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ToxStrategies has exciting news from the FDA Center for Veterinary Medicine!



The Center for Veterinary Medicine (CVM) is paving the way for innovation in the animal feed industry! In a recent Letter to Industry, CVM encourages firms developing animal food substances with scientifically substantiated claims related to animal production, well-being, food safety, and environmental benefits to connect early in the product development process. Click here to read the full FDA Letter to Industry. 

Key Highlights: 

  • Withdrawal of PPM 1240.3605: CVM intends to withdraw Policy & Procedures Manual 1240.3605, Regulating Animal Foods with Drug Claims, signaling a shift in regulatory approach. This change unlocks new opportunities and flexibility to make claims of improved production efficiency without a need to classify a product as a drug.
  • Legislative Collaboration: FDA is working actively with Congress to seek new legislative authority, providing a clear regulatory pathway for substances added to animal food or drinking water, specifically those that function in the gut of an animal. 
  • Three Functional Pathways: As part of FDA’s Animal and Veterinary Innovation Agenda, they are working with Congress for legislative authority for zootechnical animal food substances that affect the animal’s microbiome or byproducts of digestion, or reduce pathogens in food products. 
  • Interim Period: During the interim period, without an official policy, close consultation with the FDA and CVM will be essential for navigating this regulatory landscape.  

How Can We Help? 

ToxStrategies’ Food and Consumer Products Division specializes in toxicology and regulatory consulting for the human food, pet food, and animal feed industries. We’re here to guide you through this transitional phase, ensuring that your products meet compliance standards and capitalize on this regulatory evolution, acting as your liaison with CVM. Reach out to our animal feed regulatory expert, Jennifer van de Ligt, PhD, at jvandeligt@toxstrategies.com, to discuss your animal feed or pet food ingredients, and let’s navigate this exciting regulatory shift together!