A week ago, on June 7, 2019 the United States Food and Drug Administration (FDA) issued warning letters to several vaping companies for their marketing programs. They targeted primarily social influencers and their sponsored posts that did not contain mandatory warnings. The posts were on popular social media sites like Facebook, Twitter and Instagram.

The specific companies that received warnings included Solace Technologies LLC (doing business as Solace Vapor), Hype City Vapors LLC, Humble Juice Co. LLC and Artist Liquids Laboratories LLC (doing business as Artist Liquid Labs).

The FDA moved to discipline vaping companies for inappropriately promoting their products to those individuals that are underage. They determined that the e-liquid products were advertised without the proper warnings reading, “WARNING: This product contains nicotine. Nicotine is an addictive chemical,” a requirement that the FDA has enforced since August 10, 2018.

Ironically, Facebook, YouTube and most popular social media sites do not allow companies to “promote” posts or pay for paid advertising; therefore, most vaping companies rely on influencers and other tactics to reach new customers. However, with this further scrutiny vaping companies will need to take additional precautions to ensure they are following proper guidance from the FDA within the United States.

As most people have heard, the FDA is continuing to combat what they have described as an epidemic of underage vaping use. Many studies have been reported to link social media advertising to the surge of vaping among teens as many companies used paid influencers and social media posts to promote their products. Some of these studies reported that there was an 80% jump in vaping among teens last year.

Even though e-cigarettes are becoming more and more recognized for their health benefits, especially compared to traditional tobacco cigarettes there is still a lot of health experts that aren’t jumping on the bandwagon. Health experts primarily point to studies that indicate that nicotine consumed by minors impacts the development of their brains. Furthermore, many politicians and health experts claim that teenagers don’t even realize that popular vaping products contain nicotine.

Moving forward, in the industry, it’s important companies are more vigilant in controlling their advertising and marketing policies. It’s likely that you’ll end up seeing less online marketing as companies fear further complications with the FDA or even financial penalties. Some vaping companies have already cancelled their Facebook, Twitter and Instagram accounts.

India has one of the largest populations in the world and is filled with 100 million adult smokers. So you'd look that the country and their health officials would do anything to prevent the consumption of cigarettes, or at a minimum adopt products that limit its use.

However, India is pushing for bans and regulations of products like e-cigarettes that many other countries consider to be a great, and better, alternative to traditional cigarettes. As much as 13% of the 720,000 annual premature deaths in India are tobacco-related, that's an astonishing number of people.

In 2017, a working group of India’s ministry of health and family welfare assessed the health effects of vaping and quickly determined that Electronic Nicotine Delivery Systems (ENDS), which include e-cigarettes and heat not burn tobacco products, are carcinogenic and just as addictive as combustible cigarettes.

This contradicted nearly every thorough toxicology study conducted in the world. Many leading scientists consider ENDS to carry not more than 5% of the risk of combustible cigarettes, which is why in places like the UK, e-cigarettes are now welcomed as a solution to, rather than a form of, smoking.

In a comprehensive report, released early last year, the United States National Academies of Sciences, Engineering and Medicine explicitly states that there is conclusive evidence that e-cigarettes “reduce users’ exposure to numerous toxicants and carcinogens present in combustible tobacco cigarettes” and that “e-cigarettes result in reduced short-term adverse health outcomes in several organ systems” compared to combustible cigarettes.

Last month, the first heat-not-burn product, IQOS, was granted marketing approval by the US food and drug administration. This means it met the regulator’s rigorous standards, which includes being “appropriate for the protection of public health.”

Regulatory bodies in India that set rules for the import, sales, possession and use of tobacco and ENDS products must strike a balance between potential risks and opportunities for innovative products. This includes appropriate taxation, public use guidelines, enforcing a minimum age for sales, and individual product restriction surrounding flavour choices and nicotine concentration in tobacco or e-cigarette products.

Proper ENDS regulation will incentivise smokers to quit.
Policymakers should never lose sight of the fact that proper ENDS regulation will incentivise smokers to move away from combustible cigarettes.

Giving preferential treatment to combustible cigarettes, the most dangerous form of nicotine delivery, continues to put India’s smokers at risk of premature death, and is increasingly problematic from a legal point of view.

The World Trade Organization (WTO) forbids certain forms of trade discrimination in its General Agreement on Technical Barriers to Trade (GATT). Specifically, imported products must be treated at a par with “like” products manufactured domestically.

Based on the four major criteria set out by the WTO to determine “likeness”—physical properties, end use, consumer perception and tariff classification—ENDS can be considered as “like” combustible cigarettes. The test does not require that the two products be identical; rather, the greater the degree of similarity between the products based on the outlined criteria, the higher the likelihood that those products will be deemed “like.”

Cigarettes and ENDS share physical similarities and consumers perceive the two as performing the same end-use. From this broader perspective, the natural ENDS comparator is the combustible cigarette—the very product that e-cigarettes intend to mimic and compete with.

Now, e-cigarettes are largely imported into India, while combustible cigarettes are produced locally. Under an ENDS ban, the former will be accorded less-favourable treatment, while its domestic counterpart will be available, which creates a legal issue.

Countries with highest smoking-related deaths also rely the most on tobacco revenue. Unfortunately, countries carrying the biggest burden of smoking-related illnesses and deaths also rely the most heavily on tobacco revenue. Tobacco production and sales account for nearly 2% of tax revenue in India and employ nearly 7 million people. It should be acknowledged that imported ENDS products will cut into a revenue stream that India relies on.

However, a cynic might argue that this ill-conceived ban is in fact a nefarious scheme that would enable the government to continue reaping tax from the consumption of combustible cigarettes.

India’s health ministry has simply succumbed to a misinformation campaign that insists that ENDS are just as dangerous as their combustible counterparts. After all, when we start to see the benefits of ENDS in decreasing smoking-related diseases, will anyone be arguing for the continued preferential treatment of combustible tobacco?

E-cigarettes are under fire again as a federal judge ruled the Food and Drug Administration has been lax in reviewing the impact of nicotine delivery systems on vapers’ health, and North Carolina’s attorney general filed a lawsuit against Juul, accusing it of using “unfair and deceptive” marketing practices that has led to an “epidemic” among teenagers.

North Carolina is the first state to take legal action against Juul, which is the dominant brand in the U.S. e-cigarette market, with an estimated market share of 74%, according to Nielsen. The global e-cigarette market was worth $11.26 billion in 2018, and is projected to reach $18.16 billion by 2024, according to Mordor Intelligence.

“In the complaint made in Durham Superior Court, [DA Josh] Stein wants a judge to require Juul to: cease selling e-cigs to N.C. minors; limit the flavors sold in the state; stop advertising and marketing practices that are intended to or likely to appeal to minors; and delete all data for customers whom Juul cannot confirm are at least 18,” Richard Craver writes for the Winston-Salem Journal.

“The complaint cited data that said in 2017 nearly 17% of North Carolina high school students and more than 5% of the state’s middle school students reported that they had used an e-cigarette in the previous 30 days. It also said e-cigarette use among high school and middle school students across the nation skyrocketed by 78% and 48%, respectively, from 2017 to 2018,” Turner continues.

“Several of the state’s requests overlap with existing Food and Drug Administration policies, including prohibiting the sale of Juul and other e-cigarette products to minors. But the state’s complaint goes further: FDA guidelines restrict the sale of fruit or candy flavors in stores, allowing menthol, tobacco and mint to be sold. North Carolina’s request would bring mint off the market in that state, in addition to popular flavors like mango and cucumber,” writes Deanna Paul for the Washington Post.

But the FDA itself was under attack yesterday for what a federal judge characterized as “an abdication of its statutory responsibilities.”

Judge Paul Grimm of the U.S. district court for the district of Maryland ordered the FDA “to speed up its reviews of thousands of electronic cigarettes currently on the market, siding with public health groups that sued the agency,” reports Nathanal Weixel for The Hill.

The lawsuit was filed last year by the American Academy of Pediatrics, the Campaign for Tobacco-Free Kids and other public health groups. “They argued that the FDA's delay in regulating e-cigarette products led a spike in underage vaping,” Weixel adds.

“The FDA gained authority to regulate the products in 2016, but it has allowed thousands of products to remain on the market without formal rules or product standards. The agency says that both FDA staff and manufacturers need more time to prepare for regulation,” writes the AP’s Matthew Perrone.

“Under President Donald Trump’s FDA commissioner, Scott Gottlieb -- who departed last month -- the FDA said it would not require e-cigarette manufacturers to submit their products for review until 2022. Shortly before stepping down Gottlieb moved the deadline up to 2021,” he adds.

“In a meeting w/Acting FDA Commish Sharpless yesterday it became clear he has no intention of taking legal action he’s empowered to take to protect children from the addiction of e-cigarettes. No action would be taken to ban kid-friendly vaping flavors during this President’s term,” Illinois Sen. Dick Durbin, who is the Democratic whip, tweeted yesterday morning before the decision was handed down.

Meanwhile, Juul yesterday filed a notice with the San Francisco Department of Elections “indicating that it intends to collect signatures for a ballot initiative that aims to impose additional restrictions on online and brick-and-mortar e-cigarette retailers,” Catherine Ho reports for the San Francisco Examiner.

"Say what?” you may be saying.

“It might seem strange that an e-cigarette maker would seek restrictions on the use of its product. But tobacco policy experts say it would render other existing or planned city restrictions on tobacco -- like the flavored-tobacco ban and the pending legislation to ban the sale of e-cigarettes -- unenforceable,” Ho explains.

So the uncertainty of the future of the vape industry will continue as further cases undoubtedly will be brought to trial.

The impact of smoking on health is huge, obviously. Half of all lifelong smokers die early because of the habit basically losing 3 months of life expectancy for every year they smoke after the age of 35. Also, most would agree the habit is both physically and psychologically addictive. Vaping has now come along and tries to help people quit smoking; however, the jury might still be out, but Public Health England claims that vaping may be contributing to at least 20,000 smokers quitting every year.

Vaping clearly has its critics (Google vaping news and you’ll 90% of the critics). Medical professionals seem reluctant to encourage smokers to make the switch to vaping despite research from the likes of Cardiff University who showed that vaping does not act as a gateway back to tobacco, nor does it normalize smoking among youth. Similarly, the Royal College of Physicians actually announced these findings back in 2016, and now, Embarrassing Bodies' Doctor Christian Jessen has put his name to a campaign calling on fellow doctors to heed this advice and support their patients to switch from smoking to vaping (what a great idea).

There is a growing list of evidence which shows vaping can reduce smoking related harm and yet despite that, more than half of hospitals across Europe ban vaping on their grounds and the majority US hospitals ban it completely. It’s time we were consistent and gave clear advice to smokers to help combat the misinformation they are all too often bombarded with, about vaping.

A study commissioned by the UK Vaping Industry Association, and the widest to date into the health, financial and social benefits of vaping, found that vapers make an average saving of £346 a year compared to when they were smoking, which could equate to an annual nationwide saving of almost £1.1bn. Plus, the long term impact of vaping might be unknown, but is "likely to be very small, and is substantially smaller than that the implications of smoking," according to the RCP. In fact, the available data suggest the risks are unlikely to exceed 5% compared to the risks of smoking cigarettes and the actual figure may even be lower.

Vaping has already proven itself as a great way for people to quit smoking and for that reason alone we should encourage the habit. We all recognize that this doesn’t help the addition to nicotine but let’s try to reduce the risks that come with traditional cigarettes. This is very similar to our love for riding bicycles that we’d never say is harmful to us but we’d always encourage riders to wear a bicycle helmet to reduce the risk of injury. In similar fashion, we’d encourage smokers to vape to reduce the risks of smoking traditional cigarettes.

If being able to smoke within Disney World or Disneyland was on your bucket list you could now cross it off. Starting today, all forms of smoking, including vaping, are banned from all their U.S. parks including ESPN Wide World of Sports.

Previously, park guests were able to smoke in designated areas inside Disney's parks. Now, smoking will be limited to designated areas outside of park entrances.

All Disney employees will be in charge of smoking enforcement, spokeswoman Erica Ettori said in March when the ban was first announced. She said Disney does not plan to punish visitors if they are caught breaking the rules. They'll be led to the designated areas outside the park and then granted re-entry.

If it feels like it was already rare that you saw smokers in the sea of Mickey Mouse ears, it’s because smoking at Disney was already extremely limited. Magic Kingdom, the world's busiest theme park, only had two designated smoking areas.

While the ban on smoking has grabbed the most attention, it’s not the only change going into effect Wednesday.

Also joining the list of things banned from Walt Disney World will be strollers larger than 31 inches wide and 52 inches long and bags or coolers of loose ice.

Why the bans?

"Walt Disney World Resort makes updates from time to time and the removal of smoking areas is intended to provide a more enjoyable experience for everyone who visits," the company said in the release. "The reduction of stroller sizes is intended to ease guest flow and reduce congestion, making the park experience more enjoyable for everyone who visits."

Disney says the ban on ice is to "streamline the bag-check and entry processes." They recommend guests use reusable ice packs.

In the United States House of Representatives has introduced a new bipartisan bill that would set the national age to purchase tobacco and vapes products to 21 years of age. The bill would also address how tobacco products are purchased over the internet.

The bill was introduced by Alabama Republican Representative Robert Aderholt and is called the Stopping Consumption of Tobacco by Teens Act or SCOTT Act for short. The bill is a tribute to outgoing FDA Commissioner Scott Gottlieb who amplified the teenage vaping crisis to epidemic levels.

Representative Aderholt said, “this is bipartisan legislation that builds upon the work that FDA Commissioner Scott Gottlieb, has done towards stemming the tide of youth adoption of vaping products over the past few years...The fight to curb this epidemic will not end with his departure, as proven by this first step in taking tobacco out of the ready reach of underage children.”

The SCOTT Act is also known as HR 2084 and is co-sponsored by California Democrat Juan Vargas proving that anti-vaping initiatives are popular on both sides of the aisle. A bipartisan Senate bill to ban flavored vaping products, excluding tobacco, was introduced last month.

In addition to banning sales of all tobacco and vaping products to people under 21, the SCOTT Act requires online sellers of vaping products to verify a buyer’s personal information through a third-party database (which most online vape retailers, including ourselves here at Cali Steam already do). However, it would also requires a signature on delivery by an adult 21 or older. This would increase shipping cost by at least $2 per package that we oppose here at Cali Steam. Many of our customers already complain about shipping costs and we try to cover shipping costs on larger orders but the added cost would fall back on our customers.

Supporters of HR 2084 believe the laws will prevent 18-year-old high school students from buying and distributing tobacco and vaping products to underage classmates, although similar legislation to make alcohol sales illegal to under-21’s has not eliminated youth drinking. We do not believe this bill will help improve the underage vaping problems as many states already ban sales to minors under the age of 21.

We encourage our customers to reach out to their local representatives to encourage them to vote no the SCOTT Act. For doing that you can use the coupon code “VOTENO” to get 20% off your entire online order at calisteam.com.

Most vaping customers have recognized for awhile now that the media doesn’t necessarily spotlight the industry in a positive light. As if the press among new vaping laws hasn’t gotten the general public concerned of it’s benefits the most recent developments about seizures most certainly will. The US Food and Drug Administration is alerting the public to a potential new risk of having a seizure and asking the public to report any instances to the agency.

To date from 2010 to early 2019 the FDA has identified 35 cases of seizures, particularly among younger customers. The agency also mentioned that they have seen a slight increase of reported causes since the middle of last year. It’s always interesting to understand their foregone conclusion that there has been a slight increase when over the last 9 years there have only been 35 reported cases.

Furthermore, the FDA mentioned that it has not been able to determine a definitive link between vaping and seizures but are still asking the general public to bring forth additional information to help them investigate.

Seizures are known to be a possible side effect of nicotine poisoning, the FDA said. "We know that nicotine isn't a harmless substance, especially in the developing brains of our youth," FDA Commissioner Dr. Scott Gottlieb and Principal Deputy Commissioner Dr. Amy Abernethy said in the statement. "But we've also been clear that, even for adults, e-cigarettes are not risk free."

There is no clear pattern to the seizures: Some who had seizures were vaping for the first time, and some had been using these products for a while. The timing of seizures also ranged from after a few puffs on an e-cigarette to a full day later. Several people had previously received a seizure diagnosis, and a few had also been using other drugs, like marijuana or amphetamines, before the seizures occurred.

The FDA is looking into additional possible health risks when it comes to vaping, including whether they may cause cancer in the airways down the line, according to the statement.

The announcement comes as use of the products is skyrocketing among youth. The FDA revealed in November that vaping has increased nearly 80% among high schoolers and 50% among middle schoolers since the year before. Experts worry that e-cigarettes could put kids' developing brains at risk, get them hooked on nicotine early in life and be a gateway to smoking and other drugs.

The agency has made a number of other moves in recent months to counter vaping among kids, including warning and fining retailers for illegally selling e-cig products to kids. The agency has also expanded its investigation into e-cigarette companies in an effort to uncover whether they are marketing products illegally and outside the agency's compliance policy.

In January, the agency held a public hearing to consider the role of drug therapies to get kids to quit vapes and other nicotine products, with medical organizations and vaping groups weighing in on how to address rising levels of e-cigarette use among youth.

Even though most smokers will say vaping has been a blessing in their lives the media will continue to focus on its adverse effects. We’ll continue to hear more from the FDA within the United States as they provide additional guidance to manufacturers and retailers on the usage of e-cigarettes.

On March 13, 2019, FDA Commissioner Scott Gottlieb, M.D. provided the following statement regarding additional guidelines for tobacco products.

The FDA is proposing to end current compliance policy as it applies to flavored electronic nicotine delivery system (ENDS) products such as electronic cigarettes (other than tobacco-, mint-, and menthol-flavored products), and prioritize enforcement of such products offered for sale in ways that pose a greater risk for minors to access these tobacco products.

Additionally, the FDA expects manufacturers of all flavored ENDS products (other than tobacco-, mint-, and menthol-flavored) that remain on the market under these new conditions to submit premarket applications to the agency by August 8, 2021. This application date is one year earlier than the agency previously proposed.

There are many aspects of these policies outlined in a draft compliance policy published today, which we intend to review comments on and finalize as quickly as possible. We expect several things to happen because of these policy changes:

We expect that some flavored e-cigarette products will no longer be sold at all.
We expect that other flavored e-cigarette products that continue to be sold will be sold only in a manner that prevents youth access, while premarket authorization for these products is sought from the FDA by 2021.

We expect some flavored cigars will no longer be sold.

Specifically, today, with the strong support of the Secretary of Health and Human Services Alex M. Azar, and President Donald J. Trump, the FDA is proposing to end our current compliance policy as it applies to flavored electronic nicotine delivery system (ENDS) products (other than tobacco-, mint-, and menthol-flavored). Previously, for all ENDS products on the market as of August 8, 2016, the FDA had announced our intention not to enforce the premarket review requirements until August 2022, with the expectation that many such products would remain on the market. In addition, under this previous policy, we intended to continue deferring enforcement while an ENDS product’s application was pending review.

Even though these comments do not define the regulations that will be enforced it does shed light on radical changes that will be coming to flavored e-liquid products. We'd expect to hear in the months ahead what specific actions the FDA will be taking to regulate flavored e-liquid products. It will certainly limit the access of products to our customers and millions of customers in the United States.

San Francisco, like many cities in America, has picked its enemies by it's own public policy. It's recent ban on smoking throughout the city has bypassed sales on cannabis, alcohol and many other "sin" drugs. Why you'd ask the city has targeted these particular products is anyways guess. One thing is sure, relationships and connections are probably at the center of the decisions that don't necessarily make practical sense.

One of the largest vaping companies in the world, Juul, is based in Silicon Valley. The city attorney and a member of the Board of Supervisors have proposed to bar e-cigarette firms from renting city property and, more sweepingly, block the sale of e-cigarettes in the city.

The stated rationale, of course, is a concern for public health. After all, vaping companies prey on a young audience with candy-flavored offerings and a hip, streamlined device. For other users, e-cigarettes are sold as a pathway from the chemical harms of tobacco, though the danger of nicotine addiction remains unknown.

E-cigs are no fad, with the big tobacco company Altria in December buying a 35 percent share of Juul, based on Pier 70, giving the company a value of $38 billion. This city, an ostensible temple of clean living, is home to the leading edge firm in the vaping game — and yet the proposed measures can’t chase it out of town as long as its lease runs.

That annoying reality no doubt is stoking the latest legislation. But the crusade needs a reality check. It’s not as if reasonable steps are not being taken to study vaping and restrict its appeal to youth. The city cracked down on flavored e-cigarettes through a ballot measure last year. The federal Food and Drug Administration is entering the picture with its own limitations aimed at curbing sales.

Vaping is a tempting public villain. Manufacturers should be treated with skepticism about claims that vaping is a benign habit. What vaping doesn’t deserve is a dose of shortsighted demonizing that does little to change the bigger picture of tobacco abuse and other health dangers the city is loath to confront.

City Attorney Dennis Herrera isn’t buying that version. “That’s all bull—,” he told us. He wants to suspend e-cigarette sales immediately. Young vapers can pull end runs around city rules, and assurances from e-cigarette firms about controlled access are worthless, he contends. Also, the FDA has let vaping firms market their products without testing and then given those companies a long deadline to conform. That’s why he’s demanding a sales suspension.

But he and Supervisor Shamann Walton, who is sponsoring the crackdown, are sidestepping the larger issue: smoking itself. Cigarette sales are still legal. Roll your own unfiltered joint, smoke a cigar, light a pipe or fire up a cigarette. You can do it all in San Francisco, now and in the future if the featured proposals are enacted. Vaping is only one corner of a vast, dirty habit.

There’s no love here for e-cigarettes. Inhaling potential toxins in any form is a clear health danger. But this crusade offers no cure beyond symbolism. Juul won’t be ousted from its perch on Pier 70. If it left, it could continue its work in another city. Tobacco and marijuana will remain on the shelves.

Reprinted from FDA.gov Press Announcement:

"When we first announced our comprehensive plan for tobacco and nicotine regulation in July 2017, we outlined a framework to better protect kids and to significantly reduce tobacco-related disease and death. We are continuing to implement that framework today. It remains the blueprint for the agency’s tobacco-related policymaking.

This framework first and foremost includes actions aimed at ultimately bringing us closer to our vision of a world where combustible cigarettes no longer create or sustain addiction – making it harder for future generations to become addicted in the first place and allowing more currently addicted smokers to quit or transition to potentially less harmful products.

This plan puts nicotine at the center of our regulatory efforts. It seeks to regulate nicotine levels in combustible cigarettes to render them minimally or non-addictive. At the same time, we’re advancing new policies to encourage the development of products that can deliver nicotine to currently addicted adult smokers without all of the harmful effects of combustion, including novel forms of medicinal nicotine replacement therapy.

With the significant strides made in recent years to reduce conventional smoking among both youth and adults, we appeared poised to overcome one of the most pernicious public health challenges of our times – the death and disease caused by cigarette smoking. Our multi-year policy framework will continue to accelerate these declines in tobacco use.

However, it has become clear that a recent surge in e-cigarette use among youth, which had appeared to be leveling off at the time our comprehensive plan was first announced in July 2017, is threatening the progress we’ve made in reducing youth tobacco use. The most recent data show more than 3.6 million middle and high school students across the country were current (past 30 day) e-cigarette users in 2018. This is a dramatic increase of 1.5 million children since the previous year. The data also showed that youth who used e-cigarettes also were using them more frequently and they were using flavored e-cigarette products more often than in 2017. This is particularly troubling given that research shows that kids using e-cigarettes are more likely to take up combustible cigarettes.

The epidemic-level rise in youth e-cigarette use has prompted a series of escalating actions by the FDA in both enforcement and public education. It has also required us to take a critical look at our policies and regulatory priorities.

Evidence shows that youth are especially attracted to flavored e-cigarette products, and that minors are able to access these products from both brick-and-mortar retailers, as well as online, despite federal restrictions on sales to anyone under 18. We also continue to be concerned about cigar use among youth – flavored cigars in particular – which our enforcement work shows are also being illegally sold to minors. With these concerns in mind, today, we’re advancing our policies aimed at preventing youth access to, and appeal of, flavored e-cigarettes and cigars.

There are many aspects of these policies outlined in a draft compliance policy published today, which we intend to review comments on and finalize as quickly as possible. We expect several things to happen because of these policy changes:

We expect that some flavored e-cigarette products will no longer be sold at all.
We expect that other flavored e-cigarette products that continue to be sold will be sold only in a manner that prevents youth access, while premarket authorization for these products is sought from the FDA by 2021.
We expect some flavored cigars will no longer be sold.
Specifically, today, with the strong support of the Secretary of Health and Human Services Alex M. Azar, and President Donald J. Trump, the FDA is proposing to end our current compliance policy as it applies to flavored electronic nicotine delivery system (ENDS) products (other than tobacco-, mint-, and menthol-flavored). Previously, for all ENDS products on the market as of Aug. 8, 2016, the FDA had announced our intention not to enforce the premarket review requirements until August 2022, with the expectation that many such products would remain on the market. In addition, under this previous policy, we intended to continue deferring enforcement while an ENDS product’s application was pending review.

Under the proposed policy announced today, we’re putting all manufacturers and retailers on notice: you may be subject to FDA enforcement for selling certain flavored ENDS products without authorization.

We’ll prioritize enforcement to prevent the access and appeal of these products to kids.

I’m taking this step to prevent youth access and address youth appeal of flavored ENDS. But because I believe that ENDS products still hold promise to help transition currently addicted adult smokers to potentially less harmful sources of nicotine, the FDA intends to prioritize its enforcement to focus on protecting youth from becoming addicted to nicotine.

We’re proposing to prioritize enforcement of flavored ENDS products (other than tobacco-, mint-, and menthol-flavored) that are offered for sale in ways that pose a greater risk for minors to access the products. For instance, we’ll consider whether the products are sold under circumstances, whether at retail or online, without heightened age verification.

Our proposed policy provides examples of circumstances that we’ll consider – for example, if flavored ENDS products are sold in locations where minors can enter at any time (e.g., the entire establishment or an area within the establishment); or, for online sales, if the products are sold without an appropriate limit on the quantity that a customer may purchase within a given period of time, and without independent, third-party, age- and identity-verification services that compare customer information against third-party data sources, such as public records. We’re also specifically seeking comment on, among other things, whether there are new technologies that can help prevent youth access at retail locations and intend to consider the use of those tools when we finalize the guidance.

Today’s draft guidance states our expectation that manufacturers of all flavored ENDS products (other than tobacco-, mint-, and menthol-flavored) that remain on the market under circumstances to limit youth access and appeal also submit their premarket applications by Aug. 8, 2021. This is an important change in our expectations and enforcement priorities. For all flavored ENDS products, including any that continue to be offered for sale under circumstances involving heightened age verification, the FDA expects manufacturers to prepare and submit applications that demonstrate these products meet the public health standard by Aug. 8, 2021.

In addition, we’re proposing to prioritize enforcement of unauthorized ENDS products that are targeted to minors or likely to promote use of ENDS by minors. Any efforts that entice minors to use tobacco products are of particular concern to the FDA. For example, the agency has already issued warning letters for products that resemble kid-friendly foods and drinks or that resemble other non-ENDS products that are often consumed by youth. Manufacturers and retailers are on notice that we’ll continue to be vigilant about efforts to make tobacco products that appeal to kids.

At this time, we aren’t proposing to end our current compliance policy as it applies to tobacco-, mint-, and menthol-flavored ENDS products, except for those products that are targeted to minors or likely to promote use of ENDS by minors. This approach reflects a careful balancing of public health considerations.

Recent evidence indicates that mint- and menthol-flavored ENDS products are preferred more by adults than minors. We’re also aware that some adults may be using mint- and menthol-flavored ENDS products with the goal of ceasing combusted tobacco use, seeking health benefits at the individual level, and may be at risk of migrating back to cigarettes. We won’t ignore data regarding the popularity of mint- and menthol-flavored ENDS among kids, should the concern rise. We’ll continue to use all available resources to monitor the rates and use patterns among youth and adults for these products, and we’ll reconsider our policies with respect to these products, if appropriate.

We’re also continuing our efforts aimed at enforcement and education.

This summer, we’ll unveil the first television advertisement aimed at educating children about the risks of e-cigarettes. I call on others who are committed to these same goals to also consider stepping up their efforts aimed at educating children of the risks of tobacco products generally, and e-cigarettes specifically. E-cigarette use among kids has become so widespread, so pervasive, and so troubling, that we risk addicting an entire generation of children on nicotine and watching the dramatic gains we’ve made in reducing smoking rates be erased. If current trends regarding youth use of ENDS products persist, the agency will change our approach. These increases in youth use must stop. We cannot allow a generation of children to become addicted to nicotine through e-cigarettes. If the 2019 National Youth Tobacco Survey continues to show sharp increases in youth use of tobacco products, the FDA will consider additional measures to address this crisis. We’ll take all appropriate actions necessary to stop these rates from increasing.

Additionally, we’re also taking steps to address youth use of flavored cigars. Recent data show that nearly 1.3 million middle and high school students across the country were current (past 30 day) cigar users in 2018. Youth continue to use these dangerous combusted tobacco products due, in part, to the availability and appeal of fruit and other flavors. And research shows that, compared to adults (25 or older) who smoke cigars, a higher proportion of youth use flavored cigars. These data also indicate that eliminating flavors from cigars would likely help prevent cigar initiation by young people. Flavors are added to cigars and other tobacco products for various reasons, such as reducing the harshness, bitterness and astringency of tobacco products during inhalation and to soothe irritation during use.

Under the revised compliance policy, 30 days after the guidance is finalized, any flavored cigars (other than tobacco-flavored) that were on the market on Aug. 8, 2016, and that meet the definition of a new tobacco product, would be subject to enforcement. As a result, flavored cigar products that are not grandfathered tobacco products and lack marketing authorization would no longer be subject to the August 2017 Compliance Policy. The FDA would prioritize enforcement of such products if they did not come off the market 30 days after the final guidance. They would have to seek premarket authorization to be re-introduced to the market. Additionally, we’re moving forward with a proposed rule to ban all characterizing flavors in cigars.

The FDA will continue to use our enforcement tools to ensure manufacturers comply with the law. We’ll continue to hold retailers accountable for illegally selling tobacco products to minors. Manufacturers have the means to control the distribution and sale of their products to retail customers by, for example, including or requiring terms, conditions, or controls in their contracts with downstream distributors (wholesalers, distributors, importers and/or retailers) to prevent youth access. Therefore, we’ll be looking to manufacturers of flavored ENDS and cigars to comply with the requirements of the Federal Food, Drug and Cosmetic Act and regulations and prevent the sale of their products to minors.

Ultimately, we expect these steps designed to address flavors and protect youth will dramatically limit the ability of kids to access tobacco products we know are both appealing and addicting. Our proposal reflects a very careful public health balance between closing the on-ramp for kids to become addicted to nicotine through tobacco products, while allowing for the promise of an off-ramp for adult smokers through access to potentially less harmful forms of nicotine delivery.

We intend to review comments and implement the policies 30 days after the guidance is finalized. However, we’re hopeful manufacturers and retailers will begin taking voluntary steps to further curb youth access to and appeal of these products. As we’ve said before, responsible manufacturers certainly don’t need to wait for the FDA to finalize policies to act. They can immediately stop certain marketing and sales practices – the ones we believe contribute to the problem of youth access and youth appeal. Likewise, manufacturers need not wait to submit premarket tobacco product applications for ENDS products, flavored or otherwise.

In 2017, when the agency extended certain compliance deadlines for newly deemed tobacco products, we recognized that, to promote higher quality applications, we could provide greater transparency about our recommendations and requirements through guidance and rulemaking. We had already published some resources to aid industry application submission. For instance, the FDA has published the Premarket Tobacco Product Applications for Electronic Nicotine Delivery Systems (ENDS) draft guidance; we’ve published the Tobacco Product Master File Guidance and a Small Entity Compliance Guide for Deeming; and we’ve conducted educational webinars describing, among other things, the statutory requirements for premarket applications. We continue to develop proposed rulemaking regarding the requirements for premarket submissions. Manufacturers, however, need not wait to engage the agency. Our door is open, and we welcome discussions with ENDS products manufacturers about their preparation of premarket submissions.

Our pledge to reduce youth use of e-cigarettes is deeply rooted and has broad support within the Trump Administration. Nobody wants to see children becoming addicted to nicotine. Our dedication to this effort will endure and our commitment to advancing our comprehensive framework will continue. Our policies have been announced and advanced through a careful and deliberate process that involved the formulation of a broad consensus among those whose efforts are needed in making sure that these rules and guidelines come to fruition. We won’t tolerate a whole generation of kids becoming addicted to nicotine as a tradeoff for enabling adults to have unfettered access to these same unreviewed products, and we’ll continue to put the full scope of our regulatory tools against this mounting public health crisis.

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products."