Probiotics are live microorganisms that, when consumed in adequate amounts, can offer health benefits, often by improving intestinal flora balance. Many probiotic products are sold as dietary supplements. The U.S. Food and Drug Administration (FDA) does not “approve” these products in the same way it approves prescription drugs; their regulation operates under a different framework.
How the FDA Regulates Probiotics
The FDA regulates probiotics based on their intended use, categorizing them as dietary supplements, food ingredients, or drugs. Most are sold as dietary supplements, which do not require FDA approval before marketing. The Dietary Supplement Health and Education Act of 1994 (DSHEA) provides their regulatory framework, placing primary responsibility for safety and labeling on manufacturers.
Under DSHEA, manufacturers must ensure their products are safe and that any claims are truthful and not misleading. This includes adherence to Current Good Manufacturing Practices (cGMPs) outlined in 21 CFR Part 111, which establish standards for manufacturing, packaging, labeling, and holding operations to ensure product quality, purity, and proper composition.
The FDA has authority over labeling and claims for probiotic dietary supplements. Manufacturers can make “structure/function claims,” describing how a product affects the body’s structure or function (e.g., “supports digestive health” or “promotes immune function”). However, these products cannot claim to diagnose, treat, cure, or prevent any disease without meeting stricter drug requirements. Labels must also include a disclaimer stating the FDA has not evaluated the claim and that the product is not intended to diagnose, treat, cure, or prevent any disease.
The FDA conducts post-market surveillance and has mandatory adverse event reporting requirements for manufacturers. Manufacturers must report certain adverse events directly to the agency and are expected to have internal systems for monitoring product performance. This oversight allows the FDA to take action against adulterated or misbranded products, including initiating recalls.
Distinguishing “FDA Approved” from Other Oversight
The term “FDA approved” applies to prescription drugs and new medical devices after a rigorous review demonstrating safety and effectiveness through clinical trials. This pre-market evaluation is not required for most dietary supplements, including probiotics. A probiotic product marketed as a dietary supplement will not carry an “FDA approved” label.
Some probiotic ingredients or strains may achieve Generally Recognized As Safe (GRAS) status, as described in 21 CFR Part 170. GRAS status means a substance is recognized by qualified experts as safe for its intended use in food. This recognition can be established through scientific procedures or a history of safe use. Manufacturers can self-affirm GRAS status or submit a GRAS notification to the FDA for review. A “no questions” letter from the FDA regarding a GRAS notification indicates the agency’s acceptance of the manufacturer’s safety conclusion for its use in conventional foods. However, GRAS status pertains to an ingredient’s safety in food, not the approval of a finished dietary supplement or a therapeutic claim.
In rare instances, a probiotic could be investigated as an Investigational New Drug (IND) under 21 CFR Part 312 if intended to diagnose, cure, mitigate, treat, or prevent a disease. This pathway involves extensive clinical trials to prove safety and efficacy, similar to any new therapeutic agent. If a probiotic completes this drug approval process, it would be considered “FDA approved” as a drug, a distinct and less common regulatory route for these microorganisms.
Guidance for Consumers: Choosing a Probiotic Product
Given that most probiotic products are not “FDA approved” in the drug sense, consumers should take proactive steps when choosing a product. Select products from reputable brands that demonstrate transparency about manufacturing processes and product information. Looking for third-party certifications or seals can provide an added layer of assurance.
Organizations like USP (United States Pharmacopeia) and NSF International offer third-party certifications, which involve independent testing and auditing to verify product quality, purity, and potency. These certifications confirm that the product contains the ingredients listed on the label, in the declared amounts, and is free from harmful levels of contaminants.
Understanding the product label is also important. Consumers should look for the specific genus, species, and strain of the probiotic, as different strains can offer different health benefits. The label should also clearly state the number of colony-forming units (CFUs) per serving and provide storage instructions, as the viability of live microorganisms can be affected by temperature. While higher CFU counts are often marketed, the specific strain and its documented ability to survive through the digestive tract are more important than a large number alone. Consulting a healthcare professional can also provide personalized advice on selecting a probiotic that aligns with individual health goals.