Cigarette smoking among teens and young adults has been on a slight decline in the past few years, but e-cigarette use has been rapidly increasing.
Because there are no regulations and scant information on the products used to fuel e-cigarettes, many leading health organizations, including the American Academy of Pediatrics have been urging the Federal Drug Administration (FDA) to bring e-cigarettes and liquid nicotine under its authority.
The U.S. government has responded and taken action. The FDA issued a tough set of rules for the e-cigarette industry that included banning sales to anyone under 18, requiring package warning labels, and making all products—even those currently on the market—subject to government approval.
For many teen and health organizations, the ruling has been long overdue.
Though the product-approval process will be phased in during three years, that will be little solace to the fledgling but fast-growing $3.5 billion industry that has, until Aug. 8 when the rules take effect, largely been unregulated and dominated by small manufacturers and vape shops.
Many of the vape shops, device manufacturers and liquid nicotine producers are not happy with the change.
“This is going to be a grim day in the history of tobacco-harm reduction,” said Greg Conley, president of the American Vaping Association, an industry-funded advocacy group. “It will be a day where thousands of small businesses will be contemplating whether they will continue to stay in business and employ people.”
In June, the FDA proposed requiring warning labels and childproof packaging because of an increase in nicotine exposure and poisoning incidents. The agency could move to regulate advertising or flavors such as cotton candy and watermelon that also might appeal to youth.
“We’re looking at the flavor issue with e-cigarettes,” said FDA Tobacco Center Director Mitch Zeller during a news conference. Later, he said, that while the agency was aware of “anecdotal reports” that e-cigarettes have helped smokers kick their habit; those benefits were outweighed by concerns about youth using the devices.
E-cigarettes are not the only tobacco related products that will come under the control of the FDA. Unregulated tobacco items, including pipe tobacco and water-pipe tobacco, will also fall under the supervision of the FDA.
The FDA has been regulating cigarettes since Congress granted it oversight of traditional smokes with the 2009 Family Smoking Prevention and Tobacco Control Act.
“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,” Department of Health and Human Services Secretary Sylvia Mathews Burwell said in a statement.
Most researchers agree e-cigarettes are less harmful than cigarettes because, unlike cigarettes, they don’t combust. Studies have shown that when traditional cigarettes combust they release more than 60 carcinogens. But the long-term effects of using the electronic devices remain largely unknown, and many anti-tobacco groups and public health officials are concerned they could become a gateway to traditional smoking.
Anti-tobacco groups have been frustrated with FDA, saying the agency has taken far too long to finalize its rules.
Concerns escalated when a study published in August by the Journal of the American Medical Association found ninth-graders who used e-cigarettes were 2½ times as likely as peers to have smoked traditional cigarettes a year later.
The Centers for Disease Control and Prevention reported in April that e-cigarette use tripled among U.S. teenagers in 2014.
The AAP issued its recommendations on tobacco and e-cigarettes in late 2015.
In a press release, the organization said it strongly recommends the minimum age to purchase tobacco products, including e-cigarettes, should be increased to age 21 nationwide.
"Tobacco use continues to be a major health threat to children, adolescents and adults," said Karen M. Wilson, MD, MPH, FAAP, chair of the AAP Section on Tobacco Control and section head of Pediatric Hospital Medicine at Children's Hospital Colorado. "The developing brains of children and teens are particularly vulnerable to nicotine, which is why the growing popularity of e-cigarettes among adolescents is so alarming and dangerous to their long-term health."
Under the new rules, e-cigarette manufacturers would have up to two years to continue to sell their products while they submit an application to the FDA.
Story sources: Tripp Mickle, Tom Burton, http://www.wsj.com/articles/fda-to-regulate-e-cigarettes-ban-sales-to-minors-1462455060