[Federal Register Volume 68, Number 201 (Friday, October 17, 2003)]
[Rules and Regulations]
[Pages 59714-59715]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-26188]



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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 111 and 310

[Docket Nos. 91P-0186 and 93P-0306]


Iron-Containing Supplements and Drugs; Label Warning Statements 
and Unit-Dose Packaging Requirements; Removal of Regulations for Unit-
Dose Packaging Requirements for Dietary Supplements and Drugs

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule; removal of regulatory provisions in response to 
court order.

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SUMMARY: The Food and Drug Administration (FDA) is removing, in part, a 
final rule that required unit-dose packaging for iron-containing 
dietary supplement and drug products that contain 30 milligrams (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, in which the 
Court concluded that the Federal Food, Drug, and Cosmetic Act (the act) 
does not provide FDA with authority to require manufacturers of iron-
containing dietary supplement and drug products to use unit-dose 
packaging for poison prevention purposes. Today's action takes the 
ministerial step of removing the unit-dose packaging provisions from 
title 21 of the Code of Federal Regulations.

DATES: This rule is effective October 17, 2003.

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 
published a final rule (1997 final rule) that, among other things, 
required unit-dose packaging\1\ for iron-containing dietary supplement 
and drug products in solid oral dosage form that contain 30 mg or more 
of iron per dosage unit (Sec.  111.50 (21 CFR 111.50 (dietary 
supplements) and Sec.  310.518(a) (21 CFR 310.518(a) (drugs)). These 
provisions were challenged by the Nutritional Health Alliance (NHA), an 
association including manufacturers and distributors of iron-containing 
dietary supplements, on the basis that FDA did not have authority under 
the act to issue and enforce regulations for the purpose of poison 
prevention. On November 1, 2000, the U.S. District Court for the 
Eastern District of New York upheld FDA's authority to issue the 
regulations under the act (Nutritional Health Alliance v. FDA, No. 97-
CV-5042, 2000 U.S. Dist. LEXIS 22330 (E.D.N.Y. Nov. 1, 2000)). NHA 
appealed. On January 21, 2003, the U.S. Court of Appeals for the Second 
Circuit reversed the judgment of the District Court and remanded the 
case to the District Court to fashion an appropriate remedy. On May 9, 
2003, the District Court signed a final judgment 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).
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    \1\ For purposes of the rule, ``unit-dose packaging'' means a 
method of packaging a product into a nonreusable container designed 
to hold a signle dosage intended for administration directly from 
that container, irrespective of whether the recommended dose is one 
or more than one of these units (62 FR 2218, n.1; see also 
Sec. 111.50(a) and 21 CFR 310.510(a)).
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II. Summary of the Final Rule

    In accordance with the Court's ruling and the District Court's 
final judgment, FDA is removing those parts of the 1997 final rule that 
established regulations in Sec. Sec.  111.50 and 310.518(a), which 
required unit-dose packaging for dietary supplement and drug products 
that contain 30 mg or more of iron per dosage unit. The agency is also 
revising Sec.  310.518(b), which provided a temporary exemption from 
unit-dose packaging requirements for certain iron-containing drug 
products, and revising appropriate paragraphs in Sec.  310.518 
accordingly.
    This rule does not affect the provisions of 21 CFR 101.17(e), which 
requires label warning statements on all iron-containing dietary 
supplements in solid oral dosage form, or the provisions of Sec.  
310.518(c) (which is redesignated in this rule as Sec.  310.518(a)), 
which requires label warning statements on all iron-containing drugs in 
solid oral dosage form, except iron-containing inert tablets supplied 
in monthly packages of oral contraceptives. Nor does this rule affect 
the provisions of 16 CFR 1700.14(a)(12) and (a)(13), which require 
special packaging for iron-containing drug and dietary supplement 
products, respectively, to protect children from serious personal 
injury or serious illness resulting from handling, using, or ingesting 
such substances (16 CFR 1700.14(a), (a)(12), and (a)(13)). The 
regulations in 16 CFR 1700.14 were issued under the Poison Prevention 
Packaging Act of 1970 (15 U.S.C. 1471 et seq.) (PPP Act). The authority 
to administer and enforce the PPP Act was transferred from FDA to the 
Consumer Product Safety Commission in 1972 under the enactment of the 
Consumer Product Safety Act (15 U.S.C. 2051 et seq.).

III. Authority for Issuing Final Rule

    Section 553(b)(3)(B) of the Administrative Procedure Act (5 U.S.C. 
553(b)(3)(B)) provides that when an agency for good cause finds that 
notice and public procedure are impracticable, unnecessary, or contrary 
to the public interest, the agency may issue a rule without providing 
notice and an opportunity for public comment. FDA has determined that 
there is good cause under 5 U.S.C. 553(b)(3)(B) and 21 CFR 10.40(d) to 
forgo notice and comment. As a matter of law, the decision issued by 
the U.S. Court of Appeals for the Second Circuit and the final judgment 
of the U.S. District Court for the Eastern District of New York 
invalidated the provisions of the 1997 final rule requiring unit-dose 
packaging for solid oral dosage form dietary supplement and drug 
products that contain 30 mg or more per dosage unit, thereby making 
these provisions nonbinding and unenforceable. FDA finds that it is 
therefore unnecessary to provide notice and opportunity for public 
comment on this action, which merely implements the Court's order. For 
the same reasons, FDA finds that there is good cause, within the 
meaning of 5 U.S.C. 553(d)(3) and in accordance with the Congressional 
Review Act (5 U.S.C. 801 et seq., at 808(2)), to make this rule 
effective immediately.

IV. Environmental Impact

    The agency has determined under 21 CFR 25.301(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.

V. Analysis of Impacts

    Under Executive Order 12866, this action is not a regulatory action 
that is subject to review by the Office of Management and Budget (OMB). 
Because the agency has determined that there is good cause to forgo 
notice and comment requirements under the Administrative Procedure Act 
or any other statute, the requirements of the Regulatory Flexibility 
Act (5 U.S.C. 601 et seq.) and the Unfunded Mandates Reform Act of 1995 
(Public Law 104-4) do not apply.
    However, FDA has examined the impacts of this final rule under 
those

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provisions. 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. When 
applicable, the Regulatory Flexibility Act requires agencies to analyze 
regulatory options that would minimize any significant impact of a rule 
on small entities. This rule is merely technical in nature and imposes 
no new burdens on small entities. Indeed, the effect of this rule is to 
remove a requirement that manufacturers package certain iron-containing 
dietary supplement and drug products in unit-dose packaging. Finally, a 
summary statement or analysis under section 202(a) of the Unfunded 
Mandates Reform Act of 1995 is required only for nonprocedural rules 
that impose costs of $110 million or more on either the private sector 
or State, local, and tribal governments in the aggregate. This rule 
imposes no such costs.

VI. Federalism

    FDA has analyzed this final rule in accordance with the principles 
set forth in Executive Order 13132. FDA has determined that the rule 
does not contain policies that have substantial direct effects on the 
States, on the relationship between the National Government and the 
States, or on the distribution of power and responsibilities among the 
various levels of government. Accordingly, the agency has concluded 
that this final rule does not contain policies that have federalism 
implications as defined in the Executive order and, consequently, a 
federalism summary impact statement is not required.

VII. Paperwork Reduction Act of 1995

    This final rule contains no collections of information. Therefore, 
clearance by OMB under the Paperwork Reduction Act of 1995 is not 
required.

List of Subjects

21 CFR Part 111

    Dietary foods, Drugs, Foods, Packaging and containers.

21 CFR Part 310

    Administrative practice and procedure, Drugs, Labeling, Medical 
devices, Reporting and recordkeeping requirements.

0
Therefore, under the Federal Food, Drug, and Cosmetic Act and under 
authority delegated to the Commissioner of Food and Drugs, 21 CFR parts 
111 and 310 are amended as follows:

PART 111--CURRENT GOOD MANUFACTURING PRACTICE FOR DIETARY 
SUPPLEMENTS

0
1. The authority citation for 21 CFR part 111 continues to read as 
follows:

    Authority: 21 U.S.C. 321, 342, 371.

PART 111--[REMOVED AND RESERVED]

0
2. Part 111, consisting of Sec. 111.50, is removed and reserved.

PART 310--NEW DRUGS

0
3. The authority citation for 21 CFR part 310 continues to read as 
follows:

    Authority: 21 U.S.C. 321, 331, 351, 352, 353, 355, 360b-360f, 
360j, 361(a), 371, 374, 375, 379e; 42 U.S.C. 216, 241, 242(a), 262, 
263b-263n.

0
4. Section 310.518 is revised to read as follows:


Sec.  310.518  Drug products containing iron or iron salts.

    Drug products containing elemental iron or iron salts as an active 
ingredient in solid oral dosage form, e.g., tablets or capsules shall 
meet the following requirements:
    (a) Labeling. (1) The label of any drug in solid oral dosage form 
(e.g., tablets or capsules) that contains iron or iron salts for use as 
an iron source shall bear the following statement:

    WARNING: Accidental overdose or iron-containing products is a 
leading cause of fatal poisoning in children under 6. Keep this 
product out of reach of children. In case of accidental overdose, 
call a doctor or poison control center immediately.

    (2)(i) The warning statement required by paragraph (a)(1) of this 
section shall appear prominently and conspicuously on the information 
panel of the immediate container label.
    (ii) If a drug product is packaged in unit-dose packaging, and if 
the immediate container bears labeling but not a label, the warning 
statement required by paragraph (a)(1) of this section shall appear 
prominently and conspicuously on the immediate container labeling in a 
way that maximizes the likelihood that the warning is intact until all 
of the dosage units to which it applies are used.
    (3) Where the immediate container is not the retail package, the 
warning statement required by paragraph (a)(1) of this section shall 
also appear prominently and conspicuously on the information panel of 
the retail package label.
    (4) The warning statement shall appear on any labeling that 
contains warnings.
    (5) The warning statement required by paragraph (a)(1) of this 
section shall be set off in a box by use of hairlines.
    (b) The iron-containing inert tablets supplied in monthly packages 
of oral contraceptives are categorically exempt from the requirements 
of paragraph (a) of this section.

    Dated: October 7, 2003.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 03-26188 Filed 10-16-03; 8:45 am]
BILLING CODE 4160-01-S