Sunday, January 5, 2020

FDA bans sale of most flavors in cartridge-based e-cigarettes; menthol flavor still allowed, against health advocates' advice

By Melissa Patrick
Kentucky Health News

The Trump administration has announced a ban on the sale of flavored e-cigarettes except for menthol and tobacco-flavored products for cartridge-based systems, like pods produced by Juul, the leading manufacturer. The ban does not include flavors in tank systems sold in vape shops.

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The U.S. Food and Drug Administration said in a news release that it made these concessions to support adults who use e-cigarettes as a quit-aide for traditional cigarettes.

“By prioritizing enforcement against the products that are most widely used by children, our action today seeks to strike the right public health balance by maintaining e-cigarettes as a potential off-ramp for adults using combustibles tobacco while ensuring these products don’t provide an on-ramp to nicotine addiction for our youth. We will not stand idly by as this crisis among America’s youth grows and evolves, and we will continue monitoring the situation and take further actions as necessary," Department of Health and Human Services Secretary Alex Azar said in a news release.

The FDA has not approved any e-cigarette product as a smoking cessation method and the website says, "So far, the research shows there is limited evidence that e-cigarettes are effective for helping smokers quit."

President Trump suggested in September that his administration would ban all flavors from the market except for tobacco, but backed off after protests from users, retailers and manufacturers.

On Dec. 31, two days before the policy announcement, Trump told reporters that the the new policy would protect both families and the industry,

"We're going to protect our families, we're going to protect our children and we're going to protect the industry. It's become a very big industry. We're going to take care of the industry," said Trump, adding that some products could "very quickly" return to the market.

Trump was referring to an FDA review process that requires manufacturers of new tobacco products put on the market since Aug. 8, 2016, to submit pre-marketing authorization applications by May 12, 2020 for their review. This process could allow some of the products that fall under the enforcement action of this policy to be approved and re-enter the market, including flavors.

Vaping advocates have said a full ban on flavored e-cigs would put vape shops out of business, and hurt adults who are trying to use the devices to quit.

Health advocates are more concerned about the public health impacts of these products, especially related to the surge in teen use which has been driven by the flavors. They have urged the Trump administration to take all flavored products, including menthol, off the market.

The FDA release says it didn't ban menthol because a 2019 federal survey found that fruit and mint flavors were the two most popular e-cigarette flavors among teens, with menthol least favored.

The 2019 "Monitoring the Future" study found that menthol was among the least popular flavors among students, at less than 2.3% for eighth graders, less than 3% for 10th graders, and less than 6% for high-school seniors.

However, public-health officials worry that the absence of other flavors will result in a shift toward menthol products, citing the National Youth Tobacco Survey, which shows that youth use of mint and menthol e-cigarettes increased in 2019 after Juul restricted its other flavors.

More than 6 million U.S. middle and high school students are current users of tobacco products, and 5.3 million of them, or 85 percent, are using e-cigarettes, according to the latest annual National Youth Tobacco Survey.

The latest data for e-cigarette use by Kentucky teens, from 2018, shows e-cig use had nearly doubled from 2016, with more than one in four high-school seniors and one of seven eighth-graders reporting they used the devices, the Kentucky Incentives for Prevention study found.

In an analysis of the FDA's industry "guidance" document, Stanton Glantz, director of University of California, San Francisco's Center for Tobacco Control Research and Education, pointed out that it has nothing to keep e-cig companies from simply re-labeling mint-flavored e-cigs as menthol. "After all, menthol is derived from mint," he writes.

The American Medical Association called the policy a step in the right direction, but added that it didn't go far enough.

“If we are serious about tackling this epidemic and keeping these harmful products out of the hands of young people,” the association said in a statement, “a total ban on all flavored e-cigarettes — in all forms and at all locations — is prudent and urgently needed,” adding that it was “disappointed that menthol flavors — one of the most popular — will still be allowed.”

A statement from the Campaign for Tobacco-Free Kids said the policy "falls woefully short of the bold action the administration promised" to address the youth e-cigarette epidemic. Further, it called the policy a win for the e-cigarette industry, saying the Trump administration had sided with "Juul, Altria, [which owns 35% of Juul], the vape shops and other e-cigarette interest over our kids."

"By leaving menthol flavored e-cigarettes widely available and totally exempting liquid flavored products, this policy will not stop the youth e-cigarette epidemic," said the organization's president, Mathew L. Myers. "It is a capitulation to both Juul and vape shops and gives a green light to the e-cigarette industry to continue to target and addict kids with flavored products."

Glantz also expressed concern that a product called Suorin, an e-cig that is highly popular with kids that is sold empty and has refillable pods, would be exempted. Further, he noted that the industry guidance states that "self-contained, disposable products," like the Puff Bar e-cigarette, which is also popular with teens, would be exempt. The Campaign for Tobacco-Free Kids adds that the Smok product, which is an open-pod, refillable system used by teens, would also be exempt.

Glantz called for localities and cites to keep passing laws to end the sale of all flavored tobacco products, but this is not possible in Kentucky because state law preempts local laws on sale, use and distribution of tobacco products.

On Dec. 20, Trump also signed, as part of the year-end spending bill, a measure that prohibits the sale of tobacco products to anyone under the age of 21. The FDA issued a statement on the same day saying the new age limit went into place immediately.

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