Probiotics Industry Says FDA Regulatory Bar Is Set Too High
This article was originally published in The Tan Sheet
Research on probiotics’ health benefits rapidly grows, but turning studies into label claims lags due to differences between industry, NIH and FDA about standards for claims substantiation. Attendees at a U.S. Pharmacopeia conference outline the challenges to finding common ground
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While stockpiling for immune health support drove early sales growth in response to the pandemic, probiotic sales likely will continue increasing, says DuPont Nutrition probiotic marketing head Vanessa Bailey. “My gut tells me I think we could see some sustained increase. There’s going to be some difference in how we behave.”
FDA's regulatory pathway "for development of probiotic drugs is reasonably clear. But the road to develop probiotic foods, supplements or microbiome-based dietary strategies to compensate for deficient microbiota is less so," says the International Scientific Association for Probiotics and Prebiotics. FDA's Center for Biologics Evaluation and Research is conducting Sept. 17 workshop to exchange information with the scientific community about the clinical, manufacturing and regulatory considerations associated with live microbiome-based products administered to treat a disease.
Emphasize probiotics’ benefits rather than touting research supporting claims or using the technical terms linked to bacteria strains, says Mintel’s Lynn Dornblaser. P&G.’s Meta line capitalizes on consumers’ growing affinity for probiotics with the right approach to promote the brand.