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  1. HFP Constituent Updates

Recent FDA Action on Dietary Supplements Labeled as Containing DMBA

Constituent Update

April 28, 2015

On April 28, 2015, the FDA issued warning letters to 14 companies regarding a total of 17 products for which the product labeling identifies DMBA as a dietary ingredient.

The FDA considers these products to be adulterated because they are labeled as containing a new dietary ingredient, DMBA, and because they have not satisfied the conditions described above to include DMBA as a dietary ingredient.

Under existing law, including the Dietary Supplement Health and Education Act passed by Congress in 1994, the FDA can take action to remove products from the market, but the agency must first establish that such products are adulterated or misbranded.

The companies have 15 business days from the date of receipt of the letter to communicate to the agency the specific steps they will take to bring their products into compliance with the law. The warning letters also caution the companies that the FDA may take further enforcement action without warning if they do not immediately cease distribution of the products.

The agency will continue to update this page in the event additional actions are taken related to DMBA.

Warning Letters:

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