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U.S. Department of Health and Human Services

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Dietary Supplement Labeling Guide: Chapter VIII. Other Labeling Information

April 2005

Guidance for Industry
A Dietary Supplement Labeling Guide

Contains Nonbinding Recommendations

This document also available en Español (Spanish).

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Questions

  1. Are there special labeling requirements for iron-containing dietary supplements?
  2. What is the text of the warning statement?
  3. May I deviate from the specified text of the warning statement?
  4. Where must I locate the warning statement?
  5. Are there packaging requirements for iron-containing dietary supplements?
  6. Is there a limit on the folic acid content in dietary supplements?
  7. Who regulates whether I can make a claim indicating that my product is organic?

Answers

  1.  Are there special labeling requirements for iron-containing dietary supplements?

    Yes. You must label any dietary supplement in solid oral dosage form (e.g., tablets or capsules) that contains iron or iron salts for use as an iron source with a specific warning statement.

    21 CFR 101.17(e)

  2.  What is the text of the warning statement?

    The text of the warning statement is as follows:

    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.

    21 CFR 101.17(e)(1)

  3.  May I deviate from the specified text of the warning statement?

    No. You may not make deviations from the specified test.

    21 CFR 101.17(e)(1)

  4.  Where must I locate the warning statement?

    You must place the warning statement prominently and conspicuously on the information panel of the product's immediate container. You must set the warning statement off in a box using hairlines. You must also place it on any labeling that contains warnings. If the immediate container has an outer package, you must also place the warning statement on the outer package.

    21 CFR 101.17(e)(2) through(5)

  5.  Are there packaging requirements for iron-containing dietary supplements?

    No. FDA revoked its regulations on "Packaging of iron-containing dietary supplements" (21 CFR 111.5) on October 17, 2003, in response to a U.S. federal appeals court decision that FDA lacked the authority to require unit-dose packaging of dietary supplements for the purpose of poison prevention.

    68 Federal Register 59714; October 17, 2003

  6.  Is there a limit on the folic acid content in dietary supplements?

    No. FDA does not specify any limit on the folic acid content that may be contained in dietary supplements.

  7.  Who regulates whether I can make a claim indicating that my product is organic?

    Organic claims are regulated by the U.S. Department of Agriculture under the National Organic Program. Their website is www.usda.gov.