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The Probiotic Conundrum: Regulatory Confusion, Conflicting Studies, and Safety Concerns


Mar 29, 2020

The FDA categorizes products by the type of claims a manufacturer makes on their behalf, not by ingredients or other properties. If a manufacturer claims that any product, including a probiotic, cures, mitigates, treats, or prevents disease, the product is classified as a drug, thereby triggering a costly Investigational New Drug (IND) application process. Similarly, investigator-initiated human studies seeking to determine if a probiotic cures, mitigates, treats, or prevents a disease are considered drug trials and require an IND application, even if the administered intervention has a record of safety in the target population. These requirements pose barriers for researchers who are obliged to provide propriety manufacturing information (ie, Drug Master File, information held by the manufacturer) to the FDA as part of the IND application process. Thus, a company can block a study by simply withholding documentation, such as by not permitting researchers to include proprietary information about a product.

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