FDA Action Alert- Please Share!

The FDA Doesn’t Want You to Know the Healing Power of Your Nutrients

The FDA is up to no good when it comes to your nutritional supplements. They are attempting to require medical foods and dietary supplements to undergo the same extremely burdensome and expensive approval process to simply to initiate research. The FDA has just opened a public comment period and it is critical for us to flood the agency as well as Congress with messages about why we oppose this proposed legislation.

What this proposed legislation means to you is that your nutrients will become much more expensive due to the process that they will have to undergo in order to enter the marketplace. Under this new process, supplement companies would be required to submit an Investigational New Drug (IND) application if their research could support health claims or the expansion of health claims. Filing an IND is a costly process to the tune of $2.3 million.

This process would also mean that it could take years for important research on nutritional supplements to be conducted; in fact, if the FDA had this much control over the research of nutritional supplements, it would dissuade academic institutions from conducting research all together. Joshua Miller, PhD, professor of Nutritional Sciences at Rutgers University, claims, “As an academic department chair, I would be hesitant to advise junior faculty to take up precious time applying and waiting for IND approval

[for a nutrient study] as they work toward tenure. For academic research, it’s a major burden. This [guidance] may shut down new research on dietary supplements in academia. It also reduces U.S. jobs—industry will take the research overseas where they won’t need an IND.”

If this doesn’t disturb you enough already, supplements and nutrients (including Superfoods) that have entered the marketplace after 1994 could also be required to submit an IND. This could mean that nutrients that are currently helping you feel better may be taken away from you. Do not let this happen!

Action Alert! The FDA has opened a request for comments regarding the burden of filing an IND, the first step toward drug approval. (click on the green button on that page to submit your comment). Tell them that food nutrition research has no part in the drug approval regime. And tell them to make clear through their website or letters to IRBs that the guidance has not been finalized and therefore legally cannot be enforced, to help the boards know they are acting according to current regulations. Send your message today!

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