States vs. Federal Rights: The Perennial Debate Over FDA and Preemption
Since the founding of our republic, there has been debate about states’ rights vs federal rights. And in times of stress, the discussion gets more heated and gains more traction. Once again, FDA is moving into the center of such debates.
Federalism is at the Heart of FDA’s Responsibilities
National uniformity is central to FDA’s mission and responsibilities.
In general, food and drug regulation is based on the need for--and value of--comprehensive nationwide coverage of regulated goods and services. The majority of food and drug products are shipped interstate, providing the legal basis for FDA’s federal authority.
For the most part, industry supports federal primacy because it creates a level playing field for quality and safety and minimizes marketplace fragmentation. No manufacturer wants to develop, manufacture, and ship multiple variations of a product to conform to an array of state laws. This could cause some manufacturers to skip smaller markets altogether and focus exclusively on fewer but more profitable markets.
In addition, consumers benefit from the protection offered by one federal agency. Access to safe food and drugs should not vary depending on where a person lives. Many of the laws that spell out FDA’s responsibilities were enacted after significant breakdowns in consumer protection drew national attention and universal outrage. Federal laws were enacted to prevent recurrences.
FDA-Regulated Products Have Provided Fertile Ground for Litigation of Preemption
In government, preemption is the doctrine where the laws of the higher level of government (federal) take priority over the laws of lower level of government (states), overriding it.
Federal preemption and states’ rights have been extensively litigated throughout our nation’s history. There is voluminous literature on how courts resolve such conflicts (Congressional Research Service Report R45825 (2023).
FDA has had its share of such conflicts. For example: there has been litigation over drug labeling, cigarette labeling, vaccine liability, and food ingredients (such as GMO) and many other areas.
FDA appears to be on the brink of fresh engagement where states’ rights and preemption will be central issues. My interest is in the dynamics of these situations and their impact on the FDA, rather than having any opinion about the advocacy points and legal arguments that are being offered.
MAHA takes the fight to the states
Despite the momentum created by MAHA, prospects for federal reform are modest and the administration’s efforts at voluntary compliance are frustrating to consumer advocates. So, ironically, more federal interest is resulting in greater emphasis on state actions.
In my opinion, those advocates would prefer to support federal rules and regulations. They gain little by undercutting national uniformity[1]. However, if states are where they have the greatest chance of success, then that is where they will choose to spend their time and energy. That’s understandable.
This past week, the food industry has responded with the launch of a campaign to advocate for federal preemption (here). This was the logical “next step” for industry.
We can only hope that industry intends to negotiate in good faith and fully commit to a mix of regulatory and voluntary efforts. Otherwise, national uniformity of FDA-regulated products will be sorely tested in the face of so much state activity related to food ingredients and additives.
States’ Rights As an Instrument of Anti-Science “Health Freedom”
“States’ rights” also serves the promoters of anti-science. An Associated Press investigation (reprinted in https://wMedPage Today), entitled “Wave of Anti-Science Bills Pushed by Kennedy Allies Hits Statehouses,” found more than 420 bills introduced in state legislatures that would undercut established science and federal public health policies.
Some of these bills are conspiracy-driven (“fluoride is used to poison the population”). Others are being advanced under the rubric of “health freedom.” This approach treats science as opinion and espouses the belief that individuals should have the right to choose to ignore many existing mandates and laws.
Nearly all of these bills undercut the CDC and the FDA. Most are not direct challenges to the FDA’s legal authority. But some are. For example, one proposed bill would require vaccine manufacturers to run additional safety tests before marketing the vaccine in that state. Montana has a proposed bill that would promote an “anything goes" policy toward availability of experimental drug therapies (here).
The Debate Continues
In the debate between states’ rights and federal rights, there are no easy answers. There are multiple goals and issues at stake. FDA can respond in several ways, determined by circumstances and politics.
What the FDA shouldn’t do is cooperate in the destruction of national uniformity or abandon the principle that all Americans should benefit equally from the agency’s consumer protection role.
[1] Why would I think this? Open letter from consumer groups to Congress ( here). “.... for many decades, the Food and Drug Administration, or FDA, has failed to address the safety of food and food contact chemicals...In response, states have led efforts to address the risks posed by food and food contact chemicals...We understand that Congress may consider food safety legislation. As you do so, we urge you to reject efforts to limit the power of states to protect consumers. While we remain hopeful that FDA will fulfill their food safety responsibilities, we urge you to reject efforts to undermine the important supplementary role played by states.” (emphasis added)
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