A new regulation for supplements threatens access. Action Alert!
The FDA is on the record supporting mandatory product listing for dietary supplements—that is, requiring each supplement manufacturer to register all the products it makes, including all the ingredients of those products, with the FDA. It’s a strong possibility that with a Democratic appointee—which could be anti-supplement crusader Dr. David Kessler—as FDA commissioner or Secretary of Health and Human Services (HHS), this dangerous regulation will be aggressively pursued. Make no mistake: this innocuous-sounding proposal could spell big trouble for supplement access. We must proactively oppose it.
The stated purpose for mandatory listing is to improve the FDA’s ability to root out bad actors who sell dangerous products. It is a laudable goal, but the FDA already has the authority to go after companies that break the law and use illegal ingredients. The agency can, and has, enforced this law, as it should.
The mandatory list is a concern given the current state of the FDA’s “new supplement” guidance. This guidance, seeks to impose drug-like pre-approval requirements on all “new supplements” that came to the market after 1994. The FDA’s proposed definition of a “new supplement” is extremely broad, and the agency’s guidance is estimated to eliminate as many as 41,700 products from the market. A mandatory list could then be used to target and eliminate supplements that have not yet complied with the FDA’s over-reaching policy.
A mandatory list is also a concern because of its likely use to create a list of supplements that might lead to “adverse events,” similar to a legislative effort by Sen. Dick Durbin (D-IL) we defeated a number of years ago. In that case, the list would be created by the FDA and the National Academies of Science, Engineering, and Medicine (NASEM)—the same body that once said people up to the age of 70 don’t need more than 600 IU of vitamin D per day, and above 4000 IU may be dangerous. Keep in mind that researchers are recommending 4,000 IU of vitamin D a day to help reduce the severity of COVID-19. Some people may need four to five times that amount to achieve optimal blood levels of 60 ng/ml.
The point is this: a mandatory list could be used to target supplements and to remove “dangerous” high-dose supplements that don’t gel with the government’s pitifully low recommended dosages. It doesn’t matter who is in office, this is a threat: Dr. Scott Gottlieb, former FDA commissioner under Trump, voiced support for the idea.
The main issue, though, is the FDA’s still-incomplete “new supplement” guidance that threatens thousands of supplements on the market, which, under a Democratic administration, is in danger of moving forward. We have to push back.
Action Alert! Write to Congress and tell them to oppose the “new supplement” guidance being completed as is. Please send your message immediately. By sending this message, you will also be supporting our petition to ungag doctors so that they can share with patients the benefits of supplements and natural treatments for COVID.