‘Old’ Ingredient List On FDA Table Could Spur New Supplement Launches
This article was originally published in The Rose Sheet
CFSAN schedules a public meeting on developing a list of dietary ingredients available in the food supply before Congress in 1994 passed DSHEA. CRN expects the meeting to lead an “official safe harbor list” of eligible ingredients, but not directly to a final NDI notifications guidance.
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"Kratom illustrates the promise and the peril of dietary supplement regulation," says Jack Henningfield, Pinney Associates consultant and an expert on abuse liability of various substances. Kratom firms agree NDI notifications are needed for ingredients made from separate kratom alkaloids, but say the botanical itself has decades of safe use in the US.
FDA agrees with public health advocates that ingredients should be on a potential list of those available when Congress passed DSHEA only after current substantiation for a reasonable expectation of safety for their intended uses.
FDAs Oct. 3 meeting agenda includes Pieter Cohen, Harvard Medical School professor; Consumers Union Programs Director Chuck Bell; Laura MacCleery, Center for Science in the Public Interest regulatory affairs director; and Stephanie Scarmo, Pew Charitable Trusts Health Care Products Project officer.