The federal Food and Drug Administration imposed new regulations on e-cigarettes, hookahs and other tobacco products.
The FDA’s Center for Tobacco Products finalized rule announced on May 5 regulates e-cigarettes, dissolvables, pipe tobacco, hookah tobacco, cigars and extends to novel and future products.
The rule helps implement the bipartisan Family Smoking Prevention and Tobacco Control Act of 2009 and allows the FDA 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.
“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. She went on to say it is an important step in the fight for a tobacco-free generation – to help catch up with changes in the marketplace, put into place rules that protect children while giving adults information they need to make informed decisions.
“We know very little about what chemicals the e-cigarettes contain and the health effects of chronic inhaled exposure to those chemicals. It is very likely that many of the chemicals contained in these products will adversely affect user’s lungs or other organ systems,” SLUCare pulmonologist David Stoeckel, M.D. said. “Presently, I advise my patients not to use e-cigarettes. Hopefully, oversight by the FDA will help answer questions regarding the short and long term effects of e-cigarette use.”
Stuart Sweet, M.D., medical director of the pediatric lung transplant program at St. Louis Children’s Hospital, said the FDA decision to regulate e-cigarettes, and prohibit sales to minors, is a critical first step in warding off the threat they pose to our children.
“In addition to the risks nicotine poses to the developing adolescent brain, e-cigarettes can serve as a gateway for other tobacco products and substance abuse,” Sweet added. “The FDA rule will hopefully stem this tide, however, children’s health will remain at risk as long as products such as these continue to appeal to our youth.”
The final rule goes into effect on August 9 and will subject all manufacturers, importers and retailers of newly-regulated tobacco products to any applicable provisions related to tobacco products in the Federal Food, Drug, and Cosmetic Act and FDA regulations, 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; and
- Not selling modified-risk tobacco products (including those described as “light,” “low,” or “mild”) unless authorized by the FDA.
In addition, there are several provisions aimed at restricting youth access to tobacco products, 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 tobacco products in vending machines (unless in an adult-only facility); and
- Not allowing the distribution of free samples.
Smoking is the leading cause of preventable disease and death in the United States and 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.
“Too many children and teens are using e-cigarettes, cigars and other tobacco products,” said Harold P. Wimmer, National President and CEO of the American Lung Association. “At last, the Food and Drug Administration will have basic authority to make science-based decisions that will protect our nation’s youth and the public health from all tobacco products, including e-cigarettes, cigars and hookah.”
