E-cigarettes are devices composed of a cartridge, a heating element, a battery, and electronics. When the user inhales, the device is activated and some of the liquid in the cartridge is vaporized, delivering a small amount of nicotine in a mist that has the appearance of smoke.
FDA's notices to the e-cigarette vendor Smoking Everywhere (SE) stated that SE's products "are intended to alter the structure or function of the body because they contain nicotine." Smoking Everywhere offered to revise labels and websites to satisfy FDA that "this product is intended solely for recreational use ... and not intended to effect the structure or function of the body and not intended to treat, cure, mitigate or treat a disease." FDA refused, and continued seizing products.
On April 28, 2009, SE brought suit against the FDA in the United States District Court for the District of Columbia. The suit challenged FDA’s authority to regulate and ban imports of e-cigarettes under the drug/device provisions of the FDCA. On May 15, 2009, Soterra, an Arizona company doing business as NJOY, joined SE as an intervenor-plaintiff, and NJOY filed its own complaint.
In June 2009, Congress passed the Family Smoking Prevention and Tobacco Control Act (Tobacco Act), giving the FDA statutory authority to for comprehensive regulation of the content, testing, development, manufacture, labeling, packaging, advertising, promotion, distribution, and sale of any "tobacco product."
In January 2010, the Honorable Richard E. Leon, Judge for the U.S. District Court, granted an injunction in favor of the plaintiffs, SE and NJOY, ordering FDA to refrain from seizing incoming shipments until the case has been decided. Judge Leon rejected FDA's argument that e-cigarettes should be regulated as a drug/device combination under the FDCA because the products are not sold with a therapeutic purpose. Judge Leon pointed out that, since the products contain nicotine derived from tobacco, they meet the definition of a tobacco product under the Tobacco Act.
Judge Leon's opinion pointed out that the FDA's purported public health concerns regarding e-cigarettes were not supported by the evidence. The court explained that advertising the products as a healthier alternative to smoking does not constitute a therapeutic claim. The Tobacco Act allows for "modified risk tobacco products" which are “sold or distributed for use to reduce harm or the risk of tobacco-related disease associated with commercially marketed tobacco products." Judge Leon pointed out that if the FDA did have concerns about public health, it could regulate the contents, labeling, and marketing of e-cigarettes under the Tobacco Act.
FDA chose, instead, to leave the products totally unregulated and filed an appeal. On March 31, 2010, the appeals court granted a stay pending appeal. The stay temporarily lifts the injunction, allowing FDA to resume seizing shipments of SE and NJOY products. In its brief filed on May 24, 2010, the FDA attempted to shore up its argument that the products are potentially dangerous by introducing as evidence findings announced in July 2009 regarding testing of 18 SE and NJOY cartridges in March.
The lab report noted that some Tobacco-Specific Impurities (TSIs) were "detected," along with Tobacco-Specific Nitrosamines (TSNAs), some of which can be carcinogenic. The FDA's press announcement stated, "A laboratory analysis of electronic cigarette samples has found that they contain carcinogens and toxic chemicals such as diethylene glycol [DEG], an ingredient used in antifreeze." The wording was calculated to convey the false impressions that e-cigarettes are more carcinogenic and more toxic than tobacco cigarette smoke.
This strategy played well in the press, convincing untold numbers of smokers to continue inhaling tar, carbon monoxide, particles of ash, heavy metals, and many more dangerous substances found in smoke, but absent from e-cigarettes. However, it was a strategic error on FDA's part to introduce the lab report into the court record.
NJOY's attorneys have taken advantage of this opening by analyzing the report authored by FDA scientist B.J. Westenberger and incorporating the results into the NJOY appeal brief filed with the court on June 23, 2010. The NJOY brief noted the following facts:
Smoking Everywhere Complaint:
FDA's Brief in Opposition:
Judge Leon's Ruling:
Judge Leon's Opinion:
FDA's Lab Report:
Exponent Analysis of FDA Report:
Analysis of TSNAs in NJOY:
NJOY Appeal Answer Brief: