Warning Statements for Products Containing or Manufactured With Chlorofluorocarbons and Other Ozone-Depleting Substances

SUMMARY: The Food and Drug Administration (FDA) is issuing interim

regulations governing warning statements for products containing or

manufactured with chlorofluorocarbons (CFC's) and other ozone-depleting

substances. The amendments prescribe specific warning statements and

additional labeling statements for physicians and patients. These

additional statements direct patients to consult their physicians

before discontinuing use of a prescription medical product because of

concerns about the product's effect on the environment and public

health. The interim rule also provides warning statements for over-the-

counter (OTC) drug and device products and directs patients to consult

their physicians, health professional, or suppliers with questions

about the products. In addition, the interim rule revises certain

regulations concerning foods, cosmetics, and animal foods in a self-

pressurized container with a CFC propellant in order to be consistent

with current statutory requirements. FDA is issuing these regulations

as an interim rule with opportunity for public comment.

DATES: Interim rule effective May 17, 1996; comments by August 1, 1996.

ADDRESSES: Submit written comments to the Dockets Management Branch

(HFA-305), Food and Drug Administration, rm. 1-23, 12420 Parklawn Dr.,

Rockville, MD 20857.

FOR FURTHER INFORMATION CONTACT: Wayne H. Mitchell, Center for Drug

Evaluation and Research (HFD-7), Food and Drug Administration, 7500

Standish Pl., Rockville, MD 20855, 301-594-1049.

SUPPLEMENTARY INFORMATION:

I. Background

On February 11, 1993 (58 FR 8136), the Environmental Protection

Agency (EPA) issued final regulations requiring, among other things, a

warning statement on all products containing or manufactured with

specific ozone-depleting substances. In general, the EPA regulations

require each container or product containing or manufactured with

CFC's, halons, carbon tetrachloride, and methyl chloroform to bear the

following warning statement (58 FR 8136 at 8165):

Warning: Contains [or Manufactured with, if applicable] [insert

name of substance], a substance which harms public health and

environment by destroying ozone in the upper atmosphere.

EPA issued the rule under section 611 of the Clean Air Act (42

U.S.C. 7671(j)), which requires the warning statements on all products

containing or manufactured with CFC's on or after May 15, 1993. In

promulgating the rule, EPA noted that several comments had argued that

certain prescription medical products, such as metered-dose inhalers,

should be exempt from the labeling requirements because they are

essential to the health of patients. The comments indicated that a

warning statement might lead some patients to avoid their medication

because of concerns about the product's effect on the environment or

alarm over the words ``harms public health.'' EPA stated that it

understood the importance of such products to patients as well as the

need to ``tailor the labeling requirement to avoid unduly alarming

patients,'' but also stated that it lacked the authority to exempt

prescription medical products from the labeling requirement (see 58 FR

8136 at 8155). Consequently, EPA indicated that the statutorily

required warning statement could appear on supplemental printed

material intended for physicians rather than patients, provided that

the supplemental printed material intended for patients contain similar

warning language without the words ``warning'' and ``harms public

health'' (see 58 FR 8136 at 8156). EPA also indicated that

manufacturers of prescription medical products could supplement this

information with additional information for patients. EPA anticipated

that FDA would provide the specific additional language (see 58 FR 8136

at 8156). On June 29, 1993 (58 FR 34812, corrected on July 29, 1993, 58

FR 40656), FDA published a notice in the Federal Register setting out

alternative labeling warning language designed not to cause undue

patient alarm. The warnings were essentially identical to the warnings

contained in this interim rule. As part of the notice, FDA requested

comments about CFC warning statements. These comments are summarized

and responded to in section III of this preamble.

Since 1977 (42 FR 22018, April 29, 1977), FDA has required, with a

few exceptions, that OTC human drug and nonrestricted device products

containing CFC propellants be labeled with a warning (21 CFR 369.21 and

801.425). In addition, FDA established regulations in Secs. 101.17(c),

501.17(c), and 740.11(c) (21 CFR 101.17(c), 501.17(c), and 740.11(c))

that required that the package of a food, animal food, or cosmetic in a

self-pressurized container in which the propellant consists in whole or

in part of a fully halogenated CFC bear the following warning

statement:

Warning: Contains a chlorofluorocarbon that may harm the public

health and environment by reducing ozone in the upper atmosphere.

These regulations also provided requirements for placement and

conspicuousness of the warning statement. The required warning

statement applied only to self-pressurized containers that use CFC as a

propellant. For example, for foods, the use of the warning statement

was not required when the CFC was used as a stabilizer in food toppings

and spreads (Sec. 101.17(c)(3)).

Since 1978 (43 FR 11301, March 17, 1978), FDA has prohibited the

use of CFC propellants in most products it regulates (21 CFR 189.191,

300.100, 500.49, 700.23, and 801.417), except those listed as essential

uses of CFC's in Sec. 2.125 (21 CFR 2.125). Nonessential uses, which

were prohibited by the 1978 final rule, included CFC use as a

propellant in self-pressurized containers for foods and cosmetics. The

prohibitions against nonessential uses of CFC's, set out in

Sec. 2.125(c), provide that ``any food, drug, device, or cosmetic in a

self-pressurized container that contains a chlorofluorocarbon

propellant is adulterated and/or misbranded in violation of the act * *

*.'' Section 2.125(e) exempts certain essential uses of CFC's from the

adulteration and misbranding provisions of Sec. 2.125(c). Further,

Sec. 2.125(f) specifically provides for the filing of a petition in

accordance with 21 CFR part 10 to provide for the listing of additional

essential uses so as not to subject the new use to the adulteration and

misbranding provisions in Sec. 2.125(c).

FDA notes that all of the essential uses of CFC's exempted from the

adulteration and misbranding provisions of Sec. 2.125 that are listed

in Sec. 2.125(e) apply to drug products. No

[[Page 20097]]

essential uses of CFC's for foods, cosmetics, or animal foods in self-

pressurized containers have been identified.

II. Description of the Interim Rule

This interim rule describes the warning statements that should

accompany human prescription drug, biologic, and device products, and

restricted device products (hereafter referred to as ``prescription

human medical products''), OTC drug and device products, and animal

drug products that contain or are manufactured with CFC's, halons,

carbon tetrachloride, methyl chloroform, and any other class I ozone-

depleting substance designated by the EPA Administrator. (A list of

class I ozone-depleting substances can be found in 40 CFR part 82,

appendix A to subpart A, and any later EPA rulemaking adding other

ozone-depleting substances.)

The interim rule provides two options for labeling prescription

human medical products and OTC drugs and devices. The first option is

EPA's warning statement:

Warning: Contains [or Manufactured with, if applicable] [insert

name of substance], a substance which harms public health and

environment by destroying ozone in the upper atmosphere.

The second option for prescription human medical products contains

FDA's additional language for the alternative warning statements. These

warning statements are intended for physician labeling and patient

labeling.

The warning for the physician package insert would be used in

conjunction with an alternative warning statement that would appear on

patient labeling as stated in the EPA final regulation (58 FR 8136 at

8166). These alternative warning statements would be written so that

patients do not cease using their medications because of concerns over

the products' effect on the environment or alarm over the words ``harms

public health'' without first consulting their physicians. Instead,

patients would be able to discuss their concerns with their physicians

or, in the case of OTC drug or device products, another health

professional or suppliers, and, if they wish, consider the use of

alternative treatments. Also, physicians would be alerted to products

that contain ozone-depleting substances. FDA believes that these

warning statements will enable patients, physicians, pharmacists, other

health professionals, and suppliers (in the case of devices) to make

informed decisions.

Animal drug products manufactured with CFC's or other ozone-

depleting products are required to use EPA's warning statement because

the optimal alternative labeling statement is restricted to human

medical products.

A. Prescription Human Medical Products

For prescription human drug products, new Sec. 201.320 (21 CFR

201.320) provides both the EPA warning statement and FDA's alternative

warning statements. New Sec. 801.443 (21 CFR 801.443) provides the same

two options for prescription and restricted devices. A biological

product regulated as a drug or a device would use whichever labeling

applies to the particular biological product. Under new Secs. 201.320

and 801.443, all prescription drug and device products and restricted

devices containing or manufactured with CFC's, halons, carbon

tetrachloride, methyl chloroform, or any other class I ozone-depleting

substance designated by the EPA Administrator shall use the EPA warning

statement or specified alternative warning statements. For the first

option for a warning statement, new Secs. 201.320(a) and 801.443(a)

provide the EPA warning statement quoted earlier in this preamble.

Under new Secs. 201.320(a)(2) and 801.443(a)(2), the warning

statement shall be clearly legible and conspicuous on the product, its

immediate container, its outer packaging, or other labeling, and appear

with such prominence and conspicuousness as to render it likely to be

read and understood by consumers under normal conditions of purchase.

For the second option, new Secs. 201.320(b)(1) and 801.443(b)(1)

provide FDA's alternative warning statements for supplemental printed

materials intended for physicians and for patients. For patient

labeling, the warning statement would appear on the product, its

packaging, or supplemental printed material intended for the patient

and would read as follows:

Note: The indented statement below is required by the Federal

government's Clean Air Act for all products containing or

manufactured with chlorofluorocarbons (CFC's) [or name of other

class I substance, if applicable].

This product contains [or is manufactured with, if applicable]

[insert name of substance], a substance which harms the environment

by destroying ozone in the upper atmosphere.

Your physician has determined that this product is likely to

help your personal health. USE THIS PRODUCT AS DIRECTED, UNLESS

INSTRUCTED TO DO OTHERWISE BY YOUR PHYSICIAN. If you have any

questions about alternatives, consult with your physician.

These statements are designed to explain that the Clean Air Act

requires the warning statement, but that patients should continue to

use the prescription medical product unless instructed otherwise by

their physicians. The labeling for the physician would be placed on the

physician package insert after the ``How supplied'' section on the

label describing the special handling and storage conditions.

For the package insert for the physician, the warning statement

would state that:

Note: The indented statement below is required by the Federal

government's Clean Air Act for all products containing or

manufactured with chlorofluorocarbons (CFC's) [or name of other

class I substance, if applicable].

Warning: Contains [or Manufactured with, if applicable] [insert

name of substance], a substance which harms public health and

environment by destroying ozone in the upper atmosphere.

A notice similar to the above WARNING has been placed in the

information for the patient [or patient information leaflet, if

applicable] of this product under Environmental Protection Agency

(EPA) regulations. The patient's warning states that the patient

should consult his or her physician if there are questions about

alternatives.

For the second option, for the alternative placement on

supplemental printed material described in new Secs. 201.320(b) and

801.443(b), the interim rule specifies a particular location for the

warning statement intended for the physician; provided, however, that a

person places the statement intended for the patient on the product,

its packaging, or supplemental printed material for the patient. The

warning label shall be clearly legible and conspicuous on the product,

its immediate container, or other labeling as to render it likely to be

read and understood by consumers under normal conditions of purchase.

FDA further advises all parties that new Secs. 201.320 and 801.443 do

not replace or relieve a party from the requirements under 40 CFR part

82.

FDA notes that EPA's regulations (58 FR 8136 at 8166 (40 CFR

82.108(c))) state that, for prescription human medical products that

FDA finds to be essential for patient health, the warning statement may

be placed in supplemental printed material intended to be read by the

prescribing physician, as long as the alternative statement is placed

on the product, its packaging, or supplemental printed material

intended to be read by the patient at time of purchase. The agency

believes that new Secs. 201.320 and 801.443 are consistent

[[Page 20098]]

with these EPA requirements. However, FDA declines at this time to

determine which products are essential for public health. The Clean Air

Act requires that the warning labels be on all products containing or

manufactured with CFC's on or after May 15, 1993. FDA believes it would

be impractical and unnecessary to engage in case-by-case determinations

of which medical products are essential to public health before

permitting alternative warning statements. Thus, until FDA can

establish criteria and make individualized determinations as to whether

a drug is essential to public health, the most prudent course of action

is to presume, for purpose of the warning statement, that all

prescription human medical products are essential to public health.

B. OTC Drug and Device Products

This interim rule also removes the existing CFC warning statement

for OTC drug products at 21 CFR 369.21 in favor of revised warning

statements at new Sec. 201.320 (a) and (c). This interim rule also

removes the existing warning statement at 21 CFR 801.425 for

nonrestricted devices in favor of a revised warning statement at new

Sec. 801.63 (21 CFR 801.63). Under new Secs. 201.320 and 801.63, an OTC

drug or device product that contains or is manufactured with CFC's or

other class I substances may use the EPA warning statement or, as an

alternative, state:

Note: The indented statement below is required by the Federal

government's Clean Air Act for all products containing or

manufactured with chlorofluorocarbons (CFC's) [or other class I

substance, if applicable]:

Warning: Contains [or Manufactured with, if applicable] [insert

name of substance], a substance which harms public health and

environment by destroying ozone in the upper atmosphere.

CONSULT WITH YOUR PHYSICIAN OR HEALTH PROFESSIONAL IF YOU HAVE

ANY QUESTION ABOUT THE USE OF THIS PRODUCT.

For OTC devices, the sentence of the label shall state:

CONSULT WITH YOUR PHYSICIAN, HEALTH PROFESSIONAL, OR SUPPLIER IF

YOU HAVE ANY QUESTION ABOUT THE USE OF THIS PRODUCT.

The warning statement shall appear on the product, its immediate

container, its packaging, or other labeling on or within the package

from which the drug is dispensed, and must also be prominent and

conspicuous so as to render it likely to be read and understood by

consumers under normal conditions of purchase. This statement also must

be consistent with EPA's regulations at 40 CFR part 82.

The agency believes that these warning statements for OTC drug and

device products, like those for prescription human medical products,

enable patients, physicians, and other health professionals to

appreciate environmental concerns and will also avoid unduly alarming

patients.

C. Foods, Cosmetics, and Animal Foods

As noted above, no essential uses of CFC's for foods, cosmetics, or

animal foods have been identified. Any uses of CFC's or of other class

I substances deemed to be appropriate in the manufacture of foods,

cosmetics, and animal foods, or the indirect use of such substances as

additives in the manufacture of packaging materials intended to be used

for foods and animal foods, will subject the foods, cosmetics, and

food-packaging materials to the labeling requirements established by

EPA in 40 CFR part 82. Such EPA warning statement, as cited above in

the discussion on prescription and OTC medical products, must be

prominent and conspicuous so as to render it easily read and understood

by consumers under ordinary conditions of purchase.

Because the EPA warning statement is applicable to all products

``manufactured with'' or ``that contain CFC's or other class I

substances,'' the current exemption for CFC's used as a stabilizer in

food toppings and spreads is no longer appropriate and such foods must

comply with the applicable labeling requirements set forth in 40 CFR

part 82. Thus, FDA is removing the specific requirement for the CFC

warning statement for foods, cosmetics, and animal foods in

Secs. 101.17(c), 740.11(c), and 501.17 and the exemption for toppings

and spreads in Sec. 101.17(c)(3). In addition, FDA is revising these

sections to reference the EPA labeling requirements designated for

CFC's and other class I substances in 40 CFR part 82.

III. Comments

In the Federal Register of June 29, 1993 (58 FR 34812), FDA

published a notice setting out alternative labeling warnings, designed

not to cause undue patient alarm, that comply with the EPA regulation,

and that are acceptable to FDA. As part of the notice, FDA requested

comments about the labeling warning statements, which were nearly

identical to the warnings contained in this interim rule. These

comments are summarized and addressed below.

1. One comment suggested that use of the FDA alternative warnings

be made mandatory. The comment stated that if manufacturers did not opt

for the FDA alternative warning, and used the EPA warning instead, this

could cause undue concern and result in patients stopping medication.

FDA believes that manufacturers should have the option of using the

warning statement that best meets their particular needs. FDA does not

believe that a manufacturer will use the EPA warning if there is any

real likelihood that the warning's use will cause its customers to

cease using the manufacturer's product.

2. Two comments said that, due to the small size of some containers

for products with CFC's, any labeling rule should allow for alternative

placement of the warning on outer packaging or other labeling.

FDA considered these concerns during the drafting of this interim

rule, and the interim rule does allow such alternative placement.

3. One comment suggested that the phrase in the patient warning on

prescription drug labeling ``[i]f you have any questions about

alternatives please consult with your physician'' was too succinct and

that the warning should indicate that alternative delivery systems for

the drug product may be available and that an alternative therapy may

not be necessary.

FDA believes that patients will understand that the alternatives

available may include alternative delivery systems for the same drug

substance and that any need for additional clarity is outweighed by the

necessity of keeping this general warning concise.

4. Another comment suggested that the patient warning statement was

not sufficiently inclusive in directing patients to contact their

physician or pharmacist. The comment suggested that labeling refer to

``physician or health professional'' so as to refer to other health

care professionals, such as physician's assistants or nurses, who can

and do provide patients with information on drug products and medical

devices.

FDA agrees with this comment in regard to OTC products. Health care

professionals, other than physicians and pharmacists, are competent to

advise patients on OTC therapies. However, in regard to prescription

products, FDA believes that, in such a brief warning, the modification

may cause confusion and may cause consumers to direct questions to

health care professionals other than the prescribing physician (or

other authorized prescribing practitioner) and dispensing pharmacist.

In such event, the patient could receive inadequate or inappropriate

advice.

5. Several comments stated that the physician package insert does

not alert

[[Page 20099]]

the physician to the fact that patients have been instructed to consult

with their physician about possible alternatives. Two comments

suggested that the warning on the physician package insert contain the

following additional sentence: ``The patient has been instructed to

consult with you if they have questions about alternatives.''

FDA agrees with the comment and has reworded the warning in the

physician package insert with language to that effect.

Another comment suggested that the proposed OTC drug product

warning was unduly worrisome to consumers and that a warning similar to

the alternative warning contained in patient labeling for prescription

products be allowed for OTC drug products.

EPA's regulations allow an exception to the general rule of

requiring the EPA warning only on patient labeling for prescription

products when the EPA warning is contained in the physician labeling

for the product. No similar exception is provided for OTC drug

products; therefore, the warning suggested in the comment would not be

in compliance with EPA regulations.

IV. Implementation Scheme

FDA advises applicants who have an approved new drug application

(NDA) and whose products contain or are manufactured with CFC's or

other ozone-depleting substances to use the existing procedures in 21

CFR 314.70(c) (supplements for changes that may be made before FDA

approval) to notify the agency of any labeling changes to add a CFC

warning statement. Applicants who have an approved abbreviated new drug

application (ANDA) should follow the same procedures (see 21 CFR

314.97).

Applicants who have submitted either an NDA or ANDA but have not

received approval should, if necessary, amend their applications to

notify FDA about the warning statement(s) they intend to use.

Applicants should submit such amendments in accordance with 21 CFR

314.60 or 314.96, whichever is appropriate.

Applicants who hold an approved product license application (PLA)

and whose products contain or are manufactured with CFC's or other

ozone-depleting substances are to follow the guidance offered in this

interim rule. Revision of labeling to accommodate this warning

statement may be implemented without preclearance from the Center for

Biologics Evaluation and Research (CBER) and submitted to the file as

final printed labeling provided that the placement of such information

does not interfere with or render less prominent any information

required by biologics labeling regulations (21 CFR 610.60 through

610.65)).

Applicants who have submitted a PLA but have not yet received

approval should, if necessary, amend their applications to notify CBER

about inclusion of the required warning statement(s) they intend to

use. Such amendments should be submitted under the applicable reference

number.

Applicants who have submitted premarket approval applications

(PMA's) for medical devices but have not received approval should, if

necessary, amend their applications to notify FDA about the warning

statement(s) they intend to use. Applicants should submit such

amendments in accordance with 21 CFR 814.37. With respect to approved

PMA's, applicants should use the procedures in 21 CFR 814.39 to notify

the agency of any labeling changes to add a CFC warning. Applicants who

have received premarket clearance pursuant to 21 U.S.C. 360(k)

(``510(k) clearance'') do not need to file a new 510(k) submission

requesting new clearance if this rule only results in the addition of

the warning statement to the labeling.

FDA advises applicants who have an approved new animal drug

application (NADA) and whose products contain or are manufactured with

CFC's or other ozone-depleting products to use the existing procedures

as identified in 21 CFR 514.8(e) (supplements for changes which may be

made before FDA approval) to notify the agency of any labeling changes

made to add the CFC warning statement. FDA advises applicants who have

submitted an NADA but have not received approval should, if necessary,

amend their applications to reflect the required label warning. No

notification to the agency is necessary for foods, cosmetics, or animal

foods.

Manufacturers who amended their labeling to conform with the June

29, 1993, notice and who have an approved marketing application for

their product should submit a supplemental application to bring their

labeling into compliance with this interim rule. Such manufacturers may

continue to use their current stocks of labeling that comply with the

June 29, 1993, notice until those stocks are exhausted.

V. Effective Date and Opportunity for Public Comment

For the reasons described in this section, FDA is issuing these

requirements as an interim rule with an opportunity for public comment.

In view of the May 15, 1993, statutory warning label requirement, the

agency is issuing these requirements at this time, but FDA will

consider modifications to the regulations based on issues raised during

the comment period and experience gained under the interim rule.

The Administrative Procedure Act provides an exception to notice

and comment rulemaking when an agency, for good cause, finds that the

notice and comment procedures are impracticable, unnecessary, or

contrary to the public interest (see 5 U.S.C. 553(b)(B)). For this

interim rule, FDA finds that notice and comment procedures would be

impracticable for a CFC warning statement requirement because the Clean

Air Act requires such warning statements to be placed on products

containing or manufactured with CFC's or other ozone-depleting

substances by May 15, 1993.

FDA also finds that notice and comment rulemaking to be unnecessary

and contrary to the public interest. The interim rule permits parties

to use the EPA warning statement or an alternative FDA statement. FDA

has no authority to change or modify the warning statements established

in EPA's regulations, and, in this interim rule, offers, but does not

require, the use of an alternative statement. Consequently, because one

warning statement is established by another agency and because the

alternative warning statement is optional, FDA believes that notice and

comment procedures are unnecessary. Furthermore, FDA believes that,

without the availability of the alternative warning statement, patients

who are concerned about a medical product's impact on the environment

and public health might inappropriately refrain from taking their

medication. This interim rule provides an alternative warning statement

that encourages patients to continue taking their medication and to

consult their physicians, pharmacists, other health professionals, or,

in the case of devices, their suppliers, concerning the product's

effect on the environment or public health. It would, therefore, be

contrary to the public interest to delay the implementation of this

rule pending notice and comment rulemaking.

FDA believes, however, that it should invite and consider public

comment on its practices and procedures for these CFC warning

statements. Interested persons may, on or before August 1, 1996, submit

to the Dockets Management Branch (address above) comments regarding

this interim rule. Two copies of any comments are to be submitted,

except that individuals may submit one copy. Comments are to be

identified with the docket number

[[Page 20100]]

found in brackets in the heading of this document. Received comments

may be seen in the office above between 9 a.m. and 4 p.m., Monday

through Friday.

VI. Analysis of Impacts

FDA has examined the impacts of the interim rule under Executive

Order 12866 and the Regulatory Flexibility Act (Pub. L. 96-354).

Executive Order 12866 directs agencies to assess all costs and benefits

of available regulatory alternatives and, when regulation is necessary,

to select regulatory approaches that maximize net benefits (including

potential economic, environmental, public health and safety, and other

advantages; distributive impacts; and equity). The agency believes that

this interim rule is consistent with the regulatory philosophy and

principles identified in the Executive Order. In addition, the interim

rule is not a significant regulatory action as defined by the Executive

Order and so is not subject to review under the Executive Order.

The Regulatory Flexibility Act requires agencies to analyze

regulatory options that would minimize any significant impact of a rule

on small entities. The regulatory impact analysis (RIA) (January 1993)

that accompanied EPA's rule that implemented section 611 of the Clean

Air Act specifically accounted for cost increases for ``medical

aerosols, including metered-dose inhalation devices, contraceptive

foams, topical antibiotics, and local anesthetics'' (page 15 of the

RIA). A copy of this RIA is available for examination under Public

Docket No. A-91-60 at the U.S. Environmental Protection Agency, rm. M-

1500, Waterside Mall (Ground Floor), 401 M St. SW., Washington, DC

20460. Other FDA-regulated products are accounted for under separate

industry subgroupings. The compliance costs for these labeling changes

have thus been accounted for, and this interim rule adds no additional

burden or cost. Thus, the agency certifies that the interim rule does

not constitute a major rule as defined in Executive Order 12866. The

agency further certifies that the interim rule will not have a

significant economic impact on a substantial number of small entities.

Therefore, under the Regulatory Flexibility Act, no further analysis is

required.

VII. Environmental Impact

The agency has determined under 21 CFR 25.24(a)(11) that this

action is of a type that does not individually or cumulatively have a

significant effect on the human environment. Therefore, neither an

environmental assessment nor an environmental impact statement is

required.

List of Subjects

21 CFR Part 101

Food labeling, Nutrition, Reporting and recordkeeping requirements.

21 CFR Part 201

Drugs, Labeling, Reporting and recordkeeping requirements.

21 CFR Part 369

Labeling, Medical devices, Over-the-counter drugs.

21 CFR Part 501

Animal foods, Labeling, Packaging and containers, Reporting and

recordkeeping requirements.

21 CFR Part 740

Cosmetics, Labeling.

21 CFR Part 801

Labeling, Medical devices, Reporting and recordkeeping

requirements.

Therefore, under the Federal Food, Drug, and Cosmetic Act, the

Public Health Service Act, the Fair Packaging and Labeling Act, and

under authority delegated to the Commissioner of Food and Drugs, 21 CFR

parts 101, 201, 369, 501, 740, and 801 are amended as follows:

PART 101--FOOD LABELING

1. The authority citation for 21 CFR part 101 continues to read as

follows:

Authority: Secs. 4, 5, 6 of the Fair Packaging and Labeling Act

(15 U.S.C. 1453, 1454, 1455); secs. 201, 301, 402, 403, 409, 701 of

the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321, 331, 342,

343, 348, 371).

2. Section 101.17 is amended by revising paragraph (c) to read as

follows:

Sec. 101.17 Food labeling warning and notice statements.

* * * * *

(c) Food containing or manufactured with a chlorofluorocarbon or

other ozone-depleting substance. Labeling requirements for foods that

contain or are manufactured with a chlorofluorocarbon or other ozone-

depleting substance designated by the Environmental Protection Agency

(EPA) are set forth in 40 CFR part 82.

* * * * *

PART 201--LABELING

3. The authority citation for 21 CFR part 201 continues to read as

follows:

Authority: Secs. 201, 301, 501, 502, 503, 505, 506, 507, 508,

510, 512, 530-542, 701, 704, 721 of the Federal Food, Drug, and

Cosmetic Act (21 U.S.C. 321, 331, 351, 352, 353, 355, 356, 357, 358,

360, 360b, 360gg-360ss, 371, 374, 379e); secs. 215, 301, 351, 361 of

the Public Health Service Act (42 U.S.C. 216, 241, 262, 264).

4. New Sec. 201.320 is added to subpart G to read as follows:

Sec. 201.320 Warning statements for drug products containing or

manufactured with chlorofluorocarbons or other ozone-depleting

substances.

(a)(1) All drug products containing or manufactured with

chlorofluorocarbons, halons, carbon tetrachloride, methyl chloride, or

any other class I substance designated by the Environmental Protection

Agency (EPA) shall, except as provided in paragraph (b) or (c) of this

section, bear the following warning statement:

Warning: Contains [or Manufactured with, if applicable] [insert

name of substance], a substance which harms public health and the

environment by destroying ozone in the upper atmosphere.

(2) The warning statement shall be clearly legible and conspicuous

on the product, its immediate container, its outer packaging, or other

labeling in accordance with the requirements of 40 CFR part 82 and

appear with such prominence and conspicuousness as to render it likely

to be read and understood by consumers under normal conditions of

purchase.

(b)(1) For prescription drug products for human use, the following

alternative warning statement may be used:

Note: The indented statement below is required by the Federal

government's Clean Air Act for all products containing or

manufactured with chlorofluorocarbons (CFC's) [or name of other

class I substance, if applicable]:

This product contains [or is manufactured with, if applicable]

[insert name of substance], a substance which harms the environment by

destroying ozone in the upper atmosphere.

Your physician has determined that this product is likely to

help your personal health. USE THIS PRODUCT AS DIRECTED, UNLESS

INSTRUCTED TO DO OTHERWISE BY YOUR PHYSICIAN. If you have any

questions about alternatives, consult with your physician.

(2) The warning statement shall be clearly legible and conspicuous

on the product, its immediate container, its outer packaging, or other

labeling in accordance with the requirements of 40 CFR part 82 and

appear with such prominence and conspicuousness as to render it likely

to be read and understood by consumers under normal conditions of

purchase.

(3) If the warning statement in paragraph (b)(1) of this section is

used, the following warning statement must

[[Page 20101]]

be placed on the package labeling intended to be read by the physician

(physician package insert) after the ``How supplied'' section, which

describes special handling and storage conditions on the physician

labeling:

Note: The indented statement below is required by the Federal

government's Clean Air Act for all products containing or

manufactured with chlorofluorocarbons (CFC's) [or name of other

class I substance, if applicable]:

Warning: Contains [or Manufactured with, if applicable] [insert

name of substance], a substance which harms public health and the

environment by destroying ozone in the upper atmosphere.

A notice similar to the above WARNING has been placed in the

information for the patient [or patient information leaflet, if

applicable] of this product under the Environmental Protection

Agency's (EPA's) regulations. The patient's warning states that the

patient should consult his or her physician if there are questions

about alternatives.

(c)(1) For over-the-counter drug products for human use, the

following alternative warning statement may be used:

Note: The indented statement below is required by the Federal

government's Clean Air Act for all products containing or

manufactured with chlorofluorocarbons (CFC's) [or other class I

substance, if applicable]:

Warning: Contains [or Manufactured with, if applicable] [insert

name of substance], a substance which harms public health and

environment by destroying ozone in the upper atmosphere.

CONSULT WITH YOUR PHYSICIAN OR HEALTH PROFESSIONAL IF YOU HAVE

ANY QUESTION ABOUT THE USE OF THIS PRODUCT.

(2) The warning statement shall be clearly legible and conspicuous

on the product, its immediate container, its outer packaging, or other

labeling in accordance with the requirements of 40 CFR part 82 and

appear with such prominence and conspicuousness as to render it likely

to be read and understood by consumers under normal conditions of

purchase.

(d) This section does not replace or relieve a person from any

requirements imposed under 40 CFR part 82.

PART 369--INTERPRETATIVE STATEMENTS RE WARNINGS ON DRUGS AND

DEVICES FOR OVER-THE-COUNTER SALE

5. The authority citation for 21 CFR part 369 continues to read as

follows:

Authority: Secs. 201, 301, 501, 502, 503, 505, 506, 507, 701 of

the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321, 331, 351,

352, 353, 355, 356, 357, 371).

Sec. 369.21 [Amended]

6. Section 369.21 Drugs; warning and caution statements required by

regulations is amended in paragraph (d) in the warning section for

``DRUGS IN DISPENSERS PRESSURIZED BY GASEOUS PROPELLANTS * * *'' by

removing the five undesignated paragraphs after the introductory text

of paragraph (d).

PART 501--ANIMAL FOOD LABELING

7. The authority citation for 21 CFR part 501 continues to read as

follows:

Authority: Secs. 4, 5, 6 of the Fair Packaging and Labeling Act

(15 U.S.C. 1453, 1454, 1455); secs. 201, 301, 402, 403, 409, 701 of

the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321, 331, 342,

343, 348, 371).

8. Section 501.17 is amended by revising paragraph (c) to read as

follows:

Sec. 501.17 Animal food labeling warning statements.

* * * * *

(c) Animal food containing or manufactured with a

chlorofluorocarbon or other ozone-depleting substance. Labeling

requirements for animal foods that contain or are manufactured with a

chlorofluorocarbon or other ozone-depleting substance designated by the

Environmental Protection Agency (EPA) are set forth in 40 CFR part 82.

PART 740--COSMETIC PRODUCT WARNING STATEMENTS

9. The authority citation for 21 CFR part 740 continues to read as

follows:

Authority: Secs. 201, 301, 502, 505, 601, 602, 701, 704 of the

Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321, 331, 352, 355,

361, 362, 371, 374).

10. Section 740.11 is amended by revising paragraph (c) to read as

follows:

Sec. 740.11 Cosmetics in self-pressurized containers.

* * * * *

(c) Labeling requirements for cosmetics packaged in a self-

pressurized container containing or manufactured with a

chlorofluorocarbon propellant or other ozone-depleting substance

designated by the Environmental Protection Agency (EPA) are set forth

in 40 CFR part 82.

PART 801--LABELING

11. The authority citation for 21 CFR part 801 continues to read as

follows:

Authority: Secs. 201, 301, 501, 502, 507, 519, 520, 701, 704 of

the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321, 331, 351,

352, 357, 360i, 360j, 371, 374).

12. New Sec. 801.63 is added to subpart C to read as follows:

Sec. 801.63 Medical devices; warning statements for devices containing

or manufactured with chlorofluorocarbons and other class I ozone-

depleting substances.

(a) All over-the-counter devices containing or manufactured with

chlorofluorocarbons, halons, carbon tetrachloride, methyl chloride, or

any other class I substance designated by the Environmental Protection

Agency (EPA) shall carry one of the following warnings:

(1) The EPA warning statement:

Warning: Contains [or Manufactured with, if applicable] [insert

name of substance], a substance which harms public health and

environment by destroying ozone in the upper atmosphere.

(2) The alternative statement:

Note: The indented statement below is required by the Federal

government's Clean Air Act for all products containing or

manufactured with chlorofluorocarbons (CFC's) [or other class I

substance, if applicable]:

Warning: Contains [or Manufactured with, if applicable] [insert

name of substance], a substance which harms public health and

environment by destroying ozone in the upper atmosphere.

CONSULT WITH YOUR PHYSICIAN, HEALTH PROFESSIONAL, OR SUPPLIER IF

YOU HAVE ANY QUESTION ABOUT THE USE OF THIS PRODUCT.

(b) The warning statement shall be clearly legible and conspicuous

on the product, its immediate container, its outer packaging, or other

labeling in accordance with the requirements of 40 CFR part 82 and

appear with such prominence and conspicuousness as to render it likely

to be read and understood by consumers under normal conditions of

purchase. This provision does not replace or relieve a person from any

requirements imposed under 40 CFR part 82.

Sec. 801.425 [Removed]

13. Section 801.425 Nonrestricted devices in self-pressurized

containers with chlorofluorocarbon propellants is removed from subpart

H.

14. New Sec. 801.433 is added to subpart H to read as follows:

Sec. 801.433 Warning statements for prescription and restricted device

products containing or manufactured with chlorofluorocarbons or other

ozone-depleting substances.

(a)(1) All prescription and restricted device products containing

or manufactured with chlorofluorocarbons, halons, carbon tetrachloride,

methyl chloride, or any other class I substance designated by the

Environmental

[[Page 20102]]

Protection Agency (EPA) shall, except as provided in paragraph (b) of

this section, bear the following warning statement:

Warning: Contains [or Manufactured with, if applicable] [insert

name of substance], a substance which harms public health and

environment by destroying ozone in the upper atmosphere.

(2) The warning statement shall be clearly legible and conspicuous

on the product, its immediate container, its outer packaging, or other

labeling in accordance with the requirements of 40 CFR part 82 and

appear with such prominence and conspicuousness as to render it likely

to be read and understood by consumers under normal conditions of

purchase.

(b)(1) For prescription and restricted device products, the

following alternative warning statement may be used:

Note: The indented statement below is required by the Federal

government's Clean Air Act for all products containing or

manufactured with chlorofluorocarbons (CFC's) [or name of other

class I substance, if applicable]:

This product contains [or is manufactured with, if applicable]

[insert name of substance], a substance which harms the environment

by destroying ozone in the upper atmosphere.

Your physician has determined that this product is likely to

help your personal health. USE THIS PRODUCT AS DIRECTED, UNLESS

INSTRUCTED TO DO OTHERWISE BY YOUR PHYSICIAN. If you have any

questions about alternatives, consult with your physician.

(2) The warning statement shall be clearly legible and conspicuous

on the product, its immediate container, its outer packaging, or other

labeling in accordance with the requirements of 40 CFR part 82 and

appear with such prominence and conspicuousness as to render it likely

to be read and understood by consumers under normal conditions of

purchase.

(3) If the warning statement in paragraph (b)(1) of this section is

used, the following warning statement must be placed on the package

labeling intended to be read by the physician (physician package

insert) after the ``How supplied'' section, which describes special

handling and storage conditions on the physician labeling:

Note: The indented statement below is required by the Federal

government's Clean Air Act for all products containing or

manufactured with chlorofluorocarbons (CFC's) [or name of other

class I substance, if applicable]:

Warning: Contains [or Manufactured with, if applicable] [insert

name of substance], a substance which harms public health and

environment by destroying ozone in the upper atmosphere.

A notice similar to the above WARNING has been placed in the

information for the patient [or patient information leaflet, if

applicable] of this product under Environmental Protection Agency

(EPA) regulations. The patient's warning states that the patient

should consult his or her physician if there are questions about

alternatives.

(c) This section does not replace or relieve a person from any

requirements imposed under 40 CFR part 82.

Dated: April 16, 1996.

William K. Hubbard,

Associate Commissioner for Policy Coordination.

[FR Doc. 96-10961 Filed 5-2-96; 8:45 am]

BILLING CODE 4160-01-P