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Update: Major Supplement Victory

By ANH-USA


…but we’re not out of the woods yet. Let’s keep up the pressure to protect access to the supplements you need to stay healthy. Action Alert!

Last week, Congressional leaders reached an agreement for the reauthorization of FDA user fees—and the package does not include mandatory product listing for supplements, a regulation we’ve been writing about for the better part of a year that would bring us closer to a system in which quality supplements are regulated out of existence. This is a major victory, and we thank those of you who have been repeatedly urging lawmakers NOT to support this disastrous policy. Unfortunately, now Sen. Dick Durbin (D-IL) and his allies are working to add this regulation to another must-pass government spending bill, so we have to keep up the pressure.

According to reports, mandatory product listing for supplements could still be added to an end-of-the-year bill to continue funding the government that must be passed by December 16th.

As we’ve been telling you, Senator Dick Durbin (D-IL) and Senator Patty Murray (D-WA) have been working for many months to attach mandatory product listing for supplements to the must-pass FDA user fee reauthorization bill. They know Senator Durbin’s original standalone bill, S. 4090, the Dietary Supplement Listing Act, has little chance of passing on its own because it lacks broad support and isn’t a Congressional priority. As a result, the Senators are looking for any opportunity to attach Durbin’s proposal to a larger legislative package that is certain to become law.

To recap: Durbin’s mandatory listing legislation would add regulations to supplements that will increase prices for consumers and decrease available options, making it easy for the FDA to eliminate supplements that compete with the drugs that provide significant funding for the Agency. We’ve argued that mandatory product registration is a prelude to eliminating high-dose dietary supplements, as the European Union is in the process of doing, and throttling innovation in the supplement sector that delivers American consumers a diverse array of cutting-edge products that support health.

Recall, too, that the FDA has declared that NAC and CBD are illegal supplements, but stakeholders, including ANH, have pushed back and, for now, we still have access. One version of Sen. Durbin’s bill sought to change that by including language that would have allowed the FDA to immediately remove CBD and NAC from the market when the agency determined they weren’t supplements (which was in 2020 for NAC, and 2017 for CBD). The FDA has been working to eliminate these products, but because we had time to fight back, the FDA is considering an unprecedented rulemaking to allow the sale of NAC supplements. CBD supplements are technically still illegal, but while the agency develops its approach to CBD products, it only seems to be focusing enforcement actions on CBD companies making illegal health claims. Again, this is, in part, due to the public outcry at the prospect of eliminating access to CBD outside of the FDA-approved drug which costs $32,500 a year. Congress has also stepped in with bills that would legalize CBD supplements. CBD and NAC are still threatened, but the point is the FDA wasn’t able to axe them right off the bat, to Sen. Durbin’s chagrin. Durbin’s proposal is completely unnecessary as supplements are an overwhelmingly safe product category. In 2021, the FDA received a total of 2,333,453 adverse event reports. Of those, only 2,400 were related to dietary supplements. That means that dietary supplements make up 0.1% of the adverse event reports to the FDA. Adverse events from FDA approved drugs, tobacco, and food poisoning are much more significant safety concerns that the FDA should be prioritizing.

Durbin’s proposal is also a duplicative waste of taxpayer dollars. The U.S. government has already spent tens of millions of dollars creating the NIH’s dietary supplement label database, which currently lists 125,000+ supplement product labels.

We must be vigilant: Senator Durbin and Senator Murray are still working to get mandatory product listing attached to a must-pass bill in 2022. We must make sure this doesn’t happen.