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A Project of The Annenberg Public Policy Center

Q&A on the FDA’s Flavored E-Cig Policy

After months of considering a complete ban on flavored electronic cigarettes, the Trump administration announced a new policy on Jan. 2 that soon will forbid the sale of some, but not all, flavored vapes.

According to the Food and Drug Administration, the agency responsible for the policy, the change is an attempt to limit the alarming rise in the use of e-cigarettes by teens — who overwhelmingly prefer flavors — while balancing the potential benefits to adults who already smoke.

E-cigarettes may be able to help existing smokers get off combustible cigarettes, which are regarded as more harmful than the electronic versions. But mounting evidence suggests vaping has lured millions of American teens into nicotine addiction and has led some to start smoking.

Separately, a new law, signed by President Donald Trump on Dec. 20, immediately raised the federal minimum age for purchasing tobacco products — including nicotine vaping products — from 18 to 21.

We’ll explain the FDA’s new policy and review the evidence on whether e-cigarettes are likely to have a positive or negative impact on public health.

What is the new vaping policy?

The new policy doesn’t change the letter of the law surrounding vaping, since from the FDA’s perspective, all vapes, as newer tobacco products, need agency authorization to be on the market legally. But in practice, the policy prohibits the production, distribution and sale of all flavored cartridge-based e-cigarettes, with the exception of menthol and tobacco flavors, after Feb. 6. 

After that date, unless a manufacturer can show that an unauthorized flavored cartridge is “appropriate for the protection of public health” and receive FDA authorization, the product will not be allowed on the market. There are no penalties for vape users.

Cartridges, or pods, are enclosed units that hold vaping liquid that when heated in an e-cigarette is aerosolized into a breathable vapor. These designs are very popular among teens, and include the sleek and easy-to-hide Juul devices, which resemble USB sticks.

The policy does not apply to tank-style vapes, which are larger and run on refillable e-liquids that are customizable at adult-only vape shops.

The FDA also said it would take action against e-cigarette manufacturers if they do not take adequate measures to prevent teen access, or if they market to minors, regardless of whether their products are flavored or cartridge-based.

Driving the new policy change is data indicating that American teens are increasingly being drawn to vape products. Results from the 2019 National Youth Tobacco Survey, for example, suggest that around 5.3 million high school and middle school students are current e-cigarette users.

Is the new policy a ban?

The FDA does not consider its policy to be a ban. As explained in a press release, the agency is open to authorizing a flavored or cartridge e-cigarette for sale in the future if the product meets the standards set out in what’s called a premarket authorization. A company would have to show, for example, that the e-cigarette is not overly attractive to youth or other users who do not already smoke.

“The FDA has already accepted and begun review of several premarket applications for flavored ENDS products,” the release says, referring to electronic nicotine delivery systems, an acronym for e-cigarettes.

Nevertheless, University of Maryland Carey School of Law professor Kathleen Hoke told us she was skeptical that any non-menthol flavored pod product would receive premarket authorization. “I do think that long term, the effect of this will be permanent,” she said in a phone interview.

Still, because the prohibition applies to only a subset of flavored vape products, she felt it was also inappropriate to call the FDA’s policy a ban. 

Many of the targeted products have already been pulled from the market voluntarily. Juul, for instance, has not sold any of its fruit or candy flavors since October, and in November the e-cig behemoth also withdrew its mint flavor, leaving only its tobacco and menthol-flavored pods on the market.

Does this mean all other vaping products are legal?

No. Technically, all vape products are on the market illegally, even the ones the FDA has not singled out in its new policy. That’s because to be legal, a product would’ve had to receive premarket authorization, and no e-cigarette product has yet received such authorization. 

Companies and stores have nevertheless been allowed to sell e-cigarettes to legal-age customers because the FDA decided not to enforce the premarket authorization requirement — at least, not yet.

In part because of the regulatory limbo, the new flavored e-cig policy is actually what the FDA refers to as a “guidance” document, which notifies the industry that the agency will be prioritizing its enforcement actions against certain vaping products. In this way, the agency is informing the industry that it will no longer tacitly permit specific vapes, as it has been doing for several years.

The agency first gained the ability to regulate e-cigarettes in 2016, and the FDA then asked for manufacturers to submit their premarket authorization applications within two years. Companies would be allowed to continue to sell their vaping products for a year after submission to allow the FDA time for review.

But over time, the application deadline shifted, Hoke said, extending to 2022, then back to 2021. In July 2019, a court set May 12, 2020, as the last date for submissions.

Rather than wait for that process to conclude, the FDA has essentially decided with its new policy to at least temporarily remove from the market the flavored products the agency believes are most appealing to children.

Why are menthol-flavored pods still allowed?

Although the FDA originally proposed a menthol-inclusive policy, the agency ultimately decided against it, pointing to the results of a 2019 publication that found relatively few middle and high schoolers preferred the flavor.

That paper, which was published in the Journal of the American Medical Association in November, used survey results from the NIH’s Monitoring the Future study that asked kids who had “Juuled” in the past 30 days about their flavor preferences. Around 6% or less of 8th, 10th and 12th graders said menthol was the flavor they used “most often.” Mango, mint and fruit flavors were far more popular.

“Because of the relatively low numbers of youth using both menthol- and tobacco-flavored, cartridge-based ENDS products, these products are not among the current enforcement priorities,” the FDA explained in its release.

Most other surveys, including the annual National Youth Tobacco Survey, have grouped mint and menthol flavors together, making it difficult to trace the popularity of the individual flavors. The collective category of mint and menthol, however, has gained popularity over time. In the 2018 NYTS, for example, 38% of high schoolers who used e-cigarettes but not other tobacco products reported using mint or menthol flavors in the last 30 days; in the 2019 survey, the percentage surged to 57%.

Many public health advocates were disappointed that menthol was not included as a targeted flavor because they think it’s likely that teens will simply swap mint pods for menthol ones.

“Menthol and mint aren’t all that different,” said Hoke, who is also director of the Network for Public Health Law’s Eastern region. She noted that teens have already appeared to exchange flavors before.

For example, while many previous studies have shown that the most popular flavors of e-cigarettes among youth are fruit flavors, the JAMA report revealed that the most popular Juul flavor among high schoolers was mint, with 44% of 10th graders and 47% of 12th graders who used Juul reporting it as their most frequently used flavor. Among eighth graders, 29% reported mint as their most often used flavor, behind only mango. 

The JAMA survey was conducted between February and June 2019 — after Juul said it had pulled its fruit and candy flavors from retail stores, but before those flavors were eliminated from the company’s online store. The findings led Juul to end sales of its mint flavor.

Adam Leventhal, an addiction psychologist and public health scientist at the University of Southern California and a co-author on the JAMA paper, said in a phone interview that there “are no data” on whether or not teens would make the mint-to-menthol switch, but there is “reason to be concerned.”

In the release accompanying the FDA’s policy, the agency warned manufacturers that if it became aware of an increase in youth-use of other flavors or styles not targeted by the policy, it would “take additional steps to address youth use of those products.”

What has the Trump administration’s position been on e-cigarettes?

Initially, the Trump FDA was ready to ban all types of flavored e-cigarettes, including menthol, given concerns about youth use. In September 2019, HHS Secretary Alex Azar announced the administration’s intention to target non-tobacco-flavored e-cigarette products. 

At the time, Azar did not differentiate between cartridges or pods and open tank designs, and in a meeting at the White House, he said the FDA planned to remove “all flavored e-cigarettes, other than tobacco flavor.” Trump was on board with the plan.

But over the next few months — and following lobbying efforts from the industry and others — the administration changed tactics. The Washington Post reported that the night before a scheduled press conference in early November, Trump scrapped the plan because of the potential for lost vape shop jobs and votes from vapers.

Does the flavor policy exempt products other than menthol pods and open-tank vape juices?

The FDA’s policy does not explicitly address single-use disposable vapes. Former FDA Commissioner Scott Gottlieb noted this potential oversight in a Jan. 4 Washington Post editorial. “[I]n my reading of the FDA’s new policy, it could exempt certain self-contained, disposable e-cigarette products,” he wrote. “These sleek devices — including one called Puff Bar — deliver a high nicotine hit, come in fruity flavors and are rapidly gaining popularity among kids.”

Hoke said that while the single-use products are not terribly common now, given the impending flavor prohibition on pods, teens might make the switch. “Water flows, right?” she said. “Young people find their way. And so if you leave open a tiny hole, a market can blossom.”

When asked about this, an FDA spokesperson said in an email, “Generally speaking, e-liquids that are not sold in a cartridge or pod are not intended to be included in the final guidance’s description of cartridge-based ENDS products.” She added, however, that the agency “intends to prioritize enforcement against any ENDS product – regardless of whether it is cartridge-based, disposable, or flavored – that is targeted to minors or whose marketing is likely to promote use of ENDS by minors.”

Are e-cigarettes less harmful than combustible cigarettes?

Yes, according to the Centers for Disease Control and Prevention, e-cigarettes are less dangerous than combustible ones, although the agency cautions that this does not mean that e-cigs are safe — particularly for certain groups. “E-cigarettes are not safe for youth, young adults, pregnant women, or adults who do not currently use tobacco products,” the CDC says.

One of the main reasons regular cigarettes are so hazardous to human health is because they are burned. The process of combustion ultimately creates upwards of 7,000 toxins in cigarette smoke, including cancer-causing carcinogens. Smoking causes not only lung cancer, but also heart disease, stroke, diabetes, chronic obstructive pulmonary disease and numerous other cancers, according to the CDC.

With vaping, the chemicals in e-liquids, which generally include addictive nicotine, flavorings and other ingredients needed to make the aerosol, are heated, but not burned. Heating generates some additional chemicals, but fewer than with cigarettes.

A 2018 National Academy of Sciences report on e-cigarettes found that there is “substantial evidence” that with typical use, the exposure to potentially toxic substances, other than nicotine, from vaping is “significantly lower” compared with traditional cigarettes.

For this reason, some public health experts view e-cigarettes as a potential form of harm reduction, in which the risks of smoking are mitigated, if not entirely eliminated.

But scientists still have much to learn about what is in e-cigarette vapor, and how dangerous it might be, especially over the long term.

“The toxins are far lower and fewer than what you see in combustible cigarettes,” Leventhal said of e-cigarettes, “the caveat being that combustible cigarettes are one of the most deadly consumer products ever created.”

As the CDC explains on its website, e-cigarette vapor still contains “harmful and potentially harmful substances, including nicotine, heavy metals like lead, volatile organic compounds, and cancer-causing agents.”

As we’ve noted before, what is clear is that teens are especially at risk from e-cigarettes because nicotine can harm the developing brain. Nicotine is also detrimental to developing fetuses.

Do e-cigarettes introduce young people to smoking?

One of the biggest concerns public health officials have about vaping is that it will lead people who never would have smoked to pick up the habit.

There is some evidence to suggest this could be the case, although it is also clear that as vaping has become more popular, smoking rates have declined.

In 2018, the National Academy of Sciences reviewed the existing studies and concluded there is “substantial evidence” that e-cig use increases the risk of young people ever smoking, and “moderate evidence” e-cigarettes increase the frequency and intensity of smoking in young people who previously did not smoke. 

In all 10 of the observational studies reviewed, the NAS identified a positive association between vaping and switching over from never to ever using cigarettes. While suggestive, these types of studies cannot definitively show that e-cigarettes are causing young people to smoke.

A more recent study, published last February in the journal JAMA Network Open by Leventhal and others, tracked the same group of kids over several years, asking about e-cigarette and other tobacco use. The study found that teens who started using e-cigarettes were about four times more likely to have tried cigarettes two years later, and three times more likely to be current smokers, compared with those with no prior tobacco use. The authors concluded that more than 15% of current cigarette use among U.S. youth may be attributable to e-cigarettes.

Nevertheless, there are unsettled debates among researchers about how to explain the available data and trends, and there are different patterns of use in other countries, indicating that the regulatory and cultural context matter. 

In the United Kingdom, where e-cig products and marketing have been more highly regulated, teens have not taken up vaping the way they have in the U.S., and public health officials there actively encourage people to swap combustible cigarettes for electronic ones.

Do e-cigarettes help people quit smoking?

Anecdotally, many smokers have reported that e-cigarettes have made it possible for them to call it quits, but there isn’t much rigorous research on the subject yet.

Leventhal, the USC addiction researcher, said there was only one very well-done study so far, and while the results were positive, time will tell whether the findings are robust or not. 

The study was a randomized trial of nearly 900 smokers in the U.K. that pitted vaping against existing nicotine replacement therapies, including those in combination, for helping people get off cigarettes.

Published online last January in the New England Journal of Medicine, researchers found that after one year, 18% of the e-cig group no longer smoked cigarettes, compared with just 10% of the nicotine replacement group. All participants were part of the country’s National Health Service and received at least four weeks of behavioral counseling.

While the results suggest e-cigarettes can be more effective than traditional smoking cessation aids, researchers have questioned how applicable the results will be to America, where there isn’t a universal health care system to provide as much support, and where there are no limits on the amount of nicotine in vapes.

The NEJM study also found that 80% of the people in the e-cigarette group who were not smoking at the one-year mark were still vaping, compared to 9% of the nicotine replacement group that was still using replacement products. That indicates a large majority of e-cigarette users were unable to fully transition to a nicotine-free life.

A subsequent study in France, which followed what happened to smokers and former smokers after the introduction of e-cigarettes in the country in 2010, found mixed results. While e-cigarette use was associated with a greater likelihood of quitting smoking and a larger decrease in the number of cigarettes smoked, it also nearly doubled the chance of a smoking relapse among former smokers.

In 2018, before the NEJM study was published, the National Academy of Sciences concluded that overall, there was “limited evidence” that e-cigarettes are effective smoking cessation tools.

The CDC states on its website that e-cigarettes “may help” non-pregnant adults quit smoking, “if used as a complete substitute for all cigarettes and other smoked tobacco products,” but notes that the U.S. Preventive Services Task Force has found insufficient evidence to recommend e-cigs for smoking cessation. 

Experts generally recommend that people try FDA-approved smoking cessation products, such as nicotine patches, gum or medicines, before turning to e-cigarettes.

What about the outbreak of vaping-related lung injuries that began in 2019?

Along with the concern about mounting teen use of e-cigarettes, one backdrop for the push for additional e-cigarette regulation is the outbreak of vaping-related lung injuries that began in June 2019.

Known as e-cigarette, or vaping, product use-associated lung injury, or EVALI, the outbreak peaked in September and is still ongoing, according to the CDC. As of Jan. 7, more than 2,600 people in the U.S. have been hospitalized for the condition, and 57 people have died.

While experts caution that no vaping product has been cleared, research suggests the primary culprit is vitamin E acetate, an additive linked to THC vaping liquids, especially black market ones. THC is a psychoactive ingredient in marijuana.

Vitamin E acetate is not usually harmful if it’s eaten or applied to skin; the substance is found in a variety of foods, and is also used as a dietary supplement and is an ingredient in many skin creams. But when inhaled, research suggests the compound can prevent the lungs from functioning normally.

In a December CDC study, scientists identified vitamin E acetate in 48 of 51 of the lung fluid samples from EVALI patients, compared with none of the samples from healthy controls. The researchers suspect the chemical might interfere with lung surfactant — a natural film that helps with breathing — or that heating of the compound might create a lung irritant. Vitamin E acetate is thought to be added to THC vapes as a cutting agent because it has a similar viscosity, or thickness, to THC oil.

The CDC recommends that no one vape any THC liquids or those known to contain vitamin E acetate. Although the best course of action is to stop vaping entirely, the agency does not suggest that people who vape go back to cigarettes.

Correction, Jan. 31: We initially gave an incorrect start date for the new policy. The effective date is Feb. 6, or 30 days from publication in the Federal Register.