FDA to ban sale of e-cigarettes to minors, enact other tobacco product regulations

Rule extending oversight to all tobacco products, including e-cigarettes, allows agency to address public health concerns such as youth access to tobacco products

On May 5, 2016, the US Food and Drug Administration finalized a rule extending its authority to all tobacco products, including e-cigarettes, cigars, hookah tobacco and pipe tobacco, among others.

“We have more to do to help protect Americans from the dangers of tobacco and nicotine, especially our youth. 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 HHS Secretary Sylvia Burwell. “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.”

While there has been a significant decline in the use of traditional cigarettes among youth over the past decade, their use of other tobacco products continues to climb. 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 skyrocketed from 1.5% in 2011 to 16% in 2015 (an over 900% increase) and hookah use has risen significantly. Additionally, a joint study by the FDA and the National Institutes of Health shows that from 2013–2014, nearly 80% of current youth tobacco users reported using a flavored tobacco product in the past 30 days—with the availability of appealing flavors consistently cited as a reason for use.

Previously, there was no federal law prohibiting retailers from selling e-cigarettes, hookah tobacco or cigars to people under age 18. This rule changes that with provisions aimed at restricting youth access, which go into effect in 90 days, including:

• 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.
  

These new rules will help the FDA prevent misleading claims by tobacco product manufacturers, evaluate the ingredients of tobacco products and how they are made, as well as communicate their potential risks.

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 February 15, 2007. The tobacco product review process gives the agency the ability to evaluate important factors such as ingredients, product design and health risks, as well as their appeal to youth and non-users.

“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,” said 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.”—FDA press release 5 May 2016