Thursday, January 14, 2010

United States District Court Rules that FDA Most Likely Does Not Have Authority to Regulate Electronic Cigarettes as Drug-Device Combinations

Issues Preliminary Injunction Enjoining FDA From Regulating Electronic Cigarettes as Drug-Device Combinations

The United States District Court for the District of Columbia today ruled that most likely, the Food and Drug Administration (FDA) does not have the authority to regulate electronic cigarettes as drug-device combinations under the U.S. Food, Drug, and Cosmetic Act, and may instead regulate these products as "recreational" tobacco products under the Family Smoking Prevention and Tobacco Control Act.

The Court issued a preliminary injunction against the FDA, which prohibits the FDA from taking any action against electronic cigarettes on the basis of its assertion that these are unapproved drug delivery devices that must comply with the Food, Drug, and Cosmetic Act. That injunction will hold until such time as the Court fully reviews the case and issues a final decision.

The decision to grant the preliminary injunction indicates that the Court finds that there is a substantial likelihood that the case will succeed and that the FDA will be found not to have authority to regulate electronic cigarettes as drug-delivery devices.

The lawsuit was brought by two electronic cigarette distributors - Smoking Everywhere and NJOY - whose companies had shipments of their products detained by the FDA on the ground that these electronic cigarettes are unapproved drug delivery devices.

The basis for the Court's decision is that the term "tobacco product" is defined very broadly in the Family Smoking Prevention and Tobacco Control Act (which I will subsequently refer to as "the Act"). In the Act, tobacco products are defined as: "any product made or derived from tobacco that is intended for human consumption." Since the nicotine in electronic cigarettes is extracted from tobacco and intended for consumption, the Court finds, at first blush, that electronic cigarettes are a "tobacco product" under the Act.

The Act does provide an exception for any article that is a drug, device, or drug-device combination under the Food, Drug, and Cosmetic Act. The FDA argued that because electronic cigarettes are intended to effect the structure and function of the body in the way that cigarettes do, they are drug delivery devices and therefore not tobacco products.

However, the Court found a serious flaw in this logic. By that reasoning, tobacco products themselves would be exempt from the Act because they themselves are intended to effect the structure and function of the body. As the Court noted, any tobacco product that claimed to have some pharmacologic effect on the body would be excluded from the definition of "tobacco product" under the Act using the FDA's reasoning.

In other words, it is clear that Congress' intent was not to exclude products derived from tobacco that deliver nicotine from definition as tobacco products merely because they deliver nicotine and thus are intended to affect the structure and function of the body.

The FDA argued that the marketing of electronic cigarettes for the purpose of achieving relief of nicotine withdrawal symptoms represented health claims of a therapeutic effect that put electronic cigarettes in the category of drug-device combinations. The Court found that the overall nature of electronic cigarette marketing by Smoking Everywhere and NJOY was essentially framing these products as alternatives to cigarettes, rather than specifically as a nicotine cessation device. Thus, the Court ruled, electronic cigarettes are not intended to prevent or treat nicotine addiction.

Finally, the Court also found that advertising e-cigarettes as a healthier alternative to smoking does not put them in the category of a drug-device combination. Instead, this would put them into the category of a modified risk tobacco product under the Act.

The Court concludes: "In sum, absent substantial evidence of the manufacturer's objective intent that its electronic cigarettes affect the structure or function of the body in a way distinguishable from "customarily marketed" tobacco products or that its electronic cigarettes have the therapeutic purpose of treating nicotine withdrawal, there is no basis for FDA to treat electronic cigarettes, as they are marketed by the plaintiffs in this case, as a drug-device combination when all they purport to do is offer consumers the same recreational effects as a regular cigarette. Thus, the plaintiffs are substantially likely to succeed on their claim that FDA cannot regulate and thereby exclude their electronic cigarettes from the United States on the basis that those products are an unapproved drug-device combination under the FDCA."

The Court also considered the FDA's argument that removal of electronic cigarettes from the market is a huge public health benefit that outweighs any economic harm to the e-cigarette companies. However, the Court found that the FDA's argument was greatly exaggerated and failed to find any reason to think that removing electronic cigarettes from the market would protect the public's health. In fact, the ruling specifically states that there is no reason to believe that electronic cigarettes are any more dangerous than traditional cigarettes:

"While FDA's interest in protecting public health and safety is, in the abstract, paramount to plaintiffs' purely economic interests, given the particular facts and circumstances of this case, I am not convinced that the threat to the public interest in general or to third parties in particular is as great as FDA suggests. Together, both Smoking Everywhere and NJOY have already sold hundreds of thousands of electronic cigarettes, yet FDA cites no evidence that those electronic cigarettes have endangered anyone. Nor has FDA cited any evidence that electronic cigarettes are any more an immediate threat to public health and safety than traditional cigarettes, which are readily available to the public."

The Court's decision actually concludes by chiding the FDA for trying, once again, to regulate tobacco products as drugs or devices under the Food, Drug, and Cosmetic Act: "This case appears to be yet another example of FDA's aggressive efforts to regulate recreational tobacco products as drugs or devices under the FDCA. Ironically, notwithstanding that Congress has now taken the unprecedented step of granting FDA jurisdiction over those products, FDA remains undeterred. Unfortunately, its tenacious drive to maximize its regulatory power has resulted in its advocacy of an interpretation of the relevant law that I find, at first blush, to be unreasonable and unacceptable."

The Rest of the Story

The immediate effect of this decision is to prevent the FDA from taking any further action against electronic cigarette distributors on the basis that these products are unapproved drugs or devices under the federal Food, Drug, and Cosmetic Act. The injunction is preliminary, meaning that the Court will thoroughly review the case and then issue a final ruling. Thus, this does not represent a final decision. It merely reflects that the Court sees a substantial likelihood of success on the merits of the case.

If this decision is ultimately upheld, then electronic cigarettes will be classified as tobacco products under the Family Smoking Prevention and Tobacco Control Act and will be regulated like all other tobacco products, which means they will be officially approved and given the government's blessing (which would be a good thing, since the deadly tobacco products which kill hundreds of thousands of people every year are given the government's blessing under that Act).

However, it should be noted that electronic cigarette distributors who make claims that electronic cigarettes are safer than traditional cigarettes would be rendering their products into the category of modified risk products, and would have to meet very stringent criteria in order to continue to market their products in that way. The net effect would be to prevent companies from making such claims in the first place if they wish to sell electronic cigarettes.

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