Although Section 403(y) of the Federal Food, Drug, and Cosmetic Act (FFD&C Act) (21 U.S.C. 343(y), does not require a dietary supplement label to include anything other than a domestic address or phone number for the responsible person, the FDA recommends that the label also bear a clear, prominent statement informing consumers that the domestic address or phone number is for reporting serious adverse events associated with use of the product.

Under section 3(d)(2) of the Dietary Supplement and Nonprescription Drug Consumer Protection Act, the labeling requirements of section 403(y) ofthe FFD&C Act apply to all dietary supplements labeled on or after December 22, 2007. Therefore, these labeling requirements are already in effect. However, FDA intends to exercise enforcement discretion for the new labeling requirements until January 1, 2010.

FDA would have no objection to a firm’s combining the recommended statement with language informing consumers that the domestic address or phone number on the label may also be used for other purposes, as long as the information provided is not false or misleading. For example, a dual-purpose label statement might be “To report a serious adverse event or obtain product information, contact. .. ” or other similar language.

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The Act requires supplement companies to report serious adverse events (adverse event reports or AER) concerning their products to the FDA. The AER reporting requirement went into effect on December 22, 2007.

The draft guidance was just published in the Federal Register on January 2, 2008. The guidance is presented in question and answer format. To read the new guidance, click here.

We will be posting additional information regarding the new AER reporting requirements here so check back soon.

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