Classifying E-Cigarettes As Tobacco Snuffs Out Cessation Utility – FDA
This article was originally published in The Tan Sheet
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FDA makes a case for regulating electronic cigarettes as nicotine-replacement therapies, calling the products "a promising tool" in controlling tobacco use. In a Dec. 20 motion filed to reinstate a stay of preliminary injunction against e-cigarette distributor NJOY, the agency also clarifies the battery-operated products are languishing in a regulatory gray area. The motion followed a Dec. 7 ruling by the U.S. Court of Appeals for the District of Columbia Circuit that e-cigarettes are tobacco products rather than drugs or medical devices. With liquid nicotine instead of tobacco, e-cigarettes are gaining popularity as cigarette alternatives; the Tobacco Vapor Electronic Cigarette Association says there are at least 20 major manufacturers of the products and estimates annual sales at $100 million. However, the products do not have approval as drugs from FDA, a prerequisite for making treatment claims. The agency wants to study the electronic products further and bring them under an established regulatory scheme before considering nicotine-replacement and smoking-cessation claims. FDA Refutes Court's Classification FDA objects to the appeals court's decision to uphold an injunction against the agency's e-cigarette import ban, initiated when FDA said some products had tested positive for toxic substances ( (Also see "In Brief" - Pink Sheet, 13 Dec, 2010.), In Brief). The court's ruling "confuses the 'tobacco problem' with a promising tool in the tobacco control arsenal" and "undermines the incentives for companies to develop the very nicotine-replacement products that Congress sought to promote" in 2009's Family Smoking Prevention and Tobacco Control Act, FDA says. Though the law does not refer to e-cigarettes specifically, it contains a section on "drug products used to treat tobacco dependence" and mandates that FDA consider fast-tracking smoking-cessation product approvals and produce a report on "innovative" tobacco-control products.
FDA omitted e-cigarettes from guidance published Jan. 5 clarifying expectations that new tobacco products demonstrate equivalency to existing products in terms of ingredients, design, composition and heating source. Manufacturers of cigarettes, roll-your-own tobacco and smokeless products introduced since February 2007 must apply for equivalency by March 22. FDA Seeks Regulatory Home For E-Cigarettes Commenting on the appellate court's order that FDA regulate e-cigarettes through its Center for Tobacco Products, the agency says it is not a simple task and would require a new regulation. Jurisdiction under the Food, Drug and Cosmetic Act and Tobacco Control Act "are mutually exclusive, and plaintiff's products are not, at this juncture, subject to either the controls that apply to drugs and devices or the restrictions of the Tobacco Control Act," FDA's motion says.
An agency spokesman declined to estimate an expected timeline for the appeals court to rule on FDA's motion. The agency's main objection thus far to e-cigarette claims regarding smoking cessation is that such language makes the products unapproved drugs. When FDA's Center for Drug Evaluation and Research in September 2010 warned five companies regarding unapproved cessation claims, it added that new drug applications for e-cigarettes are under discussion (Also see "Smoking Cessation Claims For E-Cigarettes Draw FDA Warnings" - Pink Sheet, 13 Sep, 2010.). A year earlier, FDA warned that e-cigarette products it tested contained carcinogens and toxic chemicals and ordered the product seizures that led to the NJOY litigation. NRT Approval A Possible But Costly Option Smoking cessation experts said then they would support NRT indications for e-cigarette products that are proven safe and effective, and would expect FDA to approve the products eventually (Also see "NRT Potential Smolders Around Electronic Cigarettes" - Pink Sheet, 3 Aug, 2009.). But TVECA does not see FDA-approved NRTs as a feasible option for the relatively small e-cigarette firms that can't afford the cost of clinical studies and the NDA process. More likely to follow that route would be big pharma or major tobacco companies, according to David Goerlitz, the trade group's president. TVECA's mission is to "reel in" the behavior of e-cigarette marketers, to ensure they are not making health claims or otherwise violating the Tobacco Control Act, Goerlitz said. Ultimately, the e-cigarette industry wants FDA to regulate its products as tobacco and sees the appellate court ruling against the agency as validation. "I don't know what part of 'no' the FDA doesn't get," Goerlitz added. By Dan Schiff |