FDA Bans Sale Of E-Cigarettes To Minors; Requires Health Warnings

After a prolonged, seven-year process of drafting regulations for e-cigarettes, the Food and Drug Administration has finalized rules that treat e-cigs, hookah tobacco, pipe tobacco, and premium cigars the same as traditional cigarettes and cigars.

The FDA’s first step in regulating the popular alternative to traditional cigarettes includes banning sales to minors and requiring manufactures to put health warnings on the devices.

While the FDA released proposed rules in April 2014, prior to today’s announcement there was no federal law prohibiting retailers from selling e-cigarettes, hookah tobacco, or cigars to people under age 18.

Under the new rules, which will go into effect in 90 days, manufacturers and retailers will not be allowed to sell these products to people under 18 years of age; will be required to verify age by photo ID; will not be allowed to sell these products in vending machines; and can not distribute free samples.

The rules also require manufacturers of all newly-regulated products, to show that the products meet the applicable public health standard set forth under the Family Smoking Prevention and Tobacco Control Act (TCA) of 2009, and receive marketing authorization from the FDA, unless the product was on the market as of Feb. 15, 2007.

Through the review process, manufacturers would be required to submit separate applications for every e-cigarette, different flavor, and nicotine level.

This will take time, the FDA says, noting that it plans to allow manufacturers to continue selling their products for up to two years while they submit information, and up to one additional year while the FDA completes its review.

Under the reviews, the FDA will use science to weigh the potential benefits of e-cigarettes against any potential health risks, for both the individual users and the whole population.

Like all previously regulated products, to receive approval through the FDA review, manufactures must register and provide product listing to the agency; report ingredients and harmful and potentially harmful materials; undergo premarket review and authorization; place warnings on product packages and advertisements; and refrain from selling modified risk products — “light,” “low,” or “mild” — unless authorized by the FDA.

Mitch Zeller, director of the FDA’s Center for Tobacco Products, says that the rule announced today lays the foundation for regulating non-traditional tobacco and nicotine-delivery products, and defends the FDA’s drawn-out process from critics who believe these rules could have been finalized more expeditiously.

“The agency considered a number of factors in developing the rule and believes our approach is reasonable and balanced,”Mitch Zeller, director of the FDA’s Center for Tobacco Products, said in a statement. “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.”

In 2009, the FDA sought to impose restrictions on the devices, which it described at the time to be medical devices designed to deliver nicotine, but a federal court struck down that attempt. The following year, the agency declared it had the power to regulate the devices under its authority to regulate tobacco products.

E-cigarettes, and their potential health risks, have been at the center of heated debate between supports and opponents of the devices.

Companies who manufacture the devices believe they should be exempt from FDA regulations, contending it would stifle innovation, damage small businesses, and hurt consumers trying to quit smoking.

Still, there is no clear data on the health impact associated with the devices. Supporters contend that the devices help consumers stop smoking traditional cigarettes, while opponents argue the devices are attractive to teenagers and secondary risks, such as poisoning and a tendency for the devices to explode, could be more deadly than traditional cigarettes.