WASHINGTON (CN) — As the changing of the guard begins in Washington, the Supreme Court on Monday will provide a reminder of the administrative state’s increasingly limited reach to carry out the president’s policy agenda.
Next week, the justices take on the Food and Drug Administration’s denial of marketing applications for flavored nicotine e-liquids that could appeal to children, examining the nitty gritty details regulating e-cigarettes or vapes.
“It’s fitting into this pattern of the judiciary trying to take a more fine-toothed comb to administrative decisions,” Brandon Johnson, an assistant law professor at the University of Nebraska-Lincoln, said in a phone call.
Tobacco products are strictly regulated under the Family Smoking Prevention and Tobacco Control Act, requiring FDA approval demonstrating the product’s impact on public health. During the first Trump administration, the agency laid out guidance for evaluating e-cigarette products’ impact on existing smokers and their risk of enticing new users.
However, the agency has rejected applications for sugary flavors like candy, fruit or other desserts because of their attraction to children. The FDA says e-cigarettes are the most widely used tobacco product by youth, with 19% of high school students and 4.7% of middle-school students having used vapes in 2020. A study found that 93% of young users’ first e-cigarette was flavored, with 71% indicating they continued to vape because e-cigarettes come in flavors they like.
Triton Distribution filed a marketing application for flavored e-liquids with names like Pink Lemonade, Rainbow Road, Chewy Clouds Sour Grape and Jimmy the Juice Man Peachy Strawberry. While acknowledging the evidence of minors’ use of flavored vapes, Triton argued the flavors also appealed to adults and its scientific evidence showed that flavors were crucial to getting smokers to switch from combustible cigarettes to e-cigarettes.
In 2021, the FDA rejected Triton’s application based on flavored e-cigarette products’ risk to children. However, the agency was overruled by the Fifth Circuit. The en banc court found that the FDA rejected Triton’s application based on conflicting evidence requirements, ruling the agency had acted arbitrarily and capriciously.
The Fifth Circuit’s ruling diverged from seven other appeals courts that unanimously rejected challenges to marketing authorization denials for flavored e-cigarettes.
At the Supreme Court, the Biden administration argued that the appeals court deferred to Triton when interpreting agency guidance.
“That unfounded approach violates the courts’ obligation to ‘determine the meaning or applicability of the terms of an agency action,’” U.S. Solicitor General Elizabeth Prelogar wrote.
Prelogar said administrative policy standards require agency action to be reasonable and reasonably explained, but the rules also prevent a court from substituting its policy judgment instead of the agency’s.
“The court’s role is instead limited to ensuring that the agency ‘acted within a zone of reasonableness’ and ‘reasonably explained the decision,’” Prelogar wrote.
The heart of the conflict is whether the FDA’s standards are a policy position or a substantive rule imposed without notice and comment. Triton says it’s the latter.
“Despite FDA’s claim to the contrary, the agency’s new requirements did not evolve through case-by-case adjudication,” Triton wrote. “Instead, FDA adopted the new requirements through a substantive rule — an internal memorandum that was not tied to any particular application and that the agency only later applied when adjudicating applications.”
Johnson said the lower courts have created a set of doctrines about what constitutes an interpretive statement versus a legislative rule.
“The Supreme Court has been pretty silent on that question, but the circuit courts have been looking at that for decades, so it’d be interesting if the Supreme Court said something about it,” Johnson said.
Fewer than three dozen of over 1 million e-cigarette products have received marketing authorization from the FDA since 2016. The agency said it approved many tobacco-flavored products because they offer a substitution to get addicts to stop smoking cigarettes.
Loath to be excluded from the administrative tug-of-war, 16 Democratic lawmakers said tobacco manufacturers wanted a resource-intensive evaluation that would divert FDA resources. The lawmakers said products allowed on the market in the interim unnecessarily exposed youth tobacco users to appealing products that could hook them on tobacco for life.
“The key to reducing tobacco related deaths is preventing youth tobacco use, and FDA’s authority to oversee e-cigarette products, including by denying authorization to sell specific products, is a foundational intervention in doing so,” Democrats wrote.
A group of 13 Republican lawmakers pushed the court to return e-cigarette regulatory authority to Congress.
“By curtailing the FDA’s regulatory overreach, the court can send a clear message that Congress, and not bureaucratic agencies, must make the laws that govern the economy. Policy decisions should be restored to where they belong: the people’s representatives,” Republicans wrote.