(Note: This import alert represents the Agency's current guidance to FDA field personnel regarding the manufacturer(s) and/or products(s) at issue. It does not create or confer any rights for or on any person, and does not operate to bind FDA or the public).
Import Alert Name:
Reason for Alert:
Even if the required notification had been submitted, FDA is aware of no history of use or other evidence of safety establishing that androstenedione will reasonably be expected to be safe as a dietary ingredient. Therefore, we believe that dietary supplements containing androstenedione are adulterated regardless of whether the notification requirement has been met.
Districts should be alert to the possibility that androstenedione may be intended for drug and not dietary supplement use. If the product is coded or otherwise identified as intended for use as an active pharmaceutical ingredient, please follow the guidance in Import Alert 66-66.
For questions or issues concerning the use of the product as a dietary supplement or new dietary ingredient please contact CFSAN, Office of Compliance, Division of Enforcement, Imports Branch, HFS-606
For questions or issues concerning science, science policy, sample collection, analysis, preparation, or analytical methodology, contact the Office of Regulatory Science at 301 796-6600.
OASIS charge code - ANDRO
MULTIPLE COUNTRIES (PODS ONLY)
(54 A - - --) VitaminNotes: Dietary Supplements Containing Androstenedione; Androstenedione; a Bulk Dietary Ingredient
(54 E - - --) Herbal and BotanicalNotes: Dietary Supplements Containing Androstenedione; Androstenedione; a Bulk Dietary Ingredient
(54 F - - --) Herbal & Botanicals(other than teas)Notes: Dietary Supplements Containing Androstenedione; Androstenedione; a Bulk Dietary Ingredient
(54 Y - - --) Vit/Min/Prot/Unconv Diet Spec N.E.C.Notes: Dietary Supplements Containing Androstenedione; Androstenedione; a Bulk Dietary Ingredient