Latest FDA Moves Could Stop Further Research on Supplements

What the FDA does about supplements is usually complicated-we think intentionally so, in order to confuse Congress and critics.

November 10, 2014 | Source: | by Alliance for Natural Health

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What the FDA does about supplements is usually complicated-we think intentionally so, in order to confuse Congress and critics. Bear with us as we try to disentangle the threads.

We need to get this story out now because the FDA has just opened a public comment period. It is vital to flood the agency and especially Congress with messages.

The FDA has a history of preventing scientific information about food and supplements from being disseminated. Now, if the agency gets its way, the FDA will be able to keep scientific research from being performed in the first place. In fact, our confidential sources tell us that studies on nutrients and dietary supplements are already coming to an abrupt halt. And it’s all because of the FDA’s guidance on INDs, or Investigational New Drug applications.

By law, if any nutrient studies actually do get published, the FDA in most instances won’t allow the nutrient in question to be purchased in supplement form. Even more shockingly, if a drug company wants to turn the supplement into a drug, they will have market exclusivity because the supplement forms would be banned. That’s right: the public will no longer be able to obtain the nutrients and supplements that were studied, because the FDA says they may become drugs. The FDA is essentially making sure their drugs have no competition from supplements.

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 Investigational New Drug (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 research does not speak to the intended use of the food product.

More to the point, nutrient studies are important because they include adverse event reporting (and so can help 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 relies on such research (increasingly available on the Internet) to make informed health decisions.