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, and because there are other provisions in the Act and in other laws requiring that such claims be truthful, not misleading, and substantiated. While the article cynically refers to this well-established regulatory framework as an “honor system,” and use it a basis to make the case for a new “seal” program, the fact is it has given consumers access to countless safe, efficacious and affordable products that would not have been available had the manufacturers been required to go through the approval process required for pharmaceuticals.
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Pharmaceutical Regulatory Affairs: Open Access received 533 citations as per Google Scholar report
