IA #54-11, 6/3/04 - IMPORT ALERT #54-11, "DETENTION WITHOUT PHYSICAL
EXAMINATION (DWPE) OF BULK DIETARY INGREDIENTS AND DIETARY SUPPLEMENTS
CONTAINING ANDROSTENEDIONE"
TYPE OF ALERT: Detention Without Physical Examination (DWPE)
(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).
PRODUCT: Dietary Supplements Containing Androstenedione;
Androstenedione, a Bulk Dietary Ingredient
PRODUCT 54A[][]
CODE: 54E[][]
54F[][]
54Y[][]
PROBLEM: Adulteration
PAF: NDI New Dietary Ingredient
PAC FOR 21008
COLLECTION:
COUNTRY: All Countries (ZZ)
MANUFACTURER/
SHIPPER FEI#: All
IMPORTER'S
FEI#: NA
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
RECOMMENDING
OFFICE: CFSAN, Office of Compliance, Imports Branch (HFS-606)
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
drug, contact Ada Irizarry at (301) 827-8967.
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, (301)436-2413 or (301)436-1622.
For questions or issues concerning science, science policy,
sample collection, analysis, preparation, or analytical
methodology, contact the Division of Field Science at (301)
827-7605.
PRIORITIZATION
GUIDANCE: I
FOI: No purging is required
KEYWORDS: Androstenedione, andro, 4-androstene-3, 17-dione
PREPARED BY: Brian S. Landesberg, CFSAN, (301) 436-1622
George N. Butler, DIOP, (301) 443-6553
DATE LOADED
INTO FIARS: June 3, 2004
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