For years, we’ve been asking the FDA to stop needlessly blocking research on dietary supplements with red tape. Finally, they’ve listened!
We are excited to share a monumental victory that has come about as a direct result of ANH-USA advocacy. In 2014, the FDA started applying drug rules to research being conducted on nutrients. This caused university research on nutrients to slow or even stop in some cases, depriving us of knowledge that could be deployed to support our health. After years of pressure from ANH, the FDA has finally relented; the agency has issued a proposed rule that will allow more research to be done on nutrients without triggering drug rules. We couldn’t have accomplished this without our dedicated grassroots activists, so we thank you!
The FDA’s previous stance was absurd on its face. For example, if a university researcher wanted to evaluate a yogurt product from the grocery store that contains probiotics for its ability to prevent constipation in healthy adults, that researcher would have to file an investigational new drug application (IND) with the FDA. Because the food (or nutrient) would be studied for its effect on a disease in the study—and, according to the FDA, only drugs can claim to treat or prevent disease—the researcher would need to comply with the same regulations that the drug industry does when studying a new drug in human subjects.
Think about all of the research we’ve shared over the years about the benefits of supplements. We recently reported on the evidence for magnesium in lowering blood pressure, and fish oil for preventing heart disease. We’ve talked about the role of B vitamins in brain and heart health. When COVID hit, we needed research to be done to discover that vitamin D status was an important factor determining COVID outcomes. Research helps guide our health decisions. It’s not something we often think about, but it is incredibly important to our health that researchers are able to operate in a favorable climate, rather than be buried in an avalanche of red tape that stalls or prevents studies from happening altogether. With this victory, we have been able to foster a more open climate that will allow much more research on supplements to occur, arming us with more and better information to optimize our health.
The FDA’s newly proposed rule would, in certain situations, exempt researchers evaluating a drug use of a food or cosmetic (that is, a food or nutrient’s ability to treat or prevent a disease) from having to go through incredibly burdensome IND process. INDs are traditionally for drug research and include animal pharmacology and toxicology studies, clinical protocols, and a host of other data to demonstrate to the FDA that the substance under investigation is safe for humans and has pharmacological activity that justifies commercial development.
This makes sense for drug research—these are new chemical compounds that should demonstrate a degree of safety before they are tested on humans. But why should supplement researchers have to jump through these hoops? And here’s the kicker: requiring an IND for this research naturally creates published studies and could turn a supplement into a drug. This has to do with the infamous “FDA back-channel” that turns supplements into drugs that we’ve reported on so often. If a supplement is considered “new”—that is, it came to market after 1994—then companies have to notify the FDA in advance of marketing that supplement. But, if a drug company starts studying that nutrient before the FDA has received a “new” supplement notification on it, then the substance is technically not allowed to be sold as a supplement. This is the issue we’re facing with NAC, CBD, NMN, pyridoxamine, vinpocetine, and others.
In its proposed rule, the FDA provides exemptions from submitting an IND if the supplement research is not going to support a new health claim or the development of the product into a drug (and as long as the research does not present safety concerns, for example looking at vulnerable populations or employing unusual routes of administration). Because most studies on nutrients are performed by academic researchers, not the supplement industry, this will free up researchers working at universities and hospitals to do more studies on supplements without the burden of filing an IND.
This all sounds very technical but this is a huge win that will end years of stifled research on supplements. When these obstacles were initially put in place by the FDA in 2014, there was an immediate chilling effect on supplement research.
Take a few examples from our reporting at the time. 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 [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.”
There were also real-world scenarios in which the FDA’s baffling application of drug rules to nutrient research delayed or halted studies for no apparent reason. Two researchers trying to look at the therapeutic effects of probiotics were stymied by the FDA, despite the researchers following CONSORT guidelines (recommendations for how to report on clinical trials), receiving Institutional Review Board (IRB) approvals (IRBs review a study before it starts to make sure it’s safe for human subjects), convening data and safety monitoring boards, and registering their trials on ClinicalTrials.gov. At a symposium, the researchers expressed the concern that the U.S. would fall behind the rest of the world in probiotic clinical research due to the challenges and delays associated with submitting INDs.
ANH-USA has, over the years, pressured the FDA with grassroots activism, submitted a Citizen’s Petition asking for these very changes, and even met in-person with agency staff to discuss the urgent need for reform. While we continue to disagree with the FDA about a great many issues, we are delighted that the agency has come around on this one.