Don't Miss Out

Subscribe to OCA's News & Alerts.

FDA and Senator Durbin: Sneak Attack on Supplements

For related articles and more information, please visit OCA's Health Issues page, and our Nutri-Con page.

Today, both the FDA and Sen. Dick Durbin (D-IL) dropped policy "bombs" on those of us who use dietary supplements. It is no mere coincidence that both were released on the Friday before a holiday weekend. By timing the introduction of their anti-supplement legislation and regulatory guidance this way, the FDA and Sen. Durbin are both hoping to evade negative publicity. We think it is better to keep American citizens fully informed, and with your help, we will get the word out. Please send this communication far and wide.

First, the FDA has issued draft guidance for complying with the New Dietary Ingredient (NDI) notification protocols contained in the Dietary Supplement Health and Education Act (DSHEA). As you may recall, DSHEA said that supplements already on sale prior to the passage of the act were "grandfathered" in, and did not have to be reviewed by the FDA. New supplements developed after the Act have been in a kind of limbo waiting for the FDA to spell out the procedures to be followed.

These new supplements have always been at risk because of the uncertainly surrounding their regulatory status. And many of these new supplements are extremely important for our health. We won't name them, because to do would be to put a bull's-eye on them for the FDA to shoot at, but you would recognize many of them and may be currently taking them.

DSHEA was passed in 1994.#The FDA has thus taken seventeen years to provide regulatory guidance for these new supplements. Now a draft version of guidance is here, and it isn't good. It is just another effort by the FDA to suffocate the supplement industry so that everything-supplements and drugs alike-will go through the vastly expensive drug approval process, a process that pays for FDA salaries.

We have said it before and we will say it again. Supplements cannot usually be patented. No non-patentable substance can be taken through a drug approval process that on average costs a billion dollars. If supplements are treated like drugs, there simply won't be any supplements. The FDA knows this perfectly well.