FDA tobacco products regulations

Are Retailers and Manufacturers Ready for the FDA’s New Authority over E-cigarettes?

In June 2009, the U.S. Congress passed the Family Smoking Prevention & Tobacco Control Act, which gave the U.S. Food & Drug Administration (FDA) authority to regulate the manufacturing, distribution, and marketing of tobacco products. On June 16, 2016, a new rule was passed extending the FDA’s regulatory authority to all tobacco products, including e-cigarettes, electronic nicotine delivery systems (ENDS), cigars, hookah products, pipe tobacco, nicotine gels, and dissolvables that were not previously under its authority. The new rule requires new health warnings, bans free samples, and limits youth access to tobacco products. The main goals of the new rule are:

  • To prevent young people from starting to use such products
  • To help consumers better understand the risks of using these products
  • To prohibit false and misleading claims
  • To prevent new tobacco products from being marketed unless manufacturers can demonstrate their products meet relevant public health standards

There has been a major decline in youth purchases of traditional cigarettes over the past decade, but their use of other tobacco products is rising. E-cigarette use among American high school students has grown from 1.5% in 2011 to 16.0% in 2015 (over a 900% increase), and the use of hookah has also increased dramatically among teens, according to the U.S. Centers for Disease Control and Prevention.

Any manufacturers that began selling such products before February 15, 2007, will have to show that their products meet public health standards set by the law. Those manufacturers will need to receive marketing authorization from the FDA in order to continue selling tobacco products. The agency is allowing two years where manufacturers will be allowed to sell tobacco products while they submit new tobacco applications and one additional year for the FDA to review the applications.

Retailing Electronic Cigarettes and Vaporizers: U.S. Channel Analysis and Opportunities will provide an overview of the changing retail landscape of the dynamically growing electronic cigarettes and vaporizers market through detailed channel, retailer, and e-tailer profiles. The report will focus on market trends and dynamics for 2015 and 2016, as well as provide an outlook to 2021 and include an analysis of the e-cigarettes and vaporizers market, covering all product categories including disposable and rechargeable e-cigarettes, personal vaporizers, electronic cigars, e-shisha, pipes, and other related products.

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