An appeals court panel on Tuesday ruled that FDA is able to regulate e-cigarettes just like it does traditional cigarettes, saying the products are "indisputably highly addictive and pose health risks, especially to youth, that are not well understood."

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Lawsuit details

The lawsuit stems from FDA's 2016 final rule that extends the agency's regulatory authority over tobacco products to include e-cigarettes, cigars, pipe tobacco, and water pipe tobacco. The agency issued the final rule under the 2009 Family Smoking Prevention and Tobacco Control Act, which granted FDA broad authority to regulate cigarettes, smokeless tobacco, and rolled tobacco, and gave the agency the power to deem other tobacco products, like e-cigarettes, within its jurisdiction, as long as it first issues a rule to that effect.

The rule requires cigar and e-cigarette producers to register with FDA.

The rule also requires tobacco companies to:

• Provide FDA with a list of ingredients used in their products; and
• Submit their products for regulatory review.

In addition, the rule requires tobacco companies to include health warnings on packages and in advertisements for their products and prohibits tobacco companies from:

• Advertising their products as "light" or "mild" without explicit consent from FDA; and
• Giving out free samples of the products.

The rule also imposes retroactive premarket reviews, requiring manufacturers of affected products to receive FDA approval of products that entered the market after Feb. 15, 2007, to continue selling them.

Industry stakeholders—including Nicopure Labs, a Florida-based manufacturer of liquids used in e-cigarettes, and the Right to be Smoke-Free Coalition (RSFC)—filed lawsuits challenging the final rule.

The lawsuit filed by Nicopure Labs and RSFC argued that the final rule's restrictions on manufacturers distributing free samples of the affected products "prevent vapor companies from making truthful statements and conveying information that would help adult consumers make informed decisions regarding vaping," and therefore violates free speech rights guaranteed under the First Amendment of the Constitution.

Further, Nicopure Labs and RSFC in the lawsuit claimed federal lawmakers and FDA did not "consider the interests of adult consumers and particularly those who are looking to move away from more dangerous cigarettes" and should have granted e-cigarettes an alternative path through the premarket approval process.

But Department of Justice attorneys have argued that the final rule is aligned with the federal government's interest in addressing youth access to tobacco products, as well as its role in ensuring that statements about and advertisements for tobacco products are "complete, accurate," and "relate to the product's overall risk." Further, the attorneys said its prohibition on free samples of the products affected by the final rule is "an economic regulation, not a restriction of speech."

Court upholds final rule

In a 3-0 decision issued Tuesday, the three-judge panel of the U.S. Court of Appeals for the District of Columbia Circuit ruled that FDA's final rule is "entirely rational and nonarbitrary."

U.S. Circuit Judge Cornelia Pillard in the panel's opinion wrote, "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."

Further, the panel ruled that FDA did not act improperly and was following instructions from lawmakers. Pillard wrote, "It was Congress, not the FDA, that imposed [FDA's regulatory authority] on new tobacco products, including e-cigarettes. 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 disagreed with the plaintiff's argument that the final rule's ban on distributing free samples of the affected products violates the First Amendment. "Given the relatively unknown and potentially grave risks of e-cigarettes to all users, and their extraordinary allure to middle and high school students, we cannot agree," Pillard wrote.

Reaction

Dennis Henigan, VP of legal and regulatory affairs for the Campaign for Tobacco-Free Kids, said the ruling is a "triumph for public health" and a "resounding judicial endorsement of the need for strong regulation of e-cigarettes."

However, Nicopure Labs said the ruling "highlights the failure of the judicial system as a check and balance to government overreach and for a healthier America." The company said it is consulting with legal counsel will continue fighting the final rule.

FDA did not respond to a request for comment on the ruling, Courthouse News Service reports (Marimow, Washington Post, 12/10; Stempel, Reuters, 12/10; Ryan, Courthouse News Service, 12/10).