MONDAY, Aug. 8, 2016 (HealthDay News)—The sale of e-cigarettes to minors is banned as of today, as part of the U.S. Food and Drug Administration's long-awaited plan to extend the agency's regulatory powers across all tobacco products.
The new rules halt the sale of e-cigarettes and any other tobacco product to anyone younger than 18.
The regulations also require photo IDs to buy e-cigarettes and ban retailers from handing out free samples or selling them in all-ages vending machines.
The rules also cover other alternative forms of tobacco like cigars, hookah tobacco and pipe tobacco.
Electronic cigarettes are battery-operated devices designed to create an aerosol that delivers nicotine, flavor and other chemicals when inhaled by the user. Manufacturers have marketed the products as a way to help smokers quit cigarettes. But, opponents contend that the nicotine-laden e-cigarettes actually encourage people—especially vulnerable teens—to pick up the smoking habit.
"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, which had gone largely unregulated," Mitch Zeller, director of the FDA Center for Tobacco Products, said during a media briefing when the oversight was announced in May.
The FDA action earned universal praise from medical associations, which have been concerned that e-cigarettes serve as a gateway drug to draw teenagers into a lifetime of smoking addiction.
"Youth use e-cigarettes more than any other tobacco product on the market today, serving as an entry point to more traditional tobacco products and placing kids at risk to the harms and addiction of nicotine and other tobacco products," Harold Wimmer, national president and CEO of the American Lung Association, said in May. "Ending the tobacco epidemic is more urgent than ever, and can only happen if the FDA acts aggressively and broadly to protect all Americans from all tobacco products."
E-cigarette manufacturers also will not be allowed to promote the devices as a healthy alternative to smoking, unless they provide strong scientific evidence that supports the claim, Zeller said.
Studies have shown that as many as 70 percent of current adult e-cigarette users also continue to smoke tobacco cigarettes and may be using the devices to flout indoor clean air laws, Zeller said.
Until now, e-cigarettes and other alternative tobacco products have gone unregulated by the FDA, despite a 2009 law that granted the agency the authority to govern any tobacco sold in the United States.
Manufacturers of e-cigarettes also will be required to submit new and existing products to the FDA for review and evaluation, unless the product was sold prior to Feb. 15, 2007.
That grandfathering date means that 99 percent of all e-cigarette and "vaping" products now on the market will have to be submitted for FDA review, according to a statement by the Smoke-Free Alternatives Trade Association, an e-cigarette trade group.
The FDA anticipates that existing e-cigarette brands will have at least three more regulation-free years on the market—two years while manufacturers prepare their product application and another year for FDA review.
"The FDA is providing regulated entities with time to comply with these regulations," said FDA Commissioner Dr. Robert Califf.
E-cigarette trade associations condemned the new regulations.
The Smoke-Free Alternatives Trade Association stated in May: "Today's final rule pulls the rug out from the 9 million smokers who have switched to vaping, putting them in jeopardy of returning back to smoking, which kills 480,000 Americans each year and costs the U.S. more than $300 billion in annual health care expenses. These new regulations create an enormously cost-prohibitive regulatory process for manufacturers to market their products to adult smokers and vapers," crippling a "multibillion job-creating industry."
SOURCES: May 5, 2016, media briefing, U.S. Food and Drug Administration; statements, American Lung Association, American Academy of Pediatrics, American Vaping Association; Smoke-Free Alternatives Trade Association
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