Four trade associations have banded together to ask Congress to allocate an additional $5 million in funding to help the US Food and Drug Administration regulate dietary supplements.
Trade groups slam DSHEA 2.0 proposal related to adverse events In this story, the Center for Science in the Public Interest and industry trade groups debate the merits of requiring manufacturers to report all adverse events associated with their dietary supplements. Also weighing in: a prominent Harvard Medical School professor who studies supplements, and an expert in adverse event management and regulatory compliance services.
Editor’s note: This is the third article in a series on proposed reforms to DSHEA by several consumer groups in a recent letter to Congress.
Some consumer advocacy groups want U.S. lawmakers to impose a new requirement that manufacturers of dietary supplements report to FDA all “adverse events” associated with their products.
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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