Law, Medicine & Pharma Professors Call for Probiotics Oversight
Noting the difficulty of classifying products with probiotics, defined as live microorganisms that have a beneficial effect when consumed in sufficient quantities, due to their varied marketing as foods, dietary supplements, medical foods, foods for special dietary use, or drugs, University of Maryland professors in law, medicine and pharmacy suggest ways that the Food and Drug Administration (FDA) could regulate them. D.E. Hoffmann, et al., “Probiotics: Finding the Right Regulatory Balance,” Science, October 18, 2013. For example, probiotic products with drug claims “generally should be subject to the same rigorous requirements as other products making drug claims, including adequate and well-controlled investigations.” They also recommend an abbreviated approval format for “probiotic foods, dietary supplements, and dietary ingredients for which there is adequate evidence of safety in the target population; approved food additives; and substances generally recognized as safe (GRAS).”
They further recommend that FDA “establish a monograph for probiotic foods and dietary supplements that could be modeled on that adopted in Canada for natural health products or FDA’s monographs for OTC [over-the-counter] drugs.” In Canada, “all probiotic natural health products require premarket assessment and licensing and must be supported by evidence of strain-specific safety and efficacy under recommended conditions of use. Compliance with the monograph requirements leads to expedited review of the application for marketing the product.” While the authors recognize that foods and dietary supplements do not require premarket approval in the United States, they believe that, similar to OTC monographs, FDA probiotics monographs, specific to strains believed to be GRAS and effective for a particular benefit, “would list, among other things, active ingredients, acceptable product claims, labeling, and dosage. Ideally, a monograph would reduce the number of unsubstantiated probiotic claims and thereby help consumers make more informed decisions.”
