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Normal Enacts Tobacco 21 Ordinance

Normal has raised the minimum age to buy tobacco and vaping products from 18 to 21.

The town joins the ranks of 26 other Illinois communities with similar laws, including Peoria and Washington. The change goes into effect Dec. 1.

The unanimous council vote Monday night follows a meet-and-greet last month with representatives of the Illinois State University chapter of the Tobacco 21 coalition.

Council members commended students’ work advocating for the change, citing their own connections to the issue.

“I’m pleased to see people in that age group standing up and saying, ‘We want this, and we want this now,'” said council member Chemberly Cummings. “This was something that kind of hit home personally, knowing those who have passed away from lung disease, from prolonged tobacco usage.”

“I think we all had a similar experience that night,” said council member R.C. McBride, who is also GLT’s general manager. “It was interesting as you talked to (the students), most all of them had gotten involved because they knew someone who’d had lung cancer or something.”

“Smoking is what killed my father,” McBride continued. “So a lot of us sadly have that in common.”

Speaking on the group’s behalf at Monday night’s council meeting, Patricia Fountain of Normal said while communities with similar laws have seen reduced tobacco use among high schoolers, the rising popularity of e-cigarettes threatens to undo that progress.

Fountain cited a recent statement from FDA Commissioner Scott Gottlieb calling youth e-cigarette use and nicotine addiction an “epidemic.” The statement accompanied the publication of data from the FDA and the Centers for Disease Control and Prevention’s 2018 National Youth Tobacco Survey, showing that e-cigarette use among high schoolers jumped 78 percent between 2017 and 2018.

Normal resident Charles Sila said while preventing people from taking up smoking is a worthy goal, an ordinance goes too far, restricting the choices of legal adults.

“At age 18, most citizens can buy a house and sign a binding mortgage, or buy a car and sign a binding note without anyone’s permission,” he said. “Essentially treating some citizens as grade school students is totally unfair.”

Council member Kevin McCarthy said with tobacco and other drugs, it’s not necessarily about choice.

“We know what the cigarette industry does is put things in cigarettes that makes them addicting,” he said. “Once kids start, it’s very difficult to get off. It’s not just laziness, it’s not just social pressure, but it is a matter of the chemicals that are put in the cigarettes as well. So I think it’s important that we give them every fighting chance and keep that out of their hands as long as we can.”

Under the ordinance, vendors caught selling tobacco and vaping products to those under 21 face a $50 fine on the first offense and a $500 fine for repeat offenses.

. . .

Notes from the Field: Use of Electronic Cigarettes and Any Tobacco Product Among Middle and High School Students — United States, 2011–2018

Notes from the Field: Use of Electronic Cigarettes and Any Tobacco Product Among Middle and High School Students — United States, 2011–2018

Authors:  Karen A. Cullen, PhD1; Bridget K. Ambrose, PhD1; Andrea S. Gentzke, PhD2; Benjamin J. Apelberg, PhD1; Ahmed Jamal, MBBS2; Brian A. King, PhD2 (View author affiliations)

Electronic cigarettes (e-cigarettes) are battery-powered devices that provide nicotine and other additives to the user in the form of an aerosol (1). E-cigarettes entered the U.S. marketplace in 2007 (1), and by 2014, e-cigarettes were the most commonly used tobacco product among U.S. youths (2). Data from the 2011–2018 National Youth Tobacco Survey (NYTS), a cross-sectional, voluntary, school-based, self-administered, pencil-and-paper survey of U.S. middle and high school students, were analyzed to determine the prevalence of current use (≥1 day in past 30 days) of e-cigarettes,* current use of any tobacco product, frequency of (number of days during the preceding 30 days) e-cigarette use, and current use (any time during preceding 30 days) of any flavored e-cigarettes among U.S. middle school (grades 6–8) and high school (grades 9–12) students. Logistic regression (2011–2018) and t-tests (2017–2018) were performed to determine statistically significant differences (p<0.05).

Among high school students, current e-cigarette use increased from 1.5% (220,000 students) in 2011 to 20.8% (3.05 million students) in 2018 (p<0.001) (Figure). During 2017–2018, current e-cigarette use increased by 78% (from 11.7% to 20.8%, p<0.001). The proportion of current e-cigarette users who reported use on ≥20 of the past 30 days increased from 20.0% in 2017 to 27.7% in 2018 (p = 0.008). Among high school students, during 2017–2018, current use of any flavored e-cigarettes increased among current e-cigarette users (from 60.9% to 67.8%, p = 0.02); current use of menthol- or mint-flavored e-cigarettes increased among all current e-cigarette users (from 42.3% to 51.2%, p = 0.04) and current exclusive e-cigarette users (from 21.4% to 38.1%, p = 0.002).

Among middle school students, current e-cigarette use increased from 0.6% in 2011 (60,000 students) to 4.9% (570,000 students) in 2018 (p<0.001) (Figure). During 2017–2018, current e-cigarette use increased by 48% (from 3.3% to 4.9%, p = 0.001); the proportion of current e-cigarette users who reported use on ≥20 days of the past 30 days did not significantly change (from 12.9% to 16.2%, p = 0.26).

Current use of any tobacco product among high school students was 24.2% (3.69 million students) in 2011 and 27.1% (4.04 million students) in 2018 (p>0.05) (Figure). Current use of any tobacco product among middle school students was 7.5% (870,000 students) in 2011 and 7.2% (840,000 students) in 2018 (p>0.05). During 2017–2018, overall tobacco product use increased by 38% among high school students (from 19.6% to 27.1%, p<0.001) and by 29% among middle school students (from 5.6% to 7.2%, p = 0.008).

Current e-cigarette use increased considerably among U.S. middle and high school students during 2017–2018, reversing a decline observed in recent years and increasing overall tobacco product use (3). Moreover, during 2017–2018, frequent e-cigarette use increased among high school students. Although e-cigarettes have the potential to benefit adult smokers if used as a complete substitute for combustible tobacco smoking, the use of any form of tobacco product among youths, including e-cigarettes, is unsafe (1). The Surgeon General has concluded that e-cigarette use among youths and young adults is of public health concern; exposure to nicotine during adolescence can cause addiction and can harm the developing adolescent brain (1).

The rise in e-cigarette use during 2017–2018 is likely because of the recent popularity of e-cigarettes shaped like a USB flash drive, such as JUUL; these products can be used discreetly, have a high nicotine content, and come in flavors that appeal to youths (4). In September 2018, the Food and Drug Administration (FDA) issued more than 1,300 warning letters and civil money penalty fines to retailers who illegally sold e-cigarette products to minors, the majority of which were blu, JUUL, Logic, MarkTen XL, and Vuse; this was the largest coordinated enforcement effort in FDA’s history (5). Sustained implementation of proven population-based strategies, in coordination with the regulation of tobacco products by FDA, is key to reducing all forms of tobacco product use and initiation, including e-cigarettes, among U.S. youths (1).

Results from 2018 National Youth Tobacco Survey show dramatic increase in e-cigarette use among youth over past year

FDA News Release:

Today, the U.S. Food and Drug Administration and U.S. Centers for Disease Control and Prevention (CDC) released new findings from the National Youth Tobacco Survey (NYTS) showing that more than 3.6 million middle and high school students were current (past 30 day) e-cigarette users in 2018, a dramatic increase of more than 1.5 million students since last year. According to the results published in today’s Morbidity and Mortality Weekly Report (which will be made public at 1 p.m. ET), youth who use e-cigarettes also are using them more frequently and using flavored products more often than last year. The sharp rise in e-cigarette use has resulted in an increase in overall youth tobacco product use, reversing a decline seen in recent years, and is prompting a series of steps by the FDA to curb youth use trends.

“These new data show that America faces an epidemic of youth e-cigarette use, which threatens to engulf a new generation in nicotine addiction,” said HHS Secretary Alex Azar. “By one measure, the rate of youth e-cigarette use almost doubled in the last year, which confirms the need for FDA’s ongoing policy proposals and enforcement actions. HHS’s work will continue to balance the need to prevent youth use of e-cigarettes with ensuring they are available as an off-ramp for adults who are trying to quit combustible cigarettes.”

According to the findings, the number of U.S. high school students who reported being current e-cigarette users increased 78 percent between 2017 and 2018 to 3.05 million (or 20.8 percent). Numbers among middle school students rose 48 percent to 570,000 (or 4.9 percent). The study authors suggest the rise in e-cigarette use in the last year is likely due to the recent popularity of certain types of e-cigarettes, such as JUUL. These products include ones that are cartridge-based, can be used discreetly because of their resemblance to slim USB flash drives, have a high nicotine content and come in appealing fruit and candy flavors. The increased popularity of e-cigarettes among youth raises a number of other health concerns: risk of addiction to nicotine early on in life; potential harm from nicotine exposure to the developing adolescent brain; and exposure to chemicals associated with adverse health effects. In addition, research shows that, compared with non-users, youth who use e-cigarettes are more likely to transition to conventional cigarettes ‒ risking a lifetime of addiction to smoking and resulting smoking-attributable disease.

The uptick in e-cigarette use has led overall tobacco product use to increase by 38 percent among high school students (to 27.1 percent) and by 29 percent among middle school students (to 7.2 percent) in the last year, reversing the positive decline seen over the last few years.

Additionally, the survey also shows that high school students who reported being current e-cigarette users also reported using the product more frequently. In the last year, the proportion of those using the product more regularly (on 20 or more of the past 30 days) increased from 20 percent to 27.7 percent, an alarming one-year rise. The 2018 NYTS also found that among high school e-cigarette users, there was a significant increase in current flavored e-cigarette use within the past year, from 60.9 percent to 67.8 percent. Research shows youth and young adults identify flavors as a primary reason for e-cigarette use. Additionally, there is evidence from the Population Assessment of Tobacco and Health (PATH) Study indicating youth who first tried a flavored tobacco product have a higher likelihood of current tobacco use compared to those who first tried an unflavored product.

“We’ve been aware of these data for several months and are pursuing a robust set of new policies to address this epidemic level of e-cigarette use by kids. This spike in use threatens to stall or reverse the substantial public health gains we’ve made by reducing tobacco use overall, and especially among children. It’s clear we have a problem with access to, and appeal of these products to kids, and we’re committed to utilizing the full range of our regulatory authorities to directly target the places kids are getting these products and address the role flavors and marketing are playing in youth initiation,” said FDA Commissioner Scott Gottlieb, M.D. “We still believe that non-combustible forms of nicotine delivery, such as e-cigarettes, may be less harmful alternatives for currently addicted adult smokers who still seek nicotine. And we want to keep this option open for adults as the evidence develops to inform their use by adult smokers. But as we’ve said before, we will not allow that opportunity to come at the expense of addicting a whole new generation of kids to nicotine. We must close the on-ramp of nicotine addiction for kids even if it risks narrowing the off-ramp from smoking for adults. These are the hard tradeoffs we must take to keep these products out of the hands of kids and confront this troubling epidemic.”

NYTS is a cross-sectional, voluntary, school-based, self-administered, pencil-and-paper survey of U.S. middle and high school students. The data for the 2018 NYTS were collected from March to May 2018. The alarming rise in use and the threat of a new generation of young people becoming addicted to nicotine prompted the FDA and CDC to release these data earlier than usual so as to encourage e-cigarette companies and retailers, state, county and local health departments, public health organizations, and parents and educators to act immediately to curtail this crisis. The FDA and CDC plan to release the remaining data on usage rates of other tobacco products in early 2019.

“The markedly accelerating rate of e-cigarette use among U.S. youth within the past year is a cause for grave concern,” said CDC Director Robert R. Redfield, M.D. “E-cigarette use is unsafe among youth, and it’s critical that we implement proven strategies to protect our Nation’s youth from this preventable health risk.”

Tailoring social media, digital resources and web content for parents, teachers, coaches, and other youth influencers, CDC provides states and communities with accurate, actionable, and up-to-date science and information about the risks of e-cigarettes to young people. For example, CDC has a number of online resourcesexplaining the risks of e-cigarettes for youth and ways to prevent youth from using e-cigarettes or to help them stop.

In addition to the steps the FDA is announcing today, the agency has taken a series of actions over the past several months to target the illegal sales of e-cigarettes to youth, as well as to target companies engaged in kid-friendly marketing that increases the appeal of these products to youth. In particular, the FDA recently announced a series of critical enforcement actions that included issuing more than 1,300 warning letters and fines to retailers who illegally sold JUUL and other e-cigarette products to minors during a nationwide, undercover blitz of brick-and-mortar and online stores this summer–the largest coordinated enforcement effort in the FDA’s history. Moving forward, the FDA is indefinitely stepping up enforcement actions with a sustained campaign to monitor, penalize and prevent e-cigarette sales to minors in retail locations, including manufacturers’ internet storefronts. The agency is exploring action under both its civil and criminal enforcement tools to target potentially violative sales and marketing practices by manufacturers as well as retailers.

The agency also issued letters in September to five major e-cigarette manufacturers that produce JUUL, Vuse, MarkTen, blu e-cigs and Logic, which, combined, comprise more than 97 percent of the market share for closed-system e-cigarette products. These letters asked the companies to submit to the FDA within 60 days plans describing how each firm will address the widespread youth access and use of its products. The FDA recently met with these companies to discuss not only the potential steps they would take to restrict youth access to, and appeal of, these products, but also the measures they think the FDA and other policy-makers can take to reverse the trends in youth use of e-cigarettes.

The agency also launched “The Real Cost” Youth E-Cigarette Prevention Campaign. This new, comprehensive effort targets nearly 10.7 million youth, aged 12-17, who have used e-cigarettes or are open to trying them. The new campaign features hard-hitting advertising on digital and social media sites popular among teens, as well as posters with e-cigarette prevention messages in high schools across the nation. The FDA also recently announced a public hearing, to be held Dec. 5, to discuss efforts to eliminate youth e-cigarette use, with a focus on the potential role of drug therapies to support cessation among youth, and the issues impacting the development of such therapies for children.

As part of the agency’s comprehensive plan on tobacco product and nicotine regulation, the FDA also issued an advance notice of proposed rulemaking in March to seek public comment on the role that flavors in tobacco products, including e-cigarettes, play in attracting youth. Additionally, the agency plans to explore additional restrictions on the sale and promotion of e-cigarettes to further reduce youth exposure and access to these appealing products.

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.

High school e-cigarette use has jumped nearly 80%. Now, the FDA wants new regulations

(CNN)Vaping increased nearly 80% among high schoolers and 50% among middle schoolers since last year, prompting the US Food and Drug Administration to propose new measures against flavored nicotine products that have propelled the rise, the agency announcedThursday.

“These data shock my conscience,” FDA Commissioner Dr. Scott Gottlieb said in a statement, proposing to strengthen the agency’s policies against flavored e-cigarette products. These proposals could ultimately prompt their removal from shelves and websites that are accessible to minors.
The proposed changes do not include mint, menthol and tobacco flavors, however. Gottlieb said he wanted to leave the door open for adults who might use these products to quit smoking cigarettes. But that should not mean fueling an “epidemic” of new kids becoming addicted, he added.
“We will not allow that opportunity to come at the expense of addicting a whole new generation of kids to nicotine,” Gottlieb said.
Despite these exceptions for e-cigarette flavors, Gottlieb proposed additional bans on regular menthol cigarettes and flavored cigars.
He also proposed tightening the reins on products that are marketed or “appealing to youth.”
“This could include using popular children’s cartoon or animated characters, or names of products favored by kids like brands of candy or soda,” the announcement said.
Consumers and health experts have been locked in a contentious debate about vaping: While some see it as a smoking cessation tool for adults, others say there’s no good evidence to support this.
“We’re committed to utilizing the full range of our regulatory authorities to directly target the places kids are getting these products and address the role flavors and marketing are playing,” Gottlieb said.
“We will leave no stone unturned,” he said. “This is one of our highest priorities.”

‘Spike in use’

One in five high schoolers has vaped in the past month, according to the new numbers announced by the FDA and released in conjunction with the US Centers for Disease Control and Prevention.
“As a father of three young children, I hear daily from parents and teachers worried about the epidemic use of electronic cigarettes and nicotine addiction among kids,” Gottlieb said.
Health experts worry these products 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 data show that kids using e-cigarettes are going to be more likely to try combustible cigarettes later,” Gottlieb said. “This is a large pool of future risk.”
The new statistics also show that students who vape are doing so more frequently than last year, and they are using flavored liquids more often, according to the FDA. More than a quarter of current users vaped at least 20 of the last 30 days, and over two-thirds had used flavored products.
“Flavors are a major reason they use these products in the first place,” Health and Human Services Secretary Alex Azar said in a statement Thursday.
“Flavors increase the likelihood of kids progressing from experimentation to regular use, and a portion of them will go on to use combustible tobacco products, with the huge added dangers of tobacco-related disease.”
The new numbers come from a school-based survey, conducted from March to May, which revealed that the number of current users in middle and high school — meaning those who have vaped in the past 30 days — increased 48% and 78% from last year, respectively.
In other words, the number of current vapers in middle and high school has jumped by roughly 1.5 million since last year, now totaling 3.6 million kids, Gottlieb said.
The “alarming” surge in adolescent e-cigarette use prompted health officials to release these numbers “earlier than usual” in hopes of spurring immediate action, according to the FDA.
“Not only are we seeing a staggering increase in the number of high schoolers who use e-cigarettes, we’re seeing that more and more of them have moved beyond experimentation and are using e-cigarettes almost daily,” Dr. Colleen A. Kraft, president of the American Academy of Pediatrics, said in an emailed statement.
The rapid spread of e-cigarettes — which work by heating a liquid containing nicotine until it vaporizes — was flagged in a 2016 report by the US Surgeon General that cited a 900% increase in e-cigarette use by high school students from 2011 to 2015. E-cigarette use declined for the first time in 2016 but held steady — under 12% — the following year. Now, that number is 20.8%.
“This spike in use threatens to stall or reverse the substantial public health gains we’ve made by reducing tobacco use overall, and especially among children,” Gottlieb said.

Statement from FDA Commissioner Scott Gottlieb, M.D., on proposed new steps to protect youth by preventing access to flavored tobacco products and banning menthol in cigarettes

Statement from FDA Commissioner Scott Gottlieb, M.D., on proposed new steps to protect youth by preventing access to flavored tobacco products and banning menthol in cigarettes

. . .

Almost all adult smokers started smoking when they were kids. Nearly 90 percent started smoking before the age of 18, and 95 percent by age 21. Only about 1 percent of cigarette smokers begin at age 26 or older. When I announced the FDA’s Comprehensive Plan for Tobacco and Nicotine Regulation in July 2017, I made clear my concerns about kids’ use of e-cigarettes, especially those products marketed with obviously kid-appealing flavors. At the time, however, the trends in youth use appeared to be changing in the right direction – reported e-cigarette use among high school students, which peaked at 16.0 percent in 2015, had decreased to 11.3 percent in 2016 and held steady in 2017. What I did not predict was that, in 2018, youth use of e-cigarettes and other ENDS products would become an epidemic.

Today, the FDA and the Centers for Disease Control and Prevention are publishing data from the 2018 National Youth Tobacco Survey (NYTS). The data from this nationally representative survey, conducted of middle and high school students, show astonishing increases in kids’ use of e-cigarettes and other ENDS, reversing years of favorable trends in our nation’s fight to prevent youth addiction to tobacco products. These data shock my conscience: from 2017 to 2018, there was a 78 percent increase in current e-cigarette use among high school students and a 48 percent increase among middle school students. The total number of middle and high school students currently using e-cigarettes rose to 3.6 million — that’s 1.5 million more students using these products than the previous year. Additionally, more than a quarter (27.7 percent) of high school current e-cigarette users are using the product regularly (on 20 or more days in the past month). More than two-thirds (67.8 percent) are using flavored e-cigarettes. Both these numbers have risen significantly since 2017.

These increases must stop. And the bottom line is this: I will not allow a generation of children to become addicted to nicotine through e-cigarettes. We won’t let this pool of kids, a pool of future potential smokers, of future disease and death, to continue to build. We’ll take whatever action is necessary to stop these trends from continuing.

Over the past months, the FDA has worked aggressively to address youth use of e-cigarettes.

We deployed a range of our regulatory tools.

We launched a multi-pronged Youth Tobacco Prevention Plan. We escalated enforcement against retailers who illegally sell ENDS products to minors. We partneredwith the Federal Trade Commission to target e-liquid manufacturers whose products used misleading, kid-appealing imagery that mimicked juice boxes, lollipops and other foods. We worked with eBay to remove listings for these products on their websites. We launched innovative campaigns, including “The Real Cost” Youth E-Cigarette Prevention Campaign, to educate teens about the consequences of addiction to e-cigarettes.

And I made clear – in speeches, in statements and in interviews – that we were closely watching what appeared to be disturbing trends. I repeatedly said that, although we continue to believe that non-combustible tobacco products may provide an important opportunity to migrate adult smokers away from more harmful forms of nicotine delivery, these opportunities couldn’t come at the expense of addicting a generation of kids to nicotine. I told the manufacturers of e-cigarettes that the youth use of their products was an existential threat to this innovation. In short, over the past year we weren’t sitting still. And we weren’t quiet about our concerns. And yet these deeply disturbing trends continued to build.

In September, after receiving the raw data from the NYTS survey, I took additional action. I called on manufacturers to step up, to take voluntary actions to prevent youth access to these products and to take meaningful steps to curb their youth appeal. Some manufacturers have already responded to these requests and pledged to take some meaningful voluntary steps to curb youth access and appeal to their products. I also said that the FDA would be re-evaluating our own policy approach and that all options would be considered. Given the startling and disturbing youth use rates in the 2018 NYTS data being released today, it’s clear that we must do more – specifically, several policy changes to target what appear to be the central problems – youth appeal and youth access to flavored tobacco products.

Some of these changes would involve revisiting the FDA’s compliance policy, issued in 2017, which extended the dates by which manufacturers of deemed tobacco products that were on the market as of Aug. 8, 2016, were expected to submit premarket applications to the FDA for review (after receipt of an application, the FDA reviews the application and determines if the product meets the applicable statutory standard to be marketed). Under that policy of enforcement discretion, the premarket application compliance date for newly regulated combustible tobacco products, including certain cigars and pipe tobacco, was extended to August 2021. The premarket application compliance date for newly regulated non-combustible tobacco products was extended to August 2022. This applied to most ENDS or e-cigarettes.

Today, I’m directing the FDA’s Center for Tobacco Products (CTP) to revisit this compliance policy as it applies to deemed ENDS products that are flavored, including all flavors other than tobacco, mint and menthol. The changes I seek would protect kids by having all flavored ENDS products (other than tobacco, mint and menthol flavors or non-flavored products) sold in age-restricted, in-person locations and, if sold online, under heightened practices for age verification.

These changes will not include mint- and menthol-flavored ENDS. This reflects a careful balancing of public health considerations. Among all ENDS users, data suggests that mint- and menthol-flavored ENDS are more popular with adults than with kids. One nationally representative survey showed that, among ENDS users aged 12-17 years old, 20 percent used mint- and menthol-flavored ENDS while, among adult ENDS users, 41 percent used mint- and menthol-flavored ENDS. Any approach to mint- and menthol-flavored ENDS must acknowledge the possibility that the availability of these flavors in ENDS may be important to adult smokers seeking to transition away from cigarettes. Moreover, I recognize that combustible cigarettes are still sold in menthol flavor, including in convenience stores. I don’t want to create a situation where the combustible products have features that make them more attractive than the non-combustible products. Or a situation where those who currently use menthol-flavored cigarettes might find it less attractive to switch completely to an e-cigarette. This is a difficult compromise that I’m trying to strike, recognizing the public health risk posed by cigarettes still being available in menthol flavor.

But at the same time, I’m deeply concerned about the availability of menthol-flavored cigarettes. I believe these menthol-flavored products represent one of the most common and pernicious routes by which kids initiate on combustible cigarettes. The menthol serves to mask some of the unattractive features of smoking that might otherwise discourage a child from smoking. Moreover, I believe that menthol products disproportionately and adversely affect underserved communities. And as a matter of public health, they exacerbate troubling disparities in health related to race and socioeconomic status that are a major concern of mine. Although I’m not proposing revisions to the compliance policy for the mint- and menthol flavors in e-cigarettes at this time, we need to address the impact that menthol in cigarettes has on the public health.

I’m also aware that there are potentially important distinctions even between mint- and menthol-flavored e-cigarette products. I’m particularly concerned about mint-flavored products, based on evidence showing its relative popularity, compared to menthol, among kids. So, I want to be clear that, in light of these concerns, if evidence shows that kids’ use of mint or menthol e-cigarettes isn’t declining, I’ll revisit this aspect of the current compliance policy.

In addition, I’m directing CTP to revisit the compliance policy for all flavored ENDS products (other than tobacco, mint and menthol flavors or non-flavored products) that are sold online without additional, heightened age-verification and other restrictions in place. As part of that effort, I’m directing CTP to publish additional information regarding best practices for online sales.

 

. . .

 

Here are additional details regarding the policy framework that Commissioner Gottlieb seeks to advance (pulled directly from FDA Press Announcement):

  1. Flavored ENDS products that are not sold in an age-restricted, in-person location.
    • Have all flavored ENDS products (other than tobacco, mint and menthol flavors or non-flavored products) sold in age-restricted, in-person locations. All ENDS products, including e-liquids, cartridge-based systems and cigalikes, in flavors except tobacco, mint and menthol, would be included. For instance, the proposed policy would apply to flavors such as cherry, vanilla, crème, tropical, melon and others.
    • To advance this goal, the FDA is revisiting the compliance policy on PMTA authorization for such flavored products sold in physical locations where people under the age of 18 are permitted.
    • The FDA is not revisiting the compliance policy with respect to ENDS products sold exclusively in age-restricted locations – for instance, a stand-alone tobacco retailer (such as a vape shop) that adequately prevents persons under the age of 18 from entering the store at any time; or, a section of an establishment that adequately prevents entry of persons under the age of 18 and the flavored ENDS products are not visible or accessible to persons under the age of 18 at any time.
    • At this time, ENDS products with tobacco, mint or menthol flavors, as well as any non-flavored ENDS products, sold in any location, would not be included in any policy revisions. This distinction among flavors seeks to maintain access for adult users of these products, including adults who live in rural areas and may not have access to an age-restricted location, while evidence of their impacts continues to develop. It also recognizes that combustible cigarettes are currently available in menthol in retail locations that are not age-restricted. This approach is informed by the potential public health benefit for adult cigarette smokers who may use these ENDS products as part of a transition away from smoking.
    • The FDA, however, will not ignore data regarding the popularity of mint- and menthol-flavored ENDS among kids. We will continue to use all available surveillance resources to monitor the rates and use patterns among youth and adults for these products, and we will reconsider our policies with respect to these products, if appropriate.
  2. Flavored ENDS products (other than tobacco, mint and menthol flavors or non-flavored products) that are sold online.
    • In addition, we will seek to curtail the sale of applicable flavored ENDS products that are sold online without heightened age verification processes.
    • The FDA will be working to identify these heightened measures for age verification and other restrictions to prevent youth access via online sales. These best practices would be available soon, so sites can quickly adopt them.
    • Because no tobacco products should be sold to kids (including non-flavored ENDS products or those with tobacco, mint and menthol flavors), the FDA will continue to enforce the law whenever we see online sales of these products to minors and will closely monitor online sales of mint and menthol ENDS products.
  3. Flavored cigars.
    • Research shows that, compared to adults (25 or older) who smoke cigars, a higher proportion of youth who smoke cigars use flavored cigars. This data also indicates that eliminating flavors from cigars would likely help prevent cigar initiation by young people.
    • Given these public health concerns, I believe flavored cigars should no longer be subject to the extended compliance date for premarket authorization — regardless of the location in which the products are sold.
    • The FDA’s proposal to revisit the compliance policy for flavored cigars that are new tobacco products does not apply to the entire product category, as some products were considered “grandfathered.” Accordingly, the FDA intends to propose a product standard that would ban flavors in all cigars.
    • In July, the comment period for our ANPRM on flavors in tobacco productsclosed. The FDA has expedited review and analysis of these comments, and we intend to proceed with developing a proposed regulation. As included in the most recent Unified Agenda, the FDA intends to prioritize the issuance of this proposed rule.
  4. ENDS products that are marketed to kids.
    • The FDA will pursue the removal from the market of those ENDS products that are marketed to children and/or appealing to youth. This could include using popular children’s cartoon or animated characters, or names of products favored by kids like brands of candy or soda.
  5. Menthol in combustible tobacco products.
    • Informed by the comments from our ANPRM, the FDA will advance a Notice of Proposed Rulemaking that would seek to ban menthol in combustible tobacco products, including cigarettes and cigars.
    • The FDA started this process several years ago with an ANPRM. That ANPRM issued alongside the FDA’s preliminary scientific evaluation, which suggested menthol use is likely associated with increased smoking initiation by youth and young adults.
    • Now, armed with the additional years of data, comments from the public – and with the perspective of our Comprehensive Plan and its implementation – the FDA will accelerate the proposed rulemaking process to ensure that our policies on flavored tobacco products protect public health across the continuum of risk.