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!
Dear [Decision Maker],
Sincerely,[Your Name] [Your Address] [City, State ZIP]