Judge: e-cigarettes not subject to FDA oversight as drug delivery device

In a decision that riled the public health community, a federal judge ruled that the Food and Drug Administration cannot regulate electronic cigarettes as drug delivery devices.

The case was prompted when the FDA in September 2008 seized imports of the battery-operated devices that vaporize a nicotine solution for inhalation. Citing safety concerns over unknown levels of nicotine and other chemicals contained in e-cigarettes, the agency blocked their U.S. entry on the basis that they were unapproved and misbranded drug delivery devices being marketed as alternatives to traditional cigarettes.

Smoking Everywhere Inc. and NJOY, whose products were impounded, sued the FDA, alleging that the agency overstepped its authority. The U.S. District Court for the District of Columbia agreed in a Jan. 14 decision.

"There is no basis for FDA to treat electronic cigarettes ... as a drug-device combination when all they purport to do is offer consumers the same recreational effects as a regular cigarette," Judge Richard J. Leon wrote.

The court also found that the FDA's public health concerns did not outweigh the economic harm to the plaintiffs. "FDA cites no evidence that [e-cigarettes] ... are any more an immediate threat to public health and safety than traditional cigarettes, which are readily available."

The ruling bars federal restrictions on e-cigarette marketing while the case is being litigated. An appeal is expected. "The public health issues surrounding electronic cigarettes are of serious concern to the FDA," an agency spokeswoman said.

The relatively new technology has sparked questions over the possible role of e-cigarettes as a smoking-cessation tool, though the World Health Organization has said it does not consider it to be a legitimate therapy. The American Medical Association is studying the issue and is expected to address the topic at its House of Delegates Annual Meeting in June.

With little data available on the products, FDA regulation is an important control, said Thomas P. Houston, MD, chair of the American Academy of Family Physicians' tobacco cessation advisory committee.

"These devices may not be marketed for cessation, but anecdotally, that's what the public is using them for," he said. "We still don't know the quality control, so somebody needs to be able to set standards for safety for whatever ingredients might be added and to understand what these do for the smoker in the short and long term. Someone has to be accountable."

Companies' claims can be misleading, said Jonathan P. Winickoff, MD, MPH, chair of the American Academy of Pediatrics Tobacco Consortium. "This product delivers nicotine, and nicotine is a potent drug that fosters addiction," he said.

"The primary claim that there is a net benefit for the public health is just unproven, and there's a very real risk that even people who have not used any tobacco products -- including children and young adults -- start with an e-cigarette thinking it's safe," said Dr. Winickoff, who helped the FDA study the issue. The decision also ignores long-standing FDA authority to regulate non-tobacco products containing nicotine, such as patches and gum, he said.

An alternative approach

The decision leaves open the possibility for the FDA to regulate e-cigarettes as a tobacco product under the federal Family Smoking Prevention and Tobacco Control Act, said John F. Banzhaf III, a public interest law professor at George Washington University Law School in Washington, D.C. The law, enacted in June 2009, was not in place at the time the FDA seized the e-cigarette imports.

"The judge said several times he considers [an e-cigarette] the functional equivalent of a cigarette," said Banzhaf, executive director of the anti-smoking organization Action on Smoking and Health, which petitioned the FDA to regulate e-cigarettes. The FDA would have to create new rules before marketing could be restricted, he said. But in the meantime, the agency could issue advisory warnings about the products.

E-cigarette makers are not averse to reasonable regulation that allows their products to be left on the market, said Electronic Cigarette Assn. President Matt Salmon. The trade group was not involved in the case.

No health claims, just an "alternative"

Companies are not making health claims about their products, Salmon said. "This is simply an alternative to tobacco. It's clear that over half a million people are dying every year due to tobacco-related illnesses, and we ought to be figuring out ways to provide a mechanism for people to do things other than smoke something that emits carbon monoxide."

NJOY President and CEO Jack Leadbeater said in a statement that the ruling helps "committed smokers have continued access to this alternative smoking product."

Attorneys general in California and New Jersey have initiated consumer protection lawsuits against e-cigarette manufacturers, and other states are expected to follow, said Banzhaf, whose organization is assisting in some of the cases. The recent court ruling also may help states ban use of e-cigarettes in areas where smoking is prohibited, he said.