November 8, 2024 - FDA Roundup: November 8, 2024

Today, the U.S. Food and Drug Administration is providing an at-a-glance summary of news from around the agency:

• Today, the FDA issued a final rule, to amend the color additive regulations to increase the fees for certification services. The new fees include a $0.10 per pound increase for straight colors including lakes. There are also similar increases in fees for repacks of certified color additives and color additive mixtures.
  
  Under the Federal Food, Drug, and Cosmetic (FD&C) Act, certain color additives must be certified by the FDA for use in food, drugs, cosmetics, and certain medical devices. Certification is performed before the color additives are permitted to be used in these products. As required under the FD&C Act, manufacturers pay fees for certification services and the fees support the FDA's color certification program.
  
  The final rule will be effective 30 days after its November 8, 2024, date of publication in the Federal Register.
• On Thursday, the FDA issued a renewal of modified risk granted orders to Swedish Match USA, Inc., for eight General Snus products. With this renewal, these products may continue to be marketed - as they have been authorized to do so since 2019 - with the following modified risk claim:"Using General Snus instead of cigarettes puts you at a lower risk of mouth cancer, heart disease, lung cancer, stroke, emphysema, and chronic bronchitis." The products receiving modified risk granted orders are: General Loose, General Dry Mint Portion Original Mini, General Portion Original Large, General Classic Blend Portion White Large-12ct, General Mint Portion White Large, General Nordic Mint Portion White Large-12ct, General Portion White Large, and General Wintergreen Portion White Large. The modified risk granted orders issued by the FDA are specific to the above-mentioned products and expire Nov. 7, 2032. If at any point the agency determines that, among other things, the continued marketing of the products no longer benefits the health of the population as a whole, the agency may withdraw the orders.
• On Thursday, the FDA issued a request for public input on its export certification process for human food products. This initiative aims to gather insights from stakeholders on how the FDA's export lists and certifications impact U.S. exporters in meeting foreign requirements. The feedback collected will help guide potential updates, improve efficiencies, and consider options for implementing fees to sustain and enhance the program.
  
  For more information and to participate, see the full Request for Information (RFI).
• On Thursday, the FDA updated the Breakthrough Device designations data, as well as the number of Breakthrough Devices that have received marketing authorizations. From the launch of the Breakthrough Devices Program through September 30, 2024, the FDA has granted 1,041 Breakthrough Device designations and authorized 128 Breakthrough Devices for marketing. The program is intended to provide patients and health care providers with timely access to certain medical devices by speeding up development, assessment, and review for premarket approval, 510(k) clearance, and De Novo marketing authorization. Through the program, manufacturers can interact with the FDA's experts to receive feedback on device development, receive help navigating the path to the FDA's marketing authorization, and obtain prioritized review on regulatory submissions.
  

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