There are plenty of reason to wonder. Action Alerts!
As we revealed in our related story, the attack on picamilon (a safe supplement combining the natural substances GABA and vitamin B3) spearheaded by the attorney general of Oregon, with the assistance of Sen. Claire McCaskill (D-MO), has likely been orchestrated by the US Food and Drug Administration. Since the FDA has full power to move against any supplement, what is going on here?
To get to the bottom of this, you have to know about the agency’s recent treatment of new dietary ingredients (NDIs) —or, in other words, new supplements. You can read our previous coverage for context, but this pertains to a section of the Dietary Supplement Health and Education Act (DSHEA) that deals with how the FDA is to treat NDIs. In DSHEA, “new” means a supplement or ingredient that appeared on the market after 1994.
A few years ago, the FDA released a very bad draft guidance that, if enacted, would have eliminated thousands of supplements from the market in the blink of an eye. Essentially, the agency wrote an extremely restrictive definition of what would be considered a “new” supplement, and created an onerous set of regulations—including something akin to a pre-approval system—for “new” supplements to be allowed.
Remember, too, that drug companies can gain market exclusivity on dietary ingredients by filing investigational new drug (IND) applications before an NDI is filed. A parallel FDA guidance will accelerate this process, making a bad situation even worse and eliminating consumer access to affordable nutrients. This has happened before, most recently in the case of the pyridoxamine form of vitamin B6.
The FDA agreed to revise this bad NDI draft guidance in 2012 after substantial pushback from ANH-USA members and others, and the agency has been working on a revised guidance ever since. This means that supplement companies are in the dark about how to comply properly with DSHEA’s NDI provision.
This is part of what makes the Oregon AG’s lawsuit so troubling—thousands of “new supplements” (that is, placed on the market after 1994) whose producers have not filed NDI notifications could potentially be considered illegal “drugs” or “unlawful dietary ingredients” despite the fact that the FDA won’t say how this can be prevented. If picamilon is declared an illegal drug and driven off the market, it could leave thousands of other products—products that consumers rely on—vulnerable to similar assaults.
Action Alerts! If you haven’t taken action already, click the button below to tell the Oregon AG, the FDA, and Sen. McCaskill that this lawsuit sets a very dangerous precedent.
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Ubiquinol, the reduced form of Ubiquinone, Co-enzyme Q10 was developed by Kaneka QH in 2004 and approved by FDA in 2006 in that in doses of 300mg or 600mg cause no harm to healthy adults. This supplement would be banned because it gives oxygen to every cell in our body, especially if a person takes statin medications. The FDA has known that statins eliminate Co-enzyme Q10 and did not act on a petition to demand that CoQ10 be given with statin medications. We must elect a President who will change the direction of the FDA.