January 17, 2013
Stanton A. Glantz, PhD
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
Several of my colleagues and I submitted a public comment to the FDA docket regarding a “Report to Congress on Innovative Products and Treatments for Tobacco Dependence.”
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.
Comments
Facts versus spin
Since the FDA issued the Federal Register notice (about the December 17 public hearing on Section 918 and the public comment period that ended on the 16th), I have spent most of my time encouraging and assisting e-cigarette consumers and companies to testify at the December 17 hearing, and to submit written comments to the docket.
So if you want to blame somebody for organizing this highly successful public health campaign, then blame me.
The FDCA has long prohibited companies from marketing products with "therapeutic claims", and the FDA has been enforcing that law on a daily basis for many decades. Violators should be reported to the FDA, and the FDA will take appropriate action.
But I also think a competent lawyer for an e-cigarette company can convince the federal courts that since "smoking" is not a disease or disorder, claiming that an e-cigarette can help someone quit smoking is not a "therapeutic claim". In fact, that's why the FDA has approved drugs for treating "tobacco dependence", not for treating "smoking". And I'm not aware of any e-cigarette company that has ever claimed their products treat "tobacco dependence".
But Stan confuses commercial speech with political speech, as the US Constitution protects the rights of ALL citizens and companies to communicate with government agencies and officials. While Stan may be able to censor comments by e-cigarette consumers on this blog (and claim that they suffer from the "placebo effect"), nobody (including the FDA) has the legal authority to deny companies or citizens of their Constitutionally protected rights.
Stan is also urging the FDA to impose punitive sanctions against an entire industry simply because folks at several companies exercised their 1st Amendment rights.
But lawyers at FDA and the Justice Dept still remember that all 13 federal judges who adjudicated the SE/NJOY lawsuit against FDA (in which I and other consumer and public health advocated filed a brief in support of the e-cigarette companies and against the FDA) ruled that FDA had no legal authority to ban all e-cigarettes simply because several (out of several hundred) e-cigarette companies claimed (in advertisements) that e-cigarettes help smokers quit smoking.
Bill Godshall Executive Director Smokefree Pennsylvania 1926 Monongahela Avenue Pittsburgh, PA 15218 412-351-5880 mailto:[email protected]";smokefree@compuserve.com
Bill Godshall misses the whole point of our Comment
/sites/g/files/tkssra4661/f/u9/FDA-comment-ecig-cessation-1jx-835b-n9ph.pdf" target="_blank";Our public comment to the FDA does not challenge e-cigarette consumers’ free speech rights. Indeed, we are frankly quite happy that the consumers’ testimonials clearly establish the way consumers are using e-cigarettes as smoking cessation aids, a therapeutic use.
Rather, we challenge the e-cigarette companies’ violation of the FDCA by unlawfully promoting their products for the therapeutic use of minimizing nicotine addiction, just as nicotine gums and transdermal patches are designed to do. Like nicotine gums and transdermal patches, e-cigarettes, when used to assist in smoking cessation would fall under the jurisdiction of the drug/device provisions of the FDCA, and as Mr. Godshall correctly suggests, “should be reported to the FDA [so that] the FDA will take appropriate action” for failing to get appropriate FDA drug/device approval.
The federal judges of the D.C. Court of Appeals who heard the appeal of the Smoking Everywhere/Sottera, Inc. lawsuit agreed with Judge Leon’s interpretation of the law about how to decide whether a tobacco product shall be considered marketed for a therapeutic use, and it has nothing to do with the First Amendment. 21 CFR 801.4 makes clear that the “objective intent of the persons legally responsible for labeling the device” is determined by the totality of “the circumstances surrounding the distribution of the article,” including the knowledge of the companies or their representatives that their product or device is being used “for a purpose for which it is neither labeled nor advertised.”
Whatever use was originally intended for a device is not determinative, as the intended use “may change after it has been introduced into interstate commerce by its manufacturer,” and in such case, the distributor or seller is “required to supply adequate labeling in accordance with the new intended uses.” The crux of the issue is whether the company “knows, or has knowledge of facts that would give him notice that a device introduced into interstate commerce by him” is for a purpose that would require appropriate labeling under the FDCA.
The e-cigarette companies' actions leave little doubt about their knowledge of the devices’ actual , if not originally intended, use because they posted the testimonials of consumers’ on their websites, and because they solicited their consumers to submit Public Comments about how e-cigarettes have changed their lives to the FDA docket regarding a report to Congress on smoking cessation therapies.
I started using an electronic
I started using an electronic cigarette on January 3rd of 2012. I had my last cigarette on April 29th, and have not had one since. I know of at LEAST a dozen other people who have ceased using tobacco cigarettes in favor of an electronic one.
I still use it. I have no intention of quitting, I enjoy it and it poses no health risk to me. My doctor let's me use it in his office, my dentist was happy, and though I'm young enough that I can't say I was noticing any particular health concerns before quitting, my ever present cough has discontinued.
Having the FDA but their bureaucratic noses into the e-cig market will only cause it to be more expensive, less innovative, and will needlessly delay products availability in the marketplace. I literally just returned from the e-cig store where I purchased a new type of tank that is a drastic improvement from the old type I was using. The old type frequently spit raw juice into my mouth, clogged, was a pain to fill, a pain to prime, and required frequent replacement of the atomizer. The new model functions identically, insofar as it uses heat to vaporize the e-juice, but it's been redesigned so that the problems I noted on the older model are gone. There is no way for it to spit juice, it's is simple to fill and prime, and requires a new atomizer at about 1/4 of the frequency of the old one.
If the FDA were involved, rather than design it, build it, sell it, it would be design it, build it, test it for years, and then, maybe, if we're lucky, some government stooge will grant permission to sell it. As it is, it's in my hands in February, 2013. Were the FDA to be involved it would probably be 2017 and cost 5x as much.
No thanks.
Kevin Moseley
Tampa, Florida
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