Historic Ruling Limits FDA Authority

The Supreme Court has acted to rein in the powers of the FDA and other federal agencies. What does this mean for natural health?

THE TOPLINE

• The Supreme Court ruled 6-3 to overturn Chevron deference that has for 40 years allowed ambiguous statutes to be interpreted by the relevant federal agency, making it easier to challenge federal agencies like the FDA and FTC on their interpretations of ambiguous statutes, potentially benefiting natural health access.
• The ruling, which isn’t retroactive, is expected to lead to numerous lawsuits challenging agency actions. This decision has already influenced a Labor Department overtime rule and will continue to shape legal and administrative practices for decades.
• While the ruling limits agencies’ abilities to create policy without Congressional direction, it may result in agencies issuing more guidance documents, which are harder to challenge. Congress might also need to draft more detailed legislation, potentially including Chevron-like language for specific statutes.

Just days before the 4^th of July, the Supreme Court has delivered a ruling that will weaken the powers of the administrative state and let freedom ring, probably for decades to come.

On Friday, June 28^th, the Court voted 6-3 in favor of overturning Chevron deference—a principle of administrative law that required courts to defer to agency interpretations of ambiguous statutes. It is not an exaggeration to say that this will be a game-changer for natural health access because it will greatly increase the ability to challenge agencies like the FDA and the FTC when they stretch the limits of the law in their efforts to restrict or ban natural products and defend Big Pharma and Big Food’s market dominance.

We explained both the nuts and bolts of the Chevron doctrine that was established in 1984 following a landmark case involving herring fishermen as well as the legal challenge to it (Loper Bright Enterprises v Raimondo) in previous coverage. Here we will focus on what this decision means moving forward.

It’s not retroactive. This decision does not mean that previous rulings invoking Chevron will be overturned, as noted by Chief Justice Roberts in his majority opinion. But it is widely expected that this new ruling will lead to an avalanche of lawsuits challenging agency actions that are based on interpretations of ambiguous statutes in the hope that courts will be open to a different interpretation. Expect agencies to move even more slowly and deliberately as they save resources for these challenges.

Immediate and long-term impact. The Court’s decision to end Chevron deference has already been put to use in granting an injunction to postpone the effective date of a Labor Department overtime rule—so it’s impact has been immediate and we can expect many more cases to be affected by this ruling. Legal experts are also saying this will play out for decades in the lower courts as the legal system and the administrative state adjust to this new reality.

A potential red flag. Every action has a reaction. It’s undoubtedly a good thing—particularly for natural health access which has been hard hit by overly stringent interpretations by the FDA and FTC—that agencies need to hew closer to the law and are not given license to create policy without Congressional orders. But we should also be aware that there is a possibility that agencies like the FDA will now rely more heavily on issuing guidance documents rather than go through formal rulemaking procedures—something ANH has lamented for a long time. Why? Because guidance documents are, technically speaking, not legally binding, but in practice must be followed and are more difficult for the public or impacted companies to challenge.

Legislative overhaul. The Chevron ruling could also change how bills are written in Congress. Now that agency hands are tied when it comes to interpreting laws, Congress may have to be more specific in crafting legislation, leaving fewer statues to interpretation. This is a problem, as Congressional offices often lack the expertise necessary to lay out detailed, technical specifications that are required. To compensate, we may see individual bills including Chevron-like language, leaving the interpretation of X, Y, or Z statute to the Department of Health, etc.

A natural health game-changer. As suggested above, we can see several ways in which overturning Chevron creates a more hospitable climate for natural products. The FTC has censored speech about the benefits of natural products through its interpretation of what constitutes “competent and reliable” scientific evidence. The agency sets the bar at clinical trials because supplement companies can’t afford to do them, ignoring mountains of other kinds of legitimate scientific evidence to prevent certain health claims. This denies consumers access to crucial information that could benefit their health.

We’ve also discussed the FDA’s “New Dietary Ingredient” (NDI) notification guidance at length over the years. You may remember that companies introducing “new” supplements into commerce—that is, they came to market after the passage of the Dietary Supplement and Health Education Act (DSHEA) in 1994—are required to notify the FDA beforehand. But, once again, in a wild power grab, the agency has turned what was supposed to be a notification system into a de facto pre-approval system that could eliminate 41,700 products from the market. Through broadly interpreting various statues, the FDA is also vastly expanding the number of supplements that qualify as “new.”

For too long, federal agencies have been given a free hand to run roughshod over the law in eliminating or restricting access to natural products. The FDA and the FTC’s jobs just got harder, and that’s a good thing.

We’re already working on exciting plans to make the most of our new-found, post-Chevron reality—so expect more news on this soon!

Finally—to all our readers and supporters—in the name of independence, liberty, and freedom: Happy 4^th of July!