Supplement Attack from Congress in the Works

November 18, 2021

Congress is poised to make it harder to use natural medicine to stave off COVID-19 and other illnesses. Action Alert!

There’s good news and bad news. The good news is that new research confirms that vitamin D is a crucial weapon in the fight against COVID. The bad news is that Congress is working on a policy that will make it easier for the FDA to target and eliminate supplements like some forms of vitamin D from the market. We need to make sure this bad idea does not become law.

One study found that vitamin D supplementation was associated with less severe COVID-19 outcomes and better survival among frail elderly populations. Reviews looking at all of the evidence so far found that higher blood concentrations of vitamin D are associated with reduced risk and severity of COVID-19. The data reviewed also supports the role of higher blood vitamin D concentrations in reducing risk of infection and death from acute respiratory tract infections, including those from influenza, COVID, and pneumonia. This is on top of other studies which we’ve reported on previously that suggest vitamin D can help with COVID.

But our ability to use vitamin D and other natural medicines is threatened by developments in Congress. For a number of months, we’ve been telling you about the dangers of a “mandatory supplement filing” requirement that is percolating around Congress. This policy would create a database of all supplements on the market, potentially including product names, the list of ingredients in each supplement, labels, and additional filings for changes, reformulations, or discontinuations. The mandatory filing could also require that every supplement on the list needs a registration number, which would delay new products coming to the market.

We are now hearing there are indeed active conversations on Capitol Hill about this policy, and indeed there are draft bills that could be introduced at any moment.  In fact, Senator Durbin (D-IL) has been pursuing this policy for years. He has introduced bills in the past to require mandatory filing for supplements (for example in 2012 and 2013), and recently tried to sneak it through the appropriations process.

Part of what makes this policy so dangerous is how innocuous it sounds: who could be against a simple list of all the supplements currently on the market? The problem is that this list would likely be used by the FDA to target supplements that don’t comply with some of the agency’s ridiculous rules.

We recently described how resveratrol, a critical antioxidant, could be threatened by the passage of a mandatory filing requirement because the agency has stated that it does not meet the definition of a supplement. The agency has also said that NAC, another important antioxidant, and CBD oil, do not meet the definition of a supplement. If the agency decides it wants to remove these products from the market, all it needs to do is consult the list created by the “mandatory filing” requirement for a roadmap and easy elimination.

In fact, many, many supplements are at risk if the FDA gets the mandatory filing rules it wants. Recall the agency’s “new supplement” guidance that we have covered many times over the years. Experts have estimated that this guidance threatens as many as 41,700 supplements. The problem is that many supplements currently on the market, potentially even some basic products like vitamin D, could actually be considered “new supplements” by the FDA and thus targets for elimination if they don’t comply with the FDA’s rules. For example, the FDA may conclude that some vitamin D supplements have been “chemically altered” from older versions and thus subject to the additional regulatory requirements. There are already indications that some vitamin D products would be considered “new” because there have been “new supplement” notifications submitted for vitamin D products, including a high-dose 10,000 IU product. A master filing requirement makes the FDA’s job of finding and removing supplements that are not compliant with the “new supplement” guidance that much easier.

Of course, we don’t know what the FDA would target first. The above-mentioned threats to resveratrol, CBD, and vitamin D are hypothetical at this juncture. But it is almost certain that the FDA will use a mandatory filing requirement to target something: why else, given the sterling safety record of dietary supplements, would Senator Dick Durbin, who has demonstrated himself to be anti-supplement many times, pursue this policy?

We will continue to closely monitor the situation and update you accordingly. In the meantime, we need to keep up the pressure to make sure this bad proposal doesn’t move forward.

Action Alert! Write to Congress and oppose any efforts to pass “mandatory filing” for dietary supplements. Please send your message immediately.

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