Those who joined ECF after 2009 may be unaware of the legal battle that raged when the FDA began seizing incoming shipments of e-cigarettes, claiming that the products are an "unapproved combination drug and drug delivery device". The FDA regulates drugs and medical devices under the Food, Drug, and Cosmetics Act (FDCA). Smoking Everywhere filed a complaint in Federal Court asking for an injunction against product seizures. They were joined shortly thereafter by Soterra, Inc. (Doing Business As NJOY).
Both companies argued that e-cigarettes are not intended to treat a disease. As a means of swaying public opinion, the FDA held a press conference in July 2009, announcing that "a laboratory analysis of electronic cigarette samples has found that they contain carcinogens and toxic chemicals such as diethylene glycol, an ingredient used in antifreeze." The press gleefully picked up the story and as a result, many smokers who were considering trying an e-cigarette decided that it would be safer to stick with the practice of tobacco-filled paper tubes on fire and inhaling the smoke.
My critique of the FDA's use of propaganda techniques is published here:
FDA's partial truths and exaggerations endanger health
As luck would have it, the judge in the case of Smoking Everywhere v. U.S. Food and Drug Administration, wasn't fooled by the FDA's chicanery. When he ruled on the case in January of 2010, he granted the injunction. His opinion document agreed with the Plaintiffs that e-cigarettes are not a drug or a drug-delivery device. After the case was filed but before the judge made his ruling, the Family Smoking Prevention and Tobacco Control Act was passed. Judge Leon advised the FDA that if it felt a need to regulate the products, the agency could do so using the "Tobacco Act". Although the Tobacco Act granted the FDA authority to regulate only Cigarettes and Smokeless Tobacco, the judge noticed that the secretary could deem other tobacco products to be included in the regulatory process, and that the law's definition of "tobacco product" is "any product made of or derived from tobacco." The judge reasoned that since the nicotine in e-cigarettes is extracted from tobacco, the products met the law's definition of a tobacco product. He also reasoned that if a manufacturer or vendor did make medical claims, the FDA could regulate that particular product as a drug or drug-delivery device under the FDCA. Judge Leon's opinion document is available here:
http://www.casaa.org/uploads/SE-vs-FDA-Opinion.pdf
But the legal battle at the Federal level was not over at that time. The FDA appealed and asked the Appeals Court to set aside the injunction. Their request was granted and the FDA resumed seizing incoming shipments. Written and Oral arguments ensued. CASAA was among a group of organizations that filed an Amicus (friend of the court) Brief in support of the Plaintiffs. The Appeals Court ruled against FDA in December of 2010. Here is the opinion document of the three-judge panel:
http://www.casaa.org/uploads/ct_app_opinion_on_injunction.pdf
The tenacious agency appealed again, asking the Appeals court for rehearing with all 9 judges. The Appeals court turned down the request. At the point, the FDA's only legal recourse would have been to ask the Supreme Court to hear the case. The FDA's legal team (members of the Department of Justice) finally decided that it would be futile to continue. In April 2011, the FDA announced that in the future only products that made health claims would be detained.
http://www.casaa.org/uploads/Declar...ziano__FDA__in_NJOY_v._FDA_re_importation.pdf
For those who are unfamiliar with the nuances of what all this means: If the courts had ruled that FDA could regulate all e-cigarettes under the FDCA, this would have meant that all sales of the product would be banned. The only way an e-cigarette could be sold would be if a manufacturer made a New Drug Application with the FDA, went through all of the required testing, reports, and clinical trials, and if the FDA finally decided that it was "safe and effective" and granted the company permission to market the products. As you can imagine, the new drug approval process is complex, expensive, and time-consuming.
The FDA has since announced that it intends to "deem" e-cigarettes a product that it will regulate under the Tobacco Act. In this article, I discuss how the FDA could still manage ban sales of most, if not all, e-cigarettes.
FDA Regulation Could Make E-Cigarettes Less Effective
Legal battles were already starting in 2010 at the state and local level. CASAA has issued a Call to Action whenever a law or regulation has been proposed that would prevent sales to adults or impose restrictions on products themselves or product use. Here is a list of successful campaigns.
Successful CASAA Campaigns
These battles continue. Here is CASAA's list of Calls to Action:
CASAA Calls to Action
We welcome your participation and support.
