, the
agency's understanding of combination products, and the way in which
the agency has exercised its discretion in determining the most
appropriate authorities to apply to regulate combination products.
1. The SMDA Recognized Combination Products for the First Time
Congress enacted the SMDA's combination product provisions to
recognize combination products as distinct entities subject to
regulation under the act and to alleviate the difficulty the agency had
experienced in regulating such products, especially those consisting of
components of both a drug and a device. First, the SMDA explicitly
recognized the existence of products that ``constitute a combination of
a drug, device, or biological product'' (section 503(g)(1) of the act
(21 U.S.C. 353(g)(1))). Second, the statute provided a mechanism for
determining which agency component would be assigned the administrative
responsibility of regulating a particular combination product (Id.).
In accordance with its recognition of combination products, the
SMDA changed the statutory definitions of ``drug'' and ``device'' at
section 201(g) and (h) of the act (21 U.S.C. 321(g) and (h)). Before
the enactment of the SMDA, section 201(g) of the act provided that a
drug ``does not include devices or their components, parts, or
accessories.'' The SMDA removed this language from the definition of
``drug'' so that the terms ``drug'' and ``device'' were no longer
mutually exclusive, thereby making it possible for a combination
product consisting of both a drug and device to be regarded as an
independent entity subject to regulation. The legislative history
indicates that this definitional change was made ``to accommodate the
principle of [combination products in] section 20'' (S. Rept. 101-513,
101st Cong. 2d sess., at 30 (1990)). For the first time it was
possible, as a legal matter, for a single product to have both drug and
device components.
The SMDA also permitted a wider range of products to meet the
definition of a device. Prior to its amendment by the SMDA, section
201(h) of the act defined a ``device'' as an instrument or other item
that, among other things, ``does not achieve any of its principal
intended purposes through chemical action within or on the body of man
or other animals and which is not dependent upon being metabolized for
the achievement of any of its principal intended purposes.'' The SMDA
changed the phrase ``any of its principal intended purposes'' in the
definition to read, ``its primary intended purposes.'' This change
broadened the definition of device and allowed more products to be
categorized as devices.
2. The SMDA Leaves to FDA's Discretion the Determination of Which
Regulatory Authorities to Apply to Particular Combination Products
Having recognized combination products, the SMDA also provided a
clear mechanism for determining which agency component a particular
combination product should be directed to for review. Under the SMDA,
the agency must:
[d]etermine the primary mode of action of the combination
product. If the [agency] determines that the primary mode of action
is that of--
(A) a drug (other than a biological product), the persons
charged with premarket review of drugs shall have primary
jurisdiction,
(B) a device, the persons charged with premarket review of
devices shall have primary jurisdiction, or
(C) a biological product, the persons charged with premarket
review of biological products shall have primary jurisdiction.
(Section 503(g)(1) of the act)
This section of the SMDA ``provide[d] the [agency] with firm ground
rules to direct products promptly to that part of FDA responsible for
reviewing the article that provides the primary mode of action of the
combination product'' (S. Rept. 101-513, 101st Cong., 2d sess., 30
(1990)).
Although the SMDA provided a mechanism for determining which agency
component, i.e., a Center, should review a particular combination
product, the legislation left to FDA the discretion to decide which
statutory authorities it would use in regulating a particular
combination product. The
[[Page 44401]]
language of the SMDA makes this clear, as does the legislative history
of the statute. Indeed, an earlier version of the bill, S. 3006, would
arguably have removed this discretion by requiring the agency to
regulate a product based only on its Center assignment. Thus, for
example, if the primary mode of action were that of a drug, the product
would be subject to regulation by CDER under the act's drug
authorities. The earlier version's language, which Congress chose to
strike from the final enactment, provided in relevant part:
The [agency] shall require only one market clearance route for
an article that constitutes a combination of a device, drug, or
biological product. If the [agency] determines that the primary mode
of action of the combination article is that of--
(A) a drug (other than a biological product), neither the
combination article nor any part of the article shall be treated as
a device or as a biological product for market clearance purposes;
(B) a device, neither the combination article nor any part of
the article shall be treated as a drug or a biological product for
market clearance purposes; or
(C) a biological product, neither the combination article nor
any part of the article shall be treated as a drug or a device for
market clearance purposes.
(136 Congressional Record, S.12493, 101st Cong., 2d sess., August 4,
1990)
The omission of this language from the statute indicates that while
Congress considered dictating which regulatory authority must be
applied to particular combination products, and knew how to craft
language to accomplish such a result, Congress ultimately chose to rely
on FDA's expertise in determining the most appropriate regulatory tools
needed to ensure the safety and effectiveness of the combination
products that it regulates.
Moreover, Congress enacted language that recognizes that the agency
may choose the appropriate regulatory authority for a particular
combination product. Section 503(g)(2) of the act provides that nothing
``shall prevent the [Agency] from using any agency resources of the
Food and Drug Administration necessary to ensure adequate review of the
safety, effectiveness, or substantial equivalence of an article.''
Since the enactment of the SMDA, the agency has interpreted the phrase
``any agency resources'' to include administrative resources and all
applicable statutory authorities. See Drug/Device Intercenter
Agreement, p. 2, contemporaneous interpretation that:
[u]nder the provisions of the Safe Medical Devices Act of 1990
and regulations promulgated to implement the combination product
provisions of the Act, [the Center for Drug Evaluation and Research]
and [the Center for Devices and Radiological Health] each may use
both the drug and device provisions of the Federal Food, Drug, and
Cosmetic Act as appropriate to regulate a combination product.
(See 21 CFR Part 3).
(See also 56 FR 58754 at 58759, November 21, 1991 (FDA amending its
procedural regulations at part 5 by adding delegations of authority
relating to the premarket review of combination products to state that
those specified officials in CBER, CDRH, or CDER ``who currently hold
delegated premarket approval authority for biologics, devices, or
drugs, respectively, are hereby delegated all the authorities necessary
for premarket approval of any product that is a biologic, a device, or
a drug, or any combination of two or more of these products: * * *''
(21 CFR 5.33).) Thus, when a combination product, a single entity,
consists of a component that may be regulated as a drug, the act's drug
provisions and device provisions are ``resources'' available to the
agency for regulating the product.
(1) One comment disputed the agency's interpretation of section
503(g)(2) of the act, stating that the language of section 503(g)(2)
can be construed to mean only ``people, laboratories, and other agency
support. The term `Agency resources' does not mean `legal authorities'
as FDA would like to believe.''
FDA disagrees with this comment. The agency notes that there is
nothing in the statute itself or the legislative history that suggests
any reason that the expansive phrase ``any FDA resources'' should be
narrowly interpreted given the important public health benefit
(``ensuring an adequate premarket review'') that is the goal of this
section of the SMDA. The agency's interpretation of this language is
supported by the SMDA's legislative history, which is discussed more
fully in section II.A.2. of this document. More importantly, as
discussed previously, the agency has the discretion under the statute
as enacted to choose the regulatory authorities most appropriate to the
specific product at issue.
3. Interpreting the SMDA to Allow the Agency to Determine Which
Regulatory Scheme Best Serves the Public Health is Consistent With 50
Years of Case Law
Construing the act as allowing the agency discretion to choose the
most appropriate regulatory tools for a particular combination product
is consistent with over 50 years of judicial precedent. The importance
of interpreting the act in a manner that is consistent with the public
health purposes of the act was recognized by the Supreme Court in
United States v. Dotterweich, 320 U.S. 277 (1943). This case, decided
shortly after substantial changes were made to expand the agency's
authority by the 1938 act, addressed the breadth of the term ``person''
in determining who was subject to prosecution for violations of the
act. The Court described the spirit in which the statute should be
interpreted:
By the Act of 1938, Congress extended the range of its control
over illicit and noxious articles and stiffened the penalties for
disobedience. The purposes of this legislation thus touch phases of
the lives and health of people which, in the circumstances of modern
industrialism, are largely beyond self-protection. Regard for these
purposes should infuse construction of the legislation if it is to
be treated as a working instrument of government and not merely as a
collection of English words.
(Id. at 280)
The approach in Dotterweich was followed by a number of cases in
which FDA's interpretation of the statute, especially in the area of
selecting how to regulate a product to achieve a public health purpose,
has been granted deference and has been upheld. In United States v. An
Article of Drug * * * Bacto-Unidisk, 394 U.S. 784 (1969), FDA's
interpretation of the definition of the term ``drug'' and the
applicability of the premarket review requirements were at issue. The
Court upheld the agency's expansive interpretation of the definition of
``drug'' to include a laboratory screening product, in large part
because this interpretation resulted in greater protection of the
public health by virtue of the premarket review that the product would
be subject to as a drug. As the Court reasoned:
It is enough for us that the expert agency charged with the
enforcement of remedial legislation has determined that such
regulation is desirable for the public health, for we are hardly
qualified to second-guess the Secretary's medical judgment.
(Bacto-Unidisk, 394 U.S. at 791-792)
The Court further stated:
The historical expansion of the definition of drug, and the
creation of a parallel concept of devices, clearly show, we think,
that Congress fully intended that the Act's coverage be as broad as
its literal language indicates--and equally clearly, broader than
any strict medical definition might otherwise allow * * *. But we
are all the more convinced that we must give effect to congressional
intent in view of the well-accepted principle that remedial
legislation such as the Food, Drug, and Cosmetic Act is
[[Page 44402]]
to be given a liberal construction consistent with the Act's
overriding purpose to protect the public health, and specifically,
Sec. 507's purpose to ensure that antibiotic products marketed serve
the public with `efficacy' and `safety.'
(Id. at 798); (See also U.S. v. 25 Cases, More or Less, of An Article
of a Device, * * * Sensor Pads, 942 F.2d 1179 (7th Cir. 1991)
(upholding FDA's determination that a latex bag filled with a layer of
silicone lubricant that was intended to aid women in self-examinations
for early detection of breast cancer was a device, because, among other
reasons, the court deferred to the agency's discretion to interpret its
own statute based on the legislative history of the act and on the
principles announced in Chevron U.S.A., Inc. v. Natural Resources
Defense Council, Inc., 467 U.S. 837 (1984)); AMP, Inc. v. Gardner, 389
F.2d 825, 830 (2d Cir.), cert. denied, sub nom. AMP, Inc. v. Cohen, 393
U.S. 825 (1968) (upholding FDA's classification of appellant's product
for tying off severed blood vessels as a drug because, in part, the
court was reluctant to give a narrow construction to the act,
``touching the public health as it does'').)
These cases stand for two principles: (1) FDA's interpretations of
its own statute should be given deference, and (2) the act should be
interpreted expansively to achieve its primary purpose, protecting the
public health. These principles support the agency's determinations,
carefully made after applying its considerable scientific expertise to
the evaluation of the evidence before it, that cigarettes and smokeless
tobacco are drug delivery devices and that these combination products
are most appropriately regulated using the device authorities of the
act. The agency's decision regarding tobacco products is consistent
with other determinations that the agency has made, which have been
upheld and endorsed by the courts, to regulate products in the most
reasonable manner that will result in the best protection of the public
health.
4. The Implementing Regulations and the Delegations of Authority
Reflect FDA's Interpretation That Section 503(g) of the Act Authorizes
the Agency to Determine the Appropriate Regulatory Authorities
FDA's implementing regulations and delegations of authority,
adopted shortly after passage of the SMDA, reflect the agency's
contemporaneous interpretation of section 503(g) of the act as
authorizing the agency to apply the most appropriate regulatory
authorities to any given combination product. In Sec. 3.2(e)(1), FDA
defined a combination product to include, in relevant part:
A product comprised of two or more regulated components, i.e.,
drug/device, biologic/device, drug/biologic, or drug/device/
biologic, that are physically, chemically, or otherwise combined or
mixed and produced as a single entity[.]
In a final rule that published in the Federal Register of November
21, 1991 (56 FR 58754), the agency explained that ``the term
combination product means a product comprised of two or more different
regulated entities, e.g., drug, device, or biologic * * *'' or that are
produced together as a single entity, packaged together, or used
together to achieve the intended effect. Thus, the fact that a single
product contains elements of two or more regulated entities does not
change the regulatory status of the individual elements. Each
``different regulated entit[y]'' of the combination continues to
satisfy the criteria of its relevant statutory definition; that is, a
drug component must satisfy the definition in section 201(g) of the
act, and a device component must comply with the definition in section
201(h) of the act. Because the elements of a combination product meet
more than one jurisdictional definition, the agency may apply one or
more sets of regulatory provisions to the product.
In the same issue of the Federal Register in which the agency
published the final regulations governing combination products, the
agency published delegations of authority that allow the officials in
CDER, CDRH, and CBER to utilize the premarket approval authorities for
any product that is a drug, device, biologic, or any combination of two
or more of these (56 FR 58758, November 21, 1991 (21 CFR 5.32)). These
delegations allow the officials of one Center to conduct a premarket
review of a product under another Center's regulatory authority,
thereby making it possible, for example, for CDER to review a drug/
device combination product under the device authorities. While the
combination product regulations created the procedure for making the
proper Center assignment, the delegations were necessary in order for
FDA to exercise its discretion to determine which regulatory authority
is most appropriate and to make it possible to apply that authority to
review a particular product. If the primary mode of action of a
combination product having drug and device components resulted in the
assignment of the product to CDER, for example, but the agency
determined that the device component of the product presented the most
important regulatory and scientific questions, the delegations make it
possible for CDER officials to conduct the premarket review of the
product under the device provisions of the act.
The regulations and the delegations of authority constitute the
agency's contemporaneous interpretation of section 503(g) of the act as
granting the agency discretion to choose the premarket approval
authority that provides the best public health protection. Such
contemporaneous interpretations by an agency are entitled to
considerable deference by the courts. (See Young v. Community Nutrition
Institute, 476 U.S. 974 (1986).)
5. The Intercenter Agreements and Administrative Precedent Recognize
That FDA May Determine Which Regulatory Authority to Apply to a
Particular Product
In addition to the regulations and delegations of authority
implementing section 503(g) of the act, FDA has also adopted and made
public three guidance documents, entitled ``Intercenter Agreements,''
that describe the agreements reached among the Centers about regulatory
pathways for specified products or classes of products as of October
31, 1991. (See Intercenter Agreement Between the Center for Biologics
Evaluation and Research and the Center for Devices and Radiological
Health; Intercenter Agreement Between the Center for Drug Evaluation
and Research and the Center for Devices and Radiological Health (the
Drug/Device Agreement); and Intercenter Agreement Between the Center
for Drug Evaluation and Research and the Center for Biologics
Evaluation and Research.)
These documents detail which Center generally will have the lead
responsibility for regulating particular types of products. The
Intercenter Agreements also state which regulatory authority usually
will be applied to specific products. For example, the Drug/Device
Agreement provides that a device with the primary purpose of delivering
or aiding in the delivery of a drug and distributed containing a drug
(i.e., ``prefilled delivery system'') will be regulated by ``CDER using
drug authorities and device authorities, as necessary'' (Drug/Device
Agreement, p. 6). Examples given of such combination products include a
nebulizer, prefilled syringe, and transdermal patch (Drug/Device
Agreement, p. 6). The Drug/Device Agreement specifically provides that
such combination products may be regulated under either the drug or
[[Page 44403]]
device authorities, whichever is more appropriate for a particular
product. \22\
---------------------------------------------------------------------------
\22\ A later section of the Drug/Device Agreement states that a
``device containing a drug substance as a component with the primary
purpose of the combination product being to fulfill a drug purpose
is a combination product and will be regulated as a drug by CDER.''
While this is the approach that FDA will usually take with such
products, the earlier language of the Drug/Device Agreement
expressly recognizes that FDA may use its device authorities where
appropriate, and as discussed in the text, there are several
examples of this type of prefilled delivery system being regulated
using the device authorities.
---------------------------------------------------------------------------
FDA's implementation of the Intercenter Agreement reflects these
understandings. For example, one drug delivery product that has been
regulated under the device authorities under the Drug/Device Agreement
is the prefilled, intravenous infusion pump, manufactured by two
companies. These are pumps designed to be sold prefilled with a
diluent, either a sodium chloride solution or a dextrose solution. FDA
regulates the diluents in the pumps as drugs under section 201(g)(1)(B)
of the act because they are intended for use in the treatment of
disease. The pumps are combination products consisting of a device
component, the pump, and a drug component, the diluent; and the
product's purpose is to deliver the diluent to be mixed by the doctor
or other health care provider attending the patient with another drug
substance for infusion into the patient. These pumps prefilled with
diluents are clearly ``a device containing a drug substance as a
component with the primary purpose of the combination product being to
fulfill a drug purpose'' that would be regulated as a drug according to
the general principle stated in the Drug/Device Agreement (Drug/Device
Agreement, p. 14). However, the agency exercised its discretion and
determined that these drug delivery products should be regulated under
the device authorities.
The agency based its determination on the fact that the drugs that
were delivered by the products, saline and dextrose, are two
ingredients very commonly used in intravenous infusions about which the
agency had a wealth of scientific information and thorough regulatory
experience. The pumps, the device component of this combination,
however, operated on novel design principles. Because the device
components of these combination products were new and raised
significant regulatory questions, the agency determined that the
products would receive the most appropriate premarket review if the
device authorities were applied.
Another example of the agency's use of its discretion and its
ability under the guidance in the Intercenter Agreements to make a
sensible decision about product assignment is its decision regarding
regulation of a catheter flush solution containing a blood-thinning
drug and an antibiotic. The solution is intended as a flush solution to
prevent the catheter (or tube) inserted into a patient's body from
becoming clogged with blood and to prevent dangerous bacteria from
growing in the catheter. Under the Drug/Device Agreement, this product
would appear to fit into the category of a ``liquid * * * or other
similar formulation intended only to serve as a component * * * to a
device with a primary mode of action that is physical in nature [and]
will be regulated as a device by CDRH'' (see Drug/Device Agreement, p.
13). The agency did determine that the product's premarket review would
be conducted under the device authorities, but it assigned the review
responsibility to CDER. The decision to follow an approach different
from the one generally suggested in the Drug/Device Agreement was based
on the fact that the inclusion of the blood-thinning and anti-infective
drugs in the flush solution represented an innovation in such solutions
and raised important scientific and regulatory questions that were most
properly reviewed by the scientists in CDER. Because CDER was assigned
the lead, the sponsor of this product was informed that the clinical
investigations of this product should proceed under the investigational
drug provisions of the act (section 505(i) of the act (21 U.S.C.
355(i)). This determination tailored the act's premarket review
provisions, incorporating the most appropriate sections of both the
drug and device authorities without being redundant, to the special
features of this original product.
The agency has thus in the past made its jurisdiction decisions by
determining the most reasonable course of action to protect public
health given the scientific questions presented by each product. FDA
considers essential its ability to continue to assess the individual
circumstances of particular products. This will allow the agency to
respond to technological developments, expanded scientific
understanding, or additional factual information concerning a specific
product or class of products.
B. Cigarettes and Smokeless Tobacco Have Both a Drug and a Device
Component and Are Therefore Combination Products
As discussed in detail in the 1996 Jurisdictional Determination,
the agency has concluded that the nicotine in cigarettes and smokeless
tobacco is a drug within the meaning of section 201(g)(1)(C) of the
act. The agency has also concluded that cigarettes and smokeless
tobacco contain, in addition to the drug nicotine, delivery device
components that deliver a controlled amount of nicotine to the body.
Thus, cigarettes and smokeless tobacco are combination products that
contain both a ``drug'' and a ``device.''
The agency further concluded that processed loose cigarette
tobacco, which is used by smokers who roll their own cigarettes, is a
combination product.
C. FDA's Choice of Legal Authorities
1. FDA Will Regulate Cigarettes and Smokeless Tobacco Under the Act's
Device Authorities
Having established that cigarettes and smokeless tobacco are
combination products consisting of both a drug component and device
components, the agency has the discretion to choose whether it will
regulate these products under the act's drug authorities, device
authorities, or both if appropriate. Making this determination requires
FDA to consider how the public health goals of the act can be best
accomplished.
The act's drug and device provisions have a common objective: To
ensure the safety and effectiveness of regulated products. They also
provide the agency with similar authorities to regulate drugs and
devices. In certain ways, however, the device provisions offer FDA more
flexibility. The Medical Device Amendments of 1976 (the Medical Device
Amendments) were enacted nearly 40 years after the act itself. During
that period of time, Congress observed FDA's efforts to regulate
devices under the authority of the act, noting that the agency's
authority over devices became increasingly inadequate as the nature of
the devices on the market changed (H. Rept. 94-853, 94th Cong., 2d
sess., 6-10 (1976)).
In 1938 most of the devices in use were ``relatively simple items
which applied basic scientific concepts * * *'' (H. Rept. 94-853, 6).
However, by the time the Medical Device Amendments were enacted, the
universe of device products had evolved from primarily simple products,
such as tongue depressors and bandages, to include a
[[Page 44404]]
variety of scientifically and technologically sophisticated products,
such as cardiac pacemakers, lasers, and magnetic resonance imaging
equipment. This wide range of technology posed many more varied
regulatory concerns than those posed by drugs, which as a group of
products are less diverse in nature.
Congress recognized the need for specific authority for devices
that would take into account ``the great diversity among the various
medical devices and their varying potentials for harm as well as their
potential benefit to improved health'' (S. Rept. 94-33, 94th Cong., 1st
sess., 10 (1975)). Thus, with the Medical Device Amendments, Congress
enhanced FDA's authority to tailor regulatory controls, from an array
of statutory tools, to fit the particular safety and effectiveness
issues presented by individual devices.
Because of this additional flexibility, the agency has determined
that the device authorities provide the most appropriate basis for
regulating cigarettes and smokeless tobacco. Because millions of
Americans are addicted to cigarettes and smokeless tobacco, regulation
of these products presents unique safety problems that require careful,
tailored solutions. The Medical Device Amendments provide the agency
with regulatory options that are well suited to the unique problems
presented by cigarettes and smokeless tobacco.
Although the agency has determined that the device authorities are
the most appropriate authorities for regulating cigarettes and
smokeless tobacco, the agency disagrees with the comments that suggest
that the agency could not regulate cigarettes and smokeless tobacco as
drugs. To the contrary, as discussed in section II.D. of this document,
the agency could have used its drug authorities to implement similar
types of controls on cigarettes and smokeless tobacco as it is imposing
under the somewhat more flexible device authorities.
2. Cigarettes and Smokeless Tobacco Will be Subject to the Full Range
of Device Authorities
In regulating cigarettes and smokeless tobacco, FDA will follow the
regulatory scheme created by Congress for devices. Because the universe
of devices is extremely diverse, presenting a broad spectrum of safety
and effectiveness issues, the Medical Device Amendments include a wide
range of regulatory controls. Some of these controls, such as the
adulteration and misbranding requirements, are applicable to all
devices, while others, such as premarket approval and restrictions on
sale, distribution, and use, are to be applied only where FDA concludes
that they are necessary to provide reasonable assurance of safety and
effectiveness for particular devices. The Medical Device Amendments are
thus designed to allow the agency to regulate individual devices with
controls that are tailored to address the safety and effectiveness
problems raised by those devices.
As devices, cigarettes and smokeless tobacco will be subject to all
mandatory provisions of the act, except where exemption is permitted by
statute and is appropriate for these products. In addition, cigarettes
and smokeless tobacco will be subject to other discretionary provisions
of the act that the agency has concluded are necessary to address the
special safety issues posed by these products.
The basic requirements of the act applicable to all devices
include: Adulteration and misbranding provisions (sections 501 and 502
of the act (21 U.S.C. 351 and 352)), labeling requirements (section
502), establishment registration, device listing, and premarket
notification (section 510 (21 U.S.C. 360)), recordkeeping and reporting
requirements (section 519 (21 U.S.C. 360i)), and good manufacturing
practice (GMP) requirements (section 520(f)). As described in more
detail in section II.C.4. of this document, FDA intends to apply these
requirements, where appropriate, to cigarettes and smokeless tobacco at
a future time. In addition, the act requires the agency to classify
devices into one of three classes. Depending on the class into which a
product is classified, additional regulatory requirements may apply:
Class I (general controls), class II (special controls), and class III
(premarket approval). As described in more detail in section II.C.5. of
this document, as the act contemplates, FDA intends to classify
cigarettes and smokeless tobacco at a future time, and will impose any
additional requirements that apply as a result of their classification.
The agency has determined that the safety of cigarettes and
smokeless tobacco cannot be assured without restrictions on the sale,
distribution, and use of these products to children and adolescents.
Accordingly, FDA is imposing restrictions under the authority granted
in section 520(e) of the act.
(2) Several comments argued that the regulatory requirements
proposed by FDA for cigarettes and smokeless tobacco distort the
regulatory scheme for devices established by Congress. These comments
contended that FDA has: (1) Selectively applied the provisions of the
Medical Device Amendments; (2) inappropriately relied on section 520(e)
of the act (restrictions on sale, distribution, or use) while ignoring
other mandatory provisions of the act, such as classification; and (3)
determined that cigarettes and smokeless tobacco are unsafe and yet
failed to invoke provisions of the act that, according to the comments,
require the agency to remove them from the market.
FDA disagrees with these comments. As already described, FDA
intends to apply to cigarettes and smokeless tobacco all of the
mandatory provisions of the Medical Device Amendments. Thus, FDA is
neither selectively applying the provisions of the act nor ignoring
mandatory provisions.
Although FDA intends to impose on cigarettes and smokeless tobacco
all requirements applicable to devices, the act does not provide that
these requirements should all be imposed immediately. Classification
serves the purpose of identifying which devices need to be subject to
special controls (class II) or premarket approval (class III) in
addition to the general controls applicable to all devices.
Classification requires FDA to institute a separate rulemaking
proceeding. The act does not require the agency to classify a device
before general controls become applicable to it. Rather, the general
controls provisions of the act apply to all devices both before and
after classification and irrespective of the class into which a device
is ultimately classified. Because the classification process involves
many steps and can take years to complete, FDA does not ordinarily
complete the classification process before regulating the device under
its general controls.
Moreover, the statute contains no requirement that the agency
complete a classification rulemaking before invoking the general
controls that apply to all devices. For example, each of the literally
thousands of medical devices that have been classified by rulemaking
under section 513 of the act (21 U.S.C. 360c) were subject to the
general controls of the statute--such as the provisions on
adulteration, misbranding, registration, investigational device
controls, and GMP--in advance of the completion of the classification
rulemaking proceedings. (See, e.g., Contact Lens
[[Page 44405]]
Mfrs. Association v. FDA, 766 F.2d 592, 603 (D.C. Cir. 1985), cert.
denied 474 U.S. 1062 (1986).) Indeed, in some cases, the general
controls provisions were applicable to marketed devices for many years
before completion of classification.
Consistent with the agency's practice, FDA has made a decision to
apply the general controls provisions of the act to cigarettes and
smokeless tobacco, including restrictions on their distribution, sale,
and use under section 520(e) of the act, before classifying cigarettes
and smokeless tobacco. As described in section II.C.5. of this
document, FDA will, in a future rulemaking, classify cigarettes and
smokeless tobacco in accordance with the procedures in section 513 of
the act. In the meantime, the general controls will apply.
FDA also disagrees that the act requires the agency to remove
cigarettes and smokeless tobacco from the market. As described in the
preamble to the 1995 proposed rule (60 FR 41314), although cigarettes
and smokeless tobacco pose very grave risks, the agency cannot conclude
that removing them from the market would most effectively meet the
statutory goal of providing reasonable assurance of safety and
effectiveness. Because millions of Americans are addicted to cigarettes
and smokeless tobacco, the consequences of their removal from the
market, as discussed in greater detail in section II.C.5. of this
document, would include adverse health effects from sudden withdrawal,
the likely development of a black market, and the possibility that the
products that would be available through a black market would pose
greater risks than those currently on the market. None of the statutory
sections cited by the comments require the agency to remove products
from the market where the agency concludes that such action would be
contrary to the public health. Here, FDA has determined that the unique
safety issues presented by highly addictive and long-marketed products
like cigarettes and smokeless tobacco can most effectively be addressed
by actions to prevent new users from becoming addicted to these
devices.
In section II.C.3. of this document, FDA discusses its authority to
impose restrictions on sale, distribution, and use to prevent children
and adolescents from becoming addicted to cigarettes and smokeless
tobacco. In section II.C.4 of this document, FDA discusses imposition
of other general controls, and, in section II.C.5 of this document, FDA
discusses classification of cigarettes and smokeless tobacco.
3. The Restricted Device Provision Authorizes FDA to Establish Access
and Advertising Restrictions
Congress provided FDA with authority to prevent the use of a device
by those not competent to use it safely in the restricted device
provision (section 520(e) of the act). Specifically, section 520(e) of
the act states in part:
(1) The [agency] may by regulation require that a device be
restricted to sale, distribution, or use--
(A) only upon the written or oral authorization of a
practitioner licensed by law to administer or use such device, or
(B) upon such other conditions as the [agency] may prescribe in
such regulation, if, because of its potentiality for harmful effect
or the collateral measures necessary to its use, the [agency]
determines that there cannot otherwise be reasonable assurance of
its safety and effectiveness.
Section 520(e) is one of the act's ``general controls'' (see
section 513(a)(1)(A) of the act). As a general control, section 520(e)
of the act can be used by FDA to regulate any class of device (section
513(a) of the act). Because its applicability does not depend upon the
outcome of the classification process, 520(e) of the act--like the
other general controls--can be used by FDA to regulate a device prior
to the classification of the device.
In applying section 520(e) of the act to restrict the sale,
distribution, or use of a device, FDA must find that without the
restriction ``there cannot otherwise be reasonable assurance of its
safety and effectiveness.'' This provision requires FDA to find that
the restrictions in section 520(e) of the act are necessary to assure
the safety and effectiveness of the device, but FDA does not have to
find that the restrictions are sufficient to assure safety and
effectiveness. During the classification process, FDA determines
whether additional controls beyond section 520(e) of the act and the
other general controls applicable to all devices are needed to assure
the safety and effectiveness of the device.
The restricted device provision in section 520(e) of the act
authorizes FDA to adopt regulations that ensure that children and
adolescents, who by State law are not competent to use cigarettes and
smokeless tobacco, will not be able to obtain them. In particular, FDA
has determined that section 520(e) of the act authorizes the access and
advertising restrictions in the final rule because without these
restrictions ``there cannot otherwise be reasonable assurance of * * *
safety * * *.''
As described more fully later in this section of this document, the
agency's use of section 520(e) of the act in this rule is consistent
with the plain language of section 520(e), the legislative history, and
the agency's prior use of section 520(e) in, for example, restricting
the sale, distribution, and use of hearing aids (42 FR 9285, February
15, 1977, as amended at 47 FR 9397 through 9398, March 5, 1982).
As discussed in section II.C.5. of this document, the agency
intends to classify cigarettes and smokeless tobacco under the
procedures contained in section 513 of the act. The classification
process is the time at which the agency determines what degree of
regulation is necessary to provide a ``reasonable assurance of safety
and effectiveness'' for a particular product, such as tobacco products.
However, the act does not specify the timing of the application of
device authorities, and the agency is therefore able to issue
restrictions under section 520(e) of the act prior to initiating the
classification process. The agency also did so in its regulation of
hearing aids. In 1977, FDA adopted regulations under section 520(e) of
the act containing restrictions on the sale, distribution, and use of
hearing aids (42 FR 9285, February 15, 1977, as amended at 47 FR 9397
and 9398, March 5, 1982), but did not classify these products until
1986 (51 FR 40378 at 40389, November 6, 1986).
FDA is following a similar course here. The agency has determined
that unless measures are taken now to prohibit the sale and promotion
of these products to young people under the age of 18, there cannot
otherwise be reasonable assurance of safety. Therefore, FDA is acting
under section 520(e) of the act to restrict the sale, distribution, and
use of cigarettes and smokeless tobacco.
a. The restricted device provision authorizes FDA to prevent access
to persons who cannot use a device safely or effectively. Section
520(e) of the act is in part the device counterpart to section 503(b),
the act's prescription drug provision. Section 503(b)(1) of the act,
for instance, authorizes FDA to restrict access to potentially
dangerous drugs by requiring that they be dispensed ``only upon a * * *
prescription of a practitioner licensed by law to administer such a
drug * * *.'' Similarly, section 520(e)(1)(A) of the act authorizes FDA
to restrict access to potentially dangerous medical devices ``only upon
the * * * authorization of a practitioner licensed
[[Page 44406]]
by law to administer or use such device * * *.''
The restricted device provision, however, is significantly broader
than the prescription drug provision. Not only may FDA restrict sale,
distribution and use by prescription, but it may do so upon ``such
other conditions as [it] may prescribe in such regulation'' (section
520(e)(1)(B) of the act (emphasis added)). There is no counterpart to
this ``other conditions'' authority in the prescription drug
provisions.
Section 520(e) of the act was designed to deal with the risks that
are created by improper use of a device. The legislative history of the
Medical Device Amendments specifically states that section 520(e) of
the act was intended to ``supersede[ ]'' and ``add[ ]'' to the
prescription authority derived from section 503(b) of the act (H. Rept.
94-853, 94th Cong. 2d sess., 24-25 (1976)). This confirms that Congress
intended to give FDA broad authority to restrict access to potentially
dangerous devices. (See also ``Medical Device Regulation: The FDA's
Neglected Child,'' Report of the Subcommittee on Oversight and
Investigations, House Committee on Energy and Commerce, 98th Cong., 1st
sess., 31 (1985).)
Congress' use of the phrase ``could include'' indicates that this
discussion was intended to be illustrative rather than exhaustive. The
examples of possible restrictions described in the legislative history
demonstrate that Congress intended to give the agency authority to
restrict access to devices in a variety of ways, depending upon the
type of risk posed by the device and the measures needed to ensure that
the device is not used inappropriately. In short, the legislative
history supports the statutory language and establishes that Congress
intended FDA's authority to restrict the sale, distribution, and use of
devices ``upon such other conditions as the [agency] may prescribe'' to
be a flexible authority that allows FDA to tailor restrictions on sale,
distribution, and use according to the circumstances posed by the
device being regulated.
b. The restricted device provision also authorizes FDA to restrict
promotional activities that encourage uses that are inconsistent with
the regulatory scheme. Section 520(e) of the act is a broad grant of
authority. The Secretary, and by delegation FDA, is authorized to
restrict the sale, distribution, or use of a device ``upon such other
conditions as the [agency] may prescribe in such regulation.'' This
broad grant of authority covers all aspects of the sale of a device,
including the offer of sale.
How a device is sold involves many elements. It involves not only
the circumstances surrounding the exchange of money for the device, but
also whether the device must be sold only on the authorization of a
practitioner, whether age limits on users are appropriately
established, and how the device is represented to potential users. It
is in the latter regard that advertising plays a role and may be
restricted under section 520(e) of the act.
The Supreme Court cases on commercial speech recognize that a
State's interest in regulating sales extends to advertising promoting
the sale. In Edenfield v. Fane, 507 U.S. 761, 767 (1993), the Supreme
Court said that commercial transactions are ``linked inextricably''
with the commercial speech that proposes the transaction, and that the
State's interest in regulating the underlying transaction may give it a
concomitant interest in the expression itself. Likewise, under section
520(e) of the act, the sale of a device is ``linked inextricably'' to
the advertising that promotes the sale, giving FDA concomitant
authority to impose necessary restrictions on the advertising.
FDA's regulation of hearing aids exemplifies this aspect of section
520(e) of the act. One of the most important purposes of the
restrictions on sale, distribution, and use imposed on hearing aids was
to respond to widespread inappropriate promotion of hearing aids to
consumers for whom the devices are not effective (see 41 FR 16756 at
16757 (April 21, 1976)). In that regulation, in addition to restricting
sales to persons who had been medically evaluated for hearing aids, FDA
relied upon section 520(e) of the act to require that an instructional
brochure be distributed to each prospective hearing aid user. These
brochures described the adverse reactions and side effects associated
with hearing aids and encouraged prospective users to seek medical
evaluations. The distribution of the brochure was required as a means
of ensuring that advertising for hearing aids did not inappropriately
induce persons who had not been medically evaluated to purchase the
hearing aids.
The agency's authority to use section 520(e) of the act to restrict
advertising is especially strong when limits on advertising are
necessary to ensure that advertising does not undermine the conditions
on sale, distribution, or use that the agency adopts under section
520(e). The agency should not be--and under section 520(e) of the act
is not--powerless to prevent advertising that encourages sales that the
agency has barred under section 520(e). Rather, the agency may use its
authority to impose ``such other conditions as the [agency] may
prescribe'' to restrict advertising that directly undercuts the
agency's restrictions on sale, distribution, and use.
c. The restricted device provision authorizes FDA's restrictions on
youth access and on advertising designed to make cigarettes and
smokeless tobacco appealing to youth. The restricted device provision
authorizes the restrictions on youth access and on advertising in this
final rule. Section 520(e) of the act contemplates these types of
restrictions on sale and distribution. Moreover, they are necessary if
FDA ever were to be able to find that there is a reasonable assurance
of the safety of cigarettes and smokeless tobacco under the act. As
section 520(e) of the act provides, without these restrictions ``there
cannot otherwise be reasonable assurance of safety and effectiveness.''
The provisions in the final rule that restrict the access of minors
to cigarettes and smokeless tobacco are clearly restrictions on ``sale,
distribution, or use'' of a device within the meaning of section 520(e)
of the act. FDA's access restrictions are designed to ensure that
children and adolescents are unable to have access to cigarettes and
smokeless tobacco. These restrictions directly limit the sale of
cigarettes and smokeless tobacco by, for instance, banning the sale of
these products to persons under 18. They also directly limit the
distribution of cigarettes and smokeless tobacco by, for instance,
banning the distribution of free samples. Hence, these access
restrictions are within the plain language of section 520(e) of the
act.
The advertising restrictions in the final rule are also among the
types of restriction that section 520(e) of the act authorizes. As in
the case of the restrictions imposed on hearing aids, the advertising
restrictions are designed to address inappropriate promotion of
cigarettes and smokeless tobacco to individuals for whom the
potentiality for harm is particularly great. The advertising
restrictions are necessary to prevent advertising by the manufacturers
of cigarettes and smokeless tobacco from undercutting the access
restrictions. The effectiveness of the restrictions on youth access
[[Page 44407]]
would be substantially diminished if the manufacturers were free to
entice children and adolescents to circumvent the access restrictions.
In this circumstance, restrictions on advertising are properly treated
as restrictions on ``sale, distribution, or use'' within the meaning of
section 520(e) of the act.
The final requirement of section 520(e) of the act is that the
agency establish that without the restrictions on the device ``there
cannot otherwise be reasonable assurance of its safety and
effectiveness.'' This requirement is plainly met in the case of the
access and advertising restrictions for cigarettes and smokeless
tobacco. Without effective restrictions on sale and distribution of
cigarettes and smokeless tobacco to children and adolescents under 18,
young people will continue to become addicted to these products and,
once addicted, will as adults continue to use them in spite of their
potential for harmful effects. As stated in section I.B. of this
document, the earlier tobacco use begins, the greater the risk of
disease caused by, or associated with, the use of these products. Thus,
there can be no doubt that without the access and advertising
restrictions imposed in this final rule, no finding that there is a
reasonable assurance of safety for cigarettes and smokeless tobacco
would be possible.
Although FDA finds that the restrictions under section 520(e) of
the act are necessary for providing a reasonable assurance of safety,
FDA is not required under section 520(e) of the act to show that the
restrictions are sufficient by themselves to provide a reasonable
assurance of safety or effectiveness. Under section 520(e) of the act,
all that FDA must establish is that without the section 520(e)
restrictions, the device could not be found to be safe.
It is in the classification process--not in the application of
section 520(e) of the act--that FDA must determine what controls are
necessary if the agency is to find that there is a reasonable assurance
that a device is safe and effective for its intended use. As discussed
in section II.C.5. of this document, FDA intends to classify cigarettes
and smokeless tobacco in a future rulemaking.
d. Response to other comments. FDA received several comments on
whether section 520(e) of the act authorizes restrictions on youth
access and advertising. Most of the comments were from tobacco trade
associations, tobacco companies, and advertisers, arguing that section
520(e) of the act does not provide authority for either the access or
advertising restrictions. A comment from a public interest group,
however, fully supported FDA's reliance on section 520(e). FDA also
received a large number of comments from a broad cross-section of the
public that expressed support for, or opposition to, the proposed
restrictions without delving into the legal issues analyzed in the 1995
proposed rule.
(3) One comment said that FDA uses the term ``conditions'' in
section 520(e)(1)(B) of the act to mean any regulatory imposition that
the agency believes would bring about an improvement in safety in some
way related to the device in question. The comment argued that FDA has
used this term in such an overinclusive way that it would authorize FDA
to impose many of the requirements that Congress imposed in other
provisions of the act. For example, the comment argued that under FDA's
interpretation it could require premarket approval of a device with a
potentiality for harmful effect as a ``condition'' on the ``sale,
distribution, or use'' of the device, on the theory that without
premarket approval it would be impossible for there to be ``reasonable
assurance of its safety.''
FDA disagrees with this comment. FDA's interpretation of section
520(e) of the act does not create any redundancy with the other
provisions of the Medical Device Amendments. Most of the general
controls authorized under the act, and the major thrust of the
provisions on performance standards and premarket approval, are geared
toward ensuring that finished devices, when ready for use, will be free
from defects and will provide a reasonable assurance of safety and
effectiveness for their labeled use. Restrictions under section 520(e)
of the act, on the other hand, are imposed because the device's
``potentiality for harmful effect or the collateral measures necessary
to its use,'' and the determination that, without such restrictions,
there cannot otherwise be a reasonable assurance of safety and
effectiveness. The restrictions under section 520(e) of the act on
cigarettes and smokeless tobacco focus on those who may not purchase
and use these products rather than on those who will be using the
products. Without successful restrictions on sale, distribution, and
use of cigarettes and smokeless tobacco to children and adolescents
under 18, there will never be reasonable assurance of the safety of
these products because they would continue to be available to these
young people, who, by State law, are not competent to use them.
(4) With regard to access, industry comments contended that FDA's
authority under the provisions of the act relating to restricted
devices was intended to be no broader than its prescription drug
authority and, accordingly, could not extend to restrictions such as
those in the 1995 proposed rule.
FDA disagrees with this view and believes that it is unsupported by
the clear language of the act and the legislative history (see H. Rept.
94-853, 94th Cong., 2d. sess., 24-25 (1976)). Had Congress meant for
the authority granted FDA under section 520(e) of the act to be no
broader than the authority granted in section 503(b)(1) of the act to
limit drugs to prescription use, it could simply have amended section
503(b)(1) of the act to add ``or device'' after ``drug'' each time the
term is used. Indeed, as discussed in Becton, Dickinson and Company v.
Food and Drug Administration, 589 F.2d 1175 (2d Cir. 1978) that
approach was the one used in early versions of the legislation that
became the 1976 amendments but was abandoned in favor of the broader
``restricted device'' approach that has been a part of the law for 20
years. The plain language of the enacted provision contains no
limitation on the types of restrictions that can be imposed and
certainly is not limited by its terms to restriction to prescription
use. Moreover, as previously discussed, the legislative history
specifically states that the agency's authority under section 520(e) of
the act is broader than its authority under the prescription drug
provisions (H. Rept. 94-853, 94th Cong., 2d sess., 24-25, 1976).
(5) An industry comment contended that ``FDA uses what is merely
the medical device version of prescription drug status as the sole
legal justification for an elaborate system of controls far broader and
more intrusive than is authorized even for true medical devices.''
As discussed in section II.C.3. of this document, FDA's restricted
device authority is significantly broader than suggested by this
comment. Given the potentiality for harm from cigarettes and smokeless
tobacco, FDA has ample authority to impose the conditions on their
sale, distribution, and use that it is adopting.
As is the case with other medical devices, cigarettes and smokeless
tobacco are subject to those regulatory controls that are appropriate
for medical devices generally (e.g., registration, labeling, and
inspection), along with those tailored to the product in question
[[Page 44408]]
and the risks that it presents (access restrictions and advertising
controls). Thus, FDA is treating cigarettes and smokeless tobacco in a
manner that is consistent with how it treats other medical devices.
(6) Turning to the advertising restrictions, several comments
argued that section 520(e) of the act authorizes only restrictions on
``sale, distribution, or use,'' and that it does not include the words
``offer for sale.'' These comments pointed out that Congress used the
words ``offer for sale'' elsewhere in the act (sections 301(m) and (o)
(21 U.S.C. 331(m) and (o)) and 503(c)), and they therefore drew the
inference that if Congress had intended section 520(e) of the act to
authorize restrictions on how medical devices are offered for sale, it
would have made this fact explicit.
FDA is not persuaded by this argument. In each of the instances
cited in the comments where Congress has included the phrase ``offer
for sale'' in the act, it was defining a prohibited act, that is, an
act whose commission would violate the statute, in which the
prohibition focused, at least in part, on the sale of a food, drug, or
device. By including the phrase ``offered for sale'' in these
provisions, Congress sought to ensure that the statutory objective of
preventing the actual sale of products where advertising or labeling
does not meet the statutory requirement would be met by including
products merely ``offered for sale'' within the statute's coverage. The
agency notes that, similarly, the words ``offered for sale'' appear in
section 502(q) of the act, the provision that the agency would use to
enforce section 520(e) of the act. Thus, Congress did in fact include
``offer for sale'' in the scope of conduct regulated under section
520(e) of the act and its enforcement clause, section 502(q). The
comment's argument, however, misses the significance of section 520(e)
of the act.
As discussed in section II.C.3. of this document, the authority to
restrict the ``sale, distribution, or use'' of a device includes the
authority to restrict the circumstances surrounding the sale and
distribution of the device, including the device's advertising. The use
of section 520(e) of the act to restrict advertising is particularly
appropriate when the advertising restrictions are necessary to ensure
that access restrictions issued under section 520(e) of the act are not
undermined by a manufacturer's advertising. Here, FDA is restricting
the sale of cigarettes and smokeless tobacco because of their potential
harmful effects on individuals who start using them before the age of
18 and who lack the competency to decide to do so. FDA has determined,
as explained in sections VI.B. and D. of this document, that how
cigarettes and smokeless tobacco are advertised plays a material role
in the decision of children and adolescents under 18 to purchase and
use these products. Thus, if the restrictions on how cigarettes are
sold, distributed, and used that FDA is adopting under section 520(e)
of the act are to be effective, they must include restrictions on how
cigarettes and smokeless tobacco are advertised.
(7) The comments also argued that section 520(e) of the act on its
face says nothing about advertising. Thus, according to these comments,
FDA's authority to regulate the advertising of restricted devices is
limited by section 502(q)(1) of the act, which prohibits false or
misleading advertising, and section 502(r) of the act, which prescribes
certain statements in the advertising for these devices. One comment
implied that FDA's interpretation of section 520(e)(1) of the act had
rendered section 502(q)(1) and (r) of the act superfluous.
FDA is not persuaded by these comments. The interpretation of
section 520(e) of the act that FDA has adopted in this proceeding would
not render either section 502(q)(1) or (r) of the act inoperative or
superfluous. These sections impose requirements on advertising of the
permissible sale, distribution, and use of restricted devices. They set
out conditions on advertising to which manufacturers must adhere in
offering these devices for sale. Section 520(e) of the act, on the
other hand, is the means by which FDA demarcates permissible and
nonpermissible conditions of sale, distribution, and use of these
devices. In so doing, as has been explained in response to the previous
comments, FDA may by regulation impose limits on advertising that it
finds are necessary to ensure that advertising is not used to undermine
the conditions on sale, distribution, or use that the agency adopts.
This is what Secs. 897.30, 897.32(a), and 897.34, the regulations that
set out the restrictions on advertising, are designed to accomplish. In
fact, section 502(q)(1) of the act reinforces this authority because
any advertisement that promotes the sale of a device for a use that is
inconsistent with a restriction established by FDA would be false and
misleading because it would represent that the device is appropriate
for that use, which would not be the case.
Thus, Congress clearly intended section 502(q)(1) and (r) of the
act and any restrictions that FDA adopts under section 520(e) of the
act to be complementary. This intent is further evidenced by the fact
that section 502(q)(2) of the act provides that a restricted device is
misbranded if it is sold, distributed, or used in violation of
regulations prescribed under section 520(e) of the act. Section
502(q)(2) of the act thus complements sections 502(q)(1) and (r) of the
act, which, as previously explained, address different aspects of the
regulation of restricted devices than does section 520(e) of the act.
FDA's interpretation of section 520(e) of the act accordingly does
not render either section 502(q)(1) or (r) of the act superfluous.
Rather, the three provisions support and reinforce each other.
(8) An additional argument advanced by two tobacco trade
associations was that the interpretation of section 520(e)(1)(B) of the
act, which authorizes FDA to restrict the sale of a device upon such
``other conditions'' as it deems necessary, is governed and limited by
the rule of ejusdem generis. This rule of statutory construction
provides that, where general words follow an enumeration of persons or
things of a particular and specific meaning, such general words are not
to be construed in their widest extent but are to be held as applying
to only persons or things of the same general kind or class as those
specifically mentioned. Thus, the comment argued that here, ejusdem
generis limits the scope of ``other conditions'' in section
520(e)(1)(B) of the act to restrictions similar in nature to the
restriction to prescription use in section 520(e)(1)(A) of the act. The
comment argued that it would be totally inconsistent with the rule of
ejusdem generis to expand the scope of ``other conditions'' to include
a provision as dissimilar to a prescription requirement as a
restriction on advertising. FDA does not agree that ejusdem generis is
controlling, or that it has any application here. In Norfolk & Western
v. American Train Dispatchers Ass'n, the Supreme Court held that this
canon does not control ``when the whole context dictates a different
conclusion'' (499 U.S. 117, 129 (1991)). The context involving section
520(e) of the act does not support the application of ejusdem generis
to it. There is no indication that Congress thought that it was
providing a list of similar measures in section 520(e)(1)(A) and
(e)(1)(B) of the act. In fact, the face of the act is to the contrary.
After specifying one means of restricting
[[Page 44409]]
the sale, distribution, and use of a device, Congress granted the
Secretary broad authority to impose ``such other conditions as [she]
may prescribe in such regulation.'' Congress, rather than limiting the
Secretary's options, left it to the Secretary to decide what conditions
are necessary for a particular device. Nor does the legislative history
support the comments. As stated in section II.C.3.a. of this document,
Congress intended section 520(e) of the act to add to the agency's
authority beyond providing for use by prescription only (H. Rept. 94-
853, 94th Cong., 2d sess., 24-25 (1976)).
Moreover, the ``or'' connecting section 520(e)(1)(A) of the act
with section 520(e)(1)(B) is properly read here as disjunctive rather
than conjunctive. (See Garcia v. United States, 469 U.S. 70, 73
(1984).) Section 520(e) of the act is intended to authorize such
conditions on the sale, distribution, or use of a device as are
necessary to ensure that the device is not improperly used and without
which a reasonable assurance of its safety and effectiveness cannot be
provided. There is no basis on the face of the act or in the
legislative history to conclude that Congress was trying to limit the
conditions that FDA could impose to achieve that end (other than the
admonition not to base a physician restriction on board certification).
(9) One comment argued that the interpretation of section 520(e) of
the act that FDA is advancing in this proceeding is contrary to the
interpretation that the agency offered in imposing restrictions on
hearing aids in 1977. The comment pointed out that FDA stated at that
time: ``The Commissioner notes, however, that the [Act] regulates the
safety * * * of the [device] itself'' (42 FR 9286 at 9287, February 15,
1977). The comment asserted that, for this reason, FDA concluded that
it could not prescribe competency standards for hearing health
professionals, fix the price of hearing aids, or control the
promotional practices of hearing aid dispensers, all matters that were
being handled by the Federal Trade Commission (FTC) (42 FR 9286 at
9287). The comment argued that, for the same reasons, FDA may not,
under section 520(e) of the act, regulate attire, contests, or athletic
or cultural events.
FDA does not agree that the hearing aid proceeding provides any
support for the view that the agency has been inconsistent in its
interpretation of section 520(e) of the act. In that proceeding, FDA
was aware that FTC had developed a proposed trade regulation rule that
included a prohibition of certain selling techniques (42 FR 9286 at
9287). FDA said that it was avoiding any duplication of effort with
FTC. Thus, it was not necessary for FDA to consider the extent of its
authority to specifically regulate selling techniques of hearing aid
dispensers.
Contrary to the comment's assertion, this proceeding is consistent
with the hearing aid proceeding. Although FDA did not duplicate FTC's
effort and directly regulate selling techniques, FDA imposed various
restrictions that were tailored to restrict inappropriate promotion of
hearing aids including requiring a medical evaluation before purchase
and distribution of a user instructional brochure. In the case of
cigarettes and smokeless tobacco, FDA is imposing restrictions that are
tailored to promotion of tobacco products to ensure that advertising
does not induce the use of cigarettes and smokeless tobacco by children
and adolescents under 18.
(10) Finally, several comments argued that FDA lacks statutory
authority for the advertising restrictions that it is imposing. Some of
these comments sought to analogize this rulemaking to American
Pharmaceutical Ass'n v. Weinberger, 377 F. Supp. 824, 831 (D.D.C.
1974), aff'd sub nom. American Pharmaceutical Ass'n v. Mathews, 530
F.2d 1054 (D.C. Cir. 1976) (per curiam). That case involved an attempt
by FDA to limit the distribution of methadone to certain designated
facilities under the drug authorities of the act. The court held that
the statutory drug authority did not authorize the agency to impose
these limitations on the distribution of methadone, even though
methadone posed unique problems of medical judgement, law enforcement,
and public policy.
FDA regards the American Pharmaceutical Ass'n case as a
questionable precedent. The case predates both the Supreme Court's
decision in Chevron U.S.A., Inc. v. Natural Resources Defense Council,
467 U.S. 837 (1984), and the Medical Device Amendments. In Chevron, the
Court stated that ``considerable weight should be accorded to an
executive department's construction of a statutory scheme it is
entrusted to administer * * *'' (467 U.S. at 844). Moreover, when
Congress enacted section 520(e) of the act, one of its objectives was
to provide FDA with precisely the kind of authority over medical
devices that the court found that the agency did not have over drugs in
American Pharmaceutical Ass'n. Thus, FDA now has explicit authority
under section 520(e) of the act to impose conditions on the sale,
distribution, and use of a medical device to prevent its misuse,
including the access and advertising restrictions in the final rule.
FDA is imposing controls on the sale of cigarettes and smokeless
tobacco to ensure that individuals under 18 will not be able to
purchase them. Further, to ensure that these controls on sale,
distribution, and use are not undermined, FDA has found that they must
include restrictions on how these products are advertised, so that
individuals under 18 are not encouraged to purchase or use them. These
actions are consistent with the language and purpose of section 520(e)
of the act.
4. Application of Other Device Authorities
As described in section II.C.2. of this document, FDA intends to
follow its normal course and apply the ``general controls'' provisions
of the Medical Device Amendments to cigarettes and smokeless tobacco
pending classification of these products. The general controls
authorized by the Medical Device Amendments include adulteration and
misbranding (sections 501 and 502 of the act), establishment
registration, device listing, and premarket notification (section 510),
labeling requirements (section 502), recordkeeping and reporting
requirements (section 519), and GMP (sections 501 and 520(f)).
(11) Tobacco industry comments claimed that FDA had ignored a
number of mandatory provisions of the act applicable to devices,
``presumably because they again recognize that those provisions would
mean the prohibition of tobacco sales.'' The comments also asserted
that FDA had picked and chosen among statutory provisions and had
misinterpreted Heckler v. Chaney, 470 U.S. 821 (1985), as authorizing
this selective regulatory approach. These comments also argued that FDA
had ignored section 520(a) of the act, which provides that the
adulteration, misbranding, and records and reports requirements are
applicable to devices until the applicability of these requirements is
changed by an action under the classification, premarket approval,
standard-setting, or investigational device provisions of the act.
The agency disagrees with these comments. FDA is applying to
cigarettes and smokeless tobacco the general controls applicable to all
devices.
In the following discussion, the agency elaborates on the
applicability of the general controls provisions to
[[Page 44410]]
cigarettes and smokeless tobacco, and on matters the agency has
reconsidered in response to comments (the applicability of labeling
requirements to cigarettes and smokeless tobacco is discussed in
sections V. and VI. of this document). Overall, FDA believes that it
has developed a regulatory system for cigarettes and smokeless tobacco
that is consistent with the statutory scheme and the record of this
rulemaking.
a. Adulteration and misbranding. Cigarettes and smokeless tobacco
will be subject to the adulteration and misbranding provisions in
sections 501 and 502 of the act, and the implementing regulations, with
one exception that is permitted by statute. Section 502(f) of the act
authorizes the agency to grant exemptions from section 502(f)(1) of the
act under certain circumstances. As described in section V.E. of this
document, FDA has determined that an exemption from section 502(f)(1)
of the act is appropriate for cigarettes and smokeless tobacco. In
addition, section VI.E.6. of this document also contains a more
detailed description of the applicability of specific labeling
requirements to cigarettes and smokeless tobacco.
The adulteration and misbranding provisions are largely self-
executing and do not require the agency to impose requirements by
regulation.
b. Device registration and listing. Section 510 of the act and part
807 (21 CFR part 807) of the regulations require that device
manufacturers and importers register their establishments with the
agency. Every year an annual registration form is sent to all
registered establishments to be completed and returned to the agency
(Sec. 807.22(a)). Any significant changes of information to the
original must be reported to FDA within 30 days of the change
(Sec. 807.26).
Manufacturers are also required to list their devices that are in
commercial distribution in the United States (part 807). Foreign
manufacturers may, but are not required to, register (Sec. 807.40).
However, they are required to list their devices (Sec. 807.40(b)).
Manufacturers are required to update their listing if there are
significant changes to listing information.
Manufacturers of cigarettes and smokeless tobacco will be subject
to the establishment registration and device listing requirements in
section 510 of the act and part 807 of FDA's regulations. The
application of these provisions to cigarettes and smokeless tobacco
derives from their status under the device provisions of the act and
does not require rulemaking by the agency.
Section 510(k) of the act requires submission of a premarket
notification to the agency whenever a manufacturer markets a device for
the first time, whenever there is a major change in the intended use of
an already marketed device, or whenever an already marketed device is
to be modified in a way that could significantly alter its safety or
effectiveness (Sec. 807.81). The device may not be commercially
distributed unless the agency issues an order finding the device
substantially equivalent to one or more predicate devices already
legally marketed in the United States for which premarket approval is
not required (section 513(i) of the act (Sec. 807.100), or unless the
agency approves a premarket approval application for a device subject
to an approval requirement under section 515 of the act (21 U.S.C.
360(e)). Substantial equivalence means that a device has the same
intended use and the same technological characteristics as the
predicate device; or has the same technological characteristics, but it
can be demonstrated that the device is as safe and effective as the
predicate device and does not raise different questions regarding
safety and effectiveness (section 513(i) of the act). The premarket
notification submission must include either a summary of the safety and
effectiveness information upon which a substantial equivalence
determination may be based, or state that safety and effectiveness data
will be made available to anyone upon request (section 513(i)(3)(A) of
the act (21 U.S.C. 360c(i)(3)(A)), and Secs. 807.87(h) and 807.92).
c. Records and reports. Section 519 of the act contains several
requirements relating to the keeping of records and making of reports
on devices. In addition to implementing the specific requirements of
the act, the agency has used its authority under section 519 of the act
to issue several regulations. As nicotine delivery devices, which are
drug-device combination products that FDA is regulating under its
device authorities, cigarettes and smokeless tobacco are subject to the
requirements of section 519 of the act and the implementing regulations
unless otherwise exempted.
Section 519(a) of the act requires manufacturers, importers, and
distributors of devices to establish and maintain records, and make
reports and other information available to the agency, to ensure that a
device is not adulterated or misbranded and to otherwise ensure its
safety and effectiveness. Similarly, section 519(b) of the act requires
medical device user facilities to make reports to device manufacturers
and the agency when they become aware of information suggesting that a
device has caused or contributed to a death, serious injury, or serious
illness. Under this authority, the agency has issued part 803 (21 CFR
part 803), on medical device reporting, and part 804 (21 CFR part 804),
on medical device distributor reporting (the MDR requirements). These
regulations were recently amended by a final rule published in the
Federal Register of December 11, 1995 (60 FR 63578) (the 1995 reporting
requirements final rule), reflecting changes in the reporting
requirements of section 519 of the act that were mandated by the SMDA
and the Medical Device Amendments of 1992.
The 1995 proposed rule would have amended parts 803 and 804 to
exempt cigarettes and smokeless tobacco from the MDR requirements.
These proposed exemptions were based on the fact that ``the adverse
health effects attributable to cigarettes and smokeless tobacco
products are extensive and well-documented'' (60 FR 41314 at 41342).
The agency stated that it did not anticipate any real benefit in
requiring manufacturers and distributors of these products to report
such information (Id.).
(12) The agency received several comments criticizing this proposed
exemption. One comment from a trade association stated that, although
it disagreed with the agency's classification of cigarettes as medical
devices, the agency had no authority to exempt manufacturers from this
reporting requirement. This trade association also stated that, because
the agency has concluded that cigarettes are not safe for individual
users, this exemption cannot be reconciled with the standard under
section 519(c) of the act for exempting this product. (Section
519(c)(3) of the act provides for exemptions upon a finding that
compliance with recordkeeping and reporting is not necessary to ensure
that a device is not adulterated or misbranded or to otherwise ensure
its safety and effectiveness.) Another trade association claimed that
the agency did not follow the proper exemption procedures under the
act. A trade association also noted that the agency did not propose to
require such user facility reports for cigarettes and also noted that
such reports are not ``suitable'' for cigarettes.
[[Page 44411]]
In view of these comments, the agency has reconsidered its
tentative position regarding the application of the MDR requirements in
parts 803 and 804. The adverse health effects attributable to these
products are extensive and well-documented. As a result, the cost of
processing the enormously high volume of MDR reports related to the use
of cigarettes and smokeless tobacco would likely be prohibitive in
light of the small benefit to be gained from reports documenting
adverse health effects already known to the agency.
Nevertheless, there would be a benefit to receiving information
regarding adverse events that are not well-documented and thus, not
well-known or anticipated. Therefore, the agency has determined that it
will require MDR reporting in certain limited circumstances, and is
amending Secs. 803.19 and 804.25 of its regulations to make this clear.
In the preamble to the 1995 reporting requirements final rule, the
agency clarified that it may grant a written exemption, variance, or
alternative to some or all of the MDR requirements ``when it determines
compliance with all MDR requirements is not necessary to protect the
public health'' (60 FR 63578 at 63592). The agency cited, as an example
for an appropriate exemption, devices for which ``adverse events that
are known and well documented, are occurring at a normal rate, and do
not justify the initiation of remedial action * * *'' (Id.).
To limit the volume of reports that could otherwise be required,
the agency is modifying the MDR requirements for adverse events
relating to tobacco. The agency has added Sec. 803.19(f) to the
regulation's ``Exemption, variances, and alternative reporting
requirements'' section in order to limit the medical device reports
concerning cigarettes and smokeless tobacco; specifically, new
paragraph (f) requires reports from manufacturers only for those
adverse events related to contamination, a change in any ingredient or
any manufacturing process, or any serious adverse event that is not
well-known or well-documented by the scientific community.
The agency notes that user facilities are not likely to have direct
knowledge of even these limited adverse events required to be reported
by manufacturers. Therefore, the agency is adding Sec. 897.19(g) to
exempt user facilities from the MDR requirements relating to cigarettes
and smokeless tobacco.
For similar reasons, FDA is also modifying the MDR requirements for
distributors of cigarettes and smokeless tobacco. Because distributors
handle these products, break open cartons, and even affix the tax
stamp, the agency believes that distributors could be responsible for,
or aware of, contamination of these products. The agency does not
believe, however, that distributors are likely to have direct knowledge
of any change in ingredient or manufacturing process or any serious
adverse event that is not well-known or well-documented by the
scientific community. Therefore, the agency is limiting the MDR
requirements for distributors to require reports concerning cigarettes
and smokeless tobacco only for adverse events relating to
contamination.
The agency notes that it has granted similar variances in the past
for circumstances that justify modifications to the MDR requirements
and has issued guidance that establishes criteria for modified
reporting. Examples where reporting has been modified include events
involving health care professionals being stuck by needles and certain
events involving defibrillators. These modifications were made in order
to clarify which events would provide valuable information to the
agency given the inherently risky circumstances surrounding the use of
these devices. A variance from the MDR requirements has also been
granted to the manufacturers of breast implants in order to limit the
frequency of reports for events already known to the agency.
(13) Industry comments also questioned why FDA had not proposed to
apply device tracking and premarket surveillance provisions to
cigarettes and smokeless tobacco. Section 519(e) of the act, governing
device tracking, applies only to products that are permanently
implantable, life-sustaining or life-supporting, or have been
designated by the agency to be tracked. Cigarettes and smokeless
tobacco do not fall within the first two categories, and the agency has
not designated them for tracking.
For the reasons cited in the previous discussion of 519(e) of the
act, postmarket surveillance will not be required unless, at a future
date, the agency specifically designates these products under section
522 of the act (21 U.S.C. 360l).
Section 519(f) of the act, which requires FDA to issue regulations
to require reports on device removals and corrections, will apply to
manufacturers, importers, and distributors of cigarettes and smokeless
tobacco. To implement section 519(f) of the act, FDA issued a proposed
rule in the Federal Register of March 23, 1994 (59 FR 13828), that
would require manufacturers, importers, and distributors of devices to
report promptly to FDA any corrections or removals of a device
undertaken to reduce a risk to health posed by the device or to remedy
a violation of the act caused by the device which may present a risk to
health. The agency expects that the final rule will publish in 1996.
This rule will apply to removals and corrections of medical devices
including cigarettes and smokeless tobacco.
d. GMP. In the preamble to the 1995 proposed rule, FDA specifically
recognized that the GMP regulations may be appropriate for tobacco
products (60 FR 41314 at 41352). In this final rule, FDA is requiring
that the manufacturers of cigarettes and smokeless tobacco comply with
GMP regulations in part 820 (21 CFR part 820), which the agency is
currently revising. (See 58 FR 61952, November 11, 1993.) Application
of GMP's to cigarettes and smokeless tobacco will assist the tobacco
industry in avoiding such situations as the recall of Marlboros in 1995
because of a contamination mishap in processing and, in such cases, may
advance public health by reducing to some degree the overall risk
associated with these products.
(14) A comment from a tobacco trade association urged that FDA
provide ample time for compliance with GMP and requested a 2-year
period for compliance.
FDA recognizes that manufacturers will need an adequate amount of
time to comply with GMP requirements and is accepting the suggestion in
the comment by adopting a 2-year period for compliance. The tobacco
industry already has a sophisticated approach to quality control with
the production of their products. Thus, much of what is required to
meet the requirements of part 820 appears to be in place already, and
therefore, 2 years should be a sufficient time for compliance.
(15) In response to comments from tobacco distributors expressing
concern about present or future applicability of the GMP regulations,
FDA advises that it is exempting distributors from part 820. The agency
has decided to amend part 820 by adding a new Sec. 820.1(f) to exempt
distributors from the requirement of complying with GMP regulations
because it has concluded that compliance with GMP requirements
[[Page 44412]]
by distributors is not necessary to assure that these devices will be
safe and effective or otherwise in compliance with the act.
5. FDA Will Classify Cigarettes and Smokeless Tobacco Under Section 513
of the Act
In addition to applying the general device authorities previously
described to cigarettes and smokeless tobacco, the agency will classify
cigarettes and smokeless tobacco under section 513 of the act. The
agency relies on classification to determine what level of control of
the device is required to provide a reasonable assurance of safety and
effectiveness. For devices classified into class I, general controls
(sections 501, 502, 510, 516, 518, 519, and 520 of the act (21 U.S.C.
351, 352, 360, 360f, 360h, 360i, and 360j, respectively)) are
sufficient to provide a reasonable assurance of safety and
effectiveness. For devices classified into class II, special controls
(such as performance standards under section 514 of the act (21 U.S.C.
360d)) are needed in addition to the general controls to provide a
reasonable assurance of safety and effectiveness. For devices
classified into class III (premarket approval), neither general nor
special controls are sufficient to provide a reasonable assurance of
safety and effectiveness, without the added safeguard of premarket
approval. Therefore, these devices are subject to ``premarket
approval'' under section 515 of the act.
The process of classification is an important component of device
regulation, but it includes numerous procedural steps and thus cannot
be part of this final rule. Under section 513 of the act, FDA is
required to convene or use a classification panel, which should consist
of experts who ``possess skill in the use of, or experience in the
development, manufacture, or utilization of,'' the device and who
provide ``adequately diversified expertise in such fields as clinical
and administrative medicine, engineering, biological and physical
sciences, and other related professions'' (section 513(b)(2) of the
act). The classification panel is required to ``provide an opportunity
for interested persons to submit data and views on the classification''
and, after consideration of these data and views, to submit to FDA its
``recommendation for the classification of the device'' (section
513(c)(1) and (c)(2) of the act). Upon receipt of the panel
recommendation, FDA must publish in the Federal Register ``the panel's
recommendation and a proposed regulation classifying such device'' and
provide interested persons ``an opportunity to submit comments on such
recommendation and the proposed regulation'' (section 513(d) of the
act). After reviewing the comments, FDA must classify the device ``by
regulation'' (Id.).
As required by section 513 of the act, FDA will, in a future
rulemaking, classify cigarettes and smokeless tobacco in accordance
with the procedures in section 513 of the act. Without prejudging that
proceeding, the agency recognizes that it will involve consideration of
both the known risks of tobacco products and the public health concerns
that could be raised by withdrawal from the market of cigarettes and
smokeless tobacco to which many adults are addicted. Moreover, the
agency's restrictions on access and advertising in this final rule,
which are carefully designed to help prevent young people from becoming
addicted, will need to be factored in as well.
Consistent with the statute and the agency's normal practice,
however, FDA is not postponing regulation of cigarettes and smokeless
tobacco under its general authorities pending classification. Such a
postponement would serve no useful purpose, because the general
authorities will be applicable to cigarettes and smokeless tobacco
regardless of the outcome of the classification proceeding. To the
contrary, postponing application of FDA's general authorities would
have adverse consequences for public health because, during the several
years that it may require to complete classification, the applicability
of the controls put in place by this final rule, as well as the
registration, GMP, and other general controls discussed in this
document, would be delayed with respect to cigarettes and smokeless
tobacco. During this period, millions of children and adolescents would
be likely to use cigarettes and smokeless tobacco for the first time
and, in the absence of FDA regulation under its general authorities,
become addicted to these dangerous products.
The tobacco industry argues that FDA cannot classify cigarettes and
smokeless tobacco because, given ``FDA's view of the health effects''
of cigarettes and smokeless tobacco, classification would inevitably
lead to a ban of the products. According to the industry, FDA cannot
classify cigarettes under class I or class II because neither the
general nor the special controls will provide what FDA will regard as a
reasonable assurance of safety, leaving FDA with only one option: To
classify cigarettes and smokeless tobacco under class III. According to
the industry, classifying cigarettes and smokeless tobacco under class
III would lead to a ban of cigarettes and smokeless tobacco because FDA
cannot grant premarket approval of a class III device until it is
satisfied that there is reasonable assurance that the device is safe.
The tobacco industry argues that the inability of FDA to classify
cigarettes and smokeless tobacco without triggering a ban of the
products demonstrates that the act was never intended to apply to
cigarettes and smokeless tobacco.
It would not be appropriate for FDA to make a final determination
at this time as to whether the application of all appropriate
regulatory controls identified in a classification proceeding would
result in a reasonable assurance of safety and effectiveness for
cigarettes and smokeless tobacco for any users. This determination must
await completion of the classification process and of any regulatory
steps identified in the classification process (section 513 of the
act). Nonetheless, it seems clear that the best public health result is
one that prevents access to tobacco products by children and
adolescents while allowing their continued availability for adults.
Moreover, the agency disagrees with industry comments that argue that
it does not have the authority to permit the sale of tobacco products
to adults because the agency has found that tobacco products are
unsafe.
In considering this issue, the agency reiterates that tobacco
products are dangerous. As discussed more fully in section I. of this
document and in the preamble to the 1995 proposed rule, cigarettes and
smokeless tobacco cause great pain and suffering from illness, such as
cancer, respiratory illnesses, and heart disease. More than 400,000
people die each year as a result of tobacco use. \23\
---------------------------------------------------------------------------
\23\ ``Cigarette Smoking-Attributable Mortality and Years of
Potential Life Lost--United States, 1990,'' MMWR, CDC, vol. 42, No.
33, pp. 645-649, 1993.
---------------------------------------------------------------------------
If the act required that the agency limit its consideration to the
risks of tobacco products, then it could not find that there is a
reasonable assurance of safety. To the contrary, tobacco products are
unsafe, as that term is conventionally understood. However, as
reflected in the act and in judicial decisions, the determination as to
whether there is a ``reasonable assurance of safety'' involves
consideration of not only the risks presented by a product but also any
of the countervailing effects of use of that product, including the
consequences of
[[Page 44413]]
not permitting the product to be marketed. Thus, section 513(a)(2)(C)
of the act declares that, with respect to safety and effectiveness, the
agency must ``weigh[] any probable benefit to health from the use of
the device against any probable risk of injury or illness from such use
(see also 21 CFR 860.7(d)(1)). According to the legislative history of
the Medical Device Amendments, ``[the reasonable assurance of safety
standard] is predicated upon the recognition that no regulatory
mechanism can guarantee that a product will never cause injury''
because ``[r]egulation cannot eliminate all risks but rather must
eliminate those risks which are unreasonable in relation to the
benefits derived'' (H. Rept. 94-853, 94th Cong., 2d sess., 16, 17
(1976); see also United States v. Rutherford, 442 U.S. 544, 555
(1979)).
An example of the balancing of risks of using a product against the
risks of not using a product can be found in the agency's approval of a
number of drugs used in the treatment of various cancers. These drugs
are highly toxic to patients who receive them, and in approving these
drugs for chemotherapy, FDA balances the seriousness of the diseases
these drugs were intended to treat against the drugs' toxicity. In
cases where the risks of not treating the cancer outweighed the risks
of the drugs, FDA has approved these products.
Similarly, in the case of tobacco products, the agency must weigh
the risks of leaving cigarettes and smokeless tobacco on the market
against the risks of removing these products from the market. For
children and adolescents, the serious health consequences of using
tobacco products support an approach designed to reduce their use, as
all 50 States and many of the tobacco companies themselves recognize.
It is also relevant that many children who use tobacco products are in
the period of initiation and are not addicted, and thus a prohibition
of the sale and promotion to this segment of the population will
effectively reduce their use of tobacco products. Although some
children and adolescents are addicted to tobacco products, the agency
has concluded that the approach that most effectively takes into
account the health of young people is one that prohibits the sale and
promotion of tobacco products to children and adolescents under 18
years of age.
The issue is more difficult with respect to adults, particularly
adults who are addicted to cigarettes and other tobacco products. There
are approximately 50 million Americans who currently smoke and another
6 million who use smokeless tobacco. \24\ It is particularly relevant
that 77 to 92 percent of all smokers are addicted \25\ and that a
substantial number of all users of smokeless tobacco are addicted. \26\
---------------------------------------------------------------------------
\24\ ``National Household Survey on Drug Abuse: Population
Estimate 1993,'' DHHS, PHS, SAMHSA, Office of Applied Studies,
Rockville, MD, Pub. No. (SMA) 94-3017, pp. 89 and 95, 1994.
\25\ 1996 Jurisdictional Determination, section II(B)(2)(a).
\26\ Id.
---------------------------------------------------------------------------
The agency believes that these factors must be considered when
developing a regulatory scheme that achieves the best public health
result for these products. The sudden withdrawal from the market of
products to which so many millions of people are addicted would be
dangerous. First, there could be significant health risks to many of
these individuals. Second, it is possible that our health care system
would be overwhelmed by the treatment demands that these people would
create, and it is unlikely that the pharmaceuticals available could
successfully treat the withdrawal symptoms of many tobacco users.
Third, the agency also believes that, given the strength of the
addiction and the resulting difficulty of quitting tobacco use, a black
market and smuggling would develop to supply smokers with these
products. \27\ It also seems likely that any black market products
would be even more dangerous than those currently marketed, in that
they could contain even higher levels of tar, nicotine, and toxic
additives. \28\
---------------------------------------------------------------------------
\27\ That a black market and smuggling will occur can be
predicted by examining the current situation with illegal drugs in
the United States and past experience with prohibition of respect to
alcoholic beverages. In both situations, individuals continued using
the products. Moreover, in the case of cigarettes, even increased
cost due to tax disparities can lead to smuggling and black markets.
S. Rept. 95-962, 95th Cong., 2d Sess., (June 28, 1978); Joossens,
L., and M. Raw, ``Smuggling and Cross Border Shopping of Tobacco in
Europe,'' British Medical Journal, vol. 310, May 27, 1995.
\28\ Such has been the case with illegally produced alcohol. See
``Elevated Blood Lead Levels Associated with Illicitly Distilled
Alcohol--Alabama, 1990-1991,'' MMWR, CDC, DHHS, vol. 41, No. 17, pp.
294-295, 1992; Pegues, D. A., B. J. Hughes, C. H., Woernle,
``Elevated Blood Lead Levels Associated with Illegally Distilled
Alcohol,'' Archives of Internal Medicine, vol. 153, pp. 1501-1504,
1993.
---------------------------------------------------------------------------
Whether individuals who use these products have an opportunity to
make an informed choice is also relevant. Most individuals who use
these products begin as children and adolescents, at an age when they
are not prepared for or equipped to make a decision that for many will
have lifelong consequences.
In contrast, adults generally have the capacity to make informed
decisions. In the case of cigarette and smokeless tobacco, very few
adults who have not used tobacco as children and adolescents choose to
use these products as adults. \29\ Unfortunately, for the many
individuals who have become addicted, their capacity to choose whether
to use cigarettes or smokeless tobacco in large measure no longer
exists. Thus, the agency must take their addiction into consideration
when developing its regulatory scheme.
---------------------------------------------------------------------------
\29\ 1994 SGR, pp. 5, 58, and 65-67.
---------------------------------------------------------------------------
Serious health consequences follow both from the option of leaving
tobacco products on the market and from the option of banning tobacco
products. However, on balance, an approach that prohibits the sale and
promotion of cigarettes and smokeless tobacco to children and
adolescents, while permitting the sale to adults seems most
appropriate. It is consistent with the statutory standard of reasonable
assurance of safety and is more effective in achieving public health
goals than a ban on all tobacco products. Therefore, FDA is adopting
this approach in this final rule.
There is also a basis for finding that these products are
``effective'' for adults who are addicted to tobacco products because
such products sustain with great efficacy the individual's continued
need for the active ingredient nicotine. Tobacco products are effective
for preventing withdrawal symptoms in individuals addicted to nicotine
in much the same way that methadone is effective in preventing
withdrawal.
Section 516 of the act supports this analysis. Section 516 of the
act is the provision that gives the agency the authority to ban medical
devices. Under that provision, the agency ``may'' ban a device if it
finds that the device presents ``an unreasonable and substantial risk
of illness or injury.'' There are two elements of discretion which
plainly allow the agency to leave these products on the market--the
word ``may'' which applies to the entire banned device authority; and
the standard of ``unreasonable * * * risk of illness or injury,'' which
gives the agency ample discretion to balance the unique circumstances
surrounding this product.
[[Page 44414]]
D. The Fact That the Act's Drug Authorities Authorize the Imposition of
Similar Restrictions Supports the Reasonableness of the Restrictions
That the Agency Has Imposed
(16) At least one tobacco industry comment argued that the agency's
proposed access and advertising restrictions were an affront to
``common sense''--i.e., that the types of restrictions the agency had
proposed, under the device provisions of the act, went well beyond what
the plain language of the act could be read to support. The agency,
however, could have chosen to impose similar restrictions using the
act's drug authorities. As this section demonstrates, the agency has
restricted the marketing of a number of drug products, using the
adulteration, misbranding, and marketing provisions governing drug
products. That similar restrictions can be invoked under either the
act's device authorities or under the act's drug authorities supports
the reasonableness of restrictions adopted in the final rule.
As discussed in the 1995 proposed rule and in sections II.A. and B.
of this document, cigarettes and smokeless tobacco are drug delivery
systems--i.e., they combine a drug component and a device component in
a single combination product (60 FR 41314 at 41347 through 41349). As
such, cigarettes and smokeless tobacco are subject to regulation under
the device provisions of the act, the drug provisions of the act, or a
combination of the two. The agency has determined that it should use
the act's device authority to regulate these products because the
device provisions of the act offer the agency greater regulatory
flexibility than do the drug provisions of the act (see section II.B.
of this document and the 1995 proposed rule at 60 FR 41314 at 41347
through 41349). However, if there were no device component to
cigarettes and smokeless tobacco, or if the agency had chosen to
regulate these combination products under the act's drug authorities,
the agency nevertheless could have limited the access to and
advertising of these products in order to protect children and
adolescents.
Although the agency's authority to impose access restrictions on a
drug product is not as explicit as it is under the device provisions of
the act (see section 520(e) of the act authorizing controls over the
``sale, distribution, or use'' of a device to protect against a
potentially harmful or unsafe use), the agency has in fact drawn from
several statutory sources to achieve some of the same regulatory
results for a drug. The agency routinely imposes restrictions to
protect against unsafe uses of drug products--even where those uses are
otherwise unlawful, wholly irrational, or in contravention of express
warnings. From the time of the product's development and manufacture
through its retail sale, the agency is authorized to ensure that drug
products are neither unsafe, misbranded, nor adulterated. (See sections
201(n), 301, 501, 502, 503 and 505 of the act; United States v.
Sullivan, 332 U.S. 689, 696 (1948) (Congress intended ``to safeguard
the consumer by applying the Act to articles from the moment of their
introduction into interstate commerce all the way to the moment of
their delivery to the ultimate consumer'').)
Consistent with this broad grant of authority, Congress also
authorized the agency to issue regulations for the ``efficient
enforcement'' of the act, such as regulations that set forth the
conditions under which a drug must be marketed to ensure that it will
not be deemed violative of the act (see section 701(a) of the act (21
U.S.C. 371); United States v. Nova Scotia Food Products Corp., 568 F.2d
240, 246 (2d Cir. 1977); and Pharmaceutical Manufacturers Association
v. FDA, 484 F. Supp. 1179, 1183 (D. Del. 1980) (FDA has broad authority
to issue drug regulations reasonably related to the public health
purposes of the act, so long as the regulations further congressional
objectives evidenced elsewhere in the act)).
With this authority, the agency has imposed restrictions on the
advertising, labeling, and packaging of drug products, as well as
restrictions on access to drug products, without which the products
could not be lawfully marketed. For example, the agency has used its
authority to ensure that drug products are not adulterated to require
special packaging requirements for over-the-counter (OTC) drugs, to
protect against product tampering (see 47 FR 50442 at 50447, November
5, 1982); Sec. 211.132 (21 CFR 211.132)). Thus, the agency has imposed
industry-wide packaging requirements to protect against product
contamination as well as unintended, unsafe uses of drug products.
(Compare Sec. 897.14(d) (prohibiting retailers from breaking open
cigarette and smokeless tobacco packages to sell loose cigarettes or
smokeless tobacco).)
Similarly, the agency has authority to control carefully the
package size of drug products to protect persons who fail to follow the
directions from taking a lethal dose of the product (see 60 FR 52474 at
52491, 52502, and 52503, October 6, 1995, and Sec. 355.20 (21 CFR
355.20) (final monograph setting package size limitations on OTC
anticaries drugs to prevent individuals from ingesting an acutely toxic
dose)). (Compare Sec. 897.16(b) (setting minimum package size for
cigarettes).)
Along the same lines, the agency has used its authority to ensure
that drugs are not misbranded to restrict the marketing of certain drug
products where consumers simply were unable or unwilling to heed the
warnings on these products. In some instances, the agency has banned
altogether the marketing of persistently misused drug products. (See,
e.g., 47 FR 41716 at 41719, September 21, 1982 (camphorated oil
products deemed misbranded because, despite label warnings, consumers
continued to misuse the product); 47 FR 34636, August 10, 1982
(proposing withdrawal of all drugs containing phenacetin because of
persistent abuse, and associated health risks, despite label warnings
contained on those products).) In other instances, the agency has
restricted the product to prescription use. (See, e.g., Sec. 250.12 (21
CFR 250.12) (requiring prescription dispensing of OTC stramonium
preparations because, despite package warnings, young people continued
to abuse and misuse them); Sec. 250.100 (21 CFR 250.100) (switching
amyl nitrite inhalant from OTC to prescription dispensing because of
persistent off-label use and abuse); see also 60 FR 38643, July 27,
1995 (proposing to restrict ephedrine drug products to prescription
marketing because of the illicit use of OTC ephedrine in the
manufacture of certain controlled substances).)
Finally, the agency has approved drug products with strict limits
on distribution, to ensure that the drug will be safe for use under the
conditions, prescribed, recommended, or suggested in the product's
labeling. For example, the drug Clozaril (clozapine), used in
the treatment of schizophrenia, can cause the onset of a potentially
fatal blood condition, agranulocytosis. However, early detection of
agranulocytosis through routine blood testing can substantially reduce
the risk of death. FDA, therefore, approved the drug with labeling that
provides that the drug is available ``only through a distribution
system that ensures weekly [white blood cell] testing prior to delivery
of the next week's supply of
[[Page 44415]]
medication.'' \30\ This labeling was intended to ensure that
Clozaril would not continue to be administered to those for
whom it presents an unreasonable risk of harm. The marketing of
Clozaril in contravention of the labeling would result in the
product being deemed misbranded and subject to regulatory action. More
recently, the agency issued regulations authorizing generally
restrictions on the distribution of drug products in instances where
``a drug product shown to be effective can be safely used only if
distribution or use is restricted * * *'' (see Sec. 314.520 (21 CFR
314.520)). (Compare Sec. 897.16 (setting conditions on the manufacture,
sale, and distribution of cigarettes and smokeless tobacco);
Sec. 897.14(b)(1) (requiring retailers to verify the consumer's age to
ensure that the product will not be used by minors) Sec. 897.16(c)(1)
(prohibiting use of self-service displays at retail establishments).)
\31\
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\30\ Clozaril (clozapine tablets) product labeling,
Sandoz Pharmaceuticals, March 1994, in Physician's Desk Reference,
50th edition, p. 2252, 1996.
\31\ ``The Federal Food, Drug, and Cosmetic Act provides
authority for FDA to restrict the conditions for use, including the
channels of distribution and use, of any drug, or withdraw approval
of an NDA, if a drug cannot otherwise safely be used'' (H. Rept. No.
93-884, 93d Cong., 2d Sess., p.4, 1974, reprinted in U.S. Cong. &
Admin. News, pp. 3029-3032). But see American Pharmaceutical Ass'n
v. Weinberger, 377 F.Supp. 824, 829 (D.D.C. 1974) (striking down an
FDA regulation restricting the distribution of methadone), aff'd per
curiam sub nom. American Pharmaceutical Ass'n v. Mathews, 530 F.2d
1054 (D.C. Cir. 1976). The American Pharmaceutical Ass'n case,
however, was decided before the emergence of cases such as Chevron
U.S.A., Inc. v. Natural Resources Defense Council, 467 U.S. 837
(1984), in which the Court signaled the importance of deferring to
an agency's interpretation of its own statute, provided the
interpretation is sufficiently rational. The case also involved some
unique circumstances: the agency had withdrawn approval of the NDA
for the drug (methadone), but nevertheless permitted the drug to be
marketed under a regulation to certain treatment programs and
pharmacies. Also, because methadone is a controlled substance within
the provisions of the Controlled Substances Act, the district court
concluded that issues regarding restrictions on the distribution of
the drug were more properly within the jurisdiction of the
Department of Justice than FDA. In most other instances, however,
where a drug is not subject to the Controlled Substances Act, and
where certain marketing restrictions are necessary to ensure that
the drug will be used safely and effectively, under the conditions
contemplated in a new drug application, the American Pharmaceutical
Ass'n case is distinguishable.
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These examples illustrate how the agency has interpreted sections
501, 502, 503, and 505 of the act (in conjunction with sections 201(n),
301, and 701(a) of the act) as authorizing an array of controls to
prevent unsafe uses of drug products. The minimum age requirement for
cigarettes and smokeless tobacco (see Sec. 897.14(a)), and the controls
on packaging (see Secs. 897.14(d) and 897.16(b) and (d)), vending
machine sales (see Secs. 897.14(b) and 897.16(c)), and self-service
displays (see Secs. 897.14(c) and 897.16(c)), follow this same path.
Without these restrictions, cigarettes and smokeless tobacco as drug
products could be deemed misbranded or adulterated drug products and
could present too great a safety risk to be marketed at all.
The final rule also regulates the advertising used to promote
cigarettes and smokeless tobacco (see Secs. 897.30, 897.32, and
897.34). While the act's device provisions provide the most direct and
extensive basis for regulating the advertising of these products (see
section VI. of this document), the drug provisions of the act also
would have allowed the agency to regulate the advertising of these
products.
Whether a drug is marketed on a prescription basis or OTC, the
agency has authority to prohibit advertising that promotes the product
for a use for which it would be unapproved or misbranded (see sections
201(n), 301, 502, and 505 of the act; see also Sec. 201.128 (21 CFR
201.128) (advertising of a drug product may be used to establish that
the product is being marketed for a use for which it is neither labeled
nor approved)). Though the agency generally will defer to FTC with
respect to the advertising of OTC drugs (see Food and Drug
Administration and Federal Trade Commission Memorandum of Understanding
(36 FR 18539, September 16, 1971)), the agency retains authority to
take action against an OTC drug that is promoted for an unapproved use.
(See Sec. 330.1(d) (21 CFR 330.1(d)) (for an OTC drug to be generally
recognized as safe and effective, and not misbranded, the advertising
for the drug must not prescribe, recommend, or suggest its use under
conditions not stated in the labeling); see, e.g., Sec. 310.519 (21CFR
310.519) (prohibiting the marketing of any OTC drug that is ``labeled,
represented, or promoted as an OTC daytime sedative (or any similar or
related indication)''.)
The agency also has authority to require that a drug product not be
advertised in a manner that would undercut or counteract the product's
labeling, including label-based warnings. (See McNeilab, Inc. v.
Heckler, Food Drug Cosm. L. Rep. (CCH 1985) (Transfer Binder)
para.38,317, p. 39, 787 (D.D.C. 1985) (while FDA ``cannot rely on
advertising to make safe [an OTC] drug which is deemed too dangerous to
be sold with label warnings alone,'' it would be ``proper for the
agency * * * to ensure that ads do not undercut otherwise sufficient
labeling''); see also 57 FR 13234 at 13237, April 15, 1992 (preamble to
Accelerated Approval Regulations discussing requirement of submission
of promotional materials to ensure that the drugs approved under this
section will not be put to inappropriate or unsafe uses).) And,
irrespective of whether a drug is marketed OTC or by prescription, the
agency has authority to prohibit the distribution of ``false or
misleading'' product ``labeling'' (see section 502(a) of the act).
Last, had the agency chosen to use the act's drug authorities to
regulate these products, one possible means of limiting their access
would have been to require some form of prescription dispensing. In
that case, the agency's authority to regulate the advertising of
cigarettes and smokeless tobacco would be extensive (see section 502(n)
of the act; Sec. 202.1 (21 CFR 202.1); Sec. 314.81(b)(3)(i) (21 CFR
314.81(b)(3)(i))). The agency, for example, has discretion under the
act to regulate both the presentation and format of prescription drug
advertising. According to the House Conference Report on section 502(n)
of the act, Congress contemplated that:
[I]n administering the requirement contained in the conference
substitute that advertisements contain brief summaries of side
effects, etc., the Secretary under the conference substitute has
sufficient discretion to exercise due regard to the size of the
advertisement, the need for protecting the public health, and the
conditions for which the drug is offered in the advertisement.
(Report of the Committee of Conference, H. Conf. Rept. 2526, 87th Cong.
2d sess., (Oct. 3, 1962) reprinted in 1962 U.S. Code Cong. and Admin.
News 2927, 2934 (emphasis added).)
Further, the agency may take action against a prescription drug
advertisement to the extent it lacks ``fair balance'' or is otherwise
``false or misleading'' (see sections 201(n), 502(a), and (n) of the
act; Sec. 202.1 (21 CFR 202.1)). Thus, had the agency chosen to
regulate these products as prescription drugs, the agency's existing
prescription drug advertising regulations themselves would require
significant changes to the content and format of the tobacco industry's
advertising campaigns.
The final concern--had the agency regulated these products as
drugs--is whether cigarettes and smokeless tobacco could continue to be
marketed to adults. As discussed in greater detail
[[Page 44416]]
in section II.C.5. of this document, there are compelling public health
reasons for permitting the continued marketing of these products to
adults. The same rationale would apply had these products been
regulated as drugs. As is the case with respect to devices, there is a
basis for concluding that an approach that prohibits the sale and
promotion of cigarettes and smokeless tobacco to children and
adolescents, yet allows these products to continue to be marketed to
adults who are addicted to these products, could be found to be
consistent with the statutory standard of ``safe'' and ``effective''
under section 505 of the act for these products.
It is, of course, essential to this analysis that the agency's
youth access restrictions in new part 897 be implemented. These
restrictions are necessary to help ensure that the most alarming safety
issue associated with these products will have been contained. Absent
these restrictions, the risks associated with the continued marketing
of these products, even to adults, may be overwhelming. The close issue
of whether the public health is better served by allowing adults to
continue to use these products, such that the agency could find that
cigarettes and smokeless tobacco are ``safe'' and ``effective,''
depends heavily on the agency's ability to prevent the most alarming
use of these products, namely, use by substantial numbers of children.
Moreover, the approach of allowing the continued marketing of these
products to adults, so long as youth access is carefully controlled,
would be consistent with the agency's inherent discretion to take
enforcement action against some uses of a drug product, but not others.
Such an exercise of discretion would be unreviewable (Heckler v.
Chaney, 470 U.S. 821 (1985)). \32\
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\32\ See Cutler v. Hayes, 818 F.2d 879, 893 (D.C. Cir. 1987)
(``The FDC act imposes no clear duty upon FDA to bring enforcement
proceedings to effectuate either the safety or the efficacy
requirements of the Act''); Schering Corp. v. Heckler, 779 F.2d 683,
686 (D.C. Cir. 1985) (FDA's agreement not to take enforcement action
against an unapproved product for a period of 18 months was
unreviewable); see also Cutler v. Kennedy, 475 F.Supp. 838, 856
(D.D.C. 1979) (while FDA may not formally authorize the sale of
drugs that it has found do not comply with the safety and
effectiveness provisions of the act, the agency may use its
enforcement discretion not to move against these unapproved drug
products).
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In resolving that there is a presumption against judicial review of
agency determinations not to take enforcement action, the Chaney Court
reasoned that an agency's nonenforcement policy generally involves a
complex weighing of factors ``peculiarly'' within the agency's
expertise. (Id. at 831). These factors include, ``whether agency
resources are best spent on this violation or another,'' ``whether the
agency has enough resources to undertake the action at all,'' and
``whether the particular enforcement action requested best fits the
agency's overall policies.'' (Id. at 831-832).
A decision by the agency to focus its resources on youth access to
cigarettes and smokeless tobacco involves the same ``ordering of
priorities''--i.e., the same balancing of agency-specific factors--on
which the rule crafted in Chaney rests. Thus, were the agency to
enforce the act only with respect to the promotion and sale of these
products to children and adolescents, such a decision would enjoy the
full force of the Chaney Court's presumption of nonreviewability. \33\
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\33\ In a number of other contexts, the agency has declined to
take enforcement action against particular uses of unapproved drug
products. Indeed, the agency has on occasion set forth detailed
guidelines outlining the conditions under which it will, as a
general matter, refrain from taking regulatory action. (See, e.g.,
FDA Compliance Policy Guide, (CPG) 7132b.15 (stating that pending
completion of the OTC Drug Review, FDA generally will not take
regulatory action against unapproved or misbranded OTC drugs prior
to completion of a final monograph); CPG 7125.06 (setting conditions
exempting extra-label use of new animal drugs from regulatory
action); Regulatory Procedures Manual 9-71 (setting conditions under
which FDA generally will permit the import of small quantities of
unapproved drugs for personal use which are not available
domestically).)
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Thus, while the agency finds that cigarettes and smokeless tobacco
are more appropriately regulated as restricted devices, as the
discussion in section II.C. of this document demonstrates, the agency
could have crafted a serviceable regulatory scheme for these products
under the drug provisions of the act. Contrary to the comments that
have argued that the act is inherently unfit for regulation of these
products, or that the agency's proposed restrictions exceeded the
common sense boundaries of the act, both the device provisions and the
drug provisions of the act provide sound authority for controlling the
access to and promotion of these drug delivery devices.
E. Constitutional Issues Regarding Authority
1. Separation of Powers
The doctrine of Separation of Powers refers to the distribution
under the Constitution of the Federal Government's powers among the
legislative, executive, and judicial branches. In particular, under
this scheme only Congress has the constitutional authority to make law.
(17) Numerous comments by industry, media, and retailer trade
associations and by State legislators and individuals argued that FDA's
assertion of jurisdiction over tobacco products supersedes Congress'
legislative judgment, and, some argued, therefore violates the doctrine
of Separation of Powers. The comments contended that Congress has
provided statutory authority over tobacco products to the Executive
Branch only under the statutes that it has enacted that expressly apply
to tobacco products, such as the Comprehensive Smokeless Tobacco Health
and Education Act (the Smokeless Act) (15 U.S.C. 4401 et seq.) and the
Federal Cigarette Labeling and Advertising Act (the Cigarette Act) (15
U.S.C. 1331 et seq.) and not at all under the act. The comments cited
the history of proposals in Congress further to regulate tobacco
products, none of which came to fruition, as evidence that Congress has
exercised its legislative will not to act further on tobacco
regulation.
The agency does not agree that the rule violates the Separation of
Powers Doctrine. The relevant legal standards are set out in Youngstown
Sheet and Tube Co. v. Sawyer, 343 U.S. 579 (1952), and Chrysler Corp.
v. Brown, 441 U.S. 281 (1979), which are cited in the comments. Justice
Black's opinion for the Court in Youngstown stands for the proposition
that the Executive Branch may not act unless authorized by the
Constitution or by statute to do so. In particular, lacking
Constitutional authority, the Executive Branch may act only under the
aegis of a statute passed by Congress under its ``law making power''
(see Youngstown, 343 U.S. at 585-586, 589).
Executive Branch agencies frequently act by rulemaking. In
Chrysler, the Supreme Court considered the prerequisite for an agency's
``legislative'' or ``substantive'' rules to have the ``force and effect
of law'' (see Chrysler, 441 U.S. at 301-302). ``The legislative power
of the United States is vested in the Congress, and the exercise of
quasi-legislative authority by governmental departments and agencies
must be rooted in a grant of such power by the Congress and subject to
limitations which that body imposes'' (Id. at 302). Therefore, for
legislative rules to have the ``force and effect of law,'' they must be
``reasonably within the contemplation of [the statutory] gran
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