E-Cigarette Regulation Case Kicks Up Smoke in DC Circuit

WASHINGTON (CN) – Casting federal restrictions on e-cigarette advertising and sales as an existential threat, a trade group for the vaping industry urged the D.C. Circuit on Tuesday to block a rule change by the Food and Drug Administration.

Along with the Right to Be Smoke-Free Coalition, Florida-based e-cigarette company Nicopure Labs filed suit the suit at issue two years ago in Washington.

Because the FDA now treats vaping products as similar to traditional tobacco for regulatory purposes, Nicopure and its ilk must now file an application known as a modified risk tobacco product claim before it can advertise any health-related statements about e-cigarettes.

The rule change also bars manufacturers from handing out free samples, and it requires e-cigarette products to face FDA review in 2022.

After a federal judge sided with the government at summary judgment, Nicopure and the coalition took their case to the D.C. Circuit.

Miguel Estrada, an attorney for Nicopure with the firm Gibson, Dunn and Crutcher, argued at a hearing Tuesday the FDA has effectively stopped companies from advertising that their e-cigarettes do not include chemicals found in cigarettes or even that they are smokeless.

Repeatedly citing studies from the British government and other countries that found e-cigarettes are safer than traditional tobacco products, Estrada said there is no justification for such a “vastly overbroad” government restriction of speech.

“Having to ask permission is a First Amendment injury itself,” Estrada said.

Justice Department attorney Lindsey Powell countered that it is not so simple to say the advertisements Nicopure hopes to run are purely factual, without more study.

In addition, advertising that an e-cigarette does not contain a certain chemical can hide the presence of other harmful substances, potentially at higher doses than even traditional tobacco products, she said.

The government has a compelling interest in ensuring people, particularly children, do not get hooked on a product without knowing the associated health risks, she said.

“People believe products are safe when they’re not, they begin using them and they can’t stop,” Powell said Tuesday.

Estrada countered that it is excessively expensive to run the type of study necessary for the FDA to approve advertisements like the ones Nicopure would like to run. The government could still accomplish its goals without running the companies out of business by requiring they put health disclaimers on their products, he argued.

But Powell noted the public record about the health risks of e-cigarettes grows with each application a company files with the FDA, meaning companies are not “starting on a clean slate every time.” She did acknowledge, however, that no product has yet received FDA approval and that companies have been reluctant to move first to develop that record.

U.S. Circuit Judge Cornelia Pillard questioned why, if the government is so concerned about the potential health risks of e-cigarettes, the FDA delayed implementation of its clearance requirements until 2022.

“The argument that the bell cannot be unrung, you can imagine, rings a little hollow in light of that background,” Pillard said.

Eric Gotting, an attorney with the firm Keller and Heckman who split time with Estrada, further told the judges that handing out free samples of e-cigarettes is an expressive act the government cannot restrict.

“The only way that we can convey that information is through the sample,” Gotting said.

Though Gotting assured the court the companies are intending to send a specific message about their products to consumers by handing out free samples, U.S. Judge David Sentelle was not convinced this served as an absolute defense against government regulation.

“I could intend to send a message with my conduct if I hit you in the nose,” Sentelle said, adding that simple fact would not give him a constitutional right to do so.

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