Thursday, May 5, 2016

E-Cigarettes Will Be Subject To FDA Regulation - Law360

The FDA should regulate marijuana too.  - gwc
E-Cigarettes Will Be Subject To FDA Regulation - Law360
by Emily Field
Law360, New York (May 5, 2016, 11:08 AM ET) -- The U.S. Food and Drug Administration on Thursday announced that it's finalized a rule that expands its ability to regulate all tobacco products — including e-cigarettes, hookah and pipe tobacco, and cigars — and bars retailers from selling those products to juveniles under 18 years old.

Before Thursday, there was no federal law preventing the sale of e-cigarettes, cigars or hookah tobacco to minors, the FDA said. The rule — which will go into effect in 90 days — will require manufacturers to show the agency that tobacco products brought to market after February 2007 meet federal public health standards and to submit an application to market their new tobacco products.

The agency will take into account ingredients, product design and health risks, as well as the attraction of e-cigarettes and other tobacco products to young people and non-smokers.

"As cigarette smoking among those under 18 has fallen, the use of other nicotine products, including e-cigarettes, has taken a drastic leap," U.S. Health and Human Services Secretary Sylvia Burwell said in a statement. "All of this is creating a new generation of Americans who are at risk of addiction.”

The FDA first proposed the long-awaited regulations under the Family Smoking Prevention and Tobacco Control Act — the 2009 law that empowered the agency to oversee manufacturing standards for tobacco products — in 2014. At the time, the FDA had only regulated e-cigarettes sold for therapeutic purposes, which are overseen by the FDA's Center for Drug Evaluation and Research.

In the absence of federal regulation, various states had taken their own approaches to regulating the booming new market of e-cigarettes, battery-operated products that convert nicotine and other chemicals into an aerosol that users inhale.

E-cigarette makers have tended to market the products as a safer option to traditional cigarettes, but the FDA said that since the regulations were first proposed there have not been enough studies to show if that is true, or even how much nicotine or other potentially harmful chemicals its users inhale.

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