Drug Innovation Needs Exclusivity For Some Natural Substances, PhRMA Recommends
In comments on VMS industry oversight, PhRMA recommends FDA adhere to clear regulations that determine whether substances are eligible for use as dietary ingredients. DSHEA makes clear that some dietary ingredients are not eligible for use VMS products.
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US CBD Supplement Market Anxious For Lawful Use Proposal, And FDA Offers Cannabis Drug Research Guidance
Adding more cannabis-containing drugs to the three already approved in the US relies on research, but hundreds of supplements and other FDA-regulated non-drug products containing CBDs already are available under enforcement discretion by the agency.
Align Supplement Industry Regulation With DSHEA, Groups Tell FDA In 'Responsible Innovation' Comments
Targeted guidance on questions around NDINs and using import alerts to keep violative products off market are among supplement industry trade groups' suggestions for improving FDA oversight of the industry. Groups also continue asserting that the agency can strengthen its VMS product manufacturing and marketing oversight with its existing authorities.
Legal dispute between FDA and Pharmanex decided in 1999 could be precedent for using hemp-derived ingredients including CBD in supplements, even though CBD already has been authorized for clinical drug evaluation and for use in a drug, says attorney Miriam Guggenheim.