Georgetown Professor: FDA Deeming Rule has “Good and Bad Aspects”

Article ID: 652965

Released: 5-May-2016 10:05 AM EDT

Source Newsroom: Georgetown Lombardi Comprehensive Cancer Center

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Newswise — WASHINGTON (May 5, 2016) — In an historic development to the long-awaited “deeming rule,” the FDA today has finalized its authority to regulate all tobacco products, including e-cigarettes, cigars, hookah tobacco and pipe tobacco.

Georgetown professor David D. Levy, PhD, commends the FDA for moving deliberately, and says tobacco products should be regulated. But he also points out that there is increasing evidence that e-cigarettes provide a safer alternative to traditional cigarettes, and that evidence of their benefits and harms should be measured with an open mind.

“Today’s announcement has good and bad aspects," says Levy, a professor in the department of oncology at the Georgetown Lombardi Comprehensive Cancer Center. “The good is that it will limit access by youth, and hopefully will also enable the FDA to limit marketing to youth and to effectively regulate content. Nicotine is bad for youth in whatever form.”

But he says, “The potential downside is that it somewhat arbitrarily requires manufacturers of all products that were not on the market by Feb. 15, 2007 to show that the product meets the applicable public health standard set forth in the law. Depending on how this requirement is implemented, it could favor the current cigarette manufacturers who have the financial resources and experience to overcome the regulatory obstacles that are likely to accompany the review process.”

Levy adds, “There is now strong evidence that e-cigarettes can be an effective cessation aid, but the more effective e-cigarettes were mostly put on the market after 2007 and are not those marketed by the cigarette manufacturers.”

Levy and his colleagues synthesize much of the evidence published to date on e-cigarettes, and suggest that use of these products can lead to reduced cigarette smoking overall with a potential reduction in deaths from cigarette smoking. Their findings where published in the journal Addiction on April 25 (click here for press release).

Levy says, “E-cigarettes marketed by cigarette manufacturers, particularly Altria’s (formerly Philip Morris and maker of Marlboro cigarettes) appear to be inferior products in satisfying nicotine cravings and effectively acting as a substitute for cigarettes. It will be important in the coming days that the FDA is able to keep the market open to e-cigarette products that help smokers quit or move completely to e-cigarettes.”

“Still, the number one public health problem is cigarettes, and we should not take the focus off reducing cigarette use,” Levy concludes.

To schedule an interview with Levy, contact Karen Teber at km463@georgetown.edu.

About Georgetown Lombardi Comprehensive Cancer CenterGeorgetown Lombardi Comprehensive Cancer Center, part of Georgetown University Medical Center and MedStar Georgetown University Hospital, seeks to improve the diagnosis, treatment, and prevention of cancer through innovative basic and clinical research, patient care, community education and outreach, and the training of cancer specialists of the future. Georgetown Lombardi is one of only 45 comprehensive cancer centers in the nation, as designated by the National Cancer Institute (grant #P30 CA051008), and the only one in the Washington, DC area. For more information, go to http://www.lombardi.georgetown.edu.


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