Import Alert 54-11

(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 # 54-11
Published Date: 12/10/2020
Type: DWPE

Import Alert Name:

"Detention Without Physical Examination of Bulk Dietary Ingredients And Dietary Supplements Containing Androstenedione"

Reason for Alert:

FDA is not aware of any information demonstrating that androstenedione was lawfully marketed as a dietary ingredient in the United States before October 15, 1994. Nor is FDA aware of any information demonstrating that this ingredient has been present in the food supply as an article used for food in a form in which the food has not been chemically altered. In the absence of such information, androstenedione is subject to the notification requirement for a new dietary ingredient in 21 U.S.C. 350b(a)(2) and 21 CFR 190.6. FDA has not received any such notifications.

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.

Guidance:

Districts may detain without physical examination (DWPE) all bulk dietary ingredients intended for dietary supplement use that appear to be androstenedione (among other names, also called 4-androstenedione or 4-androstene-3, 17-dione); all dietary supplements that appear to contain androstenedione as an ingredient; and all dietary supplements that appear to contain ester or ether derivatives of androstenedione or other chemical derivatives of androstenedione.

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.

Product Description:

Dietary Supplements Containing Androstenedione; Androstenedione, a Bulk Dietary Ingredient

Charge:

"The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to declare and/or contain androstenedione, a new dietary ingredient for which there is inadequate information to provide reasonable assurance that such ingredient does not present a significant or unreasonable risk of illness or injury [Adulteration, Section 402(f)(1)(B)]."

OASIS charge code - ANDRO

Countries

MULTIPLE COUNTRIES (PODS ONLY)

  • (54 A - - --) Vitamin
    Notes: Dietary Supplements Containing Androstenedione; Androstenedione; a Bulk Dietary Ingredient
  • (54 E - - --) Herbal and Botanical
    Notes: 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