November 30, 2015
On November 30, 2015, the FDA issued warning letters to five companies whose products marketed as dietary supplements claim to contain picamilon. These products are misbranded because picamilon does not meet the statutory definition of 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 (e.g., that the product is unsafe) or misbranded (e.g., that the labeling is false or misleading).
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 agency will continue to update this page in the event additional actions are taken related to picamilon.