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FDA has found the law's new dietary ingredient notification requirement would not adequate protect the public from CBD products that could pose safety concerns. ....
Despite a recent FDA enforcement action, bringing hangover products to market with provocative claims continues to be a siren call for the dietary supplement industry. ....
The Council for Responsible Nutrition has requested in a petition that FDA reverse its position that NAC cannot be lawfully marketed as a supplement. ....
FDA ‘not looking to throw out DSHEA’ An FDA official on Monday discussed the potential modernization of a 27-year-old law governing the regulation of dietary supplements. FDA in recent years has supported efforts to modernize the Dietary Supplement Health and Education Act of 1994 (DSHEA). But the agency “is not looking to throw out DSHEA and start fresh,” an FDA official said Monday during an event hosted by the American Herbal Products Association (AHPA). “Rather, we’re talking about building on the current framework,” said Cara Welch, Ph.D., acting director of FDA’s Office of Dietary Supplement Programs (ODSP). FDA officials are among those in favor of modernizing the law to reflect changes in the marketplace over the last 27 years. The industry has ballooned “from $4 billion in sales in the ’90s to well over $40 billion today [and] from fewer than 4,000 products to estimates as high as 80,000,” Welch reflected during AHPA’s 9th B ....
CRN: ‘This is not the final word on NAC’ While Amazon moves ahead with removing NAC-containing dietary supplements from its website, the FDA’s Office of Dietary Supplement Programs (ODSP) acknowledges that it is still reviewing the information around the ingredient. NAC (N-acetyl-L-cysteine) is a derivative of the amino acid L-cysteine and is a precursor of the cellular antioxidant glutathione. The ingredient was first approved as an inhaled mucolytic drug in 1963. At present it is used in emergency rooms as a treatment in cases of acetaminophen poisoning to prevent severe liver damage. Despite its early use as a respiratory medication, the ingredient has been widely used for many years in finished dietary supplements, frequently as a standalone product. A search of the Dietary Supplement Label Database from the NIH’s Office of Dietary Supplements yields 1,468 products containing NAC (database accessed May 7, 2021), including ....