From ANH’s Legislative Team.
Last week, the Biden Administration released its fiscal year 2023 budget proposal. As you may remember from Government 101, our U.S. Constitution grants the power of the purse to Congress, so Congress doesn’t have to follow the President’s budget proposal. However, the President’s budget is important because it shows his Administration’s policy priorities. And when the President is of the same party that controls Congress, there is a much greater likelihood that Congress may actually agree with and follow the priorities provided in the his budget.
Deep within the FDA’s 400 page justification of their budget estimates are a number of insights on the Administration’s views on some of ANH’s top priorities.
More Regulation on Dietary Supplements
Access to a broad range of safe, affordable dietary supplements is a pillar of our natural health freedom, and the Administration’s budget makes it clear that they want to clamp down on the U.S. dietary supplement market – increasing costs and decreasing options for consumers.
The FDA’s budget includes 14 legislative proposals “designed to bolster the FDA’s authorities to further its mission to protect and promote public health.” Included on this relatively short list, “…FDA is seeking to amend DSHEA to: (1) require annual listing with FDA of individual dietary supplement products, including basic information about each unique product; and (2) clarify FDA’s authorities over products marketed as dietary supplements to facilitate enforcement against unlawfully marketed products. These amendments would allow FDA to know when new products are introduced, quickly identify dangerous or illegal products on the market, and take appropriate action to protect consumers when necessary.”
One has to wonder, why is the Administration prioritizing this legislative proposal, when clearly the safety issues with other products regulated by the FDA are so much more critical? Supplements are overwhelmingly safe. In this same FDA budget justification document, it states that in FY 2021, the FDA received 2,400 adverse event reports related to dietary supplements. To put this in context, according to the FDA’s adverse event database, in 2021 FDA received a total of 2,333,453 adverse event reports. That means that dietary supplements make up 0.1% of the adverse event reports to the FDA – clearly this is not among the top priority issues on which the FDA should focus. (I’m sure you can think of other FDA regulated products where our precious taxpayer dollars could be spent more effectively to protect Americans’ health.)
Additionally, the FDA currently has full authority to take action against any supplement products that are improperly manufactured, mislabeled or unsafe. And the National Institutes of Health (NIH) already has a taxpayer-funded database of more than 100,000 dietary supplement product labels. The FDA’s argument that this mandatory annual supplement listing is a necessary top priority for our public health, and not a ploy to increase supplement costs, create greater barrier to entry for innovative supplement products, and eliminate access to supplement ingredients the FDA believes should be protected for Big Pharma, is ridiculous.
Dwelling on CBD Safety
In a section on cannabis and other cannabis-derived compounds, the FDA’s budget justification ignores the elephant in the room that the agency hasn’t made a decision on permitting CBD in dietary supplements. Instead it includes a lengthy discussion concerning the safety of CBD, along with cannabis and other cannabis-derived compounds.
This is in spite of Congress recently telling the FDA it “expects further progress on regulatory pathways for cannabis-derived products that contain cannabidiol.”
Continued Bias Against Bioidentical Hormones
The FDA also responded to the House Appropriations Committee FY 2022 report request that urged “FDA to engage with compounders and other stakeholders to help ensure access to compounded drugs for patients who need them.” In the FDA’s FY 2023 budget explanation, the agency expresses bias for FDA-approved drugs instead of personalized compounded bioidentical hormone therapy. It diplomatically states that FDA will consider the information in the flawed National Academies of Sciences, Engineering, and Medicine (NASEM) report on compounded bioidentical hormones “when developing agency policies, while also taking into account various concerns, including patient access concerns.”
Of course we know that although it may be moving at a glacial government regulatory process pace, the FDA is working to ban access to compounded bioidentical hormones like estriol.
Silence on Homeopathy
Homeopathy is nowhere to be found in the FDA’s budget justification document. We’ll take this as good news since we know the FDA never has anything nice to say about it. In this case, silence is better than the alternative, although we can’t read into this too much.
Now that the President has released his budget proposal, what’s the next step in the process? The House and Senate Appropriations Committees will take the Administration’s proposal under consideration and then develop 12 FY 2023 appropriations bills responsible for funding the federal government. If Congress does not pass these bills by the time fiscal year 2022 ends on September 30 (which they typically do not) then Congress will need to pass a continuing resolution to fund the government, or we will have a government shut down.
Action Alert! Write to Congress and tell them to oppose mandatory FDA listing for supplements. Please send your message immediately. Please also forward this alert to three friends and ask them to act. We need all hands on deck to defeat this!