NewsPublic Affairs / May 5, 2016

FDA Releases First-Ever E-Cigarette Regulations

The rules mean electronic cigarettes will be regulated in the same way as traditional tobacco products.E-cigarettes, FDA2016-05-05T00:00:00-04:00
FDA Releases First-Ever E-Cigarette Regulations

Prior to Thursday, there were no federal rules regulating e-cigarettes.

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The Federal Drug Administration released its first-ever regulations for electronic cigarettes Thursday. The rules mean e-cigarettes will fall under the same regulations as traditional tobacco products.

Prior to Thursday, there were no federal rules regulating e-cigarettes. And the Federal Drug Administration says that made it too easy for them to fall into the hands of teenagers, whose use of the products increased more than 900 percent between 2011 and 2015.

“We know from the history of cigarette smoking the earlier that someone becomes addicted to nicotine the harder it is for them quit later in life,” says FDA Center for Tobacco Products director Mitch Zeller.

The Indiana Youth Institute is applauding the new rules.

“This move by the FDA will provide clarity on the exact ingredients included in e-cigarettes, as well as expressly prohibiting businesses from selling them to minors,” Tami Silverman, president and CEO of the Indiana Youth Institute, said in a statement. “It also will allow the FDA to expose the potential risks to anyone using these products, including teens.”

The regulations means those who make or sell e-cigarettes and e-liquids will be subject to the Tobacco Control Act of 2009. Among other rules, manufacturers will have to report the ingredients of their products and have them reviewed and authorized by the FDA before going on the market.

The rules will apply to all products on the market after Feb. 15, 2007, but manufacturers can continue to sell their products for up to two years while going through the approval process.

Attorney General Greg Zoeller, who pushed for more strict regulations at the state level says the regulations are a step in the right direction but should have been adopted earlier.

“While the rule may be a positive step by the FDA, the two-year delay in the process to reach a final rule and the bureaucratic delays built into the compliance requirements and the length of the review process before any FDA enforcement actions guarantees that nothing will happen in the near future,” Zoeller said in a statement. “My overall complaint is that the FDA has shown more concern for the business of tobacco than the public health risks to youth over four to five years.”

American Vaping Association president Greg Conley says that will force many vape shops to go out of business.

“The actual final rule makes clear that just to get one single product approved is going to cost well over a million dollars, likely several million dollars,” he says. “So the only companies that are going to still be in business two years from now are going to be large cigarette companies that make e-cigarettes.”

The FDA says the highest estimated costs will actually be in the hundreds of thousands of dollars.

The new rules also apply to premium cigars and hookah.



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