New Rule Gives FDA Authority to Regulate E-Cigarettes



The US Food and Drug Administration (FDA) has finalized a rule that extends its authority to all tobacco products, including e-cigarettes, hookah tobacco, and pipe tobacco. This move will help implement the Family Smoking Prevention and Tobacco Control Act of 2009 and let the FDA restrict the sale of these alternative products to minors nationwide.

“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,” said Sylvia Burwell, secretary of the Department of Health and Human Services (HHS).

According to the FDA, smoking is the leading cause of preventable disease and death in the United States and is responsible for 480,000 deaths each year. Smoking also is considered a significant risk factor specifically in oral cancer, which sees 48,250 new diagnoses and 9,575 deaths each year, according to the Oral Cancer Foundation.

Additionally, the ADA reports that smoking presents many other risks to oral health, including stained teeth and tongue, dulled taste and smell, slow healing after tooth extractions and other surgery, difficulties in correcting cosmetic dental problems, and gum disease.

The connections between e-cigarettes and these health issues have yet to be fully determined. However, a report from the FDA and the Centers for Disease Control and Prevention does show that e-cigarette use among high school students has climbed from 1.5% in 2011 to 16% in 2015. Many agencies are cautious that youth alternative tobacco use will lead to use of traditional cigarettes in adulthood.

“Today’s announcement is an important step in the fight for a tobacco-free generation,” said Burwell. “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.”

Previously, there was no federal law prohibiting retailers from selling e-cigarettes, hookah tobacco, or cigars to people under the age of 18. The new rule includes provisions restricting youth access, which go into effect on August 10, including:

  • Not allowing products to be sold to people under the age of 18, neither in person nor via the Internet;
  • Requiring age verification by photo ID;
  • Not allowing the selling of covered tobacco products in vending machines, except in adults-only facilities;
  • Not allowing the distribution of free samples.

The rule also will help the FDA prevent misleading claims by tobacco manufacturers, evaluate the ingredients of tobacco products and how they are made, and communicate their potential risks. Furthermore, the rule requires manufacturers of these newly regulated products to show they meet the applicable public health standards set forth in the law.

These manufacturers also must receive marketing authorization from the FDA, unless the product was on the market before February 15, 2007. The tobacco product review process enables the FDA to evaluate ingredients, product design, and health risks, as well as their appeal to youth and non-users. Manufacturers can still sell their products for up to 2 years while they submit new tobacco product applications to the FDA.

Manufacturers, importers, and retailers of these products are now subject to the same provisions of other tobacco products, including:

  • Registering manufacturing establishments and providing product listings to the FDA;
  • Reporting ingredients and harmful and potentially harmful constituents;
  • Requiring premarket review and authorization of new tobacco products by the FDA;
  • Placing health warnings on product packages and advertisements;
  • Not selling modified-risk tobacco products unless authorized by the FDA.  

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

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