Three more companies join FDA fight

Three Alabama-based e-cigarette companies challenged the finalized rule that expands the U.S. Food and Drug Administration’s (FDA) ability to regulate all tobacco products, contending in a lawsuit filed on Tuesday that the measure goes too far and will likely push them out of business.

Cyclops Vapor 2, Tiger Vapor and Karma S Clouds object to the FDA’s rule, which goes into effect  August 8, requiring manufacturers to show the agency that vapor products brought to market after February 2007 meet federal public health standards and will have to submit applications to market new products, according to a story published on Law360.

The rule doesn’t reflect that vaping devices are a safer alternative to tobacco products and consequently puts an unfair burden on e-cigarette companies, which are often small operations that can’t afford to go through the rigorous approval process, the complaint says.

“Because the deeming rule ignores the health benefits of vaping products, as opposed to tobacco products, the burdens imposed by the deeming rule appear to be nothing more than an arbitrary and capricious regulatory system designed to regulate the entire vaping industry out of existence,” the complaint says.

Cyclops is a distributor of e-liquids and Tiger and Karma both manufacture e-liquids and sell vaping devices, the complaint says. All of the companies offer e-liquids that contain nicotine derived from tobacco, as well as products that don’t, according to the complaint.

Studies confirm that those vaping products are far less harmful than cigarettes and that most of the chemicals leading to smoking-related disease aren’t present in e-cigarette vapor, the complaint says.
Although the FDA recognizes this reduced risk, the rule subjects vaping devices and e-liquids to the same regulatory requirements designed for cigarettes and smokeless tobacco, which Congress has said cause more than 400,000 deaths in the United States every year, the companies allege.

The agency estimates that a single pre-market tobacco application will cost hundreds of thousands of dollars, a tall order for vaping companies that produce scores of e-liquids, each of which would require its own approval, according to the complaint. Ultimately, the cost-prohibitive and lengthy process will force existing products out of the market and make it incredibly difficult to introduce new ones, likely driving consumers back to cigarettes and undercutting the purpose of the Family Smoking Prevention and Tobacco Control Act, a 2009 statute intended to address the cancer, heart disease and other health issues associated with tobacco use, the companies say.

The complaint asks the court to vacate the rule and declare that it exceeds the FDA’s authority, is arbitrary and capricious, applies an unlawful cost-benefit analysis and defies the First Amendment. Four other lawsuits also challenge the rule, one in Los Angeles and three in Washington, D.C., bringing primarily the same claims.

Joe Hubbard of the Joe Hubbard Law Firm, a lawyer for the three Alabama companies, said that the litigation comes down to the FDA’s overreach of its constitutional and statutory authority in issuing regulations that are intended to “regulate this industry out of existence, according to the story.

“The vapor industry and these three businesses have no objection to reasonable and lawful regulations,” he said. “What they object to is the FDA using its power not to regulate, but to annihilate their business.”

The suit is Cyclops Vapor 2 LLC et al. v. U.S. Food and Drug Administration et al., suit number 2:16-cv-00556, in the U.S. District Court for the Middle District of Alabama.