Import Alert 54-14

DETENTION WITHOUT PHYSICAL EXAMINATION OF DIETARY SUPPLEMENT
PRODUCTS FROM FIRMS WHICH HAVE NOT MET DIETARY SUPPLEMENT GMPS

Section 402(g)(2) of the Federal Food, Drug, and Cosmetic Act provides, in part, that the Secretary of Health and Human Services may, by regulation, prescribe good manufacturing practices (GMP) for dietary supplements. On June 25, 2007, FDA published a final rule setting out the GMP requirements for dietary supplements in the Federal Register [72 FR 34942].

The final rule created Title 21, part 111 (21 CFR Part 111), which establishes the minimum current GMPs necessary for activities related to manufacturing, packaging, labeling, or holding dietary supplements to ensure the quality of the dietary supplement. Per the regulation, quality means that the dietary supplement consistently meets the established specifications for the identity, purity, strength, and composition. Any dietary supplement imported or offered for import into the United States is subject to the aforementioned regulation.

FDA performs foreign inspections of dietary supplement manufacturers to determine compliance with the regulation. FDA may detain affected products if inspection has revealed that a firm is not operating in conformity with current good manufacturing practices (GMP's).

When, and if, FDA confirms that corrections have been made, the respective firm's dietary supplement products will be removed from detention without physical examination.

Districts may detain, without physical sampling and analysis, all dietary supplement products from the foreign processors (manufacturers) as noted in the Red List of this import alert.

DWPE will be indicated when CFSAN determines that inspectional findings demonstrate the manufacture of dietary supplement products is not operating in conformity with current good manufacturing practices (GMP's).

Foreign processors listed on the Red List of this import alert may request removal from that list by submitting documentation demonstrating that the firm is in compliance with the CGMP regulation (21 CFR, Part 111). The documentation may include reports from a third- party (e.g., a government inspection authority) demonstrating that an inspection of the processor was conducted and that dietary supplement products are manufactured in accordance with CGMPs.

The above documentation should be submitted to CFSAN's Office of Compliance, Division of Enforcement, at the following address:

Food and Drug Administration
Center for Food Safety and Applied Nutrition
Office of Compliance
Division of Enforcement
Labeling Compliance Team (HFS-608)
5100 Paint Branch Parkway
College Park, MD 20740

For questions related to the Center for Food Safety and Sanitation, contact Anam Pasha at (301)-436-1563.

Dietary Supplements, Bulk or Finished

PROBLEM: Failure to meet Dietary Supplement GMPs

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the dietary supplement product appears to have been prepared, packed, or held under conditions that do not meet current good manufacturing practices. [Adulteration, 402(g)(1)]
OASIS Charge Code: SUPPLGMP