E-Cigarette Makers Lose Legal Challenge to FDA’s Regulatory Authority

By | December 10, 2019

U.S. rules for marketing e-cigarettes withstood a legal challenge by a maker of the devices and an industry group.

A federal appeals court in Washington upheld the Food and Drug Administration’s regulatory authority over electronic cigarettes, which deliver to users a vaporized form of nicotine. The ruling in a lawsuit brought by e-cigarette maker Nicopure Labs and an industry group affirms the FDA’s power at a time when the agency is expected to announce restrictions on flavors, which have become the focus of proposed legislation and lawsuits claiming they are used to hook children on nicotine.

The unanimous three-judge panel said on Tuesday that the agency’s application to e-cigarettes of rules governing tobacco marketing was rational because the new products “are indisputably highly addictive and pose health risks, especially to youth, that are not well understood.”

Nicopure and the Right to be Smoke Free Coalition argued the FDA violated the federal Tobacco Control Act by failing to provide an easier path to market for their products and their First Amendment rights by banning the distribution of free samples.

“The First Amendment does not bar the FDA from preventing the sale of e-cigarettes as safer than existing tobacco products until their manufacturers have shown that they actually are safer as claimed,” U.S. Circuit Judge Cornelia Pillard wrote for the court.

Flavor Restrictions

Neither Nicopure nor attorney Eric Gotting, who argued the case for the company and coalition, immediately responded to requests for comment. The FDA also did not immediately respond to a request for comment.

While the FDA prevailed in the case, the agency still faces stiff resistance from trade groups and conservative activists in anticipation of its e-cigarette flavor restrictions.

Flavors have taken center stage as lawmakers and regulators move toward removing them from the market in an attempt to address a surge in youth vaping. Leading e-cigarette maker Juul Labs Inc. has been besieged by lawsuits accusing it of using flavors to overtly target under-aged users.

Opponents to flavor restrictions say they will stifle a budding e-cigarette industry while killing thousands of jobs and small businesses.

The Trump Administration was expected in November to announce a ban on all flavors except tobacco following a proposal by Health and Human Services Secretary Alex Azar, but the policy was stalled by a last-minute lobbying amid reports the White House was considering making exceptions for mint and menthol flavors.

White House senior adviser Kellyanne Conway said last week the policy would come from the FDA, but the agency has yet to comment on its timing.

Tuesday’s appellate ruling affirmed a 2017 decision by U.S. District Judge Amy Berman Jackson in Washington.

The case is Nicopure Labs LLC v. Food and Drug Administration, 17-5196, U.S. Court of Appeals, District of Columbia (Washington).

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