Pharmaceutical Regulatory Affairs: Open Access

Amin Talati Wasserman, LLP, Washington, DC, USA

Publications

• Review   
  A Review of AGA’s Proposed Seal Program for Probiotic Substantiation
  Author(s): Corey J Hilmas* and Ivan Wasserman
  
  The American Gastroenterological Association recently published an article, entitled Probiotics and the Microbiome: How Can We Help Patients Make Sense of Probiotics? Detailing their plans to offer a seal service for companies looking to substantiate the evidence behind their probiotic product claims. The paper discussed how under the Federal Food, Drug, and Cosmetic Act (the Act), dietary supplement and food products can claim to affect the “structure or function” of the body without going through the FDA approval process required for pharmaceuticals to make such a claim. Congress’ decision to treat supplements and foods differently than pharmaceuticals was undoubtedly based on the relative safety of food and supplement products, because structure/function claims do not claim that the product can treat, cure or prevent a disease.. Read More»
  DOI: 10.37421/2167-7689.21.10.244

  Abstract HTML PDF