FDA can regulate e-cigarettes just like conventional cigarettes, appeals court says

WASHINGTON - The Food and Drug Administration can regulate e-cigarettes like conventional cigarettes, an appeals court said Tuesday, finding the products are "indisputably highly addictive and pose health risks, especially to youth, that are not well understood."

The case before the U.S. Court of Appeals for the District of Columbia Circuit, brought by an e-cigarette manufacturer, was not about banning the sale of the devices and did not pose the question of whether e-cigarettes are more or less safe than traditional cigarettes. The issue for the court was whether the FDA has the authority to treat e-cigarettes as "tobacco products" and to subject the vaping products to the same set of rules and regulations.

The case is the first to be decided by a federal appeals court, among a set of lawsuits filed throughout the country.

The three-judge panel unanimously rejected arguments from the industry, calling the FDA's decision "entirely rational and nonarbitrary" to require that before ane-cigarette can be marketed, its manufacturer must show that it is selling "consistent with public health."

In a 48-page opinion, the judges also disagreed with the industry's position that the ban on the distribution of free samples of tobacco products, including e-cigarettes, is unconstitutional and 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," according to the opinion, written by Judge Cornelia Pillard and joined by Judges Judith Rogers and David Sentelle.

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

The decision comes as government officials have moved to restrict or ban sales of e-cigarettes because of health concerns and the popularity among teens. Michigan in September became the first state to prohibit sales of flavored e-cigarettes. Massachusetts has since announced a four-month ban on all sales of vaping products.

President Trump last month backed away from a plan to ban most flavored e-cigarettes because of concerns it would lead to job losses.

Nicopure Labs, LLC, a Florida manufacturer of liquids used in e-cigarettes, and the Right to be Smoke-Free Coalition, which includes the American Vaping Association, e-cigarette companies and state trade groups, initiated the challenge to the 2016 FDA decision.

At the D. C. Circuit, industry lawyers said in court filings that the FDA's regulations and ban on the distribution of free samples "prevent vapor companies from making truthful statements and conveying information that would help adult consumers make informed decisions regarding vaping." Congress and the FDA,the Florida company said, failed to "consider the interests of adult consumers and particularly those who are looking to move away from more dangerous cigarettes."

A company representative did not immediately respond to a request for comment Tuesday.

The regulatory landscape has changed since the lawsuit was filed. In 2017, then-FDA commissioner Scott Gottlieb delayed e-cigarette regulations for several years that require the products to go through agency review.

In a separate case in Maryland, public health groups successfully challenged that delay and a federal judge in July required the F.D.A. to speed up oversight to May 2020.

Justice Department attorneys, defending the regulations, said the rules fit with the government's interest in curbing youth access to tobacco products and are in line with its role inguaranteeing that advertisements and other statements about such products are "complete, accurate" and "relate to the product's overall risk."

The prohibition on distribution of free e-cigarette samples, the government said, is "an economic regulation, not a restriction of speech."

Public health organizations, including the Campaign for Tobacco-Free Kids and the American Academy of Pediatrics, told the court in filings that allowing the industry to promote the idea that e-cigarettes are safer than conventional cigarettes could have severe consequences for teens who are most likely to be misled or confused by the claims.

The rules, they said, are intended to ensure that claims by manufacturers are accurate, backed by reliable science, and informative enough to permit adult consumers to make their own reasoned decisions.

The appeals court was reviewing a 2017 ruling from U.S. District Judge Amy Berman Jackson. In her decision, Jackson concluded Congress gave the FDA broad authority to deem new products to be "tobacco products" and said that "the agency acted within the scope of its statutory authority."

The FDA has the power to regulate "components" of tobacco products, the judge wrote, finding that empty e-cigarettes and nicotine free e-liquids are "components" of a tobacco product because they make up the "delivery system."

Under the FDA rule, the judge noted, “manufacturers of e-cigarettes are now required to tell the 30 million people who use the devices what is actually in the liquid being vaporized and inhaled.”