Tell FDA: Supplements are Not Drugs

An FDA supplement policy infringes on free speech and makes it more difficult to study the health benefits of food and food supplements. Help us fight back! Action Alert!

For years, ANH has fought against the federal government’s censorship of free speech about the benefits of food and supplements. One important battle in that war is to stop the FDA from forcing researchers who are studying nutrients to submit investigational new drug (IND) applications, which are costly and burdensome, have stifled important research about the health benefits of nutrients, and in fact can end up turning those nutrients into drugs.

In 2014, the FDA released a guidance that, under certain conditions, required those studying the benefits of supplements to meet the same standards as new drugs. This policy has made it exponentially more difficult to study the many health benefits of vitamins and nutrients.

ANH staff recently met with the FDA to discuss a variety of issues, this flawed guidance among them. Thanks to the grassroots activism of ANH members, FDA staff showed a willingness to re-examine this policy in light of the information ANH presented. To drive the point home, ANH submitted a Citizen’s Petition explaining in detail FDA’s flawed reasoning and requesting the policy be modified.

Here’s how this policy works. If a researcher—be it an academic working at a university or a supplement company—is studying a nutrient for its potential to treat or prevent a disease, an IND application must be filed. This is the process that drug companies must go through to develop new drugs.

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 because research does not speak to the intended use of the food product.

Requiring IND applications to study supplements is ludicrous. By definition, supplements are not drugs. IND regulations were created as part of the drug approval process, not as a way to regulate the clinical study of foods and dietary supplements. In the IND guidance, FDA explains that an IND is needed if the research involves a drug. As the FDA has made painfully clear in other areas, supplements are not drugs—so IND regulations should not apply to them.

Further, a supplement company may need to conduct a study that investigates a supplement’s ability to diagnose, cure, mitigate, treat, or prevent a disease in order to substantiate a legal dietary supplement claim, like a structure/function claim (e.g. “Helps maintain cholesterol levels already within the normal range”). Yet if such a study conducted under an IND were to be published, according to the letter of the FDA’s policy, the supplement can become a drug. That’s right: by doing the necessary legwork to substantiate a legal dietary supplement claim, the supplement being studied can be turned into a drug if those studies are published, according to the FDA.

This does not apply to dietary supplements and foods “marketed in or as dietary supplements” before October 1994, and there is an exception made for those that came into the market afterwards—as long as the FDA’s “new dietary ingredient” (NDI) protocols have been followed. The problem is that the FDA hasn’t told supplement companies how to comply with these rules yet—the supplement industry has in fact been waiting for 24 years (and counting) for direction from the FDA on this issue.

Not only has the FDA’s IND policy chilled research on food and supplements; it has provided a back channel by which supplements can be turned into drugs. With your help, we can make the FDA change this guidance.

Action Alert! Send a message to the FDA supporting ANH’s Citizen’s Petition. Please send your message immediately.

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