Requesting Expansion of Availability of Nicotine Replacement Therapy to Consumers Who Use Tobacco - CLOSED

March 27, 2008 Division of Dockets Management Food and Drug Administration Department of Health and Human Services 5630 Fishers Lane, Room 1061 Rockville, MD 20852 Re:Docket number FDA-2008-P0116 On behalf of the physician and medical student members of the American Medical Association (AMA), I am writing in support of the petition submitted by Richard F. Daines, MD, Commissioner of the New York State Department of Health (NYSDOH), requesting that the Food and Drug Administration (FDA): 1.Allow the sale of over-the-counter (OTC) nicotine replacement therapy (NRT) in all retail locations where cigarettes are sold, including convenience stores, gas stations, tobacco specialty stores, grocery stores, and other retail businesses that sell tobacco; 2.Allow OTC NRT to be sold in "daily" units (containing an amount of NRT that would typically be consumed in a 24-hour period) at prices competitive with one 20-count pack of cigarettes and allow OTC NRT to be advantageously positioned near cigarettes and other tobacco products to promote the sale of OTC NRT products; and 3.Modify labeling requirements to fully disclose to smokers the benefits of OTC NRT use relative to continued cigarette use, with risks associated with OTC NRT compared to risks associated with continued cigarette use. We concur with the statement of grounds and evidence put forth by the NYSDOH that: 1) OTC NRT should be more widely available to smokers in order to increase use, increase quit attempts and, eventually, increase quit success; 2) increased availability of OTC NRT will not lead to increased abuse by adolescents; 3) OTC NRT is safe and safer than cigarettes for all smokers; and 4) use of OTC NRT for situations of temporary smoking restriction in order to moderate transient withdrawal, as a substitute for smoking, and concomitantly with cigarette use in order to reduce consumption (and eventually quit) is safe and even desirable to advance public health. Despite the proven effectiveness of OTC nicotine replacement therapies, there is widespread misinformation among smokers about their efficacy and safety. A recent survey of 900 adult smokers, fielded in July 2007 by Richard Day Research through an online panel that screened for adults age 18 and over who smoke cigarettes every day (Smokers Remain Unaware of the Health Effects of Smoking, New Survey Finds, at http://www.americanlegacy.org/304.aspx), highlights the need to both make NRTs more available and to correct misperceptions among smokers about them. According to the survey, while many smokers are aware that smoking can lead to serious health problems, there is widespread misinformation or ignorance about the health effects of nicotine and use of NRT. Among all survey respondents, over eighty percent incorrectly believed or were unsure: whether ?nicotine caused cancer, emphysema or heart attacks;? that ?long-term use of NRTs are not known to be associated with any serious harmful effects;? and that ?smokers dramatically underestimate the safety and efficacy of NRT products such as nicotine gum, patches, and lozenges.? The survey also revealed that sixty-five percent wrongly believe or are unsure whether nicotine in NRT products is more dangerous than the nicotine in cigarettes and two-thirds wrongly believe or do not know if nicotine gum, patches, or lozenges can cause cancer despite research that has indicated that there is not a link between cancer and nicotine replacement therapy. We support the NYSDOH request that the FDA allow the expansion of the sale of OTC NRT to all retail locations where cigarettes are sold, and that they may be sold in ?daily units.? We also support the request that labeling requirements, reflecting the research that support their use for smoking cessation and which supported the initial current limited distribution conditions, be modified to fully disclose to smokers the benefit of their use relative to continued cigarette…