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.
About Joel Rothman
Joel B. Rothman represents clients in intellectual property infringement litigation involving patents, trademarks, copyrights, trade secrets, defamation, trade libel, unfair competition, unfair and deceptive trade practices, and commercial matters. Joel’s litigation practice also includes significant focus on electronic discovery issues such as e-discovery management and motion practice relating to e-discovery.
