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It has finally been announced that starting in 2016 the FDA will begin regulation of ENDS (Electronic Nicotine Delivery Systems).  The debate over the health effects of ENDS is still ongoing.  Since ENDS are still relatively new, there are not many health studies, and certainly no long term studies of what exactly are the health risks.


In 2016, FDA finalized a rule extending our regulatory authority to cover all tobacco products, including vaporizers, vape pens, hookah pens, electronic cigarettes, e-pipes, and all other ENDS. FDA now regulates the manufacture, import, packaging, labeling, advertising, promotion, sale, and distribution of ENDS. This includes components and parts of ENDS but excludes accessories.


FDA also has regulations to directly affect the manufacture of ENDS and the liquids used; a required nicotine warning statement; the retail sale of ENDS, E-Liquids, or their components or parts made or derived from tobacco; shops that mix E-Liquids on the premises; the importation on ENDS and E-Liquids; and the reporting of adverse experiences and product violations.


These new regulations come from alarming statistics concerning ENDS use:

  • More than 3 million middle and high school students were current users of e-cigarettes in 2015, up from an estimated 2.46 million in 2014.
  • Sixteen percent of high school and 5.3 percent of middle school students were current users of e-cigarettes in 2015, making e-cigarettes the most commonly used tobacco product among youth for the second consecutive year.
  • During 2011-2015, e-cigarette use rose from 1.5 percent to 16.0 percent among high school students and from 0.6 percent to 5.3 percent among middle school students.
  • In 2013-2014, 81% of current youth e-cigarette users cited the availability of appealing flavors as the primary reason for use.
  • In 2014, 12.6% of U.S. adults had ever tried an e-cigarette, and about 3.7% of adults used e-cigarettes daily or some days.

For a complete list of resources, restrictions and statistics please visit http://www.fda.gov/TobaccoProducts/Labeling/ProductsIngredientsComponents/ucm456610.htm

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