Products that are marketed as foods, including products marketed as dietary supplements, that contain an active pharmaceutical ingredient

Why FDA issued it

FDA field investigations and laboratory analyses have concluded that a number of imported products marketed as dietary supplements that are often promoted for sexual enhancement, weight loss, muscle building, lifestyle, and other claims, contain undeclared active pharmaceutical ingredients (APIs). FDA investigations find the APIs include: � anticoagulants (e.g., Warfarin) � anticonvulsants (e.g., Phenytoin) � HMG-CoA reductase inhibitors (e.g., Lovastatin), � Phosphodiesterase type 5 inhibitors (e.g., Sildenafil) � prescription nonsteroidal anti-inflammatory drugs (NSAIDS) (e.g., Indomethacin) � beta-blockers (e.g., Propranolol) � controlled substances (Benzodiazepines and anabolic steroids) � APIs removed from the market for reasons of safety or efficacy (e.g., Sibutramine) � novel synthetic steroids, and new chemicals ingredients of unknown safety and efficacy. These APIs, because of t

Quoted from the “Reason for Alert” section of the FDA page for 54-16, mirrored 30 August 2026. The quotation is truncated at the length this copy carries.