Labeling of Drug Products for Over-The-Counter Human Use

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 330

[Docket No. 92N-0454]

RIN 0905-AA06

Labeling of Drug Products for Over-The-Counter Human Use

AGENCY: Food and Drug Administration, HHS.

ACTION: Proposed rule.

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SUMMARY: The Food and Drug Administration (FDA) is proposing to amend

its general labeling policy for over-the-counter (OTC) drug products

that allows for the interchangeable use of certain words in labeling

required by an OTC drug monograph. Examples of words already allowed

include: ``doctor'' or ``physician,'' ``consult'' or ``ask,'' and

``indications'' or ``uses.'' This proposal provides for an additional

phrase (``Drug interaction precaution'' or ``Avoid mixing drugs'' or

``Do not mix drugs''). The agency is also requesting public comment on

changing the wording of warnings from negative phraseology to a more

positive approach (i.e., ``Do not use more than 7 days'' to ``Use only

7 days'').

DATES: Written comments by October 17, 1994; written comments on the

agency's economic impact determination by October 17, 1994. The agency

is proposing that any final rule that may issue based on this proposal

become effective 30 days after the date of its publication in the

Federal Register.

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: William E. Gilbertson, Center for Drug

Evaluation and Research (HFD-810), Food and Drug Administration, 5600

Fishers Lane, Rockville, MD 20857, 301-594-5000.

SUPPLEMENTARY INFORMATION:

Background

In the Federal Register of April 5, 1993 (58 FR 17553), the agency

proposed to amend its general labeling policy for over-the-counter

(OTC) drug products to allow for the interchangeable use of certain

words in the labeling required by an OTC drug monograph. The agency had

previously proposed in a number of tentative final monographs and

included in a number of final monographs a provision that the words

``doctor'' and ``physician'' may be used interchangeably in the

labeling of OTC drug products. Instead of including this provision in

each OTC drug monograph, the agency proposed to include such a

provision in Sec. 330.1 (21 CFR 330.1) as part of the general

conditions under which an OTC drug is generally recognized as safe,

effective, and not misbranded. The agency also proposed that, at

manufacturers' discretion, the word ``ask'' could be substituted for

the word ``consult,'' which appears in the directions for many OTC drug

monograph ingredients. Thus, the agency proposed that the phrases

``consult a physician,'' ``consult a doctor,'' ``ask a physician,'' and

``ask a doctor'' could be used interchangeably. The agency invited

comments and suggestions as to such other terms that could be used

interchangeably, i.e., terms general in nature that appear in more than

one OTC drug monograph. The comments received in response to the

proposed rulemaking were favorable and suggested a number of additional

terms that could be used interchangeably.

In a final rule published in the Federal Register of January 28,

1994 (59 FR 3998), the agency allowed the following terms to be used

interchangeably: (1) ``Ask'' or ``consult,'' (2) ``assistance'' or

``help,''(3) ``clean'' or ``cleanse,'' (4) ``continue'' or ``persist,''

(5) ``continues'' or ``persists,'' (6) ``doctor'' or ``physician,'' (7)

``indication'' or ``use,'' (8) ``indications'' or ``uses,'' and (9)

``lung'' or ``pulmonary.'' These terms are included in Sec. 330.1(i).

The agency intends to continue to examine labeling required by OTC

drug monographs to provide consumers more simplified and understandable

information. This includes interchangeable terms, alternative

phraseology, and possibly a new or different labeling format. At this

time, the agency is proposing additional words or phrases that could be

used interchangeably. The words ``Drug interaction precaution'' appear

in a number of OTC drug monographs. See, for example, Sec. 341.76(c)(4)

(21 CFR 341.76(c)(4)) which states: ``Drug interaction precaution. Do

not use this product if you are presently taking a prescription drug

for high blood pressure or depression, without first consulting a

doctor.'' The agency believes the phrase ``Avoid mixing drugs'' or ``Do

not mix drugs'' may be better understood by consumers than ``Drug

interaction precaution.'' Accordingly, the agency is proposing to amend

Sec. 330.1(i) to include these additional terms that may be used

interchangeably in the labeling of OTC drug products.

Additionally, the agency is requesting comment from manufacturers

and the public on whether it would be desirable to change negatively

worded warnings to a more positive phraseology. For example, in the

labeling of first aid antibiotic drug products in Sec. 333.150(c)(1)

(21 CFR 333.150(c)(1)), the warning ``Do not use in the eyes or apply

over large areas of the body,'' could be changed to read: ``Avoid use

in the eyes or over large areas of the body.'' Similarly, the warning

in Sec. 333.150(c)(2), which states: ``Do not use longer than 1 week

unless directed by a doctor,'' could be changed to read: ``Use for only

1 week unless directed by a doctor.''

Another example is the warnings in Sec. 331.30(c)(4) (21 CFR

331.30(c)(4)), which states: ``Do not use this product except under the

advice and supervision of a physician if you have kidney disease,'' and

in Sec. 331.30(c)(5) (21 CFR 331.30 (c)(5)), which states: ``Do not use

this product except under the advice and supervision of a physician if

you are on a sodium restricted diet.'' These warnings could be changed

to read: ``Use only with a physician's help if * * *,'' or ``Use only

with the help of a doctor if * * *.''

The warning statements cited are only selected examples. There are

many other similar statements in proposed and final OTC drug

monographs. At this time, the agency seeks comments on the following

specific questions:

(1) Should the terms ``Drug interaction precaution,'' ``Avoid

mixing drugs,'' or ``Do not mix drugs'' be used interchangeably?

(2) Is a positive phraseology for some warnings a desirable

labeling approach or should the more emphatic negative phraseology be

retained as the only allowed language in warning statements?

(3) Will consumers pay more attention to ``Do not use'' language

than to ``Use only'' language? Do repetitive terms such as ``Do not

use'' lose their impact and become less important when read by

consumers?

(4) Should negative warnings be used only for the most important

advice?

(5) Is it essential that similar products have identical warning

language or may the language vary and still be desirable provided the

meaning is the same?

The agency seeks comments from manufacturers, health professionals,

and consumers on these issues. Any party having any survey data on

these labeling approaches should provide that information to the

agency.

FDA has examined the impacts of the proposed 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 proposed rule is consistent with the regulatory philosophy and

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

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

Order and, thus, 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. If this proposed rule becomes a final rule, the

labeling options could be implemented at very little cost by

manufacturers at the next printing of labels, for those products for

which the manufacturer chooses to make a change. Accordingly, the

agency certifies that the proposed 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.

The agency invites public comment regarding any substantial or

significant economic impact that this rulemaking would have on the

labeling of OTC drug products. Types of impact may include, but are not

limited to, costs associated with relabeling. Comments regarding the

impact of this rulemaking on OTC drug products should be accompanied by

appropriate documentation. The agency will evaluate any comments and

supporting data that are received and will reassess the economic impact

of this rulemaking in the preamble to the final rule.

The agency has determined under 21 CFR 25.24(c)(6) 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.

Interested persons may, on or before October 17, 1994, submit to

the Dockets Management Branch (address above) written comments

regarding this proposal. Written comments on the agency's economic

impact determination may be submitted on or before October 17, 1994.

Three copies of all comments are to be submitted, except that

individuals may submit one copy. Comments are to be identified with the

docket number found in brackets in the heading of this document and may

be accompanied by a supporting memorandum or brief. Received comments

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

through Friday.

List of Subjects in 21 CFR Part 330

Over-the-counter drugs.

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

authority delegated to the Commissioner of Food and Drugs, it is

proposed that 21 CFR part 330 be amended as follows:

PART 330--OVER-THE-COUNTER (OTC) HUMAN DRUGS WHICH ARE GENERALLY

RECOGNIZED AS SAFE AND EFFECTIVE AND NOT MISBRANDED

1. The authority citation for 21 CFR part 330 continues to read as

follows:

Authority: Secs. 201, 501, 502, 503, 505, 510, 701 of the

Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321, 351, 352, 353,

355, 360, 371).

2. Section 330.1 is amended by redesignating paragraphs (i)(7),

(i)(8), and (i)(9) as paragraphs (i)(8), (i)(9), and (i)(10),

respectively, and by adding new paragraph (i)(7), to read as follows:

Sec. 330.1 General conditions for general recognition as safe,

effective and not misbranded.

* * * * *

(i) * * *

(7) ``Drug interaction precaution'' or ``Avoid mixing drugs'' or

``Do not mix drugs''.

* * * * *

Dated: July 27, 1994.

Michael R. Taylor,

Deputy Commissioner for Policy.

[FR Doc. 94-18925 Filed 8-2-94; 8:45 am]

BILLING CODE 4160-01-F