3 New Lawsuits Challenge the FDA's Deeming Rule

Three new lawsuits — filed simultaneously Tuesday in three separate federal court jurisdictions — are challenging the FDA’s Deeming Rule. The legal actions were filed on behalf of several small vaping businesses by attorneys from the Pacific Legal Foundation.

The Deeming Rule (also known as the deeming regulations) took effect on Aug. 8, 2016. The rule allows the FDA to regulate e-cigarettes and vapes as tobacco products, and forces manufacturers to go through a brutally expensive and burdensome process to keep products on the market that weren’t sold before Feb. 15, 2007.

No products currently being sold were available before that date. That means that every single vaping product — including every e-liquid — currently on the market would have to go through the FDA’s Premarket Tobacco Application (PMTA) process in order to be available for sale after Aug. 8, 2022. (That date was changed last year by the FDA. Originally the date was set to be Aug. 8, 2018.)

The new lawsuits challenge the FDA on two fronts. First, the Pacific Legal Foundation (PLF) lawyers assert that regulations like the Deeming Rule that carry the force of law must be signed by federal employees who have been appointed by the President and confirmed by the Senate. The Deeming Rule was signed by a career civil servant, Associate Commissioner Leslie Kux.

“These regulations don’t just harm small businesses and consumers, they undermine constitutional safeguards for individual liberty,” PLF attorney Thomas Berry said in a press release. “Rules that affect the American people must be issued by officials who are answerable to the political process, not by bureaucrats who have no political accountability.”

The lawsuits also challenge the rule on freedom of speech grounds, claiming that businesses are restrained from truthfully explaining the benefits of vaping to customers.

“The vaping edict flouts the First Amendment by forcing businesses to run a daunting regulatory gauntlet in order to advertise truthful information,” says the PLF website. “The government can’t require pre-approval for truthful speech, and it especially can’t shift the burden of proof to the speaker to prove the benefits of his speech will outweigh any harms the government perceives may result.”

There are other legal challenges to the Deeming Rule still pending in several federal courts. The most well known is the Nicopure Labs lawsuit (which was combined with the suit by the Right to be Smoke-Free Coalition and several other industry associations), which was denied by U.S. District Court Judge Amy Berman Jackson last July 21.

The vaping plaintiffs filed an appeal in that case, and Nicopure and its allies expect a result this year. The PLF lawsuits — and possible appeals — could stretch out for years. Meanwhile, FDA Commissioner Scott Gottlieb promised standards-based regulations last year, just a week after the Nicopure decision was handed down.

One of the PLF lawsuits was filed in the same court as the Nicopure case, the U.S. District Court for the District of Columbia. The others will be heard in federal district courts in Minnesota and Texas. There may be a legal strategy to forcing the FDA to defend its unpopular rule in multiple courts, but that’s not clear.