miércoles, 25 de mayo de 2016

New E-Cigarette Regulations, FDA Creates Final Rule

New E-Cigarette Regulations, FDA Creates Final Rule


Earlier this month the Food and Drug Administration (FDA) announced a final rule that will extend its authority to all products that meet the statutory definition of “tobacco product,” including e-cigarettes, cigars, hookah tobacco, and pipe tobacco. When the regulation is in place, it will prohibit the sale of all tobacco products to anyone under the age of 18 years – both in person and online. In addition, it will subject all manufacturers, importers, and retailers of newly-regulated tobacco products to any applicable provisions, bringing them in line with other tobacco products that the FDA has regulated since 2009. This includes reporting ingredients and harmful and potentially harmful substances. The final rule also said “[the] FDA envisions that there could be tobacco products developed in the future that provide nicotine delivery through means (e.g., via dermal absorption or intranasal spray) similar to currently marketed medicinal nicotine products, but which are not drugs or devices,” and therefore predictively included these in the definition of “tobacco products.”

Some Background on E-cigarettes

An electronic cigarette (eCig or e-cigarette) is a battery powered appliance that simulates cigarette smoking, but administers nicotine through a vapor. People using an e-cigarette are referring to it as “vaping” – not smoking, as with tobacco cigarettes. The device uses a liquid solution of nicotine and flavorings, inhaled when the e-cigarette is used. Marijuana concentrates can also be added to the liquid solution to vape. When the user exhales, an aerosol intended to resemble smoke is visible.
E-cigarettes have been in the marketplace since 2003 and, until now, there was no regulatory oversight. Manufacturers, many of which also produce traditional cigarettes, market e-cigarettes as a less-harmful alternative and a cessation tool for those wanting to quit. In addition, teen use of e-cigarettes is on the rise. According to the FDA, e-cigarette use for youth in high school increased nearly 800 percent from 2011 to 2014. The addictive nature of nicotine and exposure to the nicotine solution in the device raised questions regarding the benefits and risks of e-cigarettes, both to users and to the people around them – and especially for adolescents. Now, the FDA has stepped in to put some controls in place.

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