[Federal Register Volume 59, Number 148 (Wednesday, August 3, 1994)]
[Unknown Section]
[Page 0]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-18925]


[[Page Unknown]]

[Federal Register: August 3, 1994]


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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