FDA Roundup: A Look at the Latest FDA Activity

  • This week, FDA revealed its new Dietary Supplement Ingredient Directory, a webpage where the public can search for ingredients used in products that are marketed as dietary supplements to quickly assess FDA’s position on the ingredient and any regulatory or enforcement action. The directory is intended to be a one-stop shop for information on ingredients, and to help manufacturers, retailers and consumers stay informed about ingredients marketed in dietary supplements. Members of the industry have praised the Dietary Supplement Ingredient Directory as a positive step forward, but have also called for FDA to provide additional context in using the Directory, including for instance why some ingredients made the list and others have been left off.

  • FDA also this week revised and reissued the overarching Emergency Use Authorization (EUA) for disposable, single-use surgical masks that are intended for use in health care settings by healthcare professionals during the COVID-19 pandemic. The revision of the EUA limits approval to emergency use of only surgical masks listed in the EUA’s Appendix A as of the date of the reissuance. FDA will no longer be adding surgical mask models to Appendix A. We recommend that manufacturers who are seeking to bring new surgical masks to market follow traditional premarket pathways, such as a premarket notification. We are happy to provide further advice and counsel on compliantly marketing surgical masks and similar products in the U.S.

  • FDA issued a Warning Letter to Golden Bridge Gourmet Inc. for failure to comply with the FSVP regulations. FDA alleges that the Company failed to develop, maintain and follow an FSVP, and failed to perform supplier verification activities. FDA also commented that a qualified individual is required to develop the Company’s FSVP plan and perform FSVP activities. FDA also issued a Warning Letter to Ada Teff and several other companies on similar grounds. We have seen an uptick in FDA FSVP inspections and encourage food companies and FSVP importers to ensure that they have an FSVP plan in place. We also recommend conducting a mock FSVP and/or GMP inspection to ensure compliance and prepare for an FDA inspection. See also our previous post here.

  • FDA made updates to several Import Alerts including Import Alert 89-17, Medical Devices that Appear to be Adulterated due to Quality Concerns; 16-129, DWPE of Seafood Products Due to Nitrofurans, 71-04, DWPE of Animal Foods Due to the Presence of Salmonella, 99-08, DWPE of Raw Agricultural Products for Pesticides, 66-41, DWPE of Unapproved New Drugs Promoted in the U.S., 99-39 DWPE of Imported Food Products that Appear to be Misbranded and 66-41 DWPE of Drugs from Firms Which Have Not Met Drug GMPs. Companies on these Import Alerts or any other Import Alert should examine the conditions for removal and seek removal to permit more expedited entry and reduce fees associated with automatic detention (including testing, storage, and delay costs).

  • FDA issued a newly updated guidance for industry on the Labeling of Infant Formula. The FDA Guidance provides information about the labeling requirement for infant formula including addressing the agency’s concerns on statement of identity, nutrient content claims, directions for preparation and use, warning statements and more. We recommend companies in this space review the Guidance to ensure compliance, and we are pleased to assist on any additional regulatory questions.

  • Following a recall last month of eyedrops made in India linked to an outbreak of drug-resistant infections, FDA alerted consumers to two additional recalls of eyedrops due to contamination risks that could cause vision problems and serious injury. See recall notice for more information.

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