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Published: Friday, March 4, 2016
The Food and Drug Administration (FDA) has corrected its Dietary Supplement Labeling Guide after AHPA notified the agency of inaccurate information posted online.
AHPA notified FDA in September 2015 that its guidance for industry titled "A Dietary Supplement Labeling Guide," included one detail that contradicted current law and FDA regulations. Specifically, the answer to the third question in Chapter II titled "Identity Statement" inaccurately stated that the term "dietary supplement" by itself could not be considered the statement of identity for dietary supplement products.
FDA is posting a Federal Register notice to alert the industry that it has revised its guidance to state that the term "dietary supplement" may be used as the entire statement of identity for a dietary supplement and to explain the basis for that change. FDA also revised questions 1, 2, and 3 for clarity and consistency with current regulations and FDA's guidance on statements of identity for conventional foods in "A Food Labeling Guide:Guidance for Industry."
"AHPA and the supplement industry greatly appreciate FDA correcting this guidance," said AHPA President Michael McGuffin. "Many dietary supplement products are labeled with 'Dietary Supplement' as the only statement of identity in accordance with FDA regulations. Correcting this guidance will help eliminate any confusion that could lead to unsubstantiated allegations of misbranding and AHPA appreciates FDA's attention to our request."
AHPA was alerted to the issue through a blog post by Wes Siegner, a director at Hyman, Phelps & McNamara, PC.