H.R. 10336: Dietary Supplement Innovation Act

This bill would change how the FDA can treat certain ingredients in food and dietary supplements when those ingredients have also been studied or approved as drugs or biologic products.

What the bill changes

• It rewrites part of the Food, Drug, and Cosmetic Act to narrow when a food or dietary supplement is considered illegal just because it contains a substance that is also a drug or biologic product.
• It creates several exceptions allowing a substance to be used in food or supplements if, for example:
  • it was already marketed in the U.S. before October 15, 1994, in food or in something that would have qualified as a dietary supplement;
  • it was marketed as food or in a supplement before the drug/biologic was approved, licensed, or publicly placed into Phase 2 or Phase 3 clinical trials;
  • the clinical trials have been inactive, withdrawn, or discontinued for at least seven years, or the sponsor has publicly said development has stopped;
  • it is a new animal drug that is not unsafe;
  • it is used to make the food safer, rather than to create a direct effect on people, and the use fits within existing FDA food-additive or safety rules;
  • it had been marketed for smoking cessation before the 2007 FDA Amendments Act; or
  • the FDA, through a formal administrative process, approves the use in food or supplements.

How FDA decisions would be evaluated

• The bill says FDA must consider whether the substance is different when used in a food or supplement, including:
  • how it is taken;
  • the recommended dose or serving size;
  • its concentration or composition; and
  • how safe it is when used in food or supplements.

Legal challenge process

• If the FDA sends a warning letter, gives a response, or posts a statement saying a food or supplement violates this drug-preclusion rule, that action would be immediately reviewable in court.
• In such a court case, the federal government would have the burden of proving that the product does violate the rule.

Dietary supplement definition

• The bill makes technical changes to the statutory definition of “dietary supplement” to match the new wording elsewhere in the law.

Relevant Companies

• None found