Masters of Health Magazine May 2022 - Page 68

Next Six Months Critical for Supplements

The next six months are critical to halting a terrible policy that would restrict your supplement access

Action Alert!

A new policy being considered in Congress, known as mandatory product registration, threatens consumer access to over 41,000 supplements. This proposal would require all supplement products to register and be listed with the FDA – and to update that registration with any tiny change to the product’s formulation or edits to the product’s label or marketing. For reasons we’ll describe below, the next six months are a critical period—we must keep up the pressure on Congress.

Why are the next six months so critical? Senator Mike Braun (R-IN) has agreed to join Senator Dick Durbin (D-IL) in introducing a bill to require mandatory product registration for supplements. But that’s not all. Separately, Senator Patty Murray (D-WA), chair of the Senate Health, Education, Labor, and Pensions (HELP) Committee, is determined to attach mandatory product registration for supplements to the reauthorization of the Prescription Drug User Fee Act (PFUFA), a bill that must pass by the end of September. If PDUFA is not reauthorized by then, the FDA will not be able to collect drug company user fees moving forward. These are the fees the FDA collects from Big Pharma to fund the drug approval process—they constitute 45 percent of the agency’s budget.

There is another reason why the next several months are critical: we are approaching an election season, which is a time when Congress is not in session very often. (They are busy campaigning at home for reelection.) This forces Congress to prioritize their legislative goals. If Sen. Durbin does not get his legislation passed before election season, it is much less likely to happen this year.

All of this is to say, we must remain vigilant and demonstrate powerful opposition to stop mandatory product registration in its tracks. That Sen. Durbin has Sen. Murray’s support is troubling. Sen. Murray’s position as HELP Chair means this proposal could be rapidly ushered through the committee. FDA Commissioner Robert Califf, MD, has also voiced his support for additional regulation of supplements.