Synopsis

The FDA can only regulate e-cigarettes as a tobacco product, unless a product is specifically being marketed as a cessation device.

Background

On April 15, 2009, the FDA denied the import into the U.S. of e-cigarettes and accessories made by two companies called Smoking Everywhere, Inc. and Sottera, Inc., doing business as NJOY. According to the FDA, these products appeared to be unapproved drug-device combination products that were intended to help treat the withdrawal symptoms of nicotine addiction. In other words, the FDA was using its authority to regulate drugs under the Food, Drug, and Cosmetic Act (“FDCA”) to regulate e-cigarettes.

District Court Proceedings

Smoking Everywhere filed suit in the United States District Court for the District of Columbia, claiming that electronic cigarettes are not intended to help treat withdrawal symptoms of nicotine addiction but, rather, that they are for smoking enjoyment, similar to conventional cigarettes. Therefore, the companies asserted, the products could not be regulated by FDA as drug-device combination products under the FDCA, and FDA could not enforce its import ban. On May 15, 2009, the court allowed NJOY to join the case with Smoking Everywhere. Both companies sought a preliminary injunction, which would prohibit the FDA from blocking their imports until the case has been decided.

On January 14, 2010, the court granted the companies’ motion for a preliminary injunction... Judge Richard Leon reasoned that the companies were likely to succeed on the merits of their underlying claims because Congress did not intend tobacco products to be “drugs” merely because they deliver nicotine—if this were true, traditional cigarettes would also be a drug-device combination product as well. The court also noted that the intended use of an electronic cigarette is to encourage nicotine use, rather than prevent or mitigate it, so the notion that the products were therapeutic in nature was also misplaced. In addition, the court found that the companies also stood to suffer irreparable harm if FDA continued to export or seize and destroy their products, and any harm to the public interest was relatively minimal. FDA subsequently filed an appeal of the ruling granting the preliminary injunction.

Proceedings in the U.S. Court of Appeals for the D.C. Circuit

The FDA filed its appeal of the district court’s preliminary injunction ruling on February 1, 2010. On December 7, 2010, Senior Circuit Judge Stephen Williams affirmed the District Court’s ruling that electronic cigarettes can be regulated solely as tobacco products, and not as drug-device combination products unless they are being marketed with a therapeutic purpose (cessation). Citing the U.S. Supreme Court’s decision in FDA v. Brown & Williamson, the court noted that the FDCA does not allow FDA to regulate tobacco products as “customarily marketed” because they are not drugs, devices, or combination products. Further, the court noted that the passage of the Tobacco Control Act (which amended the FDCA) provided FDA with explicit authority to regulate tobacco products, which it broadly defines as “any product made or derived from tobacco that is intended for human consumption,” other than drugs, devices, and combination products. Although the Tobacco Control Act at that time did not yet apply to e-cigarettes, the court pointed out that the FDA has two distinct regulatory regimes—the regulation of all tobacco products as “customarily used” under the Tobacco Control Act, and the regulation of products marketed with specific claims of therapeutic effect under the FDCA. In other words, because the products at issue made no claims of therapeutic effect, FDA’s sole source of regulatory authority existed under the Tobacco Control Act, and the injunction issued by the lower court was warranted.

Litigation Status

The FDA did not request review of the decision by the U.S. Supreme Court and instead issued a statement of its intent to regulate e-cigarettes as tobacco products. The so-called “deeming rule” establishing the FDA’s authority over e-cigarettes took effect in August of 2016. The case is closed.