Court Rejects FDA Bid To Regulate Nicotine Products Outside Tobacco Law

By Alaina Busch
FDA Week
December 9, 2010

A federal appeals court ruled that nicotine products, including electronic cigarettes, are to be regulated as tobacco, reaffirming previous decisions while going against recent FDA actions to regulate the products as drugs and devices. While opponents of the decision are raising safety concerns saying it will lead to an uptick in nicotine items and be detrimental to public health, some anti-smoking advocates have long pushed for the products to be regulated as tobacco, not requiring safety and efficacy data, to keep them on the market for former smokers who rely on them as cessation aids.

One opponent of the decision, which reaffirmed that FDA cannot ban electronic cigarette imports, equated the ruling to the creation of a "wild west" of nicotine products, while a longtime anti-smoking advocate lauded it as a public health victory saying FDA's attempt to strictly regulate the products has bolstered the tobacco industry.

The U.S. Court of Appeals for the District of Columbia Circuit on Tuesday (Dec. 7) affirmed a January ruling that tobacco-derived products are subject to the Family Smoking Prevention and Tobacco Control Act, which brought tobacco under FDA's power in 2009.

The ruling comes three months after FDA announced that it would regulate the products as drugs and devices under the Food, Drug and Cosmetic Act, requiring safety and efficacy studies. The agency sent letters to five distributors and a trade group announcing its intentions. The distributors received warning letters for making unsubstantiated claims and poor manufacturing practices (see FDA Week, Sept. 10).

Citing FDA v. Brown & Williamson Tobacco Corp., a Supreme Court case that denied FDA's efforts to regulate cigarettes as a drug-device combination in the 1990s, the court ruled that the tobacco law that has since passed further established that other tobacco products cannot be regulated as such either.

"To the extent that Congress believed Brown & Williamson left an insufficiently regulative environment for cigarettes, smokeless tobacco, cigars, and other tobacco products, it found the Tobacco Act an adequate remedy," according to the court decision, written by Circuit Judge Stephen Williams.

A federal judge had previously ruled that electronic cigarettes are not drug-device combinations and FDA could not block their shipment. The agency had been taking action against the products since 2008 (see FDA Week, Jan. 22).

Groups like Campaign for Tobacco-Free Kids said the decision will lead an unsafe level of nicotine in products. The group's president, Matthew Myers, said the ruling will have harmful implications for public health.

"While the court found that the FDA could regulate electronic cigarettes as tobacco products, it will take the FDA time to assert jurisdiction over these products and issue regulations governing them, leaving these products unregulated in the meantime," he said in a statement. "This ruling invites the creation of a wild west of products containing highly addictive nicotine, an alarming prospect for public health."

Other anti-smoking advocates, like Smokefree Pennsylvania, have lauded the decision as a public health victory. The group, in addition to the Washington Legal Foundation, filed an amicus curae brief on behalf of Sottera, Inc., the company listed in the lawsuit. The American Association of Public Health Physicians has also filed citizen petitions requesting the agency reclassify electronic cigarettes as tobacco products.

Bill Godshall, executive director of Smokefree Pennsylvania, said FDA's move to strictly regulate the products, which are mostly used by former smokers, has bolstered the tobacco industry because the most harmful products are still on the market. The majority of the e-cigarette companies, he said, were not making therapeutic claims, which would have made them subject to stricter regulations.

By reclassifying the products as tobacco, the 2009 tobacco law allows for safety monitors, he said. Quality concerns about the products, which are primarily imported, were cited when FDA announced its regulatory plans earlier this year.

"A lot of these things people are claiming are problems with the products can be resolved," Godshall said. The Tobacco Control Act would give FDA power to regulate health claims and require manufacturer registration as well as laboratory analyses of the products.

Depending on whether FDA appeals the decision, he said he expects tobacco companies to get into the product's market. Other nicotine products that had previously been banned, like lollipops, water and skin cream, will likely resurface, he said. "And that's good because these are all far less hazardous tobacco alternative products," he said.

The ruling comes as a collaborative study on the safety of electronic cigarettes was released by Legacy, Georgetown University School of Medicine and Johns Hopkins Bloomberg School of Public Health. After an analysis of several electronic cigarette brands, researchers found that there was no consistency in the delivery of nicotine, suggesting poor quality controls.

Nathan Cobb, a researcher at Schroeder Institute for Tobacco Research and Policy Studies at Legacy, said the poor standards present a new set of risks associated with e-cigarettes. "These devices and accessories present a new and wholly different set of risks apart from those of tobacco, including the real risk of inadvertent nicotine overdose," Cobb said in a release. "The variation in design and poor quality control emphasizes that they should not be on the market until and unless regulation to ensure device safety has been established."