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NPA working on safe harbor list of pre-DSHEA dietary ingredients


WASHINGTON – The Natural Products Association announced Wednesday it is in the later stages of developing a comprehensive safe harbor list of pre-DSHEA dietary ingredients for the industry based largely on evidence from past media reports, advertising and other public sources.  

“NPA has a treasure trove of useful labels and label information dating back to the 1940s from our retailing magazines, which will be used as evidence of dietary ingredients sold in interstate commerce before Oct. 15, 1994,” stated Daniel Fabricant, NPA CEO. “There are industry lists from the late 1990s and NPA’s own list from 1996.  In short, we have the evidence FDA is seeking to make these determinations, and we look forward to engaging FDA on developing a safe harbor list," he said. “The most common question we get from our members is whether something is an old ingredient and therefore off-limits to FDA or a new dietary ingredient, which triggers the NDI notification process.  While future dietary ingredients may be appropriately subjected to that process, we are developing a safe harbor list now for greater clarity as to exactly what ingredients fall safely into the approved category and can be used in products today.”

NPA hopes to complete the Safe Harbor database of dietary ingredients in the near future, and will engage FDA in the coming months on its methodology and evidence.

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