FDA Expects Safety As Ticket To Enter 'Pre-DSHEA' Dietary Ingredient List
This article was originally published in The Rose Sheet
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.
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FDA has little priority, and limited resources available for finalizing its 2016 draft guidance on NDI notifications and for establishing a process that certifies dietary ingredients as being available before October 1994, says regulatory attorney Miriam Guggenheim.For both of those developments, she says, "I'm not holding my breath."
NPA published a book listing pre-DSHEA dietary ingredients and FDA is interested in reviewing the trade group's methodology for compiling the list, which could be a litmus test for how the agency will evaluate industry-produced lists of “old” ingredients.
Rose Sheet’s editorial team counts down top news items in the cosmetics and dietary supplement sectors over the past month, including possible cosmetics regulatory convergence under a renegotiated NAFTA, the FTC’s first enforcement action against social media influencers, FDA movement to develop a list of “old dietary ingredients” pre-dating DSHEA, and more.