Smoking Everywhere v. Food & Drug Administration

Two electronic cigarette distributors sued the Food and Drug Administration (FDA) to stop the agency from blocking shipment of their products into the U.S. The FDA prohibited entry of the shipments because they believed the e-cigarettes were unapproved “drug-device” combinations. The court granted the e-cigarette companies’ request for a preliminary injunction prohibiting the FDA from refusing entry of the e-cigarette products or from regulating e-cigarettes as a drug-device combination. The court believed that the FDA was not likely to succeed in regulating the e-cigarettes as a drug-device combination. Instead, the court said that e-cigarettes are more likely subject to FDA regulation as a tobacco product under the 2009 Family Smoking Prevention and Tobacco Control Act, unless the e-cigarettes are marketed for therapeutic use. Additionally, the e-cigarette companies were entitled to a preliminary injunction because of the risk of irreparable financial harm if their products were not allowed to enter the U.S.

Smoking Everywhere, Inc. v. U.S. Food and Drug Admin., 680 F.Supp.2d 62 (2010).

  • United States
  • Jan 14, 2010
  • U.S. District Court, District of Columbia

Parties

Plaintiff

  • Smoking Everywhere, Inc.
  • Sottera, Inc., d/b/a NJOY

Defendant

  • Kathleen Sebelius, HHS Secretary
  • Margaret Hamburg, FDA Commissioner
  • U.S. Department of Health and Human Services
  • U.S. Food and Drug Administration

Legislation Cited

Related Documents

Type of Litigation

Tobacco Control Topics

Substantive Issues

Type of Tobacco Product

"FDA also contends that the electronic cigarettes marketed by Smoking Everywhere are drug-device combinations, not only because they contain nicotine and are intended to affect the structure or function of the body in the same way as traditional cigarettes, but because they are intended "to prevent or alleviate nicotine withdrawal symptoms." (FDA Opposition [# 14] at 21). According to FDA's "Correspondence" issued on December 23, 2008, FDA found that " 'Smoking Everywhere E-Cigarette' and its component parts appear to be intended... to prevent, mitigate, or treat the withdrawal symptoms of nicotine addiction." (AR DET 97-98, 100-01).Unfortunately for FDA, however, this finding is "unsupported by substantial evidence" in the record. See5 U.S.C. § 706(2)(E). The "intended use" of a product is determined by "the objective intent of the persons legally responsible" for labeling the product. 21 C.F.R. § 201.128. Objective intent may be shown, for example, "by labeling claims, advertising matter, or oral or written statements" by the labeler. Id. It may also be shown "by the circumstances that the article is, with the knowledge of such persons or their representatives, offered and used for a purpose for which it is neither labeled nor advertised." Id. Here, the overwhelming sum of Smoking Everywhere's promotional material is aimed, not toward preventing, mitigating, or treating nicotine addiction and the effects of withdrawal, but toward encouraging nicotine use. Just a sampling of the promotional claims reveals, for instance, that Smoking Everywhere intends its electronic cigarettes to provide "the nicotine hit that smokers crave," to "refresh smokers and satisfy their smoking addiction," and to provide "the same pleasures of smoking a traditional cigarette." (AR DET 51, 56). The brand name itself is evidence that the product is not intended to prevent, treat, or mitigate nicotine use and addiction but to promote "the freedom to smoke everywhere." (AR DET 49). Not only does Smoking Everywhere offer low nicotine dosages, it offers high dosages as well. (AR DET 25, 28). It even offers its product in assorted flavors. (AR DET 28). Indeed, the overarching theme of the marketing campaign, from the pictures to the promotional claims, is that smoking electronic cigarettes is fun and exciting. One certainly does not get the impression from the advertising materials in the record that nicotine addiction is something that Smoking Everywhere intends its product to treat and cure. Moreover, there is little evidence in the record that Smoking Everywhere offers its product with the knowledge that any significant number of its customers will use electronic cigarettes to treat nicotine addiction, even though the product is not labeled or marketed that way."
"Because Congress was acting "against the backdrop of the FDA's consistent and repeated statements that it lacked authority under the FDCA to regulate tobacco absent claims of therapeutic benefit by the manufacturer" id. (emphasis added), the Supreme Court had little choice but to conclude that Congress had "effectively ratified" FDA's position that it lacked authority over tobacco products as "customarily marketed," id. at 156, 120 S.Ct. 1291. Thus, the line drawn by the Supreme Court was not between traditional and non-traditional tobacco products, as FDA suggests, but between tobacco products as customarily marketed and those that claim therapeutic benefits. Against this backdrop, the Tobacco Act reflects Congress's intent to undo what it had earlier ratified. No longer will FDA lack jurisdiction over tobacco products as customarily marketed. Congress enacted the Tobacco Act to confer FDA jurisdiction over any tobacco product—whether traditional or not—that is sold for customary recreational use, as opposed to therapeutic use. As such, the Tobacco Act, in effect, serves as an implicit acknowledgment by Congress that FDA's jurisdiction over drugs and devices does not, and never did, extend to tobacco products, like electronic cigarettes, that are marketed in customary fashion for purely recreational purposes. Furthermore, the Tobacco Act's broad definition of "tobacco product" is also an implicit admission by Congress that the existing tobacco-specific legislation, such as the FLCAA and CSTHEA, failed to cover the full array of tobacco products that were beyond FDA's jurisdiction under the FDCA."