The FDA recently unveiled the Dietary Supplement Ingredient Advisory List, designed to alert consumers to unlawful ingredients identified in products marketed as dietary supplements. Unlike drug companies, supplement manufacturers do not need to prove that a product is safe or effective before marketing it. Under current law, dietary supplements may include substances such as vitamins, herbs, botanicals, amino acids, and ingredients commonly found in the food supply. Manufacturers wishing to include any ingredients not meeting these qualifications must demonstrate that the ingredient “will be reasonably expected to be safe.”
A substance’s presence on the list does not necessarily mean it is unsafe. Additional steps will be taken to alert consumers if true safety concerns arise, and products containing unsafe ingredients will be removed from the marketplace. The new online list (available at https://www.fda.gov/food/dietary-supplement-products-ingredients/dietary-supplement-ingredient-advisory-list) currently contains the ingredients andarine, hordenine, 1,4-DMAA, and higenamine. Of these, only higenamine is currently considered “potentially unsafe.” It is expected the list will be updated regularly.