[Federal Register Volume 68, Number 201 (Friday, October 17, 2003)]
[Notices]
[Page 59797]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-26189]



[[Page 59797]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 1997D-0443]


Iron-Containing Supplements and Drugs: Label Warning Statement 
Requirements; Small Entity Compliance Guide; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of a small entity compliance guide (SECG) entitled ``Iron-
Containing Supplements and Drugs: Label Warning Statements; Small 
Entity Compliance Guide'' to revise and update an earlier SECG entitled 
``Iron-Containing Supplements and Drugs: Label Warning Statements and 
Unit-Dose Packaging Requirements; Small Entity Compliance Guide.'' The 
revised SECG is being issued in response to the withdrawal, in part, of 
a final rule. The SECG is intended to set forth in plain language the 
requirements for label warning statements for iron-containing dietary 
supplement and drug products in solid oral dosage form and to help 
small businesses understand these requirements.

DATES: Submit written or electronic comments on the SECG at any time.

ADDRESSES: Submit written comments on the SECG to the Division of 
Dockets Management (HFA-305), Food and Drug Administration, 5630 
Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic comments 
on the SECG to http://www.fda.gov/dockets/ecomments.
    Submit written requests for single copies of the SECG to the Iron 
Labeling, Industry Activities Staff (HFS-565), Center for Food Safety 
and Applied Nutrition, Food and Drug Administration, 5100 Paint Branch 
Pkwy., College Park, MD 20740. Send one self-addressed adhesive label 
to assist that office in processing your request. See the SUPPLEMENTARY 
INFORMATION section for electronic access to this guidance document.

FOR FURTHER INFORMATION CONTACT: Robert J. Moore, Center for Food 
Safety and Applied Nutrition (HFS-810), Food and Drug Administration, 
5100 Paint Branch Pkwy., College Park, MD 20740, 301-436-1441.

SUPPLEMENTARY INFORMATION:

I. Background

    In the Federal Register of January 15, 1997 (62 FR 2218), FDA 
issued a final rule (1997 final rule) requiring: (1) Label warning 
statements on iron-containing products taken in solid oral dosage form 
to supplement the dietary intake of iron or to provide iron for 
therapeutic purposes, and (2) unit-dose packaging for iron-containing 
dietary supplement and drug products that contain 30 milligrams (mg) or 
more of iron per dosage unit. This final rule became effective July 15, 
1997. In the Federal Register of December 12, 1997 (62 FR 65432), FDA 
announced the availability of a SECG entitled ``Iron-Containing 
Supplements and Drugs; Label Warning Statements and Unit-Dose Packaging 
Requirements; Small Entity Compliance Guide'' (1997 SECG). The 1997 
SECG was prepared in accordance with section 212 of the Small Business 
Regulatory Enforcement Act (Public Law 104-121) and was intended to 
help small businesses understand the requirements of the 1997 final 
rule.
    Elsewhere in this issue of the Federal Register, FDA is withdrawing 
those parts of the 1997 final rule that established regulations in 
Sec. Sec. 111.50 and 310.518(a) and (b) (21 CFR 111.50 and 310.518(a) 
and (b)) requiring unit-dose packaging for iron-containing dietary 
supplement and drug products that contain 30 mg or more of iron per 
dosage unit. FDA is taking this action in response to the Court's 
ruling in Nutritional Health Alliance v. FDA (318 F.3d 92 (2d Cir. 
2003)), in which the U.S. Court of Appeals for the Second Circuit 
invalidated the unit-dose packaging regulations based upon its 
conclusion that the Federal Food, Drug, and Cosmetic Act does not 
provide FDA with authority to regulate packaging of iron-containing 
dietary supplement and drug products for poison prevention purposes. 
The Court's ruling affects only the unit-dose packaging requirements of 
the 1997 final rule and not the label warning statement requirements. 
On remand, the U.S. District Court for the Eastern District of New York 
entered final judgment in accordance with the Court's decision, 
declaring the provisions of Sec. Sec.  111.50 and 310.518(a) invalid 
and without legal force or effect (Nutritional Health Alliance v. FDA, 
No. 97-CV-5042 (E.D.N.Y. filed May 29, 2003)). As a result, the 1997 
SECG is being revised in accordance with the Court's ruling and FDA's 
withdrawal of the unit-dose packaging regulations.
    Therefore, FDA is making available the revised SECG entitled 
``Iron-Containing Supplements and Drugs: Label Warning Statements; 
Small Entity Compliance Guide,'' which states in plain language the 
requirements of the final rule on label warning statements for iron-
containing dietary supplement and drug products.
    FDA is revising this SECG as level 2 guidance consistent with FDA's 
good guidance practices regulation (21 CFR 10.115(c)(2)). The SECG 
represents the agency's current thinking on this subject. It does not 
create or confer any rights for or on any person and does not operate 
to bind FDA or the public. An alternative approach may be used if such 
approach satisfies the requirements of the applicable statutes and 
regulations. If you want to discuss an alternative approach, contact 
the FDA staff responsible for implementing this guidance (see FOR 
FURTHER INFORMATION CONTACT).

II. Comments

    Interested persons may submit to the Division of Dockets Management 
(see ADDRESSES) written or electronic comments regarding this document. 
Submit a single copy of electronic comments to http://www.fda.gov/dockets/ecomments or two paper copies of any mailed comments, except 
that individuals may submit one paper copy. Comments are to be 
identified with the docket number found in brackets in the heading of 
this document. Received comments may be seen in the Division of Dockets 
Management between 9 a.m. and 4 p.m., Monday through Friday.

III. Electronic Access

    Persons with access to the Internet may obtain the document at 
http://www.cfsan.fda.gov/guidance.html.

    Dated: October 7, 2003.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 03-26189 Filed 10-16-03; 8:45 am]
BILLING CODE 4160-01-S