Probiotics Industry Says FDA Regulatory Bar Is Set Too High
This article was originally published in The Tan Sheet
Executive Summary
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
You may also be interested in...
GRAS Path Draws Interest As NDI Alternative, But Carries Challenges
In the wake of FDA’s draft guidance on NDI notifications, more companies reevaluate the status of their ingredients before going to market. The GRAS for use in foods process is a clear – but rigorous – alternative pathway.
NDI Guidance Protects Public Health And Allows Innovation – FDA's Fabricant
Present and former top FDA officials with oversight of dietary supplements defend the draft guidance on new dietary ingredient notifications, saying the document serves important public health priorities and will not be onerous to industry.
Jurors' Answers In FTC's Prevagen Complaint Might Burst A Memory Bubble For Health Claims
“No” answers in New York federal court on whether all but two of Prevagen claims were “materially misleading” could put a fork in the road of a long dispute between FTC and supplement product manufacturers and marketers.