JUUL Tries to Avoid FDA Sanctions

Nov. 15, 2018

The Food and Drug Administration on Thursday announced a series of restrictions aimed at combating a growing public health menace — flavored e-cigarettes and tobacco products that have lured young people into vaping and smoking.

And in a bold regulatory move, the agency said it would move to outlaw two traditional tobacco products that disproportionately harm African-Americans: menthol cigarettes and flavored cigars.

The proposed menthol ban would be the most aggressive action the F.D.A. has taken against the tobacco industry in nearly a decade, and it was notable given the Trump administration’s business-friendly approach to regulatory issues. But the proposal is likely to face a protracted legal battle, so it could be years in the making.

The effort to cut off access to flavored e-cigarettes stopped short of a ban that the F.D.A. had threatened in recent months as it sought to persuade e-cigarette makers like Juul Labs to drop marketing strategies that might appeal to minors. The agency said it would allow stores to continue selling such flavored products, but only from closed off-areas that would be inaccessible to teenagers.

Approximately 3.6 million people under 18 reported using e-cigarettes, the agency said.

“Almost all adult smokers started smoking when they were kids,” Dr. Scott Gottlieb, the agency’s commissioner, said in a statement. “Today, we significantly advance our efforts to combat youth access and appeal with proposals that firmly and directly address the core of the epidemic: flavors.”

Still, the plan to sequester flavored e-cigarettes in stores, rather than ban selling them, was surprising to many people since details of a stronger proposal leaked out widely from the agency over the past week. Members of Congress sent out news releases, praising the agency for a ban that did not materialize. Federal law already prohibits the sale of cigarettes and e-cigarettes to anyone under 18.

But lawyers said the agency did not have the legal authority to impose such a ban without going through a long, complicated process that would have inevitably ended up in court.

In trying to navigate between public health concerns about nicotine addiction among teenagers and a reluctance to heavily restrict e-cigarettes that can help adult smokers quit, Dr. Gottlieb urged manufacturers to police themselves. “We hope that in the next 90 days, manufacturers choose to remove flavored ENDS products”— referring to the devices — “where kids can access them and from online sites that do not have sufficiently robust age-verification procedures,” he said in the statement.

The mere threat of a ban, which he suggested two months ago, led e-cigarette makers in recent days to announced plans of their own that go beyond what the F.D.A. laid out on Thursday.

Juul Labs, which is by far the largest e-cigarette seller, said the agency’s plans would not change its decision, announced this week, to suspend store sales of its flavored pods, except for mint, menthol and tobacco, and to shut down its social media promotions. In addition, the company said it would toughen its online age-verification requirements. But it left the door open to resume sales at thousands of convenience stores, gas stations and other outlets across the country, if the retailers use age verification technology, including scanning customer IDs.

Public health advocates said they were disappointed with the F.D.A.’s new vaping measures.

“Does this mean a simple curtain with a sign like we used to see at the entrance to the pornography section of video stores?” asked Matt Myers, president of Campaign for Tobacco-Free Kids.

Azim Chowdhury, a lawyer who represents vape manufacturers and vape shops, said that one way for the shops to continue to sell all flavors without walling off displays was to restrict entire stores to consumers 18 and older, a policy that many of his clients were already following.

“The F.D.A. seems to be recognizing the value that these products have for adults,” he said. “My clients don’t want kids to use them either. But adults enjoy flavors, too.”

Dr. Gottlieb insisted that the restrictions were akin to a ban. “This policy will make sure the fruity flavors are no longer accessible to kids in retail sites, plain and simple,” he said. “That’s where they’re getting access to the e-cigs and we intend to end those sales.”

When asked whether a fair interpretation of the new rules might be that convenience stores could sell flavored e-cigarettes as long as the products are under the counter, out of sight and inaccessible to minors, Lyle Beckwith, a spokesman for the National Association of Convenience Stores, a trade group, said that he had no comment on that possibility.

The F.D.A. said it would provide more detail on how to restrict access at a later date. But Dr. Gottlieb said putting the vaping products under counters would not be sufficient. “What we are envisioning is a separate room or a walled-off area,” he said. “It needs to be a complete separate structure. A curtain won’t cut it.”

Industry lawyers challenged the commissioner’s authority to impose such requirements. “The Tobacco Control Act is clear that the F.D.A. can’t discriminate against one type of retail outlet and that’s what they’re trying to do here,” said Doug Kantor, counsel to the National Association of Convenience Stores. “There is a very good chance this will end up in litigation and lawyers are looking at that right now.”

Critics said that exempting menthol and mint e-cigarettes from the restriction was misguided, because of the large number of youth vapers who buy them.

But Mr. Chowdhury considered Juul’s pre-emptive move to limit visible flavors to mint, menthol and tobacco shrewd. If indeed a ban on menthol cigarettes is enacted, he said, “Juul is in a good position to offer an alternative product for smokers who are used to their menthol flavor. Because Juul has market dominance, they stand to benefit from an ultimate ban.”

But a prohibition against menthol cigarettes would have to clear the usual federal regulatory hurdles, a process that could take at least two years. If successful, the menthol ban could make a significant dent in cigarette sales. Menthol cigarettes account for about 35 percent of cigarette sales in the United States.

Murray Garnick, the general counsel for Altria Group, which sells vaping products like MarkTen Elite and Apex through its Nu Mark subsidiary, said in an email that the tobacco giant welcomed the F.D.A.’s new e-cigarette policies.

But, he predicted a lengthy debate over the proposed prohibition on menthol cigarettes: “We continue to believe that a total ban on menthol cigarettes or flavored cigars would be an extreme measure not supported by the science and evidence.”

The other major tobacco companies have all made clear to the F.D.A. that they will fight any ban on menthol cigarettes — as they have for many years. The scientific evidence does not support treating menthol cigarettes differently from others, said RJ Reynolds, the nation’s largest producer of menthol cigarettes, including Newport. Imperial Brands, the maker of Kools and blu vaping devices, also said it would oppose a menthol ban.

Flavored e-cigarette and vape products in a store window in Manhattan. Several e-cigarette manufacturers said they would halt orders of most flavors until shops and stores imposed tighter age restrictions on consumers.CreditJoshua Bright for The New York Times

Kenneth Warner, a public health professor emeritus at the University of Michigan, and longtime tobacco expert, disagreed emphatically with the argument that there isn’t enough evidence to rid the market of menthol.

“The science is very strong,” Dr. Warner said. “This is what the tobacco industry was saying a couple of decades ago about lung cancer — the science wasn’t strong enough.”

Menthol, he said, does not cause disease but it does lure more people to smoking and make it more difficult to quit. “If you would remove it,” he said, “you would avoid many smoking-caused deaths.”

While smoking rates among adults have reached record lows in the United States, about 34 million people still smoke and about 480,000 die each year from cigarette-related deaths, according to the Centers for Disease Control and Prevention.

Several of the major tobacco companies have developed alternatives to traditional cigarettes as the smoking rates declined and e-cigarettes became popular. Bonnie Herzog, a Wells Fargo analyst, said tobacco sales for the past year amounted to about $60 billion, with the burgeoning market for e-cigarettes, vaping devices and related products reaching about $6.6 billion.

Ms. Herzog, a tobacco analyst for Wells Fargo, said it was unlikely that the F.D.A. would succeed in getting menthol cigarettes banned, saying the agency would encounter political opposition as well as industry resistance.

The industry contends that restricting sales of flavored e-cigarettes will make it harder for adults to reduce their health risks by substituting them for traditional, combustible cigarettes.

“Flavors are important for switching,” said Dr. Moira Gilchrist, a scientist with Philip Morris International, which wants to sell its IQOS heat-not-burn device in the United States in tobacco and menthol flavors, during a visit to Washington last month for an F.D.A. public meeting.

She added: “The focus should be on what is the right thing to do for the 40 million men and women in the United States would otherwise continue to smoke cigarettes.”

The tobacco industry has fought to protect menthol for many years, to the frustration of public health activists, especially in the African-American community. Menthol is particularly popular among black smokers, and black leaders have accused the tobacco industry of targeting African-American communities in marketing campaigns.

In a statement circulated upon news of the ban, the NAACP, National Urban League, the National Medical Association, and the African American Tobacco Control Leadership Council said a menthol ban is long overdue.

“While we’re saddened by the number of lives lost and new smokers addicted over the past decade, we’re pleased that the F.D.A. is moving in this direction,” said Delmonte Jefferson, executive director of the National African American Tobacco Prevention Network. The group also praised the agency for taking on flavored cigars.

“Little cigars like Black & Milds and Swisher Sweets are heavily marketed to African Americans and are often cheaper in our neighborhoods,” said LaTroya Hester, a spokesman for the network. “A lot of young, black kids don’t know that cigarillos are just as dangerous, so hopefully this will send that message. This is a huge step in protecting their health — it’s about time our young people are prioritized.”

Published by Tobacco Stops With Me on November 29, 2018