U.S. FDA considering ban on flavored e-cigarettes
- Author: Eleanor Harrison Sep 16, 2018,
Sep 16, 2018, 13:15
Such a step would be a major blow to the e-cigarette companies - Juul, Vuse, Blu, Logic and MarkTen - which often feature cream and fruit flavorings in their products.
"I now have good reason to believe that it's reached nothing short of an epidemic proportion of growth", Gottlieb said.
As of September 1, the FDA said it has conducted 978,290 retail inspections, issued 77,180 warning letters to retailers for violating the law, and initiated 18,560 civil money penalty cases in its checks of retail establishments selling tobacco products.
Under Wednesday's announcement, the five largest e-cigarette manufacturers will have 60 days to produce plans to reverse underage use of their products.
The FDA furthermore centered Juul stores this spring, issuing 56 warning letters and 6 civil monetary penalties. The agency had for decades had no power to regulate cigarettes or other tobacco products, but Congress passed a law in 2009 giving FDA limited power to do so.
Dr. Gottlieb said his agency's aggressive posture may create obstacles for adults who use e-cigarettes as substitutes for traditional smokes, but he added that he is willing to pay that price to stop children from getting hooked on tobacco.
Last year, the FDA announced that it would delay regulations that could have halted the sales of many e-cigarettes. The agency may require the companies to revise their sales and marketing practices, to stop distributing products to retailers that sell to kids and to stop selling some or all of their flavored e-cigarette products until the companies clear the application process. Gottlieb said at the time he was trying to ease the regulatory pathway for products that are potentially less harmful sources of nicotine than smoking. It is considering restricting e-cigarette manufacturers from selling flavored nicotine liquid or making the products undergo an agency review.
Fervent on an "epidemic" surge in teen employ of e-cigarettes, the highest of the US Meals and Drug Administration launched this day a "ancient action" against more than 1,300 stores and five predominant producers for their roles in perpetuating formative years access to the devices in the US. Of the 3.6 million middle and high school students who said in 2017 they were tobacco product users, 2.1 million used e-cigarettes, Bloomberg reports, citing CDC stats. As part of today's action, the agency sent an additional 12 warning letters to another 12 companies that continue to sell the products.
The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. "We can not allow a whole new generation to become addicted to nicotine".
The steps announced Wednesday are just the initial elements of these new efforts, Gottlieb said.
Ana Navas-Acien, a Columbia University professor who also tracks the issue, said some form of government regulation is needed "as companies are unlikely to implement voluntary strategies to effectively cut use among youth".
Shares of British American Tobacco were up almost 6 percent and shares of cigarette-maker Imperial Brands PLC were up more than 3 percent. "We're seriously considering a policy change that would lead to the immediate removal of these flavored products from the market", Gottlieb said in a speech at FDA headquarters. They're generally considered a less unsafe alternative to regular cigarettes. The companies insist that the flavors are critical to helping nicotine-addicted adult smokers switch from conventional cigarettes. That data has not been released publicly yet, with the data coming from the early stages of the National Youth Tobacco Survey.