More evidence that the FDA is working with Sen. Durbin to eliminate your supplement access. Action Alert!
The dominoes continue to line up for Senator Dick Durbin (D-IL) and his plan to restrict your supplement access. Last week, the FDA issued a policy designed to get companies to comply with its troublesome “new supplement” guidance that threatens over 41,000 supplements. We think that one of the main goals of Sen. Durbin’s policy is to help the FDA eliminate products that run afoul of the “new supplement” procedures, so the timing of all this is deeply suspect. We must keep up the pressure on Congress to make sure this policy never sees the light of day.
At first glance, the FDA’s new guidance seems harmless. It is a policy of enforcement discretion noting that many products on the market have not complied with the agency’s “new supplement” guidance, which is still in draft form, but the agency is allowing a grace period for late compliance without any penalties. It would be generous if the agency’s “new supplement” policy wasn’t already an outrageous overreach, since, as we’ve explained previously, it installs a drug-like pre-market approval system for supplements that goes far beyond what the law calls for.
We are deeply suspicious of the timing. The FDA releases a guidance encouraging compliance with its “new supplement” policy mere weeks after Sen. Durbin introduces his bill for mandatory supplement registration, and just days after the Senate adds a version of Sen. Durbin’s bill to its reauthorization of the Prescription Drug User Fee Act. The FDA has said it plans to release the final version of its “new supplement” guidance by the end of this year. The FDA also sent a flurry of warning letters recently to supplement companies alleging their products contain “new supplements” for which no “new supplement” notifications have been received.
To us, it seems obvious that these are coordinated efforts. The FDA is making headlines urging compliance with its “new supplement” policies just as Congress is considering a new regulation that will help the FDA target companies for not complying.
We at ANH are also experiencing some déjà vu from 2011. That was the year in which Sen. Durbin first introduced his supplement registration bill. Then, days later, over the July 4th weekend, the FDA released the first version of its “new supplement” guidance. Coincidence?
In our view, no supplement is safe from being targeted by the FDA, even if the follow the rules are followed. We saw this with vinpocetine, as we reported earlier this week. There, companies did the right thing and complied with the FDA’s ridiculous “new supplement” requirements—only to be told years later that, actually, vinpocetine isn’t a supplement because it was being studied as a drug first—sorry! The company spent the money to comply, submitted the information required to demonstrate safety—but it didn’t prevent the FDA from pulling the rug out from under them. Companies cannot operate under such conditions.
We cannot repeat this enough. Sen. Durbin’s regulations are not about keeping you safe from dangerous supplements. They undermine consumer choice and restrict our ability to stay healthy, naturally. We must keep up the pressure so this policy does not become law and our supplement choices disappear.
Action Alert! Write to Congress and tell them to oppose mandatory product registration for supplements. Please send your message immediately.