BALTIMORE —Some academics are recommending the FDA allow probiotics to make drug claims without going through the formal drug approval process under "limited circumstances".
The exceptions should apply to probiotic foods, dietary ingredients and supplements for which there is sufficient evidence of safety, approved food additives and substances that are generally recognized as safe (GRAS), according to an article published in Science, "Probiotics: Finding the Right Regulatory Balance."
"An 'abbreviated' process would allow probiotics to be excused from Phase 1 trials, the first step in clinical testing," according to a press release issued by the University of Maryland Medical Center.
The authors also recommended FDA develop a monograph for probiotic foods and dietary supplements, following models used in Canada and by the FDA for over-the-counter drugs.
Frank Palumbo, Ph.D., professor and executive director of the University of Maryland School of Pharmacy Center on Drugs and Public Policy, said compliance with monograph requirements will result in an expedited review of applications to market probiotic products. It also will curtail the number of false scientific claims because claims in monographs must be substantiated by evidence-based science, he said.
Researchers said probiotics haven't been approved for therapeutic purposes, but they noted some are undergoing clinical trials and may soon be marketed as drugs such as biologics.
FDA doesn't define probiotics but regulates them based on whether they fall into an existing product category, according to Diane Hoffmann, lead author and director of the Law and Health Care Program at the University of Maryland Francis King Carey School of Law.
The co-authors summoned a working group of scientists, legal academics, food and drug law attorneys, government representatives, bioethicists and consumer advocates to study the current regulatory framework of probiotics. Jacques Ravel, Ph.D., of the University of Maryland School of Medicine, said in a statement the current regulatory regime is confusing and "discourages the development of probiotic food in preventing disease, improving health, or possibly treating disease."