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FDA - Important Tobacco Announcement

 Jul 30, 2017    Rules and Regulations, News and Press

Dr. Scott Gottlieb's at FDA

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The FDA, an American governmental agency that promotes public health, announced July 28th that it will be releasing a new comprehensive plan to better regulate tobacco and nicotine products. They have detailed a four-pronged approach that directly attacks the issue of addiction, the process at the heart of the growing smoking epidemic. Firstly, they want to adequately assess the current situation so that they can properly and effectively implement policies to complement and support the Family Smoking Prevention and Tobacco Control Act passed in 2009, which limits children’s exposure to tobacco products and tobacco-related marketing.

 

Dr. Scott Gottlieb's inspiring Vision FDA

 

Armed with scientific knowledge and the current public opinion about trends in the tobacco industry, the FDA will be better prepared to build policies that strike the perfect balance between regulating the public’s access to nicotine and supporting the growth of smoking alternatives like e-cigarettes. They will soon release a detailed plan requiring tobacco companies to submit their products for review under stricter guidelines. Lastly, the FDA will evaluate the public’s opinion on whether flavored tobacco product have a positive or negative influence on children and adolescents.

Smoking causes 480,000 deaths each year, and it has detrimental effects on society as a whole. Without even calculating the loss in productivity, the United States spends an estimated $300 billion in healthcare costs related to smoking. Since the majority, approximately 90%, of adult smokers start at age 18, and another 2500 young people pick up their first cigarette every single day, it’s time to take proactive measures to help usher in a world where cigarettes won’t lead to widespread addiction and adults have plenty of alternative sources to curb their nicotine addictions. The FDA hopes that by crafting a holistic approach centered around nicotine, they’ll be able to both attack the problem at its source while simultaneously limiting its ability to expand.

The FDA will soon release new standards that require manufacturers to submit their devices for inspection for any product out on the market before August 8, 2016. Any newly-regulated commodity that uses the process of combustion, i.e. cigars, pipe tobacco, and hookah tobacco, must be submitted by August 8, 2021. Any non-combustible product including electronic cigarettes--electronic nicotine delivery systems--have until August 8, 2022 to make their submissions. Do note, that this ruling only applies to newly regulated products and not cigarettes or smokeless tobacco. The FDA hopes that, provided with ample information, clear guidelines, and advance warnings, tobacco product manufacturers should have no problem meeting the deadlines for submission and passing inspection. They promise that the review process will be more efficient, transparent, and predictable so that there should be no surprises when time comes.

Lastly, the FDA announced that it plans to seek input from the public through Advanced Notices of Proposed Rulemaking (ANPRMs) to collect information about tobacco and nicotine products that may appeal to children, foremost of which would be menthol-flavored tobacco and candy-flavored e-liquid. Through collecting data and analyzing survey responses, the FDA will hopefully have a better idea of whether flavored-nicotine products encourage kids to use tobacco products or their healthier alternatives as well as how effectively they do so. The agency also plan on discussing how to make FDA-approved medicinal nicotine products both more effective and more widely available. The FDA hopes that this new plan will establish a more comprehensive understanding of current trends in tobacco usage and therefore allow them to craft more informed policies that will ultimately lead to a cleaner, healthier future for all Americans.

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