In Smoking Everywhere, Inc. v. U.S. Food and Drug Administration, 2010 U.S. Dist. LEXIS 2836 (D.D.C. Jan. 14, 2010), the United States District Court for the District of Columbia ruled that electronic cigarettes, a non-traditional tobacco product, is subject only to FDA regulation under the 2009 Family Smoking Prevention and Tobacco Control Act (the “Tobacco Act”), and not the Food, Drug, and Cosmetic Act (FDCA). This case represents the first time that a federal court has directly addressed the interplay of the two federal statutes and the regulatory authority they grant to the FDA.
In Smoking Everywhere, Inc., the plaintiffs, who are distributors of a product known as “electronic cigarettes” or “e-cigarettes” sought to enjoin the FDA from detaining inbound shipments of their products from overseas manufacturers. The FDA had detained these shipments on the ground that e-cigarettes are an unapproved drug-device combination under the FDCA.
The e-cigarettes are designed to resemble actual or traditional cigarettes by using a plastic cartridge holding a mixture of proplylene glycol and liquid nicotine which is heated using a battery and results in the vaporization of the liquid nicotine mixture. The user inhales the vapor from the cartridge, which simulates the taste and feel of smoking a traditional cigarette. The plaintiff-distributors had marketed the e-cigarettes as a healthier alternative to traditional cigarettes but did not represent the product as a cure or treatment for nicotine addition or to provide any other therapeutic benefits.
Among its array of arguments in favor of its regulatory power, the FDA asserted that it had the authority to regulate the e-cigarettes under the FDCA, and not the Tobacco Act. The FDA based this argument on its position that the product is “intended to affect the structure or any function of the body,” which qualifies as a drug-device combination under the FDCA. The district court quickly rejected the FDA’s attempts at classifying the e-cigarettes as anything other than a tobacco product subject to regulation only under the Tobacco Act. In doing so, the court relied on the Supreme Court’s opinion in FDA v. Brown & Williamson Tobacco Corp., 529 U.S. 120 (2000) in combination with the 2009 enactment of the Tobacco Act. The court stated that these authorities together make clear Congress’s intent to create a “regulatory wall” between tobacco products and drug-device combinations. To interpret any tobacco product as a drug or device under the FDCA, the court reasoned, would necessarily result in an FDA ban of those products as unsafe for their intended use and would be contrary to both Supreme Court precedent and Congressional intent as demonstrated by various tobacco product legislations in effect.
The court explained that Congress’s enactment of tobacco-specific legislation is not a narrow exception to the FDCA, but rather is a ratification of the FDA’s long-held position that it lacks jurisdiction under the FDCA to regulate tobacco products. Accordingly, the court held that the FDA indeed lacked jurisdiction to regulate e-cigarettes under the FDCA, although it noted that the FDA (contrary to its own assertions) did have the authority to regulate e-cigarettes consistent with the provisions of the Tobacco Act. In closing, however, the court hypothesized that if the plaintiff-distributors had marketed the tobacco product as having a non-therapeutic effect on the structure of function of the body that is different from nicotine, then the product might properly be classified as a drug or device, and therefore regulated pursuant to the FDCA, because it would not be a tobacco product as “customarily marketed.”
In its conclusion, the court chastised the FDA’s aggressive efforts to extend their regulatory authority beyond their jurisdiction as an unreasonable and unacceptable attempt to maximize its regulatory power.
This case illustrates how the FDA may seek to regulate alternative tobacco products as drugs, devices, or drug-device combinations under the FDCA and the importance of complying with marketing requirements and regulations of such products. In the case of the e-cigarette, had the distributors marketed the product in way that distinguished it from customarily-marketed tobacco or nicotine-related products, the FDA may have had the authority to ban the product under the FDCA. Similarly, the Tobacco Acts has a co-marketing ban that prohibits the marketing of a tobacco product in combination with any other article or product regulated under the FDCA, including a drug, biologic, food, cosmetic, medical device, or dietary supplement. See Pub. Law 111-31, § 103(b)(13); see also Draft Guidance for Industry and FDA Staff: The Scope of the Prohibition Against Marketing a Tobacco Product in Combination with Another Article or Product Regulated under the Federal Food, Drug, and Cosmetic Act, Section II.A (Sept. 30, 2009). A failure to comply with marketing and promotional requirements can result in much more stringent, and potentially a ban on the product by the FDA.
For questions, concerns, or assistance with the marketing of any FDA-regulated product, please contact