- FAMRI Center
E-cig companies want to have it both ways on whether or not they are cessation aids: The FDA can & should stop these claims now
We commented on the fact that at least two e-cigarette companies, Sottera, Inc., which promotes the e-cigarette brand NJOY, and VMR Products LLC, which promotes the e-cigarette brand V2Cigs, along with the e-cigarette industry’s trade association, Smokefree Alternatives Trade Association (SFATA), directed their consumers to provide public comment to this docket on “treatments for nicotine dependence” in direct e-mails to consumers and on their websites. The companies’ action was important because Sottera, Inc. had successfully sued the FDA to stop the agency from regulating e-cigarettes on the grounds that they were not therapeutic drugs and/or devices.
The Court of Appeals upheld the District Court ruling that e-cigarettes should be classified and regulated as tobacco products not drug devices because companies were not marketing e-cigarettes with therapeutic claims. At the same time, both the Court of Appeals and the District Court held that if e-cigarettes were marketed with therapeutic claims, the FDA could regulate them as drug devices under the Food Drug and Cosmetic Act. Thefact that the e-cigarette companies and their trade association have been encouraging their consumers to submit public comments to a docket about smoking cessation products can be read no other way than the e-cigarette companies and their trade association are promoting their products as having therapeutic benefit.
Even a cursory review of the thousands of public comments in the docket, indicates that the e-cigarette companies' and trade association's efforts generated many comments that reflect this claim of therapeutic benefit. Furthermore, many submitters appeared to be following specific instructions offered by the e-cigarette companies' Consumer Advocates for Smoke-free Alternatives Association.
The e-cigarette companies cannot have it both ways. They cannot claim they are regular tobacco products that, as “customarily marketed,” would require regulation as a tobacco product, and then create the impression through their marketing and direct consumer communication they have submitted therapeutic claims to the FDA and won approval for them.
We recommended that the FDA should take the following actions as a result of this information:
1. Make note of the therapeutic and health claims made and promoted by e-cigarette companies in its Report to Congress on Innovative Products and Treatments for Tobacco Dependence, comment on the lack of evidence to support such claims, and inform Congress that the FDA is taking actions now to stop such claims from being made until such time as the companies submit scientific evidence to substantiate these therapeutic claims.
2. Immediately order the companies to stop making claims (direct and implied) that e-cigarettes are effective cessation devices, including ordering the companies to remove and not post further testimonials to this effect.
3. Work with the Federal Trade Commission to prohibit such claims as false advertising until such time that they have been scientifically substantiated and approved by the FDA.
You can read our full public comment here.