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FDA Issues Guidance on Regulations Regarding Tobacco Products

7/22/2016

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​Tobacco use is the single largest preventable cause of disease and death in the United States. As part of its goal to improve public health and protect future generations from the risks of tobacco use, the FDA has extended its authority to cover all products that meet the definition of a tobacco product.  Previously, the FDA regulated cigarettes, cigarette tobacco, roll-your-own tobacco and smokeless tobacco, but in 2016, the FDA finalized a rule – Deeming Tobacco Products To Be Subject to the Federal Food, Drug, and Cosmetic Act – which extends the FDA’s authority to include the regulation of electronic nicotine delivery systems (such as e-cigarettes and vape pens), all cigars, hookah (waterpipe) tobacco, pipe tobacco and nicotine gels, among others.

This action is a milestone in consumer protection – going forward, the FDA will be able to: 1) Review new tobacco products not yet on the market; 2) Help prevent misleading claims by tobacco product manufacturers; 3) Evaluate the ingredients of tobacco products and how they are made; and 4) Communicate the potential risks of tobacco products.  This final rule goes into effect on August 8, 2016.   To assist the newly-regulated tobacco industry in complying with the deeming requirements, FDA has posted webinars to its website.  These webinars can be accessed at: http://www.fda.gov/TobaccoProducts/GuidanceComplianceRegulatoryInformation/ucm220111.htm.  If questions, please contact the FDA at:
Call: 1-877-CTP-1373 (M-F 9:00 a.m. – 4:00 p.m.)
Email: AskCTP@fda.hhs.gov
Visit: www.fda.gov/tobacco

Information from the Pennsylvania Department of Revenue
Cigarette Tax Bulletins

Cigarette Tax Resources for Licensees
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