On December 23, 2013, the U.S. Food and Drug Administration (“FDA”) issued an announcement warning consumers about the serious health risks associated with using “Mass Destruction,” a product marketed as a dietary supplement for muscle growth. This product is manufactured for Blunt Force Nutrition in North Carolina and is sold in retail stores, gyms, and on the internet. The FDA alleges that despite being labeled as a dietary supplement, Mass Destruction contains synthetic anabolic steroids, which makes it an unapproved new drug in violation of the Federal Food, Drug, and Cosmetic Act (“FDCA”). The FDA’s announcement may be found here.
Under the FDCA, as amended by the Dietary Supplement Health and Education Act (DSHEA) of 1994, dietary supplements–defined as products taken by mouth that contain one or more “dietary ingredients” intended to supplement the diet–are regulated as a type of food and must comply with the particular requirements for the safety and labeling of dietary supplements. With the exception of new dietary ingredients, dietary supplements are unlike drugs in that they do not require FDA- approval prior to marketing. Instead, the manufacturer is responsible for ensuring that the product is safe and that any adverse events connected to the supplements are reported to the FDA. The FDA has authority to act once it receives reports of serious health problems associated with products for sale.
As highlighted by this case, the FDA has frequently targeted companies that market dietary supplements containing synthetic steroids or steroid-like ingredients because these compounds typically do not qualify as dietary ingredients as defined by Section 201(ff)(1) of the FDCA and have not been reviewed by the FDA for safety and effectiveness, causing them to be unapproved new drugs. Accordingly, it is illegal for dietary supplements to contain these steroids, which are linked to serious health problems such as liver failure.
In sum, if you have any questions about the FDA’s requirements for dietary supplements or about compliance with food and drug law generally, please contact us at: firstname.lastname@example.org.