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More than 54 years after the Surgeon General's historic report on smoking and health, smoking – primarily smoking – remains the leading cause of preventable disease and death in the United States, responsible for 480,000 premature deaths each year. Why? Because cigarettes create an incredible addiction.
Most adult smokers want to quit and nearly half try to quit each year. But nicotine, which a cigarette effectively releases through the lungs and brain in less than 10 seconds, attracts a lot of people despite their desire to quit.
While nicotine keeps smokers addicted, it's the smoke and the 7,000 chemicals it contains that cause disease and death. This is why one of the key elements of our overall plan to significantly reduce the number of deaths and tobacco-related illnesses is the recognition that nicotine, although it creates high dependence, is transmitted through products on a continuum of risk with one-end fuel cigarettes and nicotine replacement therapy. products to each other. In particular, TRN products, which are designed to safely reduce withdrawal symptoms, including the craving for nicotine associated with smoking cessation, are generally considered to double the risk of success of the attempt. stop. Quitting smoking may reduce the chance of getting a lung disease, heart disease or certain types of cancer.
Most existing TNSs such as gums, patches and lozenges have been approved for over 30 years. They have played an important role in providing adults with tools to help quit smoking, in a way that does not require you to cut yourself immediately and completely nicotine. We now have the opportunity to leverage these NRTs with innovative products that could save even more lives by enabling adults to quit safely and effectively.
New products with different nicotine delivery characteristics or routes may potentially offer new opportunities for health-conscious smokers who want to stop smoking. This could also include products such as electronic nicotine delivery systems such as electronic cigarettes, but which should be proven safe and effective for quitting and regulated as a drug product. This would allow them to be marketed as prescription or over-the-counter medications with medical claims for quitting or related indications, which would ultimately reduce the risk that a person will continue to suffer the clinical consequences of smoking. This differs from our regulations on e-cigarettes as tobacco products.
As part of our commitment to increase access and use of nicotine-based products approved by the FDA, we created the Nicotine Steering Committee in September 2017. Since then, the committee has Is focused on creating a more flexible framework for developing innovations in products that can help smokers to stop burning cigarettes and improve their health. This included holding a public hearing in January 2018 to examine the types of safety and efficacy studies that we suggest conducting, how these products are used and labeled. as well as guidelines to facilitate the development of these products.
Building on these efforts to encourage drug innovation to help more smokers quit smoking, we are releasing today the second of two draft guidelines to support the development of new nicotine replacement therapies. be sold as new FDA-approved drugs, similar to prescription drugs and current over-the-counter medications.
The first recommendations published in August 2018, "Non-clinical trials of nicotine-containing and oral-inhaled drugs," focused on the recommended data for assessing the potential toxicities associated with orally inhaled nicotine-containing products (such as electronic cigarettes) to inform the FDA's assessment of the benefits and risks of a product. This draft guideline recognizes that a lot of information on toxicity is available for nicotine, but that this information may not be available for other compounds such as flavorings and heat-generated chemicals contained in it. in e-liquids and provided by these products. Since these products can be used for six months or more in their lifetime, it is important to understand the risks that these exposures pose to humans, including developmental and reproductive toxicity, as well as carcinogenicity.
The draft guideline published today, titled "Cessation of Smoking and Related Indications: Developing Drugs for Nicotine Replacement Therapy," helps to establish a framework for new clinically relevant outcomes for smoking cessation products at home. Tobacco, such as reducing the risk that a smoker starts smoking long term again. This orientation project takes into account the comments received during the January 2018 public hearing and is intended to serve as a basis for further discussions between the FDA, drug sponsors, the weaning research community smoking and the public.
The purpose of this guide is to describe the new parameters that make sense to help currently dependent adult smokers who can promote innovation in NRT by outlining a broader set of criteria that can be used as a basis for new approvals.
TRN's current product labeling recommends to the smoker to establish a "day off" and quit smoking cigarettes that day. While this may work for highly motivated smokers, many attempts to quit smoking fail and result in a return to smoking. However, other treatment regimens, such as pre-treatment before the day off, quit smoking by gradually reducing the number of cigarettes smoked (reduce the number of cigarettes), or use two drugs-based together, can be explored to help smokers quit. Although TNS-based drugs have been developed to date for smoking cessation, the draft guidelines, once finalized, will indicate how sponsors can develop products to reduce the risk of relapse. In addition, he will explain the ways in which sponsors might also be in favor of including additional information in labeling, such as reducing the urge to smoke and the relief of smoking. flag-induced cravings, or the relief of withdrawal symptoms not associated with an attempt to quit.
As we look to the future and the possibility of a world where combustible cigarettes can no longer create or maintain a dependency, these guidelines are part of comprehensive steps to pave the way for new safe and effective products that can help existing smokers to quit smoking. delivery form of nicotine.
The FDA, an agency of the US Department of Health and Human Services, protects public health by ensuring the safety, efficacy and safety of human and veterinary drugs, vaccines and other biological products for human use and medical devices. The agency is also responsible for the safety of food products, cosmetics, food supplements, products emitting electronic radiation and the regulation of tobacco products.
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