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FDA Proposes Rulings for Novel Tobacco Products

Darrell Hulisz, RPh, PhamD
Kevin Stack

June 2, 2014

Non-cigarette tobacco products are often viewed as less harmful than cigarettes, but some studies shown similar negative correlations with health and/or raise safety concerns. The FDA has proposed new rule as a part of the Family Smoking Prevention and Tobacco Control Act to expand its authority to include other tobacco products, including electronic cigarettes, cigars, pipe tobacco, nicotine gels, waterpipe or hookah tobacco, and dissolvable nicotine.

The rule would force manufacturers of these products to register with the FDA, report product and ingredient listings, include health warnings, not distribute free samples, eliminate vending machine sales in areas with youth access, force retailers to enforce minimum age and identification restrictions, and prevent manufacturers from claiming reduced risk without FDA confirmed scientific evidence.

The Family Smoking Prevention and tobacco Control Act of 2009, was passed to give the FDA the authority to regulate the manufacture, distribution, and marketing of tobacco products to protect public health. The act specifically sites that nearly all new users of tobacco products are under the age of 18, and decreasing the number of new tobacco users is a main goal of the act. The new rule would help restrict underage use of tobacco products, and may aid in deterring possible new tobacco use by alerting some users of the risks of non-cigarette tobacco products.

1. O'Connor RJ. Non-cigarette tobacco products: what have we learnt and where are we headed? Tob Control. 2012 Mar;21(2):181-90.

2. Hulisz DT. Are electronic cigarettes safe? Medscape January 24, 2012. http://www.medscape.com/viewarticle/757049

3. FDA proposes to extend its tobacco authority to additional tobacco products, including e-cigarettes. Retrieved from: http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm394667.htm

4. Overview of the Family Smoking Prevention and Tobacco Control Act: Consumer Fact Sheet. Retrieved from: http://www.fda.gov/TobaccoProducts/GuidanceComplianceRegulatoryInformation/ucm246129.htm

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