The Death of Chevron Deference and What It Means to You
What is this all about?
The end of Chevron Deference [1] by the Supreme Court could radically change the landscape of how the FDA regulates all products in its domain, and food ingredients and dietary supplements are the first that come to mind.
Because Congress is not especially detailed oriented, nor possessing the expertise required to write laws in such a technical area as food ingredients and supplements, laws are meant to provide only a framework for the Executive Branch agencies to institute, leaving the details for implementation to the regulators. Picking up the slack and putting “more flesh on the bone” of new laws, the Administrative Procedures Act (passed in the late 1940’s to expedite application of laws passed by Congress through “rule making”) and with the help of the 1980’s Supreme Court Decision called “Chevron Deference”, has allowed Executive agencies (mandated to implement laws) to sometimes play fast and loose with laws with which the agencies did not particularly agree.
Without getting too far into the weeds, the Administrative Procedures Act mandates regulatory agencies implement often vague laws presented to them by Congress, but the greatest source of discontent is Chevron Deference, which allows agencies (1) far reaching interpretive power to implement the law and (2) compels the lower (Federal District) courts to defer to the agency's interpretation; that is, you lose before you even get to court because the court must concede the agency's interpretation of the law is correct. Is “due process” out the window? Only if the agency’s interpretation of the law is especially egregious can the case be moved up to the Circuit Court and, as in the case of Loper Bright, on up to the Supreme Court.
But what if you don’t like the agency’s interpretation of a law as the basis for a new regulation or interpretation of the regulation itself and, knowing the District Court is not going to be of much help, to whom do you go for an appeal? According to the Administrative Procedures Act, you must appeal to the agency who turned you down in the first instance. This administrative Catch-22 [2] has been a special circle of Hell for innovators in the food and supplement industry since its inception.
Examples of Chevron’s unintended consequences.
• “Filing” of an NDIN [3]. Congress had great faith in the safety dietary supplements [DSHEA §2(14(15)] and was concerned that FDA wanted pre-market approval of all dietary supplements. Although Congress included, as a courtesy to FDA, a provision that the manufacturer must “file” the NDIN, informing the FDA of its intention to market a dietary supplement. FDA responded by raising the test data hurdle significantly and using the must “file” provision as a barrier to market entry, successfully implementing a pre-market approval process, precisely what Congress wanted to avoid.
• It’s not GRAS [4] if we say it isn’t, but we will not say if it is. Another case of pre-market approval where it wasn’t meant to be. Section 201(s) allows experts to declare the use of a substance, GRAS, with no involvement with FDA. However, manufacturers needed a method by which they could show potential buyers of their products the products were known to FDA and additionally, so FDA would not be left in the dark as to what was being added to food, the GRAS Notification process was initiated. Instead of the simple reasoning described above, FDA has turned the Notification process into a pre-market non-approval, or “no objection” process. That is, if FDA finds the notification does not meet the requirements of what the agency feels should be met for GRAS (notably, not necessarily if it is safe or not, which is the basis of GRAS), the substance cannot be marketed.
• FDA’s Center for Veterinary Medicine marches to a different drummer. The Amendment to the Food, Drug and Cosmetic Act, passed in 1958, mandated the safety of food and food ingredients be proven safe before a substance could be marketed for human or animal consumption. The proof of safety could be established via a food additive petition or a finding of generally recognized as safe (GRAS) by independent experts. However, it was nearly 50 years before the Center of Veterinary Medicine (CVM) would recognize the validity of GRAS as it applied to animal and pet food and, put a notification system [5] in place. Still, even with this recognition, the hurdles CVM has put into place via guidelines have allowed only a limited number of substances to be found GRAS. The rate of approval of GRAS notifications is miniscule compared to the rate (not cumulative total) of the human side of FDA [6].
What happens now?
Abandonment of Chevron Deference may have the same sweeping effect as former President Trump’s Executive Order 13891 which eliminated the use of draconian “guidance” documents meant more as roadblocks than suggestions for expediting a request to an agency, such as an NDIN, or putting into place an artificial pre-market approval. At the very least, what will happen is that Congress will be forced to include more details in their proposed legislation and FDA will have to be more circumspect in writing guidelines, knowing full well that court challenges await mandates that are not in the spirit of the law.
What does this mean to you?
For years, the acceptance rate of NDIN’s was abysmal, with an acceptance of around 60% and although there has been some improvement lately, the current lengthy (over 100 pages), labyrinthine and ever-changing, “Non-binding” and forever “Draft” NDIN guidance - exceeded in complexity and constant change only by Internal Revenue Service regulations – sets up the notifier for failure. Likewise, the nearly as abysmal, but often seemingly arbitrary GRAS notification acceptance by CVM discourages everyone but the bravest and the deepest pockets. Similarly, the Center for Food Safety and Nutrition’s (CFSAN) poor performance for food and color additive petition approval and even GRAS notifications may all be forced to change.
It has already been established in the courts that guidelines cannot be substituted for more draconian regulations that even the district court may have turned down and so too, these guidelines, which we find out post hoc, may actually have been shadow regulations, may all be thrown out.
Call to action
So, what happens now? It could well be that those notifiers of NDINs, GRASes for human and animal food which had been previously turned down or discouraged from filing, may find new traction for acceptance. In the attitude of “it never hurts to ask”, it is certainly possible that some discouraged notifications and petitions, now updated, should be re-submitted.
[1] Chevron USA, Inc. v. National Resources Defense Council et al. 467 U.S. 837 (1984).
[2] Apologies to Joseph Heller
[3] NDIN = New Dietary Ingredient Notification.
[4] GRAS = Generally Recognized As Safe
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