Tell the FDA to Stop Trying to Halt Food and Supplement Research

The FDA recently released a guidance on INDs, or Investigational New Drug (IND) applications—the starting point for all FDA-approved drugs. This overreaching guidance requires companies to start a burdensome and expensive drug approval process if a nutrient is to be studied for potential health claims—even if the supplement won’t be marketed as a drug.

As soon as the research is conducted and published, these nutrients and supplements would become classified as drugs. This alone will stop most research dead in its tracks, and any research that does occur is likely to eliminate access to the very nutrient being studied.

The FDA has opened a request for comments regarding the burden of filing an IND, the first step toward drug approval. Tell them—and your legislators—that food nutrition research has no part in the drug approval regime. Ask the FDA to remove the sections of the guidance requiring INDs for food—they have no authority to require INDs for products that are statutorily defined as foods and not as drugs. Tell them to make clear through their website or letters to institutional review boards that the guidance has not been finalized and will not be enforced, to help the boards know they are acting according to current regulations.

Please add your own comments if you have the time!

Recipients

  • Your Senators
  • Your Representative
  • Stephen Ostroff

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Dear [Decision Maker],

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[Your Name]
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