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What FDA's beta-alanine enforcement decision means for NDINs

Short Legal Briefs Episode 2
In this episode of Short Legal Briefs, Josh Long hosts the CEO of a supplement manufacturer and two former FDA officials to discuss a safety-related, premarket ingredient notification requirement in DSHEA.

The new dietary ingredient notification (NDIN) requirement in the Dietary Supplement Health and Education Act of 1994 (DSHEA) reflects FDA’s only chance to review the safety of novel ingredients in supplements before they are introduced to consumers. But the NDIN process is thought to be underutilized, and FDA has faced criticism for not rigorously enforcing the requirement. In a letter earlier this year, the acting director of FDA’s Office of Dietary Supplement Programs essentially denied a request to enforce against “generic forms” of beta-alanine that have not provided safety data to FDA.

Host Josh Long sits down with a roundtable of experts to weigh in on FDA’s letter and the broader controversy:

  • Dan Fabricant, president and CEO of the Natural Products Association (NPA);
  • Mark LeDoux, founder, chairman and CEO of Natural Alternatives International Inc. (NAI); and
  • Robert Durkin, of counsel in the FDA and Healthcare practices with the law firm Arnall Golden Gregory LLP (AGG).

 

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