FDA action could make supplements obsolete If not for the action of two senators
As anyone in the dietary supplements industry knows, FDA has put forth some disturbing guidelines that would allow the agency to arbitrarily deny the sale of any natural supplement created (or modified) in the past seventeen years, and that would give the agency de facto pre-market approval of pretty much any supplement that comes on the scene.
According to the draft guidance, if you are a natural supplement manufacturer or distributor, and you don’t file a request for approval for every ingredient in every product you’ve developed since 1994, then you may be at some point be considered guilty of product “adulteration,” which is punishable by jail.
Needless to say, this has been the hot button issue in the supplement industry for some time. Not only is it a direct threat to those companies that legally produce and distribute supplements, but also this sort of FDA action could make supplements obsolete. By doubling or tripling the price of supplements and disapproving more and more of them over time, the FDA could effectively ensure that everything left on the market would be considered a drug.
Enter Sen. Tom Harkin (D-IA) and Sen. Orrin Hatch (R-UT). Back in January of 2012, these two long-time proponents of natural health took the issue head on by challenging FDA’s authority to, in essence, make new laws concerning supplements.
You can read all about the senators’ arguments against the draft guidance in the Alliance for Natural Health Article titled “Senators Give Supplements a Lifeline”. It is a quick read, but well worth it, as it will help you understand exactly what may be at risk if FDA goes unchecked.
But what has happened since? Very little, as far as I can tell.
There continue to be disturbing reports of FDA classifying things as innocuous as cherry juice as unapproved drugs. It’s true. The FruitFast Company sold cherry juice concentrate with the accurate statement that it helped eliminate gout, and FDA responded by classifying it as an unapproved drug. As someone concerned about health and wellness, this sort of blind, sweeping condemnation of natural items that help people is terrifying.
I encourage everyone who reads this to use the War On Vitamins website to let their political leaders know it’s time to stop the FDA from overreaching.
I will keep this issue on my radar. Follow me on Twitter, @JessClay to catch any updates to this post. Meanwhile, I wish you—and the natural supplement industry—good health!