Education is key if we are to rebuild or maintain our health using nutrients and supplements, but scientific research on nutrients and dietary supplements is coming to an abrupt halt because of theFDA’s guidance on INDs, or Investigational New Drug applications. Shockingly, if any of the remaining studies are published, then the newly educated public will no longer be able to obtain the nutrients and supplements that were studied, because the FDA says they will become drugs.
The FDA’s guidance requires companies to start a burdensome and expensive drug approval process if a nutrient is to be studied for its potential disease prevention or treatment—even if the supplement won’t make any related health claims or be marketed as a drug.
Companies are required to submit an IND application if their research could support new health claims or the expansion of existing health claims. Historically, INDs haven’t been required for nutrients or food products simply because of the objectives of a clinical study, since study objectives do not speak to the intended use of the food product.
More to the point, nutrient studies are important because they require adverse event reporting (and so can assess safety), and they give us better understanding about the effects of the nutrient on the body, as well as any potential uses for the nutrient in the future. The public increasingly relies on such research to make informed health decisions.
There is absolutely no reason for this guidance to include food and nutrients since they are already regulated. DSHEA (the Dietary Supplement Health and Education Act) and the Orphan Drug Act already establish that dietary supplements and medical foods are not considered drugs. Having to submit INDs makes the companies publicly claim they’re marketing drugs—even if they’re not.
Even worse, medical foods have always been able to make disease claims—that’s their sole reason for being, after all—but this guidance means that all medical foods would now require an IND. Could anything be more absurd?
There is so little research done on nutrients because of the Catch-22 of drug economics, but now with this new rule the FDA has proposed, there will be even less incentive for research. The only exception to a supplement becoming a drug after study data is published is if a New Dietary Ingredient (new supplement) notification has previously been sent to the FDA. But because the FDA is twenty years behind schedule on the NDI guidance, very few notifications have been filed, making this exception a very rare one. And the sentence should link to our last article on NDI.
Here’s the kicker: this guidance is changing the industry even though the FDA hasn’t taken it through the Administrative Procedure Act’s formal rulemaking process, which requires giving the public adequate notice of the proposed changes, and offering the opportunity for comment. The nutrient industry is acting as if this guidance is binding law—which makes it especially difficult to challenge, since it is not actually law:
- Institutional review boards (IRBs) are currently rejecting clinical studies about supplements that are non-FDA compliant, mainly because the boards aren’t clear about the FDA’s authority or the ramifications of this guidance.
- Insiders tell us that industry giants like Nestle, PepsiCo, and Danone/Dannon are taking their research money overseas to avoid the extra cost and time to get the required IND—it takes years!—avoiding the process altogether.
Connie M. Weaver, PhD, is distinguished professor and department head for the nutrition science program at Purdue University. In an interview with ANH-USA, Dr. Weaver told us that many are worried that the effects of this guidance “would decrease the competitive edge of US research.”
Joshua Miller, PhD, professor of Nutritional Sciences at Rutgers University, told us, “As an academic department chair, I would be hesitant to advise junior faculty to take up precious time applying and waiting for IND approval as they work toward tenure. For academic research, it’s a major burden. This [draft 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.”
Dr. Miller continues, “The FDA’s guidance on what exactly requires an IND is unclear, somewhat ambiguous, and open to multiple interpretations. It would make sense for FDA to bring in academic and industry leaders to advise them. The guidance, as is, is too broad and doesn’t make sense for researchers.”
The cost of an IND application is currently $2.3 million. Supplement and medical foods companies can’t file for an IND without Pharma money—and a way to recoup their investment on a nutrient, which is not usually patentable.
Research proposals are dropped because the whole process becomes “too daunting,” which in turn limits innovation. A large pharmaceutical company told us that a proposed study to investigate a popular medical food for secondary uses was rejected by an IRB for not having an IND. Another source told us that their grant was approved by the IRB, but they were told that the proposal needed to be cleared with the FDA regarding the IND requirement. The proposal was ultimately approved, but the process was informal—and unclear.
And all of this is by design: it is the FDA who is making the rules, and the FDA who ultimately benefits: they get $2.3 million and full regulatory authority over the product being researched, which is now classified as a drug.
Let us say that again: as soon the research is conducted and published, these nutrients and supplements would become 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. Filing the IND application sets up a process that virtually guarantees that any nutrients that are studied become drugs and can no longer be marketed as supplements once that research is published.
This is nothing more than “an administrative power grab.” With this guidance, the FDA is vying for more administrative control over medical foods, dietary supplements, and conventional foods—even those whose manufacturers don’t intend to market for their ability to treat diseases. US food science research is suppressed once again.