AHPA sent the following letter to the editor to The Daily Beast to correct an article ("Tom Price's Other Failure: Snake Oil Supplements," April 9, 2017) which inaccurately states that the FDA has been "prohibited from regulating dietary supplements," and falsely describes the industry as "unregulated." The letter notes how Offit mischaracterizes the entire industry by identifying FDA enforcement against a few companies that didn't comply with federal regulations. AHPA emphasizes how committed the industry is to safety, and how it commits significant resources to ensure compliance with all regulations and strongly supports strict FDA enforcement of the law.
April 10, 2017
Letter to the Editor
The Daily Beast
Via email: Editorial@thedailybeast.com
Dear Editor:
Paul Offit's article ("Tom Prices Other Failure: Snake Oil Supplements," The Daily Beast, April 9, 2017) inaccurately states that the Food and Drug Administration (FDA) has been, "prohibited from regulating dietary supplements," and falsely describes the industry as "unregulated." In reality, supplements are regulated by an extensive framework of laws and regulations implemented and enforced by FDA and other federal agencies. FDA's website clearly states, "FDA regulates both finished dietary supplement products and dietary ingredients."
The Food, Drug and Cosmetic Act requires all supplement manufacturing facilities to comply with current good manufacturing practice (cGMP) requirements. Under cGMP requirements, companies must substantiate the safety of the dietary ingredients in products and ensure claims are substantiated and not misleading. They must implement manufacturing procedures that ensure products contain what is on the label and don't contain hidden or prohibited substances. These required procedures ensure the identity, purity, quality, strength, and composition of dietary supplements. Companies must register manufacturing facilities with FDA and the agency conducts inspections to enforce the law and ensure compliance with all regulations.
Offit mischaracterizes the entire industry by identifying FDA enforcement against a few companies that didn't comply with federal regulations. The regulated supplement industry is committed to safety, commits significant resources to ensure compliance with all regulations and strongly supports strict FDA enforcement of the law. It is important to note that these enforcement incidents are relatively rare compared to similar enforcement actions taken to protect consumers from potentially dangerous drugs and foods. Supplement companies must also submit to FDA any serious adverse events reported in regard to any of their products -- the same system used for drugs and over-the-counter drugs.
Sincerely,
Michael McGuffin
President
American Herbal Product Association (AHPA)