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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You pull an item out of the refrigerator, freezer or pantry and see it’s past the date on the package.
“Should I eat this or not?”
“Those dates are there for a reason,” said Martin Bucknavage, senior food safety extension associate for Penn State University in the college of agriculture at University Park. “They are set by the manufacturer for the best time to consume the product. It will be the best quality by that date.”
The manufacturer is giving the safest date, he said.
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.”