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.
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Panel discussions and public comments during FDA public meeting show industry sees agency, as it stated in draft NDI notification guidances published in 2011 and 2016, is allowing little room for innovation through making new ingredients available for use in VMS products. FDA says immense growth of the VMS market since DSHEA passed shows numerous products available in US contain substances that haven't been notified to the FDA with proof showing they are dietary ingredients and are safe for use.
"Can we maybe as an industry, and I guess the FDA, agree not to overcomplicate the NDI process in the sense that it's actually pretty easy to navigate the process and understand what you have," says Frank Jaksch, Chromadex co-founder and executive chairman. "I want to encourage companies to do the right thing," says Mark LeDoux, founder, CEO and chairman of Natural Alternatives Internationa. "Our firm spent millions of dollars and went through the front door of the FDA. … This is not a difficult process to do the right thing."