FDA Issues Rule Extending Oversight To E-Cigarettes And Other Tobacco Products

The U.S. Food and Drug Administration (FDA) finalized a rule today that extends its authority to include all tobacco products, including e-cigarettes, cigars, hookah tobacco and pipe tobacco, among others, restricting the sales of these products to minors nationwide.

“We have more to do to help protect Americans from the dangers of tobacco and nicotine, especially our youth,” says HHS Secretary Sylvia Burwell. “As cigarette smoking among those under 18 has fallen, the use of other nicotine products, including e-cigarettes, has taken a drastic leap. All of this is creating a new generation of Americans who are at risk of addiction. Today’s announcement is an important step in the fight for a tobacco-free generation—it will help us catch up with changes in the marketplace, put into place rules that protect our kids and give adults information they need to make informed decisions.”

A recent survey supported by the FDA and the Centers for Disease Control and Prevention shows current e-cigarette use among high school students has climbed from 1.5 percent in 2011 to 16 percent in 2015. Prior to the FDA’s rule, there was no federal law prohibiting retailers from selling e-cigarettes to people under age 18. The rule’s provisions are aimed at restricting youth access and go into effect in 90 days. They include:

  • Not allowing products to be sold to persons under the age of 18 years (both in person and online)
  • Requiring age verification by photo ID
  • Not allowing the selling of covered tobacco products in vending machines (unless in an adult-only facility)
  • Not allowing the distribution of free samples

The rule also requires manufacturers of all newly regulated products to show that the products meet the applicable public health standard set forth in the law and receive marketing authorization from the FDA, unless the product was on the market as of Feb. 15, 2007. The tobacco product review process gives the agency the ability to evaluate factors such as ingredients, product design and health risks, as well as their appeal to youth and non-users.

Under staggered timelines, the FDA expects that manufacturers will continue selling their products for up to two years while they submit—and an additional year while the FDA reviews—a new tobacco product application. The FDA will issue an order granting marketing authorization where appropriate; otherwise, the product will face FDA enforcement.

Today’s actions will subject all manufacturers, importers and/or retailers of newly  regulated tobacco products to any applicable provisions, bringing them in line with other tobacco products the FDA has regulated under the TCA since 2009.

“This final rule is a foundational step that enables the FDA to regulate products young people were using at alarming rates, like e-cigarettes, cigars and hookah tobacco, that had gone largely unregulated,” says Mitch Zeller, J.D., director of the FDA’s Center for Tobacco Products. “The agency considered a number of factors in developing the rule and believes our approach is reasonable and balanced. Ultimately our job is to assess what’s happening at the population level before figuring out how to use all of the regulatory tools Congress gave the FDA.”

filed under industry-news | may-2016
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