ROCKVILLE, Md. Countering the misconstrued notion that dietary supplements are unregulated in the United States, the Food and Drug Administration on Monday posted to its site a detailed explanation not only as to how supplements are regulated, but how those regulations are enforced.
“Federal law requires that every dietary supplement be labeled as such, either with the term ‘dietary supplement’ or with a term that substitutes a description of the product’s dietary ingredient for the word ‘dietary’ (e.g., ‘herbal supplement’ or ‘calcium supplement’),” the FDA stated.
And while no supplement manufacturer is required to submit safety or efficacy data in support of its product before going to market, those products are still regulated. Any supplement advertisement claims, for example, are vetted by the Federal Trade Commission, and the FDA pays close attention to any safety flags. “Once a dietary supplement is on the market, FDA has certain safety monitoring responsibilities. These include monitoring mandatory reporting of serious adverse events by dietary supplement firms and voluntary adverse event reporting by consumers and health care professionals. As its resources permit, FDA also reviews product labels and other product information, such as package inserts, accompanying literature, and Internet promotion,” the agency stated.