Regulatory Status of Probiotic Foods

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Any substance that is reasonably expected to become a component of food is a food additive that is subjected to premarket approval by FDA, so if a probiotic is intended for use as a drug, then it must undergo the regulatory process as a drug, which is similar to that of any new therapeutic agent. An Investigational New Drug application must be submitted and authorized by FDA before an investigational or biological product can be administered to humans. The probiotic drug must be proven safe and effective for its intended use before marketing. If a probiotic is intended for use as a dietary supplement, it is placed under the umbrella of “foods,” and as such is regulated by FDA’s Center for Food Safety and Applied Nutrition. In contrast to drugs, dietary supplements do not need FDA approval before being marketed. However, manufacturers need to notify FDA before marketing a product. According to Dietary Supplement Health and Education Act, 1994 (DSHEA), the manufacturer is responsible for determining that the dietary supplements that it manufactures or distributes are safe and that any representations or claims made about them are substantiated by adequate evidence to show that they are not false or misleading; the manufacturers need not provide FDA with evidence that substantiates the safety or purported benefits of their products, either before or after marketing. The law allows that in addition to nutrient content claims, manufacturers of dietary supplements may make structure/function or health claims for their products. For a structure/function claim, FDA requires that manufacturers’ substantiation is accepted by experts in the field and that the claim is truthful and not misleading. The data substantiating structure/function claims need not be publicly available and need not be disclosed.  In 2001, in an attempt to standardize the requirements needed to make health claims regarding probiotic agents, the Joint Food and Agriculture Organization of the United Nations/World Health Organization Expert Consultation on Evaluation of Health and Nutritional Properties of Probiotics developed guidelines for evaluating probiotics in food that could lead to the substantiation of health claims. The Consultation recommends that specific health claims on labeling material on probiotic food items be allowed when sufficient scientific evidence is available and that the product manufacturer take responsibility for ensuring that an independent third party reviews and evaluates the scientific evidence.