On April 28, 2009, Smoking Everywhere, Inc. (“SE”) sued FDA to “stop FDA from improperly exceeding its delegated authority by attempting to regulate electronic cigarettes” to the extent that FDA declared such products to be a new drug and/or new drug device combination. (A copy of the complaint is available here.) SE further alleges that FDA exceeded its statutory authority by adding SE’s products to an FDA Import Alert list, thus allegedly preventing their admittance into the United States. In addition to the complaint, SE filed a temporary restraining order and preliminary injunction Motion. According to SE, an electronic cigarette essentially permits the user to inhale vaporized nicotine without smoke, tar or “cancerous by-products” normally produced with a cigarette. They do not claim it as a smoking cessation aid, but rather as an alternative to smoking cigarettes. FDA added electronic cigarettes to Import Alert 66-41 in early 2009.
SE argues that FDA exceeded its authority in a March 2009 Notice of Action to SE which stated that electronic cigarettes are combination drug/device products that require FDA approval. SE submits that Congress has clearly indicated that FDA does not have the authority to regulate the non-therapeutic use of nicotine or its delivery systems. FDA v. Brown & Williamson Tobacco Corp., 529 U.S. 120 (2000). SE further contends that FDA lacks the authority to regulate electronic cigarettes because nicotine is not a drug.
On May 11, 2009, FDA filed a brief in opposition to SE's Motion. FDA contends that electronic cigarettes are indeed both a drug and a device, and that Brown & Williamson does not exempt them from FDA’s jurisdiction. FDA argues that it has scientifically determined that nicotine has a psychoactive effect on the brain in such a way as to cause addiction as well as other physical issues. Additionally, FDA argues that some of SE’s promotional materials demonstrate that electronic cigarettes are intended to “prevent, treat, or mitigate the withdrawal symptoms of nicotine addiction,” specifically because SE claimed their product was a “healthier way” to consume nicotine.
FDA also disputes SE’s claim that Brown & Williamson precludes FDA regulation of nicotine products in general, asserting that the Court based its determination that FDA lacks authority to regulate tobacco products because other laws set out a different statutory scheme for regulation of those products (i.e., Federal Cigarette Labeling and Advertising Act and the Comprehensive Smokeless Tobacco Health Education Act). However, FDA notes, electronic cigarettes are not traditional tobacco products as defined under those other laws, thus making Brown & Williamson inapplicable to electronic cigarettes.
SE also argues that the inclusion of electronic cigarettes on Import Alert 66-41 is tantamount to a substantive rule, which required FDA to first use notice and comment rulemaking. In support, SE cites Bellarno Int’l Ltd. v. FDA, 678 F. Supp. 410 (E.D.N.Y. 1998) and Benten v. Kessler, 799 F. Supp. 281 (E.D.N.Y. 1992). Bellarno held that FDA violated the Administrative Procedure Act by issuing an Import Alert that left no enforcement discretion, thus making it a “substantive rule of general applicability…rather than a discretionary general statement of policy.” Benten also determined that an Import Alert issued by FDA was a substantive rule requiring notice and comment rulemaking because it was essentially a binding pronouncement that left no room for enforcement discretion.
In its opposition brief, FDA distinguishes Import Alert 66-41 from the Import Alert at issue in Bellarno, asserting that the language used in Import Alert 66-41 permits districts to use their discretion when determining whether a product subject to the alert should be detained. FDA cites the language in the Bellarno import alert, “automatically” and “shall,” as creating a detention requirement, while the phrase “districts may detain . . .” from Import Alert 66-41 as allowing for district discretion.
This parsing of words by FDA, as a practical matter, does not reflect the way that FDA personnel treats Import Alerts. In reality, FDA districts do not look at Import Alerts as mere "advice" that may or may not be followed based on district discretion. The concept of district discretion contradicts FDA’s stated reasons for the creation of the Import Alert system. In chapter 9-13 of its Regulatory Procedures Manual, FDA states that prior to the implementation of the Import Alert system, “coverage of imported products was often conducted on a district-by-district basis, resulting in less effective consumer protection.” In practice FDA relies upon the Import Alert system to identify problem commodities and/or shippers and/or importers and provide something more than mere "guidance" - something that results in more uniform enforcement actions against the specified products/shippers/importers mentioned in the alert.