[Federal Register Volume 62, Number 79 (Thursday, April 24, 1997)]
[Rules and Regulations]
[Pages 19923-19925]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-10595]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 201

[Docket No. 90N-0309]


Drug Labeling; Sodium Labeling for Over-the-Counter Drugs; 
Partial Delay of Effective Date

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule; partial delay of effective date.

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SUMMARY: The Food and Drug Administration (FDA) is delaying the 
effective date of the sodium labeling final rule for over-the-counter 
(OTC) drug products intended for oral ingestion, except for those 
products that contain sodium bicarbonate, sodium phosphate, or sodium 
biphosphate as an active ingredient. The regulation established 
conditions under which the labeling must include the sodium

[[Page 19924]]

content and a general warning that persons who are on a sodium-
restricted diet should not take the product unless directed by a 
doctor. This partial delay of the effective date of the sodium labeling 
final rule is in response to requests that the effective date for the 
sodium labeling final rule coincide with the effective date for the 
calcium, magnesium, and potassium labeling final rule. The final rule 
for calcium, magnesium, and potassium labeling is expected to publish 
in the Federal Register in the near future and will be effective 12 
months after the date of publication. The agency is delaying the 
effective date of the sodium labeling final rule to correspond with the 
effective date of that final rule.
DATES: The effective date of paragraphs (a) through (h) of Sec. 201.64 
added at 61 FR 17806 (April 22, 1996) is delayed until further notice. 
The revision of paragraph (i) of Sec. 201.64 in this document is 
effective April 24, 1997.

FOR FURTHER INFORMATION CONTACT: Ida Yoder, 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 April 22, 1996 (61 FR 17798), FDA issued 
a final rule amending the general labeling provisions for OTC drug 
products (Sec. 201.64 (21 CFR 201.64)) to: (1) Require that the sodium 
content of all OTC drug products intended for oral ingestion be 
included in labeling when the product contains 5 milligrams (mg) or 
more sodium per a single dose; (2) require that all OTC drug products 
intended for oral ingestion containing more than 140 mg sodium in the 
labeled maximum daily dose bear a general warning that persons who are 
on a sodium-restricted diet should not take the product unless directed 
by a doctor; and (3) provide for the voluntary use of certain terms 
(``sodium free,'' ``very low sodium,'' and ``low sodium'') relating to 
an OTC drug product's sodium content per labeled maximum daily dose. 
The effective date of the final rule is April 22, 1997. In the final 
rule, the agency also sought comments concerning whether the rule 
should be amended to include sodium content labeling for OTC rectal 
laxative, vaginal, dentifrice, mouthwash, and mouth rinse drug 
products. Interested persons were invited to submit comments by July 
22, 1996. In response to two requests for extension of time to file 
comments to the final rule, FDA published a notice in the Federal 
Register of July 22, 1996 (61 FR 38046), extending the comment period 
until September 20, 1996.
    In response to the final rule, comments were received from four 
manufacturers and two trade associations. Two of the comments requested 
that the effective date of the final rule be extended for at least an 
additional 6 months, to October 1997 or later. One comment mentioned 
the need for ongoing technical work, noting that manufacturers have 
undertaken formal product testing to ascertain precise sodium content 
before preparing new labels with accurate content declarations. The 
comment pointed out that the sodium content of inactive ingredients in 
products was a problem because specifications for some OTC drug 
ingredients do not include limits for sodium, suppliers often do not 
provide entire formulation information to companies, and sodium content 
may vary from lot to lot and/or supplier to supplier, especially for 
ingredients of natural origin. The comment stated that it would be 
difficult for some companies to complete product testing in time to 
have new labeling prepared by April 1997. The other comment stated that 
additional time would reduce label obsolescence, allow the use of 
already printed labeling, and allow labeling to be changed using 
current staff levels.
    Both comments emphasized that FDA should delay implementation of 
the sodium labeling final rule until the proposed rule on labeling for 
OTC drug products containing calcium, magnesium, and potassium (61 FR 
17807, April 22, 1996) was finalized. The comments contended that 
coordinating the effective date of both rules, which could apply to any 
single product, would avoid two label changes and the related economic 
impact of phasing in label changes for two separate rulemakings. One 
comment added that no major public health consequence should be 
expected from this delay for the sodium labeling because OTC drug 
products with relatively high sodium contents, e.g., antacids and 
laxatives, already bear a restricted sodium-use warning.

II. The Agency's Response to the Comments

    FDA agrees with the comments' rationale that it is desirable to 
coordinate implementation of the sodium labeling with the calcium, 
magnesium, and potassium labeling. A single effective date for both 
final rules avoids two labeling changes and reduces the economic impact 
of phasing in labeling changes for two separate, but related, 
rulemakings. In addition, a short delay provides manufacturers 
additional time that should be sufficient to complete all product 
analyses. FDA notified all commentors of its intentions in a feedback 
letter (Ref. 1) and asked the Nonprescription Drug Manufacturers 
Association (NDMA) to notify its members and suggest that they 
incorporate calcium, magnesium, and potassium analyses into current 
plans to do sodium analyses so that all analyses can be completed and 
new labeling implemented by the effective date. FDA concurs with one 
comment that there should be no major public health consequences 
because of this short delay.
    In the near future, FDA intends to publish, in the Federal 
Register, a final rule containing the labeling requirements for orally 
ingested OTC drug products containing calcium, magnesium, and 
potassium. That final rule will become effective 12 months after date 
of publication in the Federal Register. The final rule for sodium 
labeling will become effective on the same date.
    For safety reasons, FDA is not delaying the effective date of the 
sodium labeling requirements for OTC drug products that contain sodium 
bicarbonate, sodium phosphate, or sodium biphosphate as an active 
ingredient. Section 201.64(i) of the sodium labeling final rule (61 FR 
17798 at 17806) is effective April 22, 1997 for all OTC drug products 
intended for oral ingestion that contain sodium bicarbonate, sodium 
phosphate, or sodium biphosphate as an active ingredient. Accordingly, 
the agency is amending Sec. 201.64(i) to reflect the effective date for 
these ingredients. The agency has already published notices of proposed 
rulemaking describing its concerns about these ingredients. See the 
Federal Register of February 2, 1994 (59 FR 5060), for sodium 
bicarbonate and the Federal Register of March 31, 1994 (59 FR 15139), 
for sodium phosphate and sodium biphosphate. The agency hopes to 
finalize those proposals in the near future.

III. Reference

    The following reference has been placed on display in the Dockets 
Management Branch (HFA-305), Food and Drug Administration, 12420 
Parklawn Dr., rm. 1-23, Rockville, MD 20857, and may be seen by 
interested persons between 9 a.m. and 4 p.m., Monday through Friday.
    (1) Letter from D. Bowen, FDA, to L. Totman, NDMA, January 14, 
1997, in Docket No. 90N-0309, Dockets Management Branch.

[[Page 19925]]

IV. Summary of Partial Delay of Effective Date

    This final rule extends the effective date of the final rule for 
sodium labeling of OTC drugs for almost all OTC drug products for about 
1 year, although the exact date is not known at this time. The 
effective date for the sodium labeling will coincide with the effective 
date for the calcium, magnesium, and potassium labeling. For safety 
reasons, FDA is not delaying the effective date of the sodium labeling 
requirements for OTC drug products that contain sodium bicarbonate, 
sodium phosphate, or sodium biphosphate as an active ingredient.

V. Analysis of Impacts

    The economic impact of the sodium labeling regulation was discussed 
in the final rule (61 FR 17798 at 17805 and 17806). A delay in the 
effective date will provide additional time for companies to do product 
analyses and will reduce label obsolescence, as there will be 
additional time to use up more existing labeling. Thus, this final rule 
granting a partial delay of effective date should reduce the economic 
impact on industry.
    FDA has examined the impacts of the final rule (partial delay of 
effective date) under Executive Order 12866 and the Regulatory 
Flexibility Act (5 U.S.C. 601-612). 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 final 
rule is consistent with the regulatory philosophy and principles 
identified in the Executive Order. In addition, the final rule is not a 
significant regulatory action as defined by the Executive Order and so 
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. This final rule provides a partial delay in the 
effective date. The delay in the effective date will provide 
manufacturers additional time to do product analyses and to use up 
existing product labeling. Thus, this final rule should reduce the 
economic impact on industry. Accordingly, the Commissioner of Food and 
Drugs certifies that the final 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.

VI. Paperwork Reduction Act of 1995

    FDA concludes that the labeling requirements 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 
labeling is a ``public disclosure of information originally supplied by 
the Federal Government to the recipient for the purpose of disclosure 
to the public'' (5 CFR 1320.3(c)(2)).

VII. 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 
required.

List of Subjects in 21 CFR Part 201

    Drugs, Labeling, Reporting and recordkeeping requirements.
    Therefore, under the Federal Food, Drug, and Cosmetic Act, and 
under authority delegated to the Commissioner of Food and Drugs, 21 CFR 
part 201 is amended as follows:

PART 201--LABELING

    1. The authority citation for 21 CFR part 201 continues to read as 
follows:

    Authority: Secs. 201, 301, 501, 502, 503, 505, 506, 507, 508, 
510, 512, 530-542, 701, 704, 721 of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 321, 331, 351, 352, 353, 355, 356, 357, 358, 
360, 360b, 360gg-360ss, 371, 374, 379e); secs. 215, 301, 351, 361 of 
the Public Health Service Act (42 U.S.C. 216, 241, 262, 264).

    2. The effective date for Sec. 201.64(a) through (h) that was added 
in the Federal Register of April 22, 1996 (61 FR 17798), is delayed 
until further notice and Sec. 201.64(i) is revised to read as follows:


Sec. 201.64   Sodium labeling.

* * * * *
    (i) Any product subject to this paragraph that contains sodium 
bicarbonate, sodium phosphate, or sodium biphosphate as an active 
ingredient for oral ingestion and that is not labeled as required by 
this paragraph and that is initially introduced or initially delivered 
for introduction into interstate commerce after April 22, 1997, is 
misbranded under sections 201(n) and 502(a) and (f) of the Federal 
Food, Drug, and Cosmetic Act (the act).

    Dated: April 18, 1997.
William K. Hubbard,
Associate Commissioner for Policy Coordination.
[FR Doc. 97-10595 Filed 4-21-97; 11:51 am]
BILLING CODE 4160-01-F