The Council for Responsible Nutrition has filed a citizen’s petition with FDA requesting that the Agency reverse its decision that the ingredient NAC is not legal for use in dietary supplements. CRN states that FDA’s ruling on the matter, voiced in warning letters, is not legally justified and is having grave economic consequences.
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FDA’s Welch on DSHEA 2.0: ‘We have an opportunity for real, common sense reform that I don’t believe we can let pass by’ By Stephen Daniells “FDA is not looking to throw out DSHEA and start fresh – rather we are talking about building on the current framework,” said FDA’s Dr Cara Welch. Done correctly, initiatives like a mandatory product listing would not impose significant burdens on the industry, she said.
Speaking as part of the online AHPA Botanical Congress on May 24, Dr Cara Welch, PhD, acting director of the Office of Dietary Supplement Programs (ODSP), said:
“With mandatory product listing, we believe it’s possible to construct a narrowly-tailored requirement that respects and preserves DSHEA’s original vision of consumers’ right to access safe, well-manufactured, and appropriately labeled dietary supplements with, just as important, upholding FDA’s ability to pr
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 Botanical Congre
Stakeholders can t sue FDA over NAC warning letters | Natural Products INSIDER naturalproductsinsider.com - get the latest breaking news, showbiz & celebrity photos, sport news & rumours, viral videos and top stories from naturalproductsinsider.com Daily Mail and Mail on Sunday newspapers.
Representatives of the Council for Responsible Nutrition (CRN) met this week via Zoom with the acting commissioner of FDA and about a dozen other officials to discuss areas of agreement and disagreement between the Washington, D.C.-based trade association and the public health agency.
The May 11 talks between CRN’s senior staff and FDA officials including Dr. Janet Woodcock, acting commissioner of FDA gave CRN the opportunity to raise its concerns over FDA’s position that NAC (N-acetyl-L-cysteine) cannot be lawfully marketed in dietary supplements.
Steve Mister, president and CEO of CRN, described the nearly hour-long meeting with FDA officials as an extremely “cordial” and “productive” one in which the trade group “covered a lot of territory.”