- On June 25, Frank Yiannis, Deputy Commissioner, Food Policy and Response, Food and Drug Administration (FDA), announced via Twitter that FDA has added octopamine and N-Methyltyramine to the Dietary Supplement Ingredient Advisory List (the “List”). Inclusion in the list indicates that FDA believes that the ingredient may not be legally marketed based on a preliminary evaluation though not necessarily that the ingredient is unsafe. FDA urges consumers to avoid using dietary supplements containing ingredients on the list and retailers, manufacturers, and other businesses to avoid selling, making, or distributing dietary supplements containing these ingredients.
- Though not added at the time of writing, additional details on FDA’s rationale for inclusion on the list will be included via hyperlink at FDA’s Dietary Supplement Products & Ingredients website. For example, the 1 ,3-dimethylamylamine (DMAA) page describes DMAA, explains that FDA does not view it as a dietary ingredient because it does not exist naturally, discusses safety of the product, enumerates FDA’s efforts to remove products containing DMAA, and advises consumers to avoid DMAA and take steps if being harmed by consumption of DMAA containing supplements.
- The List was introduced on April 16 as a means of protecting consumers as part of a plan for modernizing and strengthening dietary supplement oversight. This is part of a broad effort to modernize food regulation, including the Agency’s Nutrition Innovation Strategy and goal of modernizing Standards of Identity.