Note: The revision of this Import Alert (IA) dated 10/26/2023 updates the IA name, reason for alert, guidance section including agency contacts, charge code language, and product description section. Changes to the import alert are bracketed by asterisks (***). 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 34752].*** The final rule created Title 21, part 111 (21 CFR Part 111), which established 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, ***and for limits on those types of contaminations that may adulterate or that may lead to adulteration of the finished batch of the product.*** 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 without physical examination (DWPE) and refuse admission of affected dietary supplements if inspection has revealed that a firm is not operating in conformity with current GMPs.*** When, and if, FDA confirms that corrections have been made, the respective firm's dietary supplement ***product(s) may*** be removed from detention without physical examination.
Dietary Supplements, Bulk or Finished
***The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it is a dietary supplement that 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: SUPPL GMP***
***Divisions may detain without physical examination the listed dietary supplement products from the foreign processors (manufacturers) identified on the Red List of this import alert.*** DWPE is indicated when CFSAN determines that inspectional findings demonstrate that dietary supplement products have not been manufactured in conformity with current GMPs. ***Recommendations for DWPE addition to Red List require documentation of Center/Program concurrence, when the action is not covered by direct reference authority (DRA). Final recommendations for DWPE additions to Red List should be forwarded to the Division of Import Operations (DIO).*** ***Release of Articles Subject to Detention Without Physical Examination Under This Import Alert: In order to secure release of an individual shipment identified for DWPE under this import alert, the owner, consignee, and/or other responsible party for the affected goods should provide documentation that the GMP violation(s) for the affected product(s) have been adequately corrected. CFSAN will review a firm's documentation to determine whether an individual shipment of an entry may be released.*** ***Removal from Detention without Physical Examination (REMOVE FROM RED LIST): In order to remove a firm's product from the Red List of this import alert, information should be provided to the Agency to adequately demonstrate that the manufacturer has resolved the conditions that gave rise to the appearance of the violation. Such information should provide the Agency confidence that future shipments/entries will be in compliance with the Federal Food, Drug, and Cosmetic Act (FD&C Act). For further guidance on removal from detention without physical examination, refer to FDAs Regulatory Procedures Manual (RPM), Chapter 9-8, "Detention without Physical Examination (DWPE)." If a firm and/or a representative thereof would like to petition for removal from detention without physical examination under this Import Alert, all relevant documentation supporting the corrective actions for the GMP violations should be sent via email to: Importalerts2@fda.hhs.gov *** Questions or issues involving import operations should be addressed to OII Division of Import Operations (DIO) at (301) 796-0356 or Imports@fda.hhs.gov. Questions or issues with regard to human food on policy, sample collection recommendations, or any additional questions not directly related to a detained entry, should be addressed to the Human Foods Program Imports Enforcement Branch at HFP-OCE-Imports@fda.hhs.gov ***
This alert authorizes Detention Without Physical Examination (DWPE) for products matching this alert. Reason: Note: The revision of this Import Alert (IA) dated 10/26/2023 updates the IA name, reason for alert, guidance section including agency contacts, charge code language, and product description section. Changes to the import alert are bracketed by asterisks (***). 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 34752].*** The final rule created Title 21, part 111 (21 CFR Part 111), which established 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, ***and for limits on those types of contaminations that may adulterate or that may lead to adulteration of the finished batch of the product.*** 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 without physical examination (DWPE) and refuse admission of affected dietary supplements if inspection has revealed that a firm is not operating in conformity with current GMPs.*** When, and if, FDA confirms that corrections have been made, the respective firm's dietary supplement ***product(s) may*** be removed from detention without physical examination.
Country-specific information is available in the full alert detail on the FDA website.
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