FDA Unveils New Regulations on E-Cigarettes Amid Spike in Youth Use

By Andrew Simontacchi
Andrew Simontacchi
Andrew Simontacchi
May 5, 2016 Updated: May 5, 2016

On May 5, the U.S. Food and Drug Administration (FDA) extended its authority to all tobacco products.

The extension will place its governing rules into effect in 90 days on: e-cigarettes, cigars, hookah and pipe tobacco, and others, according to an FDA statement.

Retailers will now be barred from selling the aforementioned items to minors—under age 18.

The FDA says smoking is the leading cause of preventable disease and death, responsible for 480,000 deaths per year in the United States.

“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, 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.”

Known as the “Family Smoking Prevention and Tobacco Control Act of 2009,” the FDA plans to expand the act onto the recently more common forms of tobacco and smoking products in an effort to “improve public health and protect future generations from the dangers of tobacco use through a variety of steps, including restricting the sale of these tobacco products to minors nationwide.”

In the release, the United States Department of Health and Human Services Secretary Sylvia Burwell said: 

“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. 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:

  • E-cigarette use among high school students has skyrocketed from 1.5 percent in 2011 to 16 percent in 2015—over 900 percent increase—and hookah usage also has risen significantly.
  • In 2015, 3 million middle and high school students were e-cigarette users, and reports showed high school boys smoked cigars at about the same rate as cigarettes. 
  • A joint study by the FDA and the National Institutes of Health shows that in 2013 to 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 consistently cited as a reason for use.

The ruling will aid the FDA’s efforts to prevent misleading claims by tobacco-product makers, regulate and evaluate the ingredients used, as well as how they are made, and communicate usage risks to the public.

The FDA said in its statement:

“Today’s 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 important factors such as ingredients, product design and health risks, as well as their appeal to youth and non-users.”

Manufacturers will be able to sell the products for 2 years while their applications to become FDA-approved are submitted. The FDA will grant manufacturers one additional year of selling while they’re under review. Upon appropriation, the manufacturer will be authorized to create and sell the product; if not, they will become subject of the FDA’s enforcement. 

“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. That includes ensuring consumers have the information they need to make informed decisions about tobacco use and making sure that new tobacco products for purchase come under comprehensive FDA review.”