FDA asserts reg authority over e-cigarettes, other products
The U.S. Food and Drug Administration yesterday finalized a rule extending its authority to all tobacco products, including e-cigarettes, cigars, hookah tobacco and pipe tobacco. The rule helps implement the bipartisan Family Smoking Prevention and Tobacco Control Act of 2009 and allows the FDA to restrict the sale of these tobacco products to minors nationwide.
A new generation at risk
“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.”
Smoking is the leading cause of preventable disease and death in the United States and is responsible for 480,000 deaths per year. 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 percent in 2011 to 16 percent in 2015 (an over 900 percent increase) 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. Additionally, a joint 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 consistently cited as a reason for use.
What will change
Previously, there was no federal law prohibiting retailers from selling e-cigarettes, hookah tobacco or cigars to people under age 18. The 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); and
- Not allowing the distribution of free samples.
“We’ve been waiting seven years for this day,” said American Public Health Association (APHA) Executive Director Georges Benjamin, MD, although he called the action “bittersweet,” because c-cigarette manufacturers remain unrestricted from online sales and marketing, specifically of sweet flavors such as cotton candy and gummy bears designed to appeal to young people. “We know kids will remain exposed to nicotine and tobacco products. For far too long, big tobacco has used savvy marketing and regulatory loopholes to sell dangerous products, and we have suffered the consequences as a nation.”
The rule 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.
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 issue an order granting marketing authorization where appropriate; otherwise, the product will face FDA enforcement.