FDA plans to impose severe restrictions on e-cigarettes


The Food and Drug Administration, alarmed by a huge increase in vaping among minors, is expected to impose severe restrictions on the sale of e-cigarettes products throughout the United States — actions that will likely have a significant impact on an industry that has grown exponentially in recent years with little government oversight.

As soon as next week, FDA Commissioner Scott Gottlieb is expected to announce a ban on the sale of most flavored e-cigarettes in tens of thousands of convenience stores and gas stations across the country, according to senior agency officials. The agency will also impose such rules as age-verification requirements for online sales, the officials say

The FDA moves are being spurred by preliminary government data showing e-cigarette use rose 77 percent among high schoolers and nearly 50 percent among middle schoolers in 2018. That means 3.5 million children were vaping in early 2018, up 1 million from 2017.

Gottlieb, who once served on the board of a North Carolina vaping company, was at one time viewed as an ally of the e-cigarette industry, and delayed some critical e-cigarette rules shortly after becoming commissioner in 2017. He has also said his first priority is protecting children from tobacco-related disease. Most vaping products are flavored, and studies show teenagers are attracted to the flavors.

“We now have evidence that a new generation is being addicted to nicotine, and we can’t tolerate that,” he said, referring to the vaping data in an interview before he made his final decision on e-cigarette policy.

The only exception to the flavored-products ban in convenience stores involves menthol e-cigarette products. The FDA will continue to permit sales of the flavor because menthol is permitted in regular cigarettes as well, and the agency doesn’t want to give traditional cigarettes an advantage over e-cigarettes in the retail setting.

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Gottlieb’s actions apply to a specific kind of vaping product that dominates the youth market — e-cigarettes that use prepackaged flavor cartridges, or pods. That includes the wildly popular vaping products by Juul Labs. The restrictions don’t apply to the “open-tank” systems available in vape shops.

Research indicates many e-cigarette users are likely to get addicted to nicotine and some will likely end up on regular cigarettes, a product that kills half of its long-term users. Moreover, the long-term health consequences of vaping is not known.

At the same time, vaping devotees and “harm-reduction” advocates have said e-cigarettes represent a powerful tool in helping adult smokers to quit more dangerous cigarettes. They have warned making it harder for adults to buy e-cigarettes — or depriving them of flavored products — will be detrimental.

“We have to be really careful not to overreact to the youth problem,” said David Abrams, professor of social and behavioral sciences at New York University.

Juul, which accounts for more than 70 percent of the retail market, is sold in tens of thousands of retail outlets.

Gottlieb’s steps will almost certainly be denounced as too aggressive by the industry and too weak by public health groups and Democratic lawmakers, whose election victory will likely embolden them in efforts to curb youths’ use of e-cigarettes.

The tobacco-control groups are demanding restrictions on marketing and a ban on all e-cigarette flavors until manufacturers can prove that such flavors benefit public health by helping adults quit smoking regular cigarettes without increasing youth vaping.

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“As long as the FDA allows these companies to peddle these flavors, you will see a steady increase in kids addicted to this product,” said Sen. Richard J. Durbin (D-Ill.) in a recent interview.

Gottlieb has resisted an across-the-board ban because he wants to ensure that flavored products are available to adults who want to use them as aids in quitting regular cigarettes. Such devices could be a potentially less harmful source of nicotine, he said.

“We know that adults transition off combustible products and that flavors play a role in that,” he said in a recent interview. “We don’t want to foreclose the opportunity for adults to get these products.”

Adult smoking rates in the U.S. dropped to their lowest level last year, at 14 percent, continuing a long downward trend after a peak in 1965, but cigarettes still kill an estimated 480,000 Americans per year.

The flavored e-cigarette products will still be available in vape and tobacco shops, which the FDA believes are more careful about verifying the age of the purchasers. Under federal law, tobacco products can’t be sold to people under 18. In some states and localities, the age is higher.

Gottlieb also is expected to warn that further restrictions might be in order if the youth use of e-cigarettes doesn’t start to decline.

FDA officials, who recently conducted a crackdown on underage retail sales of e-cigarettes to minors and are investigating whether products are being sold illegally, were alarmed by the number of violations in convenience stores.

Greg Conley, president of the American Vaping Association, a consumer group, has stressed the importance of having e-cigarettes available to adults in convenience stores and online — especially those who live in rural areas that might not have access to vape shops. “Severely restricting the availability of these devices does not seem to be in the interest of public health,” he said.

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Convenience store interests already have started questioning Gottlieb’s legal ability to restrict the sale of e-cigarettes to a specific type of store.

Juul, a sleek e-cigarette introduced in 2015, has taken much of the blame for the rise in youth use. A technical and design breakthrough, the e-cigarette looks like a USB flash drive and, in a break from past vaping products, delivers high levels of nicotine that are smooth, not harsh. Each of its pods, which come in flavors such as mango and cucumber, provides as much nicotine as a pack of cigarettes.

The company’s early marketing strategy included a launch party with attractive young models whose images were shared widely on social media sites like Twitter and Instagram.

Today, the company is engulfed in a backlash resulting from the spike in youth use. Company officials say that the early marketing campaign was short-lived and didn’t have an impact on sales.

Now the San-Francisco-based company is running full-page advertisements touting its role to help smokers quit. The ads carry the tag­line, “The alternative for adult smokers.”It also has pledged $30 million to reduce underage use. And, along with four other e-cigarette makers, it is planning to submit plans to Gottlieb on cutting youth use.





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