Finally, the U.S. Food and Drug Administration is taking action on e-cigarettes.
The FDA has finalized a rule that extends its authority to all tobacco products, including e-cigarettes, cigars, hookah tobacco, and pipe tobacco, among others.
The rule helps the agency carry out federal tobacco control laws and allows it to improve public health and protect future generations from the dangers of tobacco use in various ways, including restricting the sale of these tobacco products to minors nationwide.
“We have more to do to help protect Americans from the dangers of tobacco and nicotine, especially our youth,” said Sylvia Burwell, secretary of the Department of Health and Human Services. “As cigarette smoking among those under 18 has fallen, the use of other nicotine products, including e-cigarettes, has taken a drastic leap.”
This is creating a new generation of Americans who are at risk of addiction, Burwell said.
“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.”
Smoking is the leading cause of preventable disease and death in the United States and is responsible for about 480,000 deaths per year. While use of cigarettes among youth has significantly decreased over the past decade, their use of other tobacco products continues to climb.
A survey 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 percent in 2011 to 16 percent in 2015 – an increase of more than 900 percent – and hookah use has risen significantly.
In 2015, 3 million middle and high school students were current e-cigarette users, and data showed high school boys smoked cigars at about the same rate as cigarettes.
In addition, a study by the FDA and the National Institutes of Health shows that in 2013-2014, nearly 80 percent of current youth tobacco users reported using a flavored tobacco product in the past 30 days – with the availability of appealing flavors cited as a reason for use.
Before the rule announced Thursday, no federal law existed prohibiting retailers from selling e-cigarettes, hookah tobacco, or cigars to people under age 18. Thursday’s rule, which goes into effect in 90 days, changes that by:
- Not allowing products to be sold to people 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.
In addition, the rule will help the FDA prevent misleading claims by tobacco product manufacturers, evaluate the ingredients of tobacco products and how they’re made, as well as communicate their potential risks.
It also requires manufacturers of all newly regulated products to show that the products meet the public health standard in the law and to 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 either issue an order granting marketing authorization or apply enforcement actions.
The rule is a new chapter in the FDA’s efforts to end preventable tobacco-related disease and death and is a milestone in consumer protection, said Burwell.
“As a physician, I’ve seen first-hand the devastating health effects of tobacco use,” said FDA Commissioner Robert M. Califf, M.D. “At the FDA, we must do our job under the Tobacco Control Act to reduce the harms caused by tobacco.”
The new rule will bring all manufacturers, importers, and/or retailers of newly- regulated tobacco products in line with other tobacco products the FDA has regulated under the TCA since 2009.
The requirements include:
- Registering manufacturing establishments and providing product listings to the FDA.
- Reporting ingredients, and harmful and potentially harmful components.
- 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, including those described as “light,” “low,” or “mild,” unless authorized by the FDA.
