Supplements: Next Six Months Critical. Oppose FDA filing requirement.

by ANH-USA Mar 17, 2022

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

ANH-USA and other stakeholders have been working hard on Capitol Hill to make sure Senator Dick Durbin (D-IL) does not get his “mandatory filing” requirement for supplements passed into law. 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: if Sen. Durbin and his allies don’t push the policy forward by that time, it likely won’t happen during this session of Congress. To stop this supplement-restricting policy, we must keep up the pressure on Congress.

Why are the next six months so critical? Our work on Capitol Hill has revealed that Sen. Durbin and his allies, including Senator Patty Murray (D-WA), who is Chair of the Senate Health, Education, Labor, and Pensions (HELP) Committee, are trying to get the “mandatory filing” requirement for supplements attached to must-pass legislation: the reauthorization of the Prescription Drug User Fee Act (PDUFA). If PDUFA is not reauthorized by September of this year, 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.

It is completely inappropriate to lump supplements in with drugs legislatively. Drugs are new chemical entities and often very dangerous, while supplements are natural and overwhelmingly safe. Yet the FDA, on key policies, attempts to treat supplements like drugs to make it impossible for supplements to compete with drugs. This is the case with the “new supplement” guidance on which we’ve written so extensively, which attempts to install a drug-like pre-approval system on supplements. In other instances, the FDA fights vigorously to differentiate supplements from drugs, for example by aggressively censoring any information about supplements’ benefits, since only FDA-approved drugs can claim to treat or prevent disease.

Why does the FDA do all of this to tilt the scales in favor of drugs? As mentioned above, drug company payments to the FDA in the form of user fees make up 45 percent of the agency’s budget, and because of that, the agency sees the drug industry as its client.

There is another reason why the next several months are critical. If “mandatory filing” does not get attached to PDUFA, there is still a possibility that Sen. Durbin will introduce standalone legislation to accomplish his goal. But his timeframe is limited: 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 introduced before election season, it is less likely to happen this year. It also looks like Democrats may lose control of Congress after elections, and if that happens, it is unlikely that Republicans would pursue “mandatory filing” in the next Congress.

All of this is to say, we must remain vigilant and demonstrate powerful opposition to stop “mandatory filing” 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. President Biden’s nominee to head the FDA, Robert Califf, MD, has also voiced his support for additional regulation of supplements.

Our previous coverage details the threat a “mandatory filing” proposal represents to supplement access. For starters, the National Institutes of Health already has a supplement label database, so “mandatory filing” requirements would be a duplicative waste of millions of taxpayer dollars. But the main threat is the way that “mandatory filing” requirements would interplay with other FDA regulations, particularly the “new supplement” regulations that have not yet been completed. “Mandatory filing” requirements would give the FDA an easy way to seek out supplements that are not in compliance with the very problematic “new supplement” guidance and remove those products from the market. As we’ve explained previously, this guidance is a power grab by the FDA in that it creates a drug-like pre-approval system for “new” supplements when the law simply called for a notification system for these products. According to an economic analysis, this could mean more than 41,000 supplements are threatened.

There is no time to lose. We must reach out to Congress and tell them to oppose this policy!

Action Alert! Write to Congress and tell them to oppose “mandatory filing” for supplements. Please send your message immediately.