[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
