Dems urge SCOTUS to back federal authority to regulate e-cigarettes

WASHINGTON (CN) — A coalition of congressional Democrats implored the Supreme Court to strike down a lower court ruling blocking federal regulators from rejecting certain e-cigarette products, arguing the move could hamstring government efforts to keep harmful vapes off store shelves.

The plea from lawmakers comes as some on Capitol Hill have pressed the Food and Drug Administration to take a stronger stance on the sale of unauthorized vape products and crack down on both manufacturers and retailers stocking e-cigarettes without federal approval.

Now, the Supreme Court is set to tackle the FDA’s power to regulate vape sales altogether this term, in FDA v. Wages and White Lion Investments, LLC . The forthcoming case challenges a January ruling from the Fifth Circuit, which found that the FDA overstepped its authority when it rejected marketing applications from two manufacturers looking to sell flavored liquids for e-cigarettes.

The agency argued at the time that it had scrapped the marketing authorizations because the companies had not adequately demonstrated that they would take steps to prevent their products from being abused by children.

In an amicus brief filed with the Supreme Court Monday, the group of Democrats — led by Senate Majority Whip Dick Durbin, Oregon Senator Jeff Merkley and New Jersey Representative Frank Pallone — argued that the FDA’s decision to reject these marketing applications was “carefully reasoned.”

They pointed out that the manufacturers in question produce e-liquid with names like “Milk and Cookies” and “Rainbow Road,” which they contended appeal more to children than to adults looking to quit nicotine.

Further, in acting to clamp down on vape sales that it deems harmful to public health, the FDA is following the direction of Congress, the Democrats told the Supreme Court, pointing to the 2009 Family Smoking Prevention and Tobacco Control Act, which gave the agency authority to address youth tobacco use.

“Guided by Congress’ chief directive — to deny such authorization unless a product under review would be ‘appropriate for the protection of the public health’ … FDA has been appropriately mindful of children and teenagers, the most vulnerable pool of non-tobacco users,” the lawmakers wrote.

Until the Fifth Circuit’s ruling, judicial oversight of the agency’s authority has been “generally consistent” and has not impeded it from accomplishing its regulatory responsibilities, they contended.

Allowing the lower court’s ruling to stand would not only force the FDA to waste resources reevaluating the rejected marketing applications, the Democrats told the high court, but it could also invite other manufacturers previously rejected by the FDA to relitigate their own marketing requests.

“While those applications are once again pending FDA review, the tobacco products they cover would continue to be sold, despite the law’s clear pre-market authorization regime,” the lawmakers said. That provides a “powerful financial incentive” for manufacturers to reapply for FDA approval, even if they know the agency will ultimately deny their applications.

The implications of upholding the Fifth Circuit’s ruling aren’t just procedural, the Democrats continued.

“Tobacco manufacturers’ efforts to keep their products on the market mean that youth tobacco users will be unnecessarily exposed to products that uniquely appeal to them and, in many cases, hook them on tobacco for life,” they wrote.

Members of Congress on both sides of the aisle have for months expressed horror at the wide availability of vape products that lack federal authorization. During a June hearing in the Senate Judiciary Committee, lawmakers accused FDA officials of being asleep at the wheel when it comes to enforcing unauthorized e-cigarette sales.

“You’ve completely fallen down on the job,” Durbin told Brian King, director of the agency’s tobacco division, during the hearing.

A federal court in 2019 found that the FDA ran afoul of the law by allowing companies to sell vape products without proper authorization. Though the agency was required to complete a review of all pending premarket tobacco product applications by September 2021, it has yet to finish that survey.

Lawmakers have lambasted the FDA for its delinquency in completing the court-ordered review, arguing that the agency is giving a “free pass” to companies which sell billions of dollars in unapproved vape products every year.

The FDA, meanwhile, has said that it is making progress on blocking illegal vape sales. King told lawmakers in June that vape use among middle and high school students has decreased by more than 60%. The agency, working alongside the Justice Department, has also seized hundreds of thousands of dollars in unauthorized e-cigarettes.

Follow @BenjaminSWeiss