WASHINGTON—FDA has issued guidance on labeling of dietary supplements relative to mandatory submission of serious adverse event reports (AERs) by dietary supplement manufacturers, packers and distributors. The guidance includes information on the contact info and language relative to serious AER submissions by consumers. However, the guidance is not a list of legal requirements, but a detailed view of the agency’s current thinking on the matter.
In short, if a supplement label does not have a domestic address or phone number for consumers to report adverse events, it is considered misbranded. For an address, a full U.S. mailing address should be used, including street address or P.O. box, city, state, and zip code of the responsible person/party. Likewise, a telephone number fulfilling the labeling requirement should include an area code, or it is considered incomplete.
FDA contends the use of incomplete contact information would increase the likelihood either the serious AER would not reach the “responsible person” or the consumer would be deterred from submitting a serious AER. On the other hand, the agency states while the law on serious AERs does not call for language informing consumers the labeled address or phone number is for AER submissions, it advises companies to include such information. FDA added it sees no harm in such language including a statement that the contact information can be also used for non-AER communications.
The law for mandatory reporting of serious adverse events is already in effect, but FDA said it will exercise enforcement discretion for the new labeling requirements until Sept. 30, 2010.
“[The American Herbal Products Association] AHPA is appreciative of FDA’s decision to provide an extended period of enforcement discretion, and encourages member companies to promptly review labels for inclusion of a domestic phone number or address,” said Michael McGuffin, president of AHPA. “At the same time, AHPA continues to have concerns about the short-cut to rulemaking expressed by FDA’s signal language recommendation, and the agency’s unwillingness to accept the clearly stated intent of Congress. Companies may want to consider the limits of their actual legal responsibility when determining whether to adopt FDA’s recommendation for use of this signal language.”
See more about the guidance, including details on how to submit comments, at the FDA Web site.
