FDA Needs More Information on “Modified Risk” Tobacco Products, Report Concludes

A new report concludes the Food and Drug Administration (FDA) needs more information about the health effects of “modified risk” tobacco products such as e-cigarettes or tobacco lozenges, before it allows tobacco companies to sell or advertise these products as being able to reduce the health risks of tobacco use. The report, which was sponsored by the FDA, was released by the Institute of Medicine (IOM), an independent nonprofit organization.

These modified risk tobacco products could be part of a strategy to lower tobacco-related death and disease, especially among tobacco users who cannot or do not want to quit entirely, the IOM said. But little is known about the products’ effects on health, and whether they are less risky than traditional tobacco products, The Wall Street Journal reports.

The FDA will decide whether to allow tobacco companies to advertise some tobacco products as safer than cigarettes, the article notes. The FDA said it would take the report into consideration as part of its assessment and ongoing review of modified risk tobacco products.

The report recommended that tobacco companies use FDA-approved, independent third parties to run health and safety research on their products. “Right now there’s a shortage of scientific evidence on the health effects of modified risk tobacco products, and the tobacco industry currently lacks the trustworthiness, expertise, and infrastructure to produce it,” Jane Henney, who chaired the committee that wrote the report, said in a statement.

Earlier this year, the FDA announced it will regulate smokeless electronic cigarettes as tobacco products, treating them the same as traditional cigarettes. The FDA said it would not try to regulate e-cigarettes under stricter rules for drug-delivery devices.

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    Elaine Keller

    December 16, 2011 at 1:30 PM

    The IOM report ignored decades of studies by credible third parties showing smokeless products to be safer than cigarettes.

    Levy DT, Mumford EA, Cummings KM, Gilpin EA, Giovino G, Hyland A, Sweanor D, Warner KE. The Relative Risks of a Low-Nitrosamine Smokeless Tobacco Product Compared with Smoking Cigarettes: Estimates of a Panel of Experts. Cancer Epidemiol Biomarkers Prev December 2004 13; 2035

    Lee PN: Summary of the epidemiological evidence relating snus to
    health. Regul Toxicol Pharmacol 2010.

    Lee PN, Hamling J: Systematic review of the relation between smokeless
    tobacco and cancer in Europe and North America. BMC Medicine 2009, 7:36.

    Gartner CE, Hall WD, Vos T, Bertram MY, Wallace AL, Lim SS.Assessment of Swedish snus for tobacco harm reduction: an epidemiological modelling study. Lancet. 2007 Jun 16;369(9578):2010-4.

    In his presentation at the FDA workshop on Risks and Benefits of Long-Term use of NRTs, Dr. Neal Benowitz cited the research on Swedish snus to show that nicotine does not cause or promote cancer and is unlikely to trigger MI or Strokes. Obviously any product that does not involve combustion is less harmful in terms of lung disease.

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