For too long, federal agencies like the FDA have shirked democratic responsibilities and ignored the law, allowing them to inject themselves into our lives without any accountability—it’s time for it to stop. Action Alert!
We are increasingly subject to rules and decrees that are undemocratically (and perhaps illegally) issued from federal agencies like the Food and Drug Administration (FDA), the Environmental Protection Agency (EPA), and the Department of Agriculture (USDA). There are tens of thousands of these types of actions, and the result is the federal government inappropriately and undemocratically injecting itself into our personal lives, our businesses, and our communities—and if we don’t like some of these rules, there isn’t much we can do to challenge them. We must reform the system to prevent these intrusions.
Federal agencies commonly ignore the normal rulemaking process to avoid its requirements and instead issue “non-binding” guidance documents that, in practice, are in fact binding and must be followed—but are more difficult for the public to challenge. This abuse of power affects many different industries and people across the country, most notably our ability to access natural products like supplements and information about their benefits.
Here are some examples:
- Through issuing a guidance, the FDA has arbitrarily limited the kind of evidence that can be used to substantiate certain health claims. This ensures that nearly all qualified health claims are rejected, limiting the information available to consumers about products that can support their health.
- The FDA has declared, through guidance, that all homeopathic medicines are being marketed illegally. The guidance establishes a risk-based regulatory approach that prioritizes enforcement against certain products, such as injectable homeopathic products. The guidance has language saying it is “non-binding,” yet actions have already been taken against manufacturers of homeopathic products based on this guidance.
Here’s how our system is supposed to work: we, the people, elect lawmakers, those lawmakers enact legislation, and federal agencies (like the FDA, EPA, and USDA) create rules to implement the laws passed by our representatives in an open and public process. For example, Congress passed the Clean Water Act creating the framework for regulating discharges of pollutants in our waterways; the EPA then is tasked with creating the rules to implement these laws in a process that allows the public to weigh in, provide feedback, and, if necessary, challenge the rule in court.
The Administrative Procedures Act (APA) governs this rulemaking process, requiring agencies to frame the problem a regulation is supposed to solve, analyze alternative solutions, conduct an economic analysis, solicit public comments, and minimize the rule’s unintended consequences. As cumbersome as this process can be, it is critical to an open and democratic system in which agencies, whose officials are not elected, are held accountable. Specifically, the process allows citizens recourse if agencies do not follow proper notice-and-comment procedures, if agency actions are considered “arbitrary and capricious,” if the agency action is against the law or Constitution, or if there is an unreasonable delay in agency decision-making.
Too often, however, agencies avoid these difficult but important requirements by issuing “interpretive rules”—that is, rules or statements issued by an agency to advise the public of the agency’s interpretation of the laws passed by Congress. These actions are exempted from APA requirements, meaning there is no recourse if the public or regulated industry wants to challenge the interpretation. These decrees are often couched in tentative and voluntary terms. For example, FDA guidance documents commonly state that they “contain non-binding recommendations.”
This matters because regulated entities end up essentially forced to follow guidance as though it were law, but neither they, nor the public, can challenge it. According to one commentator, “Regardless of the language and the format, the effect is the same for regulated entities. The agency suggests that you do something — even if it says that it might suggest something different later — and you do it.”
Why does all of this matter? Broadly speaking, agencies are usurping legislative power from Congress. We didn’t elect anybody in the FDA, yet in practice the agency is creating policy through guidance documents not approved by Congress that the public is unable to challenge.
The most glaring example of this abuse of power, for us, is the FDA’s “new supplement” guidance. We’ve argued that the new supplement guidance goes well beyond an interpretation, and we believe it is in fact a legislative rule with legal implications because the FDA goes far beyond the law Congress passed, threatening tens of thousands of supplements. The guidance alters and broadens the meaning of what qualifies as a new supplement and creates new—and very expensive—requirements to comply with the new supplement notification process (creating what we would call a de facto pre-approval system), counter to what is outlined in the Dietary Supplement Health and Education Act (DSHEA).
Further, not fulfilling the new supplement notification requirements outlined in the guidance ensures that the supplement will be considered adulterated and therefore illegal. This indicates there’s a clear, legally binding impact to the new supplement guidance.
Because the new supplement policies have been set forth in a guidance rather than a formal rule, it is more difficult to challenge legally.
This is far from an isolated example. One 2018 analysis found 608 significant guidance documents in effect across all federal agencies which, the author notes, is not a comprehensive list.
There have been some attempts to address this injustice. A federal bill, The Guidance Clarity Act of 2021, would mandate that all agency guidance documents include the following statement: “The contents of this document do not have the force and effect of law and do not, of themselves, bind the public or the agency. This document is intended only to provide clarity to the public regarding existing requirements under the law or agency policies.” This at least identifies the problem, but lacks real teeth to really change anything.
To protect our access to important supplements, and to end a fundamentally undemocratic, un-constitutional practice, we must address this abuse of power.
Action Alert! Write to Congress and tell them to enact legislation that prohibits agencies from legislating through the issuance of guidance and other “non-binding” policy statements. Please send your message immediately.