A new bill would take food and supplements out of the FDA’s jurisdiction under a new food safety agency. We are cautiously optimistic, but there are concerns. Action Alert!
The new bill, introduced by Sen. Dick Durbin (D-IL), Sen. Richard Blumenthal (D-CT), and Rep. Rose DeLauro (D-CT), moves all of the FDA’s food safety authorities, which include dietary supplements, to a newly-created Food Safety Administration. This would be a very positive move, as we’ve long argued that the FDA has a massive conflict of interest in regulating drugs and supplements, which are competitors, while FDA receives substantial funding from the drug industry. With some important caveats, we should support this important bill.
The stated purpose for this bill is that the FDA has failed to adequately ensure the safety of the American food supply. To address this failing, these authorities will be transferred to a new agency, the Food Safety Administration, single-mindedly focused on regulating food and curbing preventable foodborne illnesses. According to the law, moving foods to a new agency means that agency will also be responsible for regulating dietary supplements, which are defined as food in the Food, Drug, and Cosmetic Act. The FDA would be renamed the “Federal Drug Administration.”
ANH-USA has long advocated for an independent agency to regulate supplements, separate from both food and drugs. However, moving supplements into this new food safety agency would be a much better option than keeping them under the FDA’s jurisdiction. At the FDA they are seen as competition for drugs, and it is drugs that pay the FDA’s bills. In other words, FDA supervision of supplements involves a massive conflict of interest.
Just look at the numbers: the FDA receives 45% of its operating budget directly from drug companies in the form of “user fees” (used for the approval of new drugs, biologics and devices), but 65% of the funding for human drug regulatory activities are derived from user fees. In our view, this is the main reason the agency has so consistently attacked and undermined dietary supplements.
There are some causes for concern, though. According to our allies, Sen. Durbin, confirmed prior to the bill’s introduction that supplements would be kept under the Federal Drug Administration’s authority. To do so, however, would have required many changes to current law, since supplements are defined as food. This would make the bill harder to pass. We know Sen. Durbin’s endgame is to install drug-like pre-approval requirements on supplements because he has pursued these regulations in the past and is still doing so currently. The bill that has been introduced does keep supplements with food in the new Food Safety Administration, but the bill could be changed at any point moving forward. For example, the USDA has some food safety responsibilities, but this new bill does not transfer those authorities to the new Food Safety Administration. This means that the bill could be viewed as incomplete and require multiple revisions, so at any point supplements could be carved out of the “food” definition and placed back under the FDA as we think Sen. Durbin intends.
The point is this: if what Senator Durbin is planning is consistent with his previous legislative efforts, it will have the intended effect of removing supplements from the shelves or making them too expensive for anyone but the rich to buy. He may be taking an incremental approach to this goal with this new bill, so we have to keep a sharp eye on these developments.
This isn’t the first time this bill has been introduced. In fact, Sen. Durbin and Rep. DeLauro have been introducing versions of this bill for the last several years. Previous versions of the bill also took food safety responsibilities from the USDA and placed them under the new Food Safety Administration. None of these previous iterations of the bill picked up any steam in Congress.
For these reasons, we are cautiously optimistic about this bill. We have to be on the lookout for changes to the language that undermine supplement access, but moving supplements out from under the FDA’s thumb would be a huge step in advancing their wider use throughout American healthcare and society.
Action Alert! Write to Congress, telling them you support the Food Safety Administration Act of 2022 ONLY if dietary supplements are regulated along with other food at the Food Safety Administration. Please send your message immediately.
