EDITORIAL

FDA Proposes Ban on Supplement Research

H ard to believe, but while we were sleeping, the FDA created a so-called “guidance document” last year, on September 10, 2013 (see Federal Register entry: http://tinyurl.com/mmgj9c2). The gist of this ruling was for “Determining Whether Human Research Studies Can Be Conducted Without an Investigational New Drug Application” (from the title). This seems innocuous enough, but when you consider that it applies to medical foods and supplements, you can start to see the writing on the wall. There is nothing to worry about, just as long as you don’t investigate anything other than how the supplement affects the structure or function of the body.

However, if the clinical investigation is intended to evaluate the dietary supplement’s ability to diagnose, cure, mitigate, treat, or prevent a disease, an IND [Investigational New Drug application; price = $2.3 million] is required under part 312. For example, a clinical investigation designed to study the relationship between a dietary supplement’s effect on normal structure or function in humans (e.g., guarana and maximal oxygen uptake) or to characterize the mechanism by which a dietary supplement acts to maintain such structure or function (e.g., fiber and bowel regularity) would not need to be conducted under an IND. However, a clinical investigation designed to evaluate a dietary supplement’s ability to prevent osteoporosis or to treat chronic diarrhea or constipation would need to be conducted under an IND. [Available at http://tinyurl.com/q9tx3sp]

The FDA Doesn’t Want You to Be Informed

If you think that the FDA wants you to have scientific information on supplements, think again. Their primary “clients” are the pharmaceutical companies who don’t like competition. So in the interest of Big Pharma, the FDA has done everything it can to prevent dissemination of scientific information on food and supplements. And if the agency is able to pull this off, research on supplements will come to an end because the FDA will be able to keep scientific research from being performed in the first place. Informed sources are finding that studies on nutrients and dietary supplements are already coming to an abrupt halt. This is entirely due to the FDA’s “guidance” on INDs.

Because a Supplement May Become a Drug, It Is a Drug

Publishing a paper on a nutrient without an IND will mean that the FDA can ban the nutrient in question to be purchased in supplement form. And of course, the issuance of an IND means that no one else can sell it as a supplement, aside from the company that pays for the IND (and the study). The public will no longer be able to obtain the nutrients and supplements that were studied, because the FDA says they may become drugs. But that’s an aside, drug status or not. They cannot be sold as supplements.

A Tale Told by Kafka

Following FDA guidance, like a story of Franz Kafka, takes one into a world of alienation, where companies that study nutrients for potential therapeutic reasons, are effectively compelled to start an expensive and burdensome drug approval process. This is even true if the supplement company won’t make any related health claims or market the supplement as a drug.

Without nutrient studies, far less information on adverse events will be lacking. Moreover, we will not gain understanding about the effects of the nutrient on the body, as well as any potential uses for the nutrient in the future. Informed health decisions will be harder to make.

DSHEA (the Dietary Supplement Health and Education Act) has already established that dietary supplements and medical foods are not to be considered drugs. But mandating submission to new drug applications will make companies publicly claim that they’re marketing drugs—even if they’re not.

Medical foods have always been able to make disease claims but the new guidance means that all medical foods would now require an IND—even if a New Dietary Ingredient notification has already been filed. However, to their detriment, medical foods can remain on the market after the research is published if they had filed an NDI, but they still have to apply for an IND and pay the $2.3 million.

As we have known for a long time, little research is done on nutrients because of drug economics—if you don’t have exclusive rights to the new “drug,” you’re unlikely to recoup your investment. But with this new rule, the incentives for research will crator. Furthermore, if a New Dietary Ingredient had previously been sent to the FDA, the filer would be exempted, 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. Another exception is if the supplement was sold before 1994. However, there is no agreed upon list of these, and in the past the FDA has interpreted this provision of the law as narrowly as possible. It is not at all clear which supplements will eventually be found to qualify, and this might take years of litigation.

A Law that Is Not a Law

You may be surprised to know that even though the FDA hasn’t taken this guidance through the Administrative Procedure Act’s formal rulemaking process it is changing the industry. The nutritional supplement industry believes it has no choice but to act as if this guidance is binding law. In fact, institutional review boards (IRBs) are currently rejecting clinical studies about supplements, for the main reason that the boards aren’t clear about the FDA’s authority or the ramifications of this guidance.

According to the Alliance for Natural Health, insiders are saying 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.”*

Continuing from the above article, “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 [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.’”

The cost of an IND application is currently $2.3 million, an amount few supplement companies can afford. Only Big Pharma has this kind of money—and a way to recoup their investment on a nutrient, which is primarily not patentable.

Nutritional Innovation Will Be Limited

Under the guidance, research proposals are becoming “too daunting,” which in turn limits innovation. Even in the pharmaceutical industry, one company revealed to the Alliance that a proposed study to investigate a popular medical food for secondary uses was rejected by an IRB for not having an IND. Other such stories are being told.

Don’t believe for a moment that the FDA will not ultimately benefit financially or grow in power. Once again from the Alliance: “As soon as the research is conducted and published, these nutrients and supplements would essentially 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. 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.”

The FDA’s actions are “administrative power grabs,” in which they are vying for more administrative control not only over medical foods and dietary supplements, but also conventional foods. The tragedy is that U.S. food science research is suppressed and we are all the worst for it.

The Need for Action

There is dire need to take action! For some reason, the usual comment procedure has not yet taken place and the FDA has opened a request for comments regarding the burden of filing an IND, the first step toward drug approval.

Please let them know that food nutrition research is difference than the drug approval process. And make it clear through their website or letters to IRBs that the guidance has not been finalized and therefore legally cannot be enforced. Send your message today! (See http://tinyurl.com/oandjtg).


Will Block

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