DC Circuit Upholds Federal Regulation of E-Cigarettes

WASHINGTON (CN) - The D.C. Circuit on Tuesday extinguished a sweeping legal challenge from an e-cigarette company claiming the Food and Drug Administration has violated federal law and the Constitution in how it has chosen to regulate the company's products.

The challenge came from the e-cigarette manufacturer Nicopure and the Right to Be Smoke-Free Coalition, an e-cigarette industry group. Together they claimed regulatory decisions the FDA made on e-cigarettes were out of step with the Tobacco Control Act, the First Amendment and the Administrative Procedure Act.

The D.C. Circuit disagreed with their arguments in a 48-page opinion filed Tuesday, noting e-cigarettes are addictive and come with health risks that are still not entirely clear.

"It is entirely rational and nonarbitrary to apply to e-cigarettes the act's baseline requirement that, before any new tobacco product may be marketed, its manufacturer show the FDA that selling it is consistent with public health," wrote U.S. Circuit Judge Cornelia Pillard, a Barack Obama appointee. (Emphasis in original.)

Under the Tobacco Control Act, the FDA must review and approve all new tobacco products before they hit the market, giving a different path to approval for three categories of products, including those that are marketed as safer than those that are already available. The law also bans companies from giving out free samples of tobacco products.

In April 2014, the FDA determined e-cigarettes qualify as tobacco products that are subject to the law's restrictions. To support this finding, the agency cited the health risks from the chemicals e-cigarettes emit as well as their popularity among young people. The agency also found e-cigarettes have not been helpful in cutting back on other forms of smoking, a prime public health goal.

Nicopure and Right to Be Smoke-Free challenged the FDA's determination in federal court in 2016, claiming the agency should have given e-cigarettes an easier path through the premarket approval process and that the ban on free samples and the standards of review for products marketed as being safer than other tobacco products violate the First Amendment.

A federal judge ruled in favor of the FDA a year later, and the D.C. Circuit largely backed up the judge's ruling on Tuesday.

Addressing the claim that the FDA acted improperly by not giving e-cigarettes another way through the premarket approval process, the court ruled the FDA is simply following lawmakers' instructions.

"It was Congress, not the FDA, that imposed it on new tobacco products, including e-cigarettes," Pillard wrote. "There is no exemption in the act for certain new tobacco products speculated to be less risky than other new tobacco products."

The court also dispensed with the First Amendment claims about the premarket clearance process, citing court precedent allowing agencies to regulate based on how a product is being marketed. The court also found the clearance procedure for modified risk products is directed squarely at an issue in which the government has a clear interest.

The court finally found the ban on free samples does not violate the First Amendment because it is targeted at conduct that is not clearly expressive.

Pillard was joined in her decision by U.S. Circuit Judges Judith Rogers, a Bill Clinton appointee, and David Sentelle, a Ronald Reagan appointee.

Nicopure and the coalition are represented by Douglas Behr with the Washington, D.C., firm Keller and Heckman. Behr did not immediately return a request for comment on the decision.

The FDA also did not immediately respond to a request for comment.

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