[Federal Register Volume 61, Number 43 (Monday, March 4, 1996)]
[Proposed Rules]
[Pages 8450-8451]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-4912]


[[Page 8449]]


Part VII

Department of Health and Human Services


Food and Drug Administration


21 CFR Part 330

Labeling of Drug Products for Over-the-Counter Human Use; Proposed Rule

Federal Register / Vol. 61, No. 43 / Monday, March 4, 1996 / Proposed 

[[Page 8450]]

Food and Drug Administration
21 CFR Part 330
[Docket No. 92N-454A]
RIN 0910-AA01

Labeling of Drug Products for Over-the-Counter Human Use
AGENCY: Food and Drug Administration, HHS.
ACTION: Proposed rule.


SUMMARY: The Food and Drug Administration (FDA) is proposing to amend 
its general labeling policy for over-the-counter (OTC) drug products to 
allow for the interchangeable use of certain labeling terms 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 an additional 
phrase (``unless a doctor tells you'') that can be used in place of 
several other phrases found in various OTC drug monographs.
DATES: Written comments by May 20, 1996; written comments on the 
agency's economic impact determination by May 20, 1996. 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-105), Food and Drug Administration, 5600 
Fishers Lane, Rockville, MD 20857, 301-827-2304.
I. Background
    In the Federal Register of April 5, 1993 (58 FR 17553), the agency 
proposed to amend its general labeling policy for 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 in the labeling of OTC drug products: (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).
    In the Federal Register of August 3, 1994 (59 FR 39499), the agency 
proposed to amend Sec. 330.1(i) so that the phrases ``Drug interaction 
precaution,'' ``Avoid mixing drugs,'' or ``Do not mix drugs'' could be 
used interchangeably. The agency also requested public comment on 
changing the wording of warnings from negative phraseology to a more 
positive approach (e.g., ``Do not use more than 7 days'' to ``Use only 
7 days,'' ``Do not use in * * *'' to ``Avoid use in * * *,'' ``Do not 
use longer than 1 week * * *'' to ``Use only 1 week * * *,'' and ``Do 
not use this product except under the advice and supervision of a 
physician if * * *,'' to ``Use only with a physician's help if * * *'' 
or ``Use only with the help of a doctor if * * *'').
    The agency has received a number of comments on the proposal, and 
they are being evaluated at this time. The agency intends to publish a 
final rule in a future issue of the Federal Register.
    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 an additional phrase that could be used 
    Labeling information about not using an OTC drug product under 
certain circumstances (e.g., ``unless directed by a doctor,'' or 
``except under the advice and supervision of a physician'') appears in 
different OTC drug monographs in different language. This has occurred 
because various OTC advisory review panels recommended different 
wording, and OTC drug rulemakings have been completed over a period of 
    The phrase ``* * * unless directed by a doctor'' appears in the 
warning statements of many recent OTC drug monographs. (See, for 
example, Sec. 341.76(c)(2) (21 CFR 341.76(c)(2)) which states: ``Do not 
use this product if you have * * * unless directed by a doctor.'') In a 
number of other monographs, terms with the same (or similar) meaning 
have been used. For example, the OTC antacid drug products monograph in 
Sec. 331.30(c)(1) and (c)(4) through (c)(7) (21 CFR 331.30(c)(1) and 
(c)(4) through (c)(7)) uses the phrase ``except under the advice and 
supervision of a physician,'' and the OTC ophthalmic drug products 
monograph in Sec. 349.75(c)(2) (21 CFR 349.75(c)(2)) uses the phrase 
``except under the advice and supervision of a doctor.'' That 
terminology has not been used in more recent OTC drug monographs.
    For OTC antihistamine drug products in Sec. 341.72(c)(3) and (c)(4) 
(21 CFR 341.72(c)(3) and (c)(4)), and for OTC anorectal drug products 
in Sec. 346.50(c)(7)(ii) (21 CFR 346.50(c)(7)(ii)), the phrase ``* * * 
without first consulting your doctor'' is used. In Sec. 341.72(c)(6)(i) 
through (c)(6)(iii), the phrase ``* * * without first consulting the 
child's doctor'' is used. The warning statements for OTC dandruff, 
seborrheic dermatitis, and psoriasis drug products in 
Sec. 358.750(c)(2)(ii), (c)(3), and (c)(4) (21 CFR 358.750(c)(2)(ii), 
(c)(3), and (c)(4)) include the phrases ``* * * without consulting a 
doctor,'' ``* * * except on the advice of a doctor,'' and ``* * * 
unless directed to do so by a doctor.'' Thus, a number of different 
phrases have been used to convey the same message. The phrase ``unless 
directed by a doctor'' has been used more recently and most frequently.
    The agency believes that all of these phrases can be interpreted in 
the same way (e.g., ``* * * unless a doctor tells you''). The agency 
believes this simpler phrase may be better understood by consumers than 
some of the other phrases. Accordingly, the agency is proposing to 
amend Sec. 330.1(i) to include the phrase ``unless a doctor tells you'' 
as an alternative for these other phrases

[[Page 8451]]

where they appear in the labeling of OTC drug products. In a few 
instances, the words ``or your child's doctor'' would be used as part 
of this phrase. The agency is asking whether it would be preferable to 
say ``your'' child's doctor or ``the'' child's doctor, or whether it 
does not make any difference which wording is used. The agency is 
requesting comment from manufacturers, health professionals, and 
consumers on whether it would be desirable to use this alternative 
phrase interchangeably with the other phrases and/or whether a single 
uniform phrase should appear in all of the cited regulations. The 
agency also seeks comment whether there are additional, simpler, 
informative ways in which this information may be stated.

II. Analysis of Impacts

    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.

III. Paperwork Reduction Act of 1995

    FDA tentatively concludes that the labeling requirements proposed 
in this document are not subject to review by the Office of Management 
and Budget because they do not constitute a ``collection of 
information'' under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 
et seq.). Rather, the proposed labeling statements are a ``public 
disclosure of information originally supplied by the Federal government 
to the recipient for the purpose of disclosure to the public'' (5 CFR 

IV. Environmental Impact

    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 
    Interested persons may, on or before May 20, 1996, 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 May 20, 1996. 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:


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

    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 adding new paragraph (i)(11), to 
read as follows:

Sec. 330.1  General conditions for general recognition as safe, -
effective and not misbranded.

* * * * *
    (i) * * *-
    (11) ``Unless a doctor'' (or ``your child's doctor,'' where 
applicable) ``tells you'' may be used in place of any of the following 
    (i) ``Except on the advice of a doctor''.
    (ii) ``Except under the advice and supervision of a'' 
[``physician'' or ``doctor''].
    (iii) ``Unless directed by a doctor''.
    (iv) ``Unless directed to do so by a doctor''.
    (v) ``Without consulting a doctor''.
    (vi) ``Without first consulting your'' (or ``your child's'' or 
``the child's'') ``doctor''.
* * * * *

    Dated: February 23, 1996.
William K. Hubbard,
Associate Commissioner for Policy Coordination.
[FR Doc. 96-4912 Filed 3-1-96; 8:45 am]