An update on Sen. Durbin’s supplement attack. Action Alert!
Congress is once again down to the wire on many upcoming deadlines – the federal budget and the ability for FDA to collect user fees from drug companies will both expire at the end of September. Ultimately, Congress will likely handle these deadlines with some quick and dirty must-pass legislation, so we need to make sure our elected officials know we don’t want supplement restrictions slipped into this larger legislative package.
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. 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 – like the FDA user fee reauthorization or the federal budget.
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.
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. Does the FDA really need tens of millions more to create a similar product list?
In spite of the many reasons against Durbin’s proposal, Senator Murray has been determined to get these supplement restrictions passed into law, and she successfully attached Durbin’s proposal to the must-pass FDA user fee bill when it was considered in her Senate Health Education Labor and Pensions (HELP) Committee this June. Fortunately, HELP Committee Ranking Member Senator Richard Burr (R-NC) rebelled against Murray’s supplement restrictions and other legislative riders and introduced his own FDA user fee bill, without the supplement proposal attached.
As a result of the controversy around these legislative riders (thanks in part to the tens of thousands of messages ANH supporters have sent their Senators and Representatives opposing mandatory product listing for supplements), progress on the FDA user fee reauthorization bill has stalled and the bill has not been brought to the Senate floor for a vote.
Without passage of the FDA user fee reauthorization, FDA will have to lay off staff whose salaries are funded by these drug user fees. Without passage of the federal budget, the federal government will partially shutdown starting on Oct. 1. Given the many looming deadlines, Congressional leaders are considering attaching the FDA user fee reauthorization to a stopgap spending bill that would fund the federal government until December 16.
Should this happen, it is critical that dietary supplements don’t get wrapped up in the FDA user fee language that gets attached to the federal funding bill. Senator Durbin and Senator Murray know this is one of their last chances to get mandatory product listing attached to a must-pass bill in 2022. According to Politico, “negotiations are still fluid” and “Senate HELP Committee Chair Patty Murray (D-Wash.) is still pushing ranking member Richard Burr (R-N.C.) and House E&C leadership to include the super riders in the final user fee package”. This is why it is so important that we make sure our elected officials know we care about access to supplements and we don’t want new regulations that restrict our access.
Action Alert! Write to Congress and tell them to oppose mandatory product registration for supplements. Please send your message immediately.