Gottlieb announced a number of steps the agency plans to take as part of a broader crackdown on the sale and marketing of e-cigarettes to minors.
The Food and Drug Administration (FDA) declared teen e-cigarette use an epidemic today, threatening to slap manufacturers including Juul with crushing fines if they don't present plans to curb sales to minors.
A commerce of planLast 12 months, the FDA launched that it may perchance perchance presumably prolong regulations that can non-public halted the gross sales of many e-cigarettes. In May, they were warned, but they are still advertising and selling the violative products.
Manufacturers offer and market e-cigarette flavours that clearly appeal to minors, including candy and bubble gum flavours.
Dr. Scott Gottlieb, the FDA commissioner, said the agency is acting strongly to address the problem of e-cig use among underaged users by sending warning letters to five manufacturers as well as warnings and fines to 1,300 retailers.
Altria Group and British American Tobacco have gained the most intraday since 2008, rising as much as 7.7 percent and 6.9 percent, respectively. The academy said Gottlieb has the authority to intervene in the market to protect minors, and any further delay runs the risk that "a generation of young people will become addicted to these unsafe products".
San Francisco-based Juul said it is working to prevent underage use of its products but added that flavors can help adult smokers quit cigarettes.
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. "It's now clear to me, that in closing the on-ramp to kids, we're going to have to narrow the off-ramp for adults who want to migrate off combustible tobacco and onto e-cigs".
But Gottlieb says sales have soared, especially to teens, who can quickly become addicted to nicotine.
FDA Commissioner Scott Gottlieb has said that e-cigarettes, while still harmful, may be effective for adults who want to give up cigarette smoking, which kills nearly half a million Americans each year.
Officials said the move against more than 1,300 retailers was the largest coordinated enforcement action in the agency's history.
If the blueprints don't promise to "substantially reverse" the youth-use trend, Gottlieb said the agency will consider steps that could lead to the temporary or permanent removal of flavored products from the market.
Juul Labs, which controls about 70% of the market, said in its statement that "appropriate flavors" play a role in adults changing their smoking habits, but added that they "are committed to preventing underage use of our product, and we want to be part of the solution in keeping e-cigarettes out of the hands of young people".
In the absence of such plans, Gottlieb vowed "to revisit the FDA's exercise of enforcement discretion for products now on the market". She said the enforcement is necessary - in particular, for a certain brand of e-cigarettes called "Juul".
In April the agency launched a Youth Tobacco Prevention Opinion, created to take care of some of the crucial identified public successfully being dangers, equivalent to flavors, that make contributions to adolescent employ of e-cigarettes. The agency extended that reach to other tobacco products, including e-cigarettes, in August 2016 and allowed those products that were already on the market to continue sales while preparing an application for FDA clearance.
Gottlieb recently began to ask whether the use of Juul and other similar products by kids is overshadowing any benefit to adult smokers using the devices to help them quit cigarettes.