[Federal Register Volume 65, Number 1 (Monday, January 3, 2000)]
[Rules and Regulations]
[Pages 7-9]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-34040]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Parts 201, 341, and 369
[Docket Nos. 98N-0337, 96N-0420, 95N-0259, 90P-0201]
RIN 0910-AA79
Over-The-Counter Human Drugs; Labeling Requirements; Final Rule;
Technical Amendment
AGENCY: Food and Drug Administration, HHS.
ACTION: Final rule; technical amendment.
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SUMMARY: The Food and Drug Administration (FDA) is amending the
regulation that established a standardized format and standardized
content requirements for the labeling of over-the-counter (OTC) drug
products, and is amending several related OTC drug product labeling
regulations. This amendment corrects and conforms several aspects of
the new labeling requirements to other regulatory provisions and
eliminates unnecessary text from the new labeling regulation.
DATES: This regulation is effective January 3, 2000. Submit written
comments by March 18, 2000.
ADDRESSES: Submit written comments to the Dockets Management Branch
(HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061,
Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT: Cazemiro R. Martin or Gerald M.
Rachanow, Center for Drug Evaluation and Research (HFD-560), Food and
Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-
2222.
SUPPLEMENTARY INFORMATION:
I. Background
In the Federal Register of March 17, 1999 (64 FR 13254), FDA
published a final rule establishing a standardized format and
standardized content requirements for the labeling of OTC drug
products. The final rule is codified primarily in Sec. 201.66 (21 CFR
201.66). The rule was effective on May 16, 1999 (64 FR 18571, April 15,
1999), but is subject to a detailed implementation plan outlined in the
final rule (64 FR 13254 at 13273 to 13274).
II. Technical Amendments
1. Section 201.66(c) states that the information in paragraphs
(c)(1) through (c)(8) must appear in the order listed. Section
201.66(c)(5)(ii)(A) contains the ``Allergy alert'' warning, followed by
Sec. 201.66(c)(5)(ii)(B), which contains the ``Reye's syndrome''
warning required under Sec. 201.314(h)(1) (21 CFR 201.314(h)(1)). The
order in Sec. 201.66(c)(5)(ii) is not consistent with another FDA
labeling provision.
Under Sec. 201.314(h)(2), the Reye's syndrome warning must be the
first warning listed under the ``Warnings'' heading. To conform
Sec. 201.66(c)(5)(ii) to Sec. 201.314(h)(2), the agency is
redesignating paragraph (c)(5)(ii)(A) as paragraph (c)(5)(ii)(B) and
paragraph (c)(5)(ii)(B) as paragraph (c)(5)(ii)(A). In addition, the
agency is correcting the word ``Reye'' to read ``Reye's'' in
Sec. 201.314(h)(1).
2. Section 201.66(c)(5)(iii) requires the use of the subheading
``Do not use.'' Section 330.1(i)(38) (21 CFR 330.1(i)(38)) allows the
phrases ``give to'' and ``use in'' to be used interchangeably. However,
Sec. 201.66(f) does not allow the use of interchangeable terms in
subheadings. This limitation on the use of interchangeable terms may
cause some confusion when applied to certain monoamine oxidase
inhibitor warnings.
Specifically, the monoamine oxidase inhibitor (MAOI) warning in
Secs. 341.74(c)(4)(vi) (21 CFR 341.74(c)(4)(vi)) and
341.80(c)(1)(ii)(D) (21 CFR 341.80(c)(1)(ii)(D)) provides slightly
different language for products labeled only for children under 12
years of age. The warning states: ``Do not give to a child who * * *''.
Similarly, the warning under the entry ``SODIUM GENTISATE'' in
Sec. 369.21 (21 CFR 369.21) contains a warning that states ``Do not
give to children * * *''. To allow these warnings to conform to the
required subheadings in the new labeling format, the agency is revising
these warnings to replace the words ``give to'' with the words ``use
in.''
3. Section 201.66(d)(3) of the final rule provides, in relevant
part, that the title, headings, subheadings, and information in
paragraphs (c)(1) through (c)(9) must not appear in reverse type, and
that the required labeling must be all black or one dark color, printed
on a white or other light, neutral color, contrasting background.
Section 201.66(d)(3) also provides for the use of a single,
alternative, contrasting dark color to highlight the Drug Facts title
and headings.
Section 201.66(d)(3) is based on the finding that color contrast
between text and background is a significant factor affecting the
legibility of OTC drug product labeling. Generally, high contrast
between the color of the text and the color of the background can
significantly improve legibility. If, however, the text blends into the
background, consumers may have difficulty focusing on and reading the
information.
The final rule recognizes that black text on a white background is
the most common way to achieve high contrast. However, to emphasize the
importance of contrast and to provide more options than black on white
labeling, the agency included the terms ``dark'' text and ``light''
background in Sec. 201.66(d)(3). After receiving several inquiries from
manufacturers about the meaning of these terms, the agency has decided
that the rule would be less confusing if the terms ``dark,'' ``light,''
and ``reverse type'' (i.e., ``light'' type on a ``dark'' background)
were deleted.
Section 201.66(d)(3) is intended to ensure adequate contrast
between text and background. The terms ``dark'' and ``light'' may have
added an unnecessary element of complexity to the rule. Aside from the
difficulty in assigning a fixed meaning to these terms, the agency
acknowledges that there may be combinations of light text on a dark
background that, assuming high contrast, would be consistent with
achieving readable OTC drug product labeling. (See, e.g., Ref. 2 at 62
FR 9024 at 9049 (February 27, 1997), noting that in OTC drug labeling
white text on a brown background may provide good, readable contrast.)
To eliminate possible confusion, while keeping the emphasis in the
final rule on achieving high contrast, the agency is removing the words
``dark'' and ``light'' and the phrase ``shall not appear in reverse
type'' from Sec. 201.66(d)(3). Thus, the amended version of the rule
requires black on white text or, any other combination of a single
color of text on a contrasting background. Generally, the agency
expects the color contrast used in the Drug Facts labeling to be at
least as high as that used in a product's principal display panel or
other promotional labeling.
These amendments institute minor changes and corrections to the
rule and may provide greater flexibility in the implementation of the
new OTC drug labeling requirements. Also, with respect to the third
technical amendment, the agency notes that only few comments submitted
during the rulemaking process addressed the issue of color contrast. Of
these, most supported the need for using good contrast but did not take
a substantive position on whether to require only dark on light
labeling. As discussed above, the agency is retaining the contrast
requirement. Therefore, the agency believes this amendment does not
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present a significant or controversial issue that warrants further
opportunity for notice and comment rulemaking.
For these reasons, the agency finds for good cause that notice and
comment procedures are unnecessary in this instance and that these
changes may go into effect immediately (5 U.S.C. 553(b) and (d) and 21
CFR 10.40(c) and (e)). However, in accordance with 21 CFR 10.40(e)(1),
the agency will accept comments on these amendments to determine
whether they should be modified or revoked.
III. The Paperwork Reduction Act of 1995
FDA analyzed all relevant information collections associated with
this rule in the original final rule document (64 FR 13254 at 13274 to
13276). These amendments do not impose any new requirements and,
therefore, do not require any further analysis and are not subject to
review by the Office of Management and Budget.
IV. Analysis of Impacts
FDA provided a detailed analysis of impacts in the original final
rule document (64 FR 13254 at 13276 through 13285). This technical
amendment provides several clarifications and allows additional
flexibility in the labeling requirements. Thus, no further analysis of
impacts is necessary.
V. Environmental Impact
The agency has determined under 21 CFR 25.30(h) 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 201
Drugs, Labeling, Reporting and recordkeeping requirements.
21 CFR Part 341
Labeling, Over-the-counter drugs.
21 CFR Part 369
Labeling, Medical devices, Over-the-counter drugs.
Therefore, under the Federal Food, Drug, and Cosmetic Act, the
Public Health Service Act, and under authority delegated to the
Commissioner of Food and Drugs, 21 CFR parts 201, 341, and 369 are
amended as follows:
PART 201--LABELING
1. The authority citation for 21 CFR part 201 continues to read as
follows:
Authority: 21 U.S.C. 321, 331, 351, 352, 353, 355, 358, 360,
360b, 360gg-360ss, 371, 374, 379e; 42 U.S.C. 216, 241, 262, 264.
2. Section 201.66 is amended by redesignating paragraphs
(c)(5)(ii)(A) and (c)(5)(ii)(B) as paragraphs (c)(5)(ii)(B) and
(c)(5)(ii)(A), respectively, and revising paragraph (d)(3) to read as
follows:
Sec. 201.66 Format and content requirements for over-the-counter (OTC)
drug product labeling.
* * * * *
(d) * * *
(3) The title, heading, subheadings, and information in paragraphs
(c)(1) through (c)(9) of this section shall be legible and clearly
presented, shall have at least 0.5-point leading (i.e., space between
two lines of text), and shall not have letters that touch. The type
style for the title, headings, subheadings, and all other required
information described in paragraphs (c)(2) through (c)(9) of this
section shall be any single, clear, easy-to-read type style, with no
more than 39 characters per inch. The title and headings shall be in
bold italic, and the subheadings shall be in bold type, except that the
word ``(continued)'' in the title ``Drug Facts (continued)'' shall be
regular type. The type shall be all black or one color printed on a
white or other contrasting background, except that the title and the
headings may be presented in a single, alternative, contrasting color
unless otherwise provided in an approved drug application, OTC drug
monograph (e.g., current requirements for bold print in Secs. 341.76
and 341.80 of this chapter), or other OTC drug regulation (e.g., the
requirement for a box and red letters in Sec. 201.308(c)(1)).
* * * * *
3. Section 201.314 is amended by revising paragraph (h)(1) to read
as follows:
Sec. 201.314 Labeling of drug preparations containing salicylates.
* * * * *
(h)(1) The labeling of orally or rectally administered over-the-
counter aspirin and aspirin-containing drug products subject to this
paragraph is required to prominently bear a warning. The warning shall
be as follows: ``Children and teenagers should not use this medicine
for chicken pox or flu symptoms before a doctor is consulted about
Reye's syndrome, a rare but serious illness reported to be associated
with aspirin.''
* * * * *
PART 341--COLD, COUGH, ALLERGY, BRONCHODILATOR, AND ANTIASTHMATIC
DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE
4. The authority citation for 21 CFR part 341 continues to read as
follows:
Authority: 21 U.S.C. 321, 351, 352, 353, 355, 360, 371.
5. Section 341.74 is amended by revising paragraph (c)(4)(vi) to
read as follows:
Sec. 341.74 Labeling of antitussive drug products.
* * * * *
(c) * * *
(4) * * *
(vi) For products containing dextromethorphan or dextromethorphan
hydrobromide as identified in Sec. 341.14(a)(3) and (a)(4) when labeled
only for children under 12 years of age. Drug interaction precaution.
``Do not use in a child who is taking a prescription monoamine oxidase
inhibitor (MAOI) (certain drugs for depression, psychiatric, or
emotional conditions, or Parkinson's disease), or for 2 weeks after
stopping the MAOI drug. If you do not know if your child's prescription
drug contains an MAOI, ask a doctor or pharmacist before giving this
product.''
* * * * *
6. Section 341.80 is amended by revising paragraph (c)(1)(ii)(D)
to read as follows:
Sec. 341.80 Labeling of nasal decongestant drug products.
* * * * *
(c) * * *
(1) * * *
(ii) * * *
(D) Drug interaction precaution. ``Do not use in a child who is
taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs
for depression, psychiatric, or emotional conditions, or Parkinson's
disease), or for 2 weeks after stopping the MAOI drug. If you do not
know if your child's prescription drug contains an MAOI, ask a doctor
or pharmacist before giving this product.''
* * * * *
PART 369--INTERPRETATIVE STATEMENTS RE WARNINGS ON DRUGS AND
DEVICES FOR OVER-THE-COUNTER SALE
7. The authority citation for 21 CFR part 369 continues to read as
follows:
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Authority: 21 U.S.C. 321, 331, 351, 352, 353, 355, 371.
8. Section 369.21 is amended by revising the entry for ``SODIUM
GENTISATE.'' to read as follows:
Sec. 369.21 Drugs; warning and caution statements required by
regulations.
* * * * *
SODIUM GENTISATE. (See Secs. 201.314 and 310.301(a)(2) of this
chapter.)
Warning--Do not use in children under 6 years of age or use for
prolonged period unless directed by physician.
``Keep out of reach of children. In case of overdose, get medical
help or contact a Poison Control Center right away.''
If offered for use in arthritis or rheumatism, in juxtaposition
therewith, the statement:
Caution--If pain persists for more than 10 days, or redness is
present, or in conditions affecting children under 12 years of age,
consult a physician immediately.
* * * * *
Dated: December 22, 1999.
Margaret M. Dotzel,
Acting Associate Commissioner for Policy.
[FR Doc. 99-34040 Filed 12-30-99; 8:45 am]
BILLING CODE 4160-01-F
