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

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