Import Alert 57-15

"Detention Without Physical Examination of Allergens And/Or Allergenic Products"

FDA has determined that the firms listed below have been sending unlicensed allergens and/or allergenic products to the U.S.

Many allergenic products identified as part of Enzyme Potentiated Desensitization or EPD treatments have been misdeclared or inappropriately identified in previous entries as enzymes, reagents, biochemicals, and dietary supplements.

Districts may detain without physical examination the specified biologic product(s) from the firms in the Red List in this alert.

NOTE: (For Allergen Delivery Systems/Patches) - Allergen delivery systems only that are pre-filled with allergenic extracts or unfilled allergen delivery systems that accompany allergenic extracts in shipping should be detained. Unfilled allergen delivery system components are not subject to this guidance.

Allergens (allergenic extracts)

Allergen delivery systems (allergy patches)

"The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the labeling of the article does not appear to contain adequate directions for use, and the article does not appear to be exempt from such requirements. [Misbranding, Section 502(f)(1)]"

OASIS Charge Code - DIRSEXMPT

AND

"The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the article appears to be a biological drug for which a biologics license is not in effect under Section 351 of the Public Health Service Act. [PHS Act, Section 351(a)]"

OASIS Charge Code - NO LICENSE