Despite the constant warnings that increased experimentation with e-cigarettes would lead to more smoking, consumption of conventional cigarettes by teenagers stubbornly continues to decline, reaching a record low past year in the Monitoring the Future Study, which began in 1975. "So, now, I'm able to tell them, 'I no longer smoke cigarettes'".
Gottlieb called the action the largest coordinated enforcement effort in the agency's history.
Makers argue that e-cigarettes can help adult smokers transition away from burnt tobacco products.
The FDA set a 60-day deadline for five major tobacco manufacturers to provide a plan for mitigating youth sales, or the agency will pull them out of the market. Shares of cigarette and e-cigarette maker Altria Group also rose more than 6 percent, while Philip Morris International shares were up 4 percent. "As students start their new school year, I encourage educators, parents, and health care providers to come together and raise awareness about the dangers of e-cigarettes on our youth, so we can quickly address these troubling trends and put a full-stop to them".
Gottlieb warned action may require companies to change their sales and marketing practices; stop distributing products to retailers who sell to kids; and remove "some or all of their flavored e-cig products from the market".
Gottlieb announced the agency sent 1,100 warning letters to stores for the illegal sale of e-cigarettes to minors under the age of 18, and issued 131 fines to stores that continued to violate the restrictions on sales to minors.
"The FDA will not tolerate a whole generation of young people becoming addicted to nicotine as a trade-off for enabling adults to have unfettered access to these same products", he said.
Other studies have indicated that while e-cigarettes may have milder effects on the lungs, they are just as bad - if not worse - for the cardiovascular system, raising risks of heart disease and high blood pressure.
Gottlieb reiterated his belief that certain e-cigarette liquid flavors - including sweet ones such as mango and cucumber, popular among teenage Juul users - are particularly enticing and even marketed directly to children.
Under regulations developed by the Obama administration, manufacturers were supposed to submit most products for review by August 2018.
Several of the manufacturers targeted by the FDA - Juul, MarkTen, Vuse, Blu and Logic - issued statements agreeing with the need to limit access to minors and announcing their willingness to work with the FDA to reach a solution. Those products could include e-cigarettes, though the FDA has not given any company permission to advertise its device as a quit-smoking aid.
And some of the retailers that received warning letters are still advertising and selling these products, he said. They also show that the nicotine in e-cigarettes is addictive, and that the other chemicals added as part of the flavoring might be harmful.
"In my view, they treated these issues like a public relations challenge rather than seriously considering their legal obligations, the public health mandate and the existential threat to these products, and as they did, these risks have mounted", Gottlieb said.
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