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Guidance Issuing OfficeCenter for Food Safety and Applied Nutrition
For questions regarding this draft document, contact the Center for Food Safety and Applied Nutrition (CFSAN) at 240-402-2375.
This guidance represents the Food and Drug Administration's (FDA's) current thinking on this topic. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. You can use an alternative approach if the approach satisfies the requirements of the applicable statutes and regulations.
The Food and Drug Administration has prepared this Small Entity Compliance Guide in accordance with section 212 of the Small Business Regulatory Enforcement Fairness Act (Public Law 104-121). This guidance document restates in plain language the legal requirements set forth in sections 101.17(e) and 310.518(a) of Title 21 of the Code of Federal Regulations (21 CFR 101.17(e) and 310.518(a)) concerning label warning statements for iron-containing dietary supplement and drug products in solid oral dosage form. This small entity compliance guide (SECG) is intended to help small entities comply with the regulations that require label warning statements for iron-containing dietary supplement and drug products.
In the Federal Register of January 15, 1997 (62 FR 2218), FDA issued a final rule (1997 final rule) to require (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 small entity compliance guide 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 (P.L. 104-121).
In the Federal Register of October 17, 2003 (68 FR 59714), FDA withdrew those parts of the 1997 final rule that established regulations requiring unit-dose packaging for iron-containing dietary supplement and drug products that contain 30 milligrams (mg) or more of iron per dosage unit. FDA withdrew the regulations in response to Nutritional Health Alliance v. FDA (318 F.3d 92 (2d Cir. 2003)), in which the United States Court of Appeals for the Second Circuit invalidated the unit-dose packaging regulations based upon its conclusions that the Federal Food, Drug, and Cosmetic Act (the Act) does not provide the FDA with authority to regulate the 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 United States District Court for the Eastern District of New York entered final judgment in accordance with the Court's decision, declaring the unit-dose packaging regulations 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 has been revised in accordance with the Court's ruling and FDA's withdrawal of the unit-dose packaging regulations.
FDA's guidance documents, including this guidance, do not establish legally enforceable responsibilities. Instead, guidances describe the Agency's current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The use of the word should in Agency guidances means that something is suggested or recommended, but not required.
- Where can I find the regulations requiring label warning statements for iron-containing dietary supplements and drugs?
The regulation requiring a warning statement on the labeling of dietary supplements in solid oral dosage form can be found in 21 CFR 101.17(e). The regulation requiring a warning statement on the labeling of drugs in solid oral dosage form can be found in 21 CFR 310.518(a). You can find these regulations through links in FDA's web site, located at www.fda.gov.
- What types of dietary supplements and drugs are covered by the regulations?
The regulations apply to all iron-containing dietary supplements and drugs in solid oral dosage form (e.g., tablets, capsules, or caplets), except iron-containing inert tablets supplied in monthly packages of contraceptives. The regulations do not apply to iron-containing products in liquid or powder form.
- What is the language that must be used in the label warning statement?
The regulations require the following warning statement on the labeling of iron-containing dietary supplements and drugs in solid oral dosage form:
WARNING: Accidental overdose of 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.
- May I use a different warning statement?
No. The regulations do not provide for the use of a warning statement different from the one contained in the regulations.
- Where must the warning statement appear on the label?
For products that are not packaged in unit-dose packaging (e.g., for tablets packaged in a bottle), the regulations require that the warning statement appear prominently and conspicuously on the information panel of the immediate container label (i.e., on the label of the bottle that holds the tablets).
- If my product is packaged in unit-dose packaging, where must the warning statement appear on the label?
For products that are packaged in unit-dose packaging (e.g., "blister pack," pouch, or other nonreusable container), the regulations require that the warning statement must appear prominently and conspicuously on the unit-dose packaging itself if the unit-dose packaging bears any printed material. The regulations also require that when the warning statement is placed on unit-dose packaging, it must appear in a way that maximizes the likelihood that it can be read until all the individual dosage units are used. For example, multiple copies of the warning statement may be printed on the unit-dose packaging to increase the chances that at least one complete warning statement will remain intact until all of the individual units are used.
- If the immediate container or unit-dose packaging is placed inside of another package for retail sale, must the warning statement also appear on the retail packaging?
Yes. In instances when the immediate container (e.g., a bottle or unit-dose packaging) of iron-containing dietary supplements or drugs is placed within another package (e.g., a separate box) for retail sale, the regulations require that the warning statement must appear prominently and conspicuously on the information panel of the retail packaging, in addition to the immediate container label.
- Is the warning statement required to appear on any other labeling for these iron-containing products?
Yes. The regulations require that the warning statement must appear on any labeling (e.g., package inserts) that contains other product warnings.
- Are there any special format requirements for the warning statement?
Yes. The regulations require that the warning statement be set off in a printed boxed area.
Federal Register - 68 FR 59714 October 17, 2003: 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
This document supercedes Iron-containing Supplements and Drugs: Label Warning and Unit Dose Packaging Small Entity Compliance Guide (November 1997)
You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))
If unable to submit comments online, please mail written comments to:
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852
All written comments should be identified with this document's docket number: FDA-1997-D-0056.