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 a year ago in the Monitoring the Future Study, which began in 1975. "And we're seriously considering a policy change that would lead to the immediate removal of these flavored products from the market".
In a release, the FDA said it's taking "historic action" against companies that it believes promotes use and addiction of their products to young vapers.
In a speech at FDA headquarters, Commissioner Scott Gottlieb said the agency would also revisit its compliance policy that extended the dates for manufacturers of flavored e-cigarettes to submit applications for premarket authorization. "It's that simple", Gottlieb said in a statement.
The organisation warned the country's five largest e-cigarette makers that their products - Juul, Blu, MarkTen, Vuse and Logic - could be banned unless the companies could prove within 60 days that they had effective plans to stop sales to children. Gottlieb is talking about reneging on the FDA's four-year extension of the deadline for seeking regulatory approval to continue selling e-cigarettes, which would wreak havoc with a market that he concedes has great potential for reducing smoking-related disease and death.
The FDA's suggestions include rigorous age verification procedures for online direct sales (which Juul, the market leader, says it already has) and "discontinuing sales to retail establishments that have been subject to an FDA civil monetary penalty for sale of tobacco products to minors within the prior 12 months". As part of that plan, Gottlieb has suggested some smokers could be directed toward alternative products that deliver nicotine without the carcinogens of cigarettes.
"Let me be clear: Everything is on the table", said Gottlieb.
"JUUL Labs will work proactively with FDA in response to its request", the company said in a statement.More news: Hurricane Florence strengthens to Category 4
"They come out with cherry flavored vodka and birthday cake flavored vodka".
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The agency said it allowed the extra time to strike an appropriate balance between regulation and encouraging the development of innovative tobacco products that may help older smokers quit. "I think education is the answer to fixing the problem, just like how we have educated young people about alcohol and other tobacco products over the years", Delaney said.
"Today we can see that this epidemic of addiction was emerging when we first announced our plan last summer", said Gottlieb.
According to the Campaign for Tobacco-Free Kids' president Matthew Myers, the FDA has made a crucial step toward curtailing youth use of e-cigarettes. "Hindsight, and the data now available to us, reveal these trends".
Shortly after the launch, the FDA cracked down on e-liquids marketed to resemble kid-friendly foods like juice boxes, candy and cookies. The companies insist that the flavors are critical to helping nicotine-addicted adult smokers switch from conventional cigarettes. Today's effort notches up that action, becoming, said Gottlieb, the "largest ever coordinated initiative against violative sales in the history of the FDA". The agency issued 12 warning letters to companies they declared have deceptive marketing labels on e-liquids.