Wednesday, 12 September 2018

F.D.A. Cracks Down on Juul and E-Cigarette

Juul and E-Cigarette

FDA cracks down on Juul and e-cigarette retailers

WASHINGTON — The Food and Drug Administration on Wednesday warned that teenage use of electronic cigarettes has reached "an epidemic proportion," and it gave Juul Labs and four other manufacturers 60 days to prove they will keep their devices faraway from minors.

If they do not, the agency said, it's going to remove their flavored products from the market.

The order was a part of a sweeping government action that targeted both makers and sellers of e-cigarettes.

The agency said it had been sending warning letters to 1,100 retailers — including 7-Eleven stores, Walgreens, Circle K convenience shops and Shell gas stations — and issued another 131 fines, starting from $279 to $11,182, for selling e-cigarettes to minors.

Federal law prohibits selling e-cigarettes to anyone under 18.

during a briefing with reporters, the FDA commissioner, Dr. Scott Gottlieb, said that quite 2 million middle and high school students were regular users of e-cigarettes last year.

The government's tactics underscore a dilemma within the public health community:

In addressing one public ill-health — cigarette smoking, which kills 480,000 people in us annually — e-cigarettes are creating another — hooking teenagers who haven't smoked on nicotine?

E-cigarette users inhale far fewer toxic chemicals than do smokers of traditional cigarettes.

But they will absorb higher levels of nicotine, which is addictive.

"The developing adolescent brain is especially susceptible to addiction," the FDA said in its statement announcing the actions.

Gottlieb said the FDA would look closely at whether manufacturers were allowing bulk purchases of products through their own websites — a practice where the customer could then sell to minors.

If such "straw sales" are happening, it should be readily apparent to the manufacturers, he said.

"If the businesses do not know, or if they do not want to understand, we'll now be helping to identify it for them."

If necessary, he continued, the FDA would bring criminal or civil charges.

In an emailed statement, a Juul spokeswoman said: "Juul Labs will work proactively with the FDA in response to its request.

We are committed to preventing underage use of our product, and that we want to be a part of the answer keep e-cigarettes out of the hands of children ."

The other four products facing the 60-day deadline are RJR Vapor Co.'s Vuse, Imperial Grand's blu, and devices made by Logic. They said they were working with the FDA as well.

RJR, Imperial, and Altria are all major tobacco companies.

As smoking rates have declined, the industry sees e-cigarettes as a crucial piece of its survival, an incontrovertible fact that makes some publicly health mistrustful.

"They say they've changed from the times of Joe Camel," Gottlieb said.

"But check out what's happening immediately, on our watch and on their watch.

They need to demonstrate that they're truly committed to keeping these new products out of the hands of youngsters ."

Gottlieb has said repeatedly he believes that e-cigarettes and similar products referred to as electronic nicotine delivery systems could also be effective options for adults who want to prevent smoking but still crave nicotine.

But he said teenage vaping has become so concerning that regulators may need to curb the supply of the devices to stay them out of the hands of youths.

"Inevitably what we are getting to need to contemplate are actions that will narrow the off-ramp for adults who see e-cigarettes as a viable alternative to flammable tobacco in order to shut the on-ramp for teenagers," Gottlieb said. "It's an unfortunate trade-off."

Gottlieb's aggressive approach against private industry is unusual for a politician within the business-friendly Trump administration which has sought to roll back numerous environmental and health regulations.

But critics said that his the decision last summer to extend a deadline for e-cigarette manufacturers to demonstrate that their products comply with public health concerns helped perpetuate the present problem.

"It's nice they need to try to something but realistically, what are they getting to accomplish this way once they might be such a lot simpler by following the regulatory plan that had been able to put into place which the commissioner postponed?" said Diana Zuckerman, president of the National Center for Health Research, a nonprofit health policy group.

She also pointed to the recognition of vaping among young adults.

Researchers generally believe that the adolescent brain continues to develop through age 26.

"It's an enormous epidemic among people ages 18 to 30, too, " she said.

The attorney general of Massachusetts, Maura Healey, who recently began an investigation into the marketing and sale of e-cigarettes to minors praised the FDA's action.

"We've worked too hard over the past 50 years to scale back smoking rates among young people to let these companies profit off of getting them hooked on nicotine," Healey said.

"This move by the FDA may be a good initiative to pack up companies targeting minors."

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