Supreme Court vaping case is about the regulatory process
You don’t have to be a fan of flavored vapes to find the White Lion case, argued on December 2 at the Supreme Court, a fascinating example of a company struggling against an opaque and changing regulatory process.
The Family Smoking Prevention and Tobacco Control Act, passed in 2009 under President Barack Obama, gives the Food and Drug Administration power to authorize or reject new tobacco products. In 2016, the FDA issued a rule to add vaping products to the list of items covered by the Act. Several vaping companies sued, represented by Pacific Legal Foundation: We argued the rule violated the Appointments Clause because it was issued by an FDA employee, not a principal officer at the agency. (We ultimately lost).
Fast-forward to the current Supreme Court case: Wages and White Lion Investments, a vape manufacturer, submitted applications to the FDA in September 2020 for its flavored vape products. As requested, the applications included plans to prevent youths from accessing the products.
But eleven months later—before the agency ruled one way or another on the applications—the FDA suddenly announced a new application requirement: For flavored vape products to be authorized, applications needed to include controlled trials or studies about how the products would benefit current smokers. Shortly after that announcement, the FDA denied the pending applications from Wages and White Lion.
The company sued—and the U.S. Court of Appeals for the Fifth Circuit sided with White Lion, calling the FDA’s handling of White Lion’s applications “a regulatory switcheroo.” The Fifth Circuit also noted the FDA didn’t bother to read White Lion’s plans on restricting youth access.
The FDA took the case to the Supreme Court. At oral arguments, the FDA’s attorney began by insisting the vape company was “not unfairly surprised by FDA’s denials.”
“Well,” Justice Clarence Thomas countered, “in fairness to Respondents, I think their argument is that the guidance were actually a moving target.”
Chief Justice John Roberts later followed up with a question for the FDA: “Do you recognize an obligation to tell people what they have to do to comply with your regulation, or do you think it’s simply an obligation not to mislead?”
In response, the FDA’s attorney argued the statute gave White Lion “the basic calculus that FDA was going to apply.”
As Anastasia Boden, senior attorney at Pacific Legal Foundation, wrote in her newsletter SCOTUS Scoop, the justices seemed largely unsympathetic to White Lion:
Justice Brett Kavanaugh wondered why White Lion couldn’t simply reapply with the new evidence rather than requesting that a court overturn FDA’s decision and require the FDA to reconsider.
White Lion’s attorney responded that if forced to start again from scratch, White Lion will have to “close their doors,” because even though FDA is supposed to make decisions within 180 days, it’s been taking 3 or 4 years and the company “can’t afford to wait that out.” As a matter of fairness, he argued, the agency should be forced to re-open the current application and give the company another shot.
For more on this case, you can check out Reason Magazine and R Street.
