(CNN) – The US Food and Drug Administration (FDA) today announced a "historical action" against more than 1,300 retailers and five large manufacturers seeking youthful access to e-cigarette devices in the United States.
"I use the word epidemic with great care," said FDA Envoy Dr. Scott Gottlieb. "E-cigs have become an almost ubiquitous – and dangerous – trend among teenagers, and the disturbing and accelerating use we see in adolescence and the resulting path to addiction must end – it's just unacceptable."
A "historical" action
Gottlieb announced that the agency sent 1,100 warning letters to shops selling illegal e-cigarettes to under-18s and imposed 131 fines on businesses that continue to violate restrictions on minors.
Gottlieb called the action "historic" and said it was the largest coordinated enforcement effort in the history of the agency.
Juul and four other manufacturers, of whom Gottlieb said they control 97% of the market, must now come up with plans to reduce youth sales within 60 days or counter potential criminal or civil action.
Gottlieb warned that companies may need to change their sales and marketing practices; Stop distributing products to retailers who sell to children; and "take some or all of their flavored e-cig products off the market".
"We focus particularly on the flavored e-cigarettes," said Gottlieb. "And we are seriously considering a change in policy that would lead to the immediate removal of these flavored products from the market."
Gottlieb said that the FDA recognized the effects on adults who wanted to quit smoking, but said that emerging research on how flavored products promote excessive use by young people shows that action needs to be taken.
"I'll make it clear that the FDA will not allow an entire generation of young people to become addicted to nicotine to allow adults unhindered access to these products," said Gottlieb.
Some of the FDA targeted manufacturers – Juul, MarkTen, Vuse, Blu and Logic – agreed to the need to restrict access to minors and to declare their willingness to work with the FDA to find a solution.
Juul Labs, which controls around 70% of the market, said in its statement that "proper flavors" play a role in adults who change their smoking habits, but added that they "want to prevent under-age use of our product and want to be part of Solution to banish e-cigarettes from the hands of young people. "
The Vapor Technology Association, which says it represents more than 600 steam producers and distributors, also supports access to teenagers, but added that the FDA's new actions "ventured into dangerous territory" as they were not in the interest of public health.
In a statement, VTA Executive Director Tony Abboud asked, "Does the FDA really want millions of Americans to return to smoking cigarettes?"
During the 60-day wait, the FDA plans to investigate the marketing and sales practices of the five companies with possible "boots on the ground," said Gottlieb.
The agency will also strengthen nationwide enforcement efforts for e-cigarette sales to minors in convenience stores and other retail outlets, Gottlieb said, looking more closely at a practice called "straw buying" in which adults visit and buy web-based stores in large quantities Minors for sale.
"When young adults go online and buy 100 units of a product to sell to teens, this activity should be easy to identify for a product manufacturer," said Gottlieb. If manufacturers are not ready to do the research, he said the FDA is doing it for them, with reasonable consequences.
"Let me be clear: Everything is on the table," said Gottlieb. "These include the resources of our civil and criminal enforcement tools."
"Must go on"
While applauding the FDA for today's actions, some said the agency should step up its efforts to protect the country's youth from the dangers of fuming.
"We have to go further," said Michael Bloomberg, the billionaire philanthropist who has worked for years to reduce tobacco use.
"The FDA should start regulating flavored e-cigarettes immediately instead of waiting until 2022, as planned," Bloomberg said in a statement.
Dr. Barbara McAneny of the American Medical Association also said the FDA could do much more, promising that the association "would continue to push for stricter guidelines."
US Senate Democratic Whip Dick Durbin and Republican Sentinel Lisa Murkowski called on the FDA to put a stop to delays. In a statement, they called for support for their bipartisan legislation, which was introduced in July, banning flavored cigars and providing for strict controls on e-juice flavors.
A change to the plan
Last year, the FDA announced that it would delay regulations that could have stopped the sale of many e-cigarettes. Instead, the agency gave extensions to new and existing steam products and gave them the opportunity to submit information to support the safety and efficacy of their products as switching devices by August 2022.
The Agency said that the extra time allowed to strike a proper balance between regulation and encouraging the development of innovative tobacco products could help older smokers quit.
At that time, Gottlieb said, the agency had not foreseen the adolescent "epidemic" that had become one of the plan's biggest challenges.
"Today we can see that this epidemic of addiction started when we announced our plan last summer," said Gottlieb. "In retrospect, and the data we have now available, these trends are pointing to."
In April, the Agency launched a Youth Tobacco Prevention Plan, which targets some of the known public health risks, such as flavoring, that contribute to adolescent use of e-cigarettes.
Shortly after launching, the FDA slammed E-Liquids marketed to resemble kid-friendly foods like juice boxes, candy and biscuits. As part of today's action, the agency sent another 12 warning letters to another 12 companies that continue to sell the products.
The FDA also turned to Juul dealers this spring and issued 56 warning letters and six fines. Today's efforts mark this action and will, said Gottlieb, "be the largest ever coordinated initiative against the sale of casualties in the history of the FDA."
The agency said it plans to unveil a new e-cigarette public information campaign focused on youth next week, and soon announces wider access to new nicotine replacement therapies to help more adult smokers quit cigarettes.
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