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The Microbiome, Human Health, and the FDA

The US Institute of Medicine has released a summary of a workshop it hosted in February to discuss the role of the microbiome in human health.

According to the report, workshop participants agreed that the microbiome is "integral to human physiology, health, and disease" and is "arguably the most intimate connection that humans have with their external environment, mostly through diet."

Participants also discussed the future of dietary supplements, such as probiotics and prebiotics, that are being developed to modify the microbiome to improve human health. While the market for these products "is seeing tremendous success," according to the report, "the current regulatory framework poses challenges to industry interest and investment."

In the US, many probiotic ingredients require premarket notification with the Food and Drug Administration. At the workshop, Dan Levy, a microbiologist in the FDA's Division of Dietary Supplement Programs, discussed a draft guidance that the FDA published last year to outline what new dietary ingredient notification is necessary and what those notifications should include.

Levy "described how FDA evaluates the identity and safety of live microbial ingredients using the same logic it uses to evaluate botanical extracts," the report says. However, it adds, "research on the microbiome is advancing so rapidly that it is a challenge to develop specific recommendations."

Regulatory challenges for the fledgling probiotic food industry include the high costs of human clinical studies, combined with the fact that "it is more difficult to demonstrate health maintenance than disease intervention," the report states. "Compounding the challenge is the fact that there is no global system for scientific substantiation. Different regions, sometimes different countries, operate according to their own rules and standards for scientific substantiation, making collaboration and comparison difficult."

According to the report, Peggy Steele, global business director in the Nutrition and Health Division of DuPont, estimates that the probiotic yogurt market is growing at around 10 percent annually, but there are concerns that this growth will slow in the face of regulatory uncertainty.

"Steele suggested three general types of actions that industry can take to help drive continued growth in probiotics in the face of a changing regulatory landscape: (1) conduct efficacy studies to help the scientific and regulatory communities recognize the effects of probiotics on human health; (2) educate doctors, nutritionists, key opinion leaders, and journalists to communicate the results of human studies conducted on probiotics; and (3) explore new end points (e.g., new health end points, effects in different populations)."

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