Published on October 19th, 20151
FDA Urged to Move Quickly on E-Cigarette Cessation Claims
Five major health groups have asked the FDA to take immediate action to investigate therapeutic smoking cessation claims found on e-cigarette sites revealed in a TINA.org investigation published in September.
In a letter sent Oct 14, the organizations — American Cancer Society, American Heart Association, American Lung Association, Campaign for Tobacco-Free Kids and the Truth Initiative — said that the evidence uncovered by TINA.org “suggests that violations of federal law on a massive scale are taking place in the marketing of e-cigarettes.” The letter urged the FDA to:
immediately commence an investigation of the claims being made by these companies and take prompt and appropriate enforcement action against those found to be violating the law.
It’s been more than a year since the FDA signaled it was going to regulate new tobacco products such as e-cigarettes. The agency had said it would issue its final rule in June but didn’t meet that deadline. Meanwhile, e-cigarette sites have been proliferating on the web and many online e-cigarette companies are taking advantage of the regulatory gap to market their wares with a variety of suspect claims, including that vaping products can help smokers quit tobacco.
“As TINA.org’s investigation revealed and these health experts have acknowledged, a significant number of e-cigarette sites are making deceptive claims,” said TINA.org Executive Director Bonnie Patten. “Consumers should be on their guard.”
Quit Smoking Claims
TINA.org’s review of more than 150 e-cigarette sites found that almost one-third indicated in some way that vaping products can help smokers quit tobacco. It is a violation of federal law to market a product as a smoking cessation device without the review and approval of the FDA and thus far the agency has not approved any e-cigarettes for this purpose.
The claims found by TINA.org and noted in the letter range from express marketing statements such as “crafted to give you the best chance of smoking cessation as you stop smoking traditional cigarettes” to testimonials from purported users. Said one testimonial: “E-cigarettes changed my husband from a 2-pack-a day smoker and stroke victim to a non-smoker.” (A list of sites making smoking cessation and other misleading claims can be found on TINA.org’s database.)
The health advocates said in their letter that the FDA does not have to wait until it issues its final new tobacco regulation to take action because it already has jurisdiction over claims that render products a drug or device and which can’t be sold without premarket approval.
“Truth in Advertising has identified numerous e-cigarette websites making claims that their products help people stop smoking without complying with the FDA requirement that they be proven safe and effective for that purpose,” said Denny Henigan, director of legal and policy analysis for the Campaign for Tobacco Fee Kids. “The FDA cannot ignore these apparent violations of law in the marketing of e-cigarettes.”
Michael Felberbaum, a spokesman for the FDA, would not comment on the letter other than to say that the agency will review it and “will share any response directly with the sender.”
In response to TINA.org’s findings last month, Felberbaum said that the agency takes violations “very seriously.” To date, the agency has taken action against only eight e-cigarette companies for misleading marketing and unsubstantiated claims.
For more on TINA.org’s coverage of e-cigarettes click here.