John Atwater | Regulatory Update
30m
John Atwater presents an overview of the FDA's new organizational structure for its Human Foods Program and discusses various certification programs and tools available to the dietary supplement industry.
Key points include:
1. The FDA's new unified Human Foods Program and Office of Inspections and Investigations, aimed at strengthening oversight of the human food supply.
2. The reorganization of FDA offices, including those focused on dietary supplements.
3. The creation of a new Office of Laboratory Operations and Applied Science, with four specialized laboratories.
4. FDA's efforts to modernize chemical and microbiological test methods.
5. The use of artificial intelligence by FDA for identifying outbreaks and tracing contaminated food sources.
6. Potential applications and challenges of AI in the food and supplement industry.
7. Overview of various certification programs and organizations like AOAC, GRMA, NSF International, and USP, and their roles in supporting industry compliance.
8. The importance of utilizing available tools and standards, such as USP general chapters, for GMP compliance.
The presentation emphasizes the need for the industry to better utilize existing resources and standards to improve compliance with GMP requirements. It also notes that industry attempts to reduce GMP audit fatigue have not been successful, and suggests that a more comprehensive approach to using available tools could benefit the industry.
View slides here: https://drive.google.com/file/d/1-kT9H1DnpVqLT57kszmuvVzA1mnifHb2/view?usp=sharing