In particular, the letter expresses the senators’ expectations that the NDI guidance will be in line with the policies enacted by the Dietary Supplement Health and Education Act of 1994 (DHSEA).
A letter sent by Senators Tom Harkin (D-IA) and Orrin Hatch (R-UT) to FDA Commissioner Margaret Hamburg last week expresses support for FDA’s upcoming publication of new dietary ingredient (NDI) guidance, which the agency is due to deliver in July.
In particular, the letter expresses the senators’ expectations that the NDI guidance will be in line with the policies enacted by the Dietary Supplement Health and Education Act of 1994 (DHSEA).
“While the guidance should clarify when manufacturers must submit New Dietary Ingredient Notices, it should also refrain from erecting barriers that will inhibit or needlessly delay consumer access to safe products that were in fact marketed in the U.S. prior to October 15, 1994,” the letter states. “The intent of the law was to give FDA the tools necessary to help ensure the safety of dietary supplements and the accuracy of the limited claims allowed for them, but also to minimize regulatory burdens that might inhibit consumer access to lawfully manufactured and labeled supplement products.”
NPA’s lawsuit against FDA on NMN stayed pending agency’s decision on citizen petition
November 6th 2024The court has granted a joint motion for stay filed by NPA and FDA, pending the agency's decision on the citizen petition asking FDA to reverse its stance on NMN's status as a dietary ingredient.
Steve Mister on CRN's ongoing lawsuit against New York State
October 11th 2024Nutritional Outlook spoke to The Council for Responsible Nutrition's president and CEO, Steve Mister, at its annual meeting, Convergence '24. Mister discussed the latest in its ongoing lawsuit against NY State's law banning the sale of weight management and muscle building products to minors.