Showing posts with label electronic cigarettes. Show all posts
Showing posts with label electronic cigarettes. Show all posts

Tuesday, July 30, 2024

State judge dismisses constitutional challenge to anti-vaping law

Kentucky State Capitol Building
By Sarah Ladd

Kentucky Lantern

Franklin Circuit Judge Thomas Wingate has dismissed a lawsuit challenging the constitutionality of a 2024 law banning the sale of some vaping products.

Wingate sided with the lawsuit’s defendants — Allyson Taylor, commissioner of the state Department of Alcoholic Beverage Control, and Secretary of State Michael Adams — who filed a motion to dismiss. The law designates the ABC as its enforcement agency.

The Kentucky Smoke Free Association, which represents vape retailers, had argued that the law was too broad and arbitrary to be constitutional because it is titled “An act relating to nicotine products” but also mentions “other substances.” The state constitution says a law cannot relate to more than one subject.

In his opinion, Wingate said the law doesn’t violate the state constitution.

The law’s title “more than furnishes a clue to its contents and provides a general idea of the bill’s contents,” he wrote.

The law’s “reference to ‘other substances’ is not used in a manner outside of the context of the bill, but rather to logically indicate what is unauthorized,” Wingate wrote.

The lawsuit centers on House Bill 11, which passed during the 2024 legislative session and is scheduled to take effect Jan. 1. Its backers said it will curb underage vaping by limiting sales to “authorized products” or those that have “a safe harbor certification” based on their status with the U.S. Food and Drug Administration.

Opponents have said it will hurt small businesses and favor big companies, and could drive youth to traditional cigarettes.

Altria, the parent company of tobacco giant Philip Morris, lobbied for the bill and is pushing similar bills in other states. Altria, which has moved aggressively into e-cigarette sales, markets multiple vaping products that have FDA approval.

“The sale of nicotine and vapor products are highly regulated in every state, and the court will not question the specific reasons for the General Assembly’s decision to regulate and limit the sale of nicotine and vapor products to only products approved by the FDA or granted a safe-harbor certification by the FDA,” Wingate wrote in a Monday opinion. “The regulation of these products directly relates to the health and safety of the commonwealth’s citizens, the power of which is vested by the Kentucky Constitution in the General Assembly.”

Sunday, July 14, 2024

Cigarette tax collections in Ky. jumped, then dropped, after tax increases; state's smoking rate has also been on the decline

Kentucky Health News graph from state data
By Melissa Patrick
Kentucky Health News

Increasing state cigarette taxes has proven to be an effective policy to decrease smoking rates, and it appears that is also true in Kentucky.

Nearly 30 percent of Kentucky adults smoked in 2011, two years after the legislature had doubled the cigarette tax to 60 cents a pack. Following a 50-cent increase to $1.10 in 2018, the state's adult smoking rate fell to 17.4% in 2022, the last year for which a rate is available. 

Shannon Baker, the American Lung Association's advocacy director for Kentucky and Tennessee, said that while she could not point to something definitive to explain why Kentucky's smoking rate has been decreasing, as has also been the case in the nation, she could speak to the impact of raising cigarette taxes:

"When taxes increase, smoking rates decline. We should take advantage of that, for goodness sake, and increase the cigarette tax in Kentucky by at least $1 and then tax all other nicotine products at parity with the cigarette tax." 

After an initial boost in cigarette-tax revenue from the rate hikes in 2011 and 2018, revenue from the tax declined 24% from 2019 to 2024.

The legislature increased the tax to 30 cents from 3 cents in 2005, but smoking rates before 2011 should not be compared with those after that because of a change in survey methodology, says the Behavioral Risk Factior Surveillance System, a continuing federal-state poll of Americans' habits.

Baker stressed that its important to take advantage of all policies that are known to decrease smoking. Beyond raising taxes, she said it's important to fund the state tobacco-control program and enforce the law against underage sales, which she said would result in fewer youth becoming addicted to nicotine and growing up to be lifelong smokers, and all the health issues that come with that. 

The new report on state General Fund receipts for the fiscal year that ended June 30 showed a 1.5% increase in receipts from other tobacco products, such as electronic cigarettes or vapes.

Asked about the impact of vaping on decreasing smoking rates, Baker focused her comments on young people, who are more likely to vape than smoke.

"We really have to get a handle on this youth vaping problem," she said, noting that Kentucky is one of about 10 states that doesn't require tobacco retailers to be licensed. "We don't even know where all of these shops are in order to enforce the law against underage sales."

Baker added, "We really need a better method of enforcing the law against underage sales. And what that looks like is licensure and routine regular enforcement opportunities that result in significant penalties all the way up to license suspension and revocation, for scofflaws that routinely violate the law. We're not talking about any onerous policy on those who are compliant with the law. We're simply talking about those who violate the law and violate it routinely." 

The 2023 Youth Risk Behavior Survey found that 5.3% of Kentucky high-school students said they currently smoked cigarettes and 19.7% said they used electronic vapor products. Among middle schoolers, the 2.2% said they smoked cigarettes and 12.8% used a vapor product. "Current use" is considered having used a product on at least one day during the 30 days prior to the survey.

Asked if she thought the new law that bans retailers from selling unauthorized vapor products would be effective in decreasing youth vaping, as it has been touted to do, Baker said, "House Bill 11 turned into . . . an industry market-share grab and nothing more; it is not a protection for kids. What we saw was a bill passing that, in effect would, if it's upheld in court, remove certain products, primarily imported products, from the market shelves, which in and of itself is not a bad thing. But, it certainly doesn't protect kids who will just switch to the other products that remain on the shelves." 

The law has been challenged in court. If it holds up, it will go into effect January 2025.

Baker also wanted to make sure people know that the funds for the state's tobacco control program come from the Master Settlement Agreement with cigarette manufacturers, not from the cigarette tax.

"We need to increase funding for tobacco control because . . .  Kentucky has the highest lung-cancer incidence and mortality rates in the entire nation and most of that is due to our high smoking rate," Baler said. "So even though the smoking rate may be declining, it isn't gone. It isn't good, even."

Saturday, June 22, 2024

FDA OKs menthol e-cigs made by firm Altria recently bought, thus supporting its smoking-cessation claims; health advocates object

By Matthew Parrone
Associated Press

The Food and Drug Administration on Friday authorized the first menthol-flavored electronic cigarettes for adult smokers, acknowledging that vaping flavors can reduce the harms of traditional tobacco smoking.

Njoy menthol product
The FDA said it authorized four menthol e-cigarettes from Njoy, the vaping brand recently acquired by tobacco giant Altria, which also sells Marlboro cigarettes.

The decision lends new credibility to vaping companies’ longstanding claim that their products can help blunt the toll of smoking, which is blamed for 480,000 U.S. deaths annually due to cancer, lung disease and heart disease. E-cigarettes have been sold in the U.S. since 2007 but in recent years their potential benefits for smokers have been overshadowed by their use by adolescents and teens.

Parents and anti-tobacco groups immediately criticized the decision, which follows years of advocacy efforts to keep menthol and other flavors that can appeal to teens off the market.

“This decision could mean we’ll never be able to close the Pandora’s box of the youth vaping epidemic,” said Meredith Berkman, co-founder of Parents Against Vaping E-cigarettes. “FDA has once again failed American families by allowing a predatory industry to source its next generation of lifetime customers — America’s children."

Youth vaping has declined from all-time highs in recent years, with about 10% of high schoolers reporting e-cigarette use last year. Of those who vaped, 90% used flavors, including menthol.

In Kentucky polling in 2021, 45% of high-school students said they had used an electronic vapor product, 22% were current users, 8% were frequent users, and 7% used the products daily. Among Kentucky middle-school students, 24% said they had used an electronic vapor product, 11% said they were current users, nearly 3% said they were frequent users, and 2% said they used daily.

All the e-cigarettes previously authorized by the FDA have been tobacco, which isn't widely used by young people who vape.

Njoy is one of only three companies that previously received FDA's OK for vaping products. Two of the four FDA-approved products are "sealed, pre-filled, non-refillable pods that are used with a previously authorized Njoy device, and two are disposable e-cigarettes with a prefilled, non-refillable e-liquid reservoir," reports Jessica Karins reports of Inside Health Policy.

Njoy’s products accounted for less than 3% of U.S. e-cigarette sales in the past year, according to Nielsen. Vuse, owned by Reynolds American, and Juul control about 60% of the market, while hundreds of disposable brands account for the rest.

Most teens who vape use disposable e-cigarettes, including brands like Elf Bar, which come in flavors such as watermelon and blueberry ice.

Altria's data showed Njoy e-cigarettes helped smokers reduce their exposure to the harmful chemicals in traditional cigarettes, the FDA said. The agency stressed the products are neither safe nor “FDA approved,” and that people who don’t smoke shouldn’t use them.

Friday’s action is part of a sweeping FDA review intended to bring scientific scrutiny to the multibillion-dollar vaping market after years of regulatory delays. The U.S. market includes thousands of fruit- and candy-flavored vapes that are technically illegal but are widely available in convenience stores, gas stations and vape shops.

The FDA faced a self-imposed court deadline at the end of this month to wrap up its yearslong review of major vaping brands, including Juul and Vuse.

Those brands have been sold in the U.S. for years, awaiting FDA action on their scientific applications. To stay on the market, companies must show that their e-cigarettes provide an overall health benefit for smokers, without significantly appealing to kids.

“Based upon our rigorous scientific review, in this instance, the strength of evidence of benefits to adult smokers from completely switching to a less harmful product was sufficient to outweigh the risks to youth,” said Matthew Farrelly of FDA’s Center for Tobacco Products.

Richmond-based Altria previously took a $13 billion stake in Juul in 2018, when the brand controlled most of the U.S. vaping market. But Juul's value plummeted after it was hit with lawsuits and investigations over its role in sparking a national spike in underage vaping.

Several longtime health-advocacy groups criticized the decision.

American Lung Association CEO Harold Wimmer wrote, “The tobacco industry has been using menthol and other flavors to attract kids for decades - this opens up a legal pathway for Njoy to market their highly addictive products.”

Lisa Lacasse, president of the American Cancer Society Cancer Action Network, noted that the move comes less than two months after the Biden adminisration announced an indefinite delay in FDA’s proposed rule to ban menthol cigarettes and flavored cigars, which had bene pending for two years.

"FDA has been more closely scrutinized by Congress over its e-cigarette regulation approach in recent months," Karins notes. "Lawmakers in both parties agree FDA isn’t doing enough to combat illegally imported e-cigarettes, but a partisan divide is emerging on whether the agency should respond by approving more domestic products. Some Republicans have suggested the agency should approve more applications for American companies’ products while Democrats largely want those products off the market as well."

In its announcement, "FDA appeared to respond to criticisms," Karins writes. Center for Tobacco Products Director Brian King said, “This action is further reinforcement that authorization of an e-cigarette product is possible when sufficient scientific evidence has been submitted to the agency to justify it.” 

King said Njoy submitted evidence "showing a benefit to adult smokers relative to the company’s previous tobacco-flavored products that is sufficient to outweigh risks of the products, including potential appeal to youth."

Karins notes, "FDA’s statement says authorization of the products does not mean they are safe, adding that people who do not use nicotine products shouldn’t start. It also says the agency remains concerned about youth vaping. It will monitor the marketing of the Njoy products levels of use of the products among youth and former smokers, and the number of smokers who are able to completely switch to the products."

Under the FDA rule, Njoy may not "use most advertising methods," and ads "cannot include cartoon images, images of food or fruit, or depictions of people who appear to be younger than 45," Karins reports. "Retailers must place Njoy products only in non-self-service areas of stores."

Friday, May 31, 2024

Today is World No Tobacco Day; youth group coordinated by UK pharmacy student aims for tobacco-free future for Kentucky

Members of the #iCANendthetrend Youth Advistory Board and
and UK coordinator Griffin Nemeth pose with Gov. Andy Beshear
outside the state Capitol. (UK College of Pharmacy photo)
By Rosa Mejia-Cruz
University of Kentucky

On this World No Tobacco Day, May 31, the importance of educating and engaging youth in tobacco use prevention cannot be overstated. The theme of this year's observance, "Protecting children from tobacco industry interference," emphasizes the vital role young people play in promoting healthier lifestyles and positive community change.

According to the World Health Organization, an estimated 37 million youths aged 13–15 use tobacco globally, with children surpassing adults in elecgtronic-cigarette usage in all regions. 

Griffin Nemeth, a student at the University of Kentucky College of Pharmacy and coordinator for the #iCANendthetrend Youth Advisory Board, exemplifies the significant impact young people and pharmacists can have in this public-health mission.

Nemeth's involvement in tobacco prevention began his sophomore year of undergraduate studies through his role as a college facilitator with #iCANendthetrend, a youth e-cigarette prevention and empowerment initiative. Project Director Melinda Ickes, a professor in the UK College of Education, worked with students to bring a near-peer prevention approach to decrease initiation of tobacco use by youth, support those who are already dependent on tobacco, and ensure that student voices are at the forefront of prevention and policy advocacy.

Since 2019, the team has reached more than 20,000 Kentucky youth. The advisory board, a group of 10 high school advocates from across Kentucky, fosters a generation of changemakers dedicated to educating peers, community members and policymakers about the negative health outcomes of vaping and tobacco use.

“I am thrilled to see young people engage in something they traditionally haven't been involved in, especially in the policy sphere,” said Nemeth. “Witnessing our Youth Advisory Board advocate for their communities and interacting with local leadership is immensely rewarding."

A key element of Nemeth's work is the comprehensive, yearlong training program he helps coordinate for younger Kentuckians. Each summer, new members of the Youth Advisory Board gather at UK for an in-person training session, followed by bimonthly virtual meetings throughout the year. This training includes online modules, skill-building opportunities and sessions led by near peers who are part of #iCANendthetrend. Each year, the Youth Advisory Board selects a project to work collaboratively on throughout the year to equip them with the knowledge, skills and confidence to effectively support their goals.

The #iCANendthetrend program's efforts have earned significant recognition. The Campaign for Tobacco-Free Kids named the board the 2024 Group Advocates of the Year, highlighting the critical contributions of youth in tobacco prevention and the necessity for ongoing support.

Pharmacists are uniquely positioned to support tobacco cessation efforts. With most people in the U.S. living within five miles of a pharmacy, trained pharmacists can bridge the gap in treatment resources, particularly in rural areas.

"Even if patients are unsure they want to begin treatment, pharmacists can ask, advise and refer, which can make a significant difference for a patient who might otherwise continue to smoke for years until a severe health condition develops,” Nemeth said. “Pharmacists can play a crucial role in early intervention.”

As Nemeth advances in his pharmacy studies, he remains committed to advocacy. He envisions a future where his role as a pharmacist intersects with his passion for public health. "There's a significant health disparity in tobacco prevention and use, especially in Kentucky. Learning about the science and treatment in pharmacy school has further prepared me as an advocate," Nemeth explained.

For those looking to reduce or quit tobacco use, pharmacists offer invaluable support. Many pharmacies provide resources and counseling for smoking cessation, including nicotine replacement therapies and other medications to manage withdrawal symptoms. Pharmacists can also offer personalized advice and support, making it easier for individuals to navigate their cessation journey.

World No Tobacco Day 2024 is a call to action for health care providers, communities and individuals to support tobacco prevention and cessation efforts. By combining the power of youth advocacy, the accessibility of pharmacists and the collaboration of health-care providers, educators, policymakers and community leaders, Kentucky can move toward a tobacco-free future. This comprehensive approach, which includes prevention, education, policy advocacy and accessible treatment resources, is essential for ensuring healthier lives for generations to come.

Monday, May 20, 2024

Korean study finds former smokers who use e-cigarettes or vapes have higher risk for lung cancer than ex-smokers who don't

Photo by Steve Helber, The Associated Press
Kentucky Health News

Former cigarette smokers who use electronic cigarettes or vaping devices may be at higher risk for lung cancer than former smokers who don’t vape, according to new research in South Korea.

“This is the first large population-based study to demonstrate the increased risk of lung cancer in e-cigarette users after smoking cessation,” said Dr. Yeon Wook Kim of Seoul National University, corresponding author of the study published at the 2024 international conference of the American Thoracic Society (ATS).

E-cigarettes are promoted as an aid to smoking cessation, but "There is little knowledge about the long-term consequences of vaping, and epidemiological evidence for the association between e-cigarette use and lung cancer is lacking," said an ATS news release.

"Biological studies suggest the possible dangers of e-cigarettes, including pulmonary toxicity and lung cancer. E-cigarettes and heating elements have been shown to contain carbonyl compounds (such as formaldehyde, acetaldehyde, acrolein and diacetyl) and toxic metals (such as chromium, nickel and lead), which are known to be carcinogenic. These toxins are also present in conventional cigarettes."

Kim said, “Our results indicate that when integrating smoking cessation interventions to reduce lung cancer risk, the potential harms of using e-cigarettes as an alternative to smoking must be considered.”

To determine the risk to former smokers, the researchers looked at the records of more than 4.3 million Koreans with a history of conventional smoking who participated in the Republic of Korea’s National Health Screening Program in 2012-14 and 2018. They conducted follow-up in December 2021.

"They found that 53,354 individuals had developed lung cancer," or 1.24%, and 6,351 died from it, or 0.147%, the release says. "Ex-cigarette smokers who had quit five years or more and used e-cigarettes were at greater risk of lung cancer-related death than ex-smokers who had quit five years or more and hadn’t used e-cigarettes. For smokers who had quit less than five years, those who used e-cigarettes were found to have both a higher risk of both lung cancer and lung cancer mortality than non-e-cigarette users."

The researchers also looked at people aged 50 to 80 with a smoking history of 20 or more pack-years , because in the U.S. they would be likely be referred for lung cancer screening under American guidelines. "Ex-smokers in this group who had quit smoking for five years or more and used e-cigarettes reported a higher risk of both lung cancer and lung cancer-related death than those who didn’t use e-cigarettes," the release says. "In addition, ex-smokers who used e-cigarettes and had quit smoking less than five years before had a higher comparative risk of lung cancer.

The authors conclude, “Clinicians must highlight the potential harmful effects of alternative e-cigarettes use when integrating smoking-cessation interventions, to reduce lung-cancer risk.”

Study: E-cig use raises risk of early development of asthma 252%

Studies show vaping may contribute to the development of asthma. (Image from Very Well Health) 
Kentucky Health News

There is a significant link between vaping and asthma in adults, according to a new study published in the Journal of the American Medical Association Network Open.

The study found that adults who did not have any asthma symptomps at the beginning of the study and reported e-cigarette use in the past 30 days increased their risk of developing asthma at an earlier age by 252%.

“While previous studies have reported that e-cigarette use increases the risk of asthma, our study was the first to examine the age of asthma onset,” said first author Adriana Pérez, professor of biostatistics and data science at the University of Texas-Houston School of Public Health. “Measuring the potential risk of earlier age of asthma onset as it relates to past 30-day e-cigarette use may help people from starting use or motivate them to stop.”

The study used data from the Population Assessment of Tobacco and Health Study, a national longitudinal study of tobacco use and how it affects the health of adults and youths in the U.S.

“The findings of the study underscore the need for further research, particularly regarding the impact of e-cigarette use on youth and its association with early age of asthma onset and other respiratory conditions,” Pérez said in a news release. The study says the lack of youth impact "could be due to a lack of statistical power."

"Pérez said the study highlights the need to address the health burden of asthma, which results in $300 billion in annual losses due to missed school or workdays, mortality, and medical costs according to the Centers for Disease Control and Prevention," the release says. "Tobacco regulations, prevention, intervention campaigns, and cessation programs are needed to prevent early age of asthma onset due to e-cigarette use, the authors wrote."

Monday, April 22, 2024

Vape retailers and hemp association file suit to block new law that limits sale of vape products to those approved by the FDA

Only vaping products authorized or pending approval by
the FDA can be sold in Kentucky as of Jan. 1. (Getty Images photo)
By Sarah Ladd
Kentucky Lantern

Four vape shops, the Kentucky Vaping Retailers Association and the Kentucky Hemp Association have filed suit in Franklin Circuit Court seeking to strike down a new state law outlawing the sale of some of their products.

Greg Troutman, a lawyer for the Kentucky Smoke Free Association, which represents vape retailers, said he’s “hoping that we can get a resolution to this well before” the law is scheduled to take effect Jan. 1.

The lawsuit, which was filed Friday, argues that House Bill 11’s definitions of “vapor products” and “other substances” lump electronic cigarettes and vapable hemp and marijuana products together, making it too broad and arbitrary to satisfy the state constitution.

It also violates due process by requiring retailers to comply with a nonexistent regulatory process for hemp and other non-nicotine products, Troutman said.

Retailers will be subject to fines and penalties for selling vapable hemp-derived products once the law takes effect, the lawsuit says.

HB 11’s backers tout the bill as a way to curb underage vaping by limiting sales to “authorized products” or those that have “a safe harbor certification” based on their status with the U.S. Food and Drug Administration.

The bill was backed by Altria, the country’s largest manufacturer of cigarettes, which also markets FDA-approved vape products. Altria has spent more than $500,000 lobbying the legislature since January 2022, according to records filed with the Legislative Ethics Commission.

The suit alleges that the new law requires FDA approval for products that cannot possibly win FDA approval because the FDA has no regulatory process for them, such as those containing amanita muscaria (a mushroom) and hemp-derived products. The law would also apply to vapable marijuana products set to become available in Kentucky 2025 under a law the legislature passed last year, the lawsuit says.

“Unless the manufacturers are making a therapeutic claim — that is, they’re intended to cure, treat, mitigate disease — they’re not subject to an FDA regulatory process,” Troutman said. “So how can you condition market approval in Kentucky upon complying with a nonexistent process? That is absolutely Kafkaesque.”

In 2009, Congress required the FDA to regulate tobacco products to “protect the public health of the U.S. population and create a healthier future.” The FDA began regulating “electronic nicotine delivery systems” — e-cigarettes — under that authority in 2016.

The suit also alleges the new law violates a provision in the state constitution limiting laws to one subject. HB 11 is titled an “Act relating to nicotine products” but applies to non-nicotine vaping products such as those derived from hemp, the lawsuit says.

The defendants are Allyson Taylor, in her capacity as commissioner of the Kentucky Department of Alcoholic Beverage Control, and Secretary of State Michael Adams.

In the final days of the session, lawmakers merged HB 11 with Senate Bill 344, which created an e-cigarette registry. Gov. Andy Beshear signed the combined bill  into law April 5. Some advocates fear it could force more people back to traditional cigarettes, which are worse for bodily health than vaping.

Vape-store owners also testified the law could create a monopoly for big retailers and hurt small businesses.

A spokeswoman for House Republicans said Tuesday that she could not comment on pending litigation, but believes “the legislature’s efforts to keep potentially dangerous e-cigarettes out of the hands of our children will stand the test.”

Tobacco use can lead to all sorts of health problems, according to the Centers for Disease Control and Prevention. They include cancer, diabetes, heart disease and more. Nicotine is the addictive chemical in tobacco and can harm the developing brain, the CDC says.

Sunday, April 21, 2024

Kentucky is No. 4 in smoking, down from No. 2, but at 17.4% of adults, experts say the state's smoking rate is still way too high

By Melissa Patrick
Kentucky Health News

Kentucky still has one of the nation's highest adult smoking rates, but has fallen to fourth among the states, after many years of either ranking first or second. The rate for 2022, the last year for which a rate has been calculated, is 17.4%.

Asked why Kentucky might have seen a drop in its ranking, Amanda Fallin-Bennett, director of the Kentucky Center for Smokefree Policy, said it could be because Kentuckians have good access to treatment programs. 

"Compared to other states, it does have pretty good access to tobacco-treatment services for most all Kentuckians," she said, adding later, "The majority of people who smoke cigarettes would like to quit. So we know that making cessation services available and accessible is a big help."

Kentucky passed a law in 2017 to require all insurance policies sold in Kentucky to cover all smoking-cessation medications and counseling approved by the U.S. Food and Drug Administration. This also includes Medicaid, which covers one in three Kentuckians. The law also removed many of the barriers to such treatment, such as co-payments and limits on length of treatment.

Kentucky offers a program called Quit Now Kentucky. The quit line can be reached at 1-800-QUIT-NOW(784-8669); through text QUITKY to 797979; or online at www.quitnowkentucky.org. The services are free and confidential. 

Fallin-Bennett added that it's important to consider that another reason that Kentucky's smoking rate has dropped could be because of increases in the uses of alternative tobacco products, like vapes. or heat-not-burn devices.

1 in 4 in Ky. smoked five years ago; now 1 in 6

With 17.4% of Kentucky adults reporting they smoke every day or some days, Kentucky ties with Mississippi for the fourth highest smoking rate in the nation, behind West Virginia (21%); Arkansas (18.7%); and Tennessee (18.5%). The figures are from the Behavioral Risk Factor Surveillance System, a continuing national survey by the Centers for Disease Control and Prevention.

Kentucky's smoking rate has been on a steady decline since 2011, even though it was nearly 20% in 2021 and nearly 25% just five years ago, according to America's Health Rankings, using CDC data.

This means that instead of more than one in four people smoking in Kentucky just five years ago and one in five in 2021, now just over one in six Kentucky adults are considered "current smokers."

Fallin-Bennett said any decrease in smoking is to be celebrated: "Smoking is the leading cause of preventable death and disease and so anytime someone stops smoking, they are dramatically reducing their risk for cancer, heart disease, stroke, preterm birth, just a myriad of adverse health outcomes that are associated with smoking."

Shannon Baker, advocacy director for the American Lung Association for Kentucky and Tennessee, said she had no data to analyze why Kentucky now ranks fourth among states instead of second, and cautioned that the focus should remain on the fact that Kentucky's smoking rate is still among the worst in the nation.

"I can tell you that 17.4% of Kentucky adults smoke compared to the national average rate of 14%. So still, it's still a terrible statistic, right? . . .  So I guess I would caution us to look at that, instead of how we rank," she said. 

Baker said any drop in the state's smoking rate is great news, but noted that Kentucky continues to have the nation's highest rates of lung cancer and lung-cancer deaths: "We still have miles to go." 

What next? 

Asked what needs to happen to bring this rate down further, Fallin-Bennett said increasing tobacco taxes would help, as would more Kentucky counties and cities passing  comprehensive smoke-free policies.

"So only 38% of Kentuckians are covered by comprehensive smoke-free policies where smoking is not allowed in restaurants, bars and workplaces," she said. "So that is an area that Kentucky continues to struggle with and that would likely further reduce smoking rates." 

Baker praised the efforts of the state's Lung Cancer Screening Advisory Committee, but said more Kentuckians and providers need to be educated about the availability of low-dose CT screening for smokers and former smokers who qualify for it.

She said she thinks the committee is the first in the nation "that's really focusing on what we can do to increase the number of eligible individuals actually getting the low-dose CT scan done, and making making it more accessible and affordable statewide," she said. "That's a huge opportunity for us."

A missed opportunity, she said, was in the recent legislative session, when legislators removed strict enforcement measures from House Bill 11, aimed at decreasing youth vaping. She said that the current laws that prohibit retailers from selling nicotine products to youth is "not effectively enforced." 

Baker added, "We need three things: We need licensing, and we need regular compliance checks, and we need penalties for violations that escalate for repeat violations all the way up to the point of suspension and revocation of your license for the worst actors, the scofflaw, and we know that they're out there. And those things together represent a tremendous opportunity to address youth e-cigarette use and nicotine addiction, and we missed the boat."

Gov. Andy Beshear signed HB 11 into law on April 5. It limits legal sale of vape products to those approved by the FDA. It will create a database of retailers that sell the products and set fines for retailers, manufacturers and wholesalers who violate the law, but penalties for retailers are much less than in the bill's original version.

Tuesday, April 16, 2024

Top senators, one of whom lost both parents to smoking, say no advocates spoke to them about increasing anti-tobacco spending

By Al Cross
Kentucky Health News

Kentucky's top two state senators said Tuesday that none of the advocates for more funding of tobacco prevention spoke to them about it during the legislative session that ended Monday night.

"I never heard from those advocates. They never came to meet with me, and they probably should've. . . . I was in the room where it happened, and nobody ever spoke to me," Majority Floor Leader Damon Thayer of Georgetown said in response to a question from Kentucky Health News.

Thayer spoke at a Capitol rotunda press conference where leading Senate Republicans discussed what they considered to be the session's accomplishments. Senate President Robert Stivers told Kentucky Health News afterward that no one ever spoke to him about the proposal to increase tobacco-prevention spending to $10 million a year from $2 million.

Letter to senators (For a larger version, click on it.)
The proposal came from the American Cancer Society and several other groups interested in better health, including the Kentucky Chamber of Commerce. In a letter to senators, they said smoking is the No. 1 cause of preventable death in Kentucky and causes $2.23 billion in health-care costs, including $634 million in the federal-state Medicaid progam that covers more than one in three Kentuckians.

"A well-funded, fact-based tobacco control program is needed to counteract the $251 million per year that tobacco companies are spending to market their deadly and addictive products in Kentucky," the letter concluded. "As Big Tobacco has been working hard to addict future generations with e-cigarettes and other tobacco products, the need for more funding for tobacco-prevention programs has never been greater."

Thayer said after the press conference, "I get stacks and stacks of budget requests, and if they say, "I sent him a letter or an email,' that's not effective."

Kentucky Health News asked Doug Hogan, the Kentucky lobbyist for the cancer society, what legislators the advocates spoke with and why Stivers and Thayer were not included. He replied with this email:

“The American Cancer Society Cancer Action Network (ACS CAN) is proud to have advocated for the health of Kentuckians during this General Assembly session by asking for an increase in funding for the state’s tobacco prevention and cessation program. ACS CAN staff and volunteers were able to contact Senate and House offices to share the importance of this funding. ACS CAN is disappointed that our message was not heard, and a significant investment was not made in programs to help prevent kids from starting to use tobacco products, including e-cigarettes, and help those already addicted to quit.”

Neither side noted that the administration of Gov. Andy Beshear didn't ask for more money, either. Asked why, Cabinet for Health and Family Services spokeswoman Stephanie French said in an email that the legislature "reduced the tobacco prevention and cessation budget by more than $2.6 million" in the previous state budget, and "after flat-funding at $2 million" a year in the current budget, "The legislature has further reduced the tobacco prevention and cessation budget by another $130,700 in the recently enacted ... biennial budget. Both of these reductions were significantly lower than what Governor Beshear proposed in his Executive Branch budget."

French said Beshear put nearly $1 million extra into tobacco control due to increased receipts from the Master Settlement Agreement with cigarette manufacturers. "This was a doubling of the budget for tobacco cessation and prevention investment for this year and that money is being deployed now."

At the press conference, Stivers was asked if tobacco-control spending would be a good investment in the long term, by reducing health-care costs. He gave Thayer the microphone.

Asked if he thinks the current $2 million tobacco-control budget doesn't work, Thayer said, "I honestly don't know that it does. Honestly. I mean, how much money can you spend trying to dissuade people from doing something that everybody knows is unhealthy?"

Earlier, he said, "Everybody knows that smoking cigarettes is bad for you. . . . My dad knew the health risk his whole life and he never quit." Earlier, he said, "Both my parents died of cancer from the fact that my father was a multi-pack-a-day smoker, so this is an issue that's a little sensitive to me."

Thayer told Kentucky Health News after the press conference he believes that smoking killed his father, who died of esophageal cancer, and that secondhand smoke in their home killed his mother, who died first, of multiple myeloma: "I never saw her smoke a cigarette in my life." He acknowledged that more education on the risks of seocndhand smoke is needed.

When the final budget was released, Kentucky Health News asked Senate budget committee Chair Chris McDaniel of Northern Kentucky why there was no increase in tobacco-control spending. He said, "We kind of distributed it more broadly, with increases in funding for cancer research."

Stivers said likewise at the press conference, adding that health departments also got more funding. "What we are trying to do in all areas is to encourage people to have better and healthier lifestyles," he said.

Monday, April 15, 2024

Legislature rejects pleas, cuts tobacco-prevention spending; passes vape bill that some say could spur youth smoking

Letter requesting much more state funding of tobacco prevention
UPDATE, April 16: Senate President Robert Stivers and Majority Floor Leader Damon Thayer told Kentucky Health News that no one spoke to them about more money for tobacco prevention, and they had no duscussions with the tobacco industry during the session.

By Sarah Ladd
Kentucky Lantern

In a year when the American Cancer Society asked the Kentucky legislature to greatly increase spending on tobacco prevention, lawmakers cut it and passed an anti-vaping bill that some say could increase cigarette use in the state.

The allocation for tobacco prevention in the next two-year state budget — about $8 million shy of advocates’ ask — “certainly is not” enough to combat use in the state, said Doug Hogan, the government relations director in Kentucky for the cancer society and its Cancer Action Network.

The cancer society and others — including the Kentucky Hospital Association, Foundation for a Healthy Kentucky and the Kentucky Chamber of Commerce — signed onto a letter in January asking for a $10 million investment in the state’s Tobacco Prevention and Cessation Program.

Also writing in support of the $10 million for prevention and cessation were Dr. B. Mark Evers, director of the Markey Caner Center at the University of Kentucky, and Jason Chesney, director of the Brown Cancer Center at the University of Louisville.

“A well-funded fact-based tobacco control program is needed to counteract the $251 million per year that tobacco companies are spending to market their deadly and addictive products in Kentucky,” that letter stated. “As Big Tobacco has been working hard to addict future generations with e-cigarettes and other tobacco products, the need for more funding for tobacco prevention programs has never been greater.”

According to that letter, Kentucky sees $55 savings for every $1 it spends on tobacco control programs.

This session, lawmakers passed a bill touted as a way to curb underage vaping. The bill limits vaping products that can be sold in Kentucky to those that have approval from the U.S. Food and Drug Administration, have applied for FDA approval or are challenging denial of FDA approval.

Advocates said that by limiting available vaping products, the bill could result in more Kentuckians turning to cigarettes. Tobacco cigarettes are worse for bodily health.

Vaping has eclipsed traditional smoking among Kentucky youth, advocates say, though Kentucky’s rates for both are higher than the national average.

“The only effective strategy is to adequately fund evidence-based programs,” the Cancer Society’s Hogan said, “that have a meaningful, measurable track record of success.”

Alicia Whatley, policy and advocacy director for Kentucky Youth Advocates, said the state needs a “comprehensive” battle against nicotine use in general. The roughly $2 million going toward cessation is “not nearly enough” to accomplish that goal.

“​​We don’t just want a database of who’s selling vape products,” she said. “We want something comprehensive that tells us who’s selling any of those products” — traditional cigarettes, chew tobacco, nicotine patches, vapes, she said.

Under a new law, the Kentucky secretary of state is required to keep a list of retailers that sell vaping products. That law, HB 11, is meant to curb underage vaping by limiting sales to “authorized products” or those that have “a safe harbor certification” based on their FDA status.

In the final days of the session, this bill absorbed Senate Bill 344, which created an e-cigarette registry. The combined bill was signed into law by Gov. Andy Beshear on April 5. It goes into effect Jan. 1.

“It really should be more comprehensive, but I did not see that that was the case this year,” Whatley said. “I saw a lot of people just talking about vaping.”

Another new law, HB 142, directs boards of education to distribute tobacco prevention and cessation materials to students every year. It also requires schools to confiscate tobacco and vaping products and allows them to suspend students for subsequent violations of the ban on smoking and vaping on school property. It was delivered to Beshear in late March and he signed it on April 9. 

What’s in the state budget for tobacco prevention?

The legislature’s two-year budget slightly cut funding for tobacco control in 2025, according to Cara Stewart, the director of policy advocacy at Kentucky Voices for Health. The funding then flattens out in 2026.

Right now, there’s about $2 million per year set for tobacco prevention efforts, said Hogan. That number drops by about $130,000 for the first year of the new budget. Then, for 2025-2026, it is restored to $2 million.

“Quite frankly, it’s outrageous that lawmakers ignored the urgent need for a significant investment in tobacco prevention and cessation,” Hogan told the Lantern in early April. “Lives are at stake. The health of our next generation is at stake with e-cigarettes and other products.”

Citing Centers for Disease Control and Prevention data, Stewart said Kentucky should be putting closer to $56.4 million every year into tobacco control, considering the state’s population and smoking rate.

Two bills that did not advance this session — HB 813 and SB 335 — would have assisted that goal by moving Juul settlement dollars from the General Fund to the Department for Public Health to support the Smoking and Vaping Cessation Program. Both were dead on arrival.

Public health advocates think that money should indeed be spent on tobacco prevention.

“Tobacco use is our number one preventable cause of disability, disease and death,” said Stewart. “Every single county in the state has a smoking rate above the national average.” 

‘All smokers want to quit’

The CDC reports that “most” vaping products have nicotine in them, an “addictive” chemical that is “toxic to developing fetuses.”

Vaping products can also harm lungs and brain development in youth, the CDC says. E-cigarettes are not safe, the CDC says, though they’re safer than smoking traditional cigarettes, which the CDC reports is a leading cause of preventable death in the country.

Some research suggests vaping can help people quit traditional smoking. That hope helped push Louisville businessman Troy LeBlanc into the vape business.

About 11 years ago, it worked in getting — and keeping — him off cigarettes.

“All smokers want to quit,” LeBlanc said. “I went through Chantix. I did the gum. I did the patches. I did cold turkey. I did all these different things that never worked. Well, you know what did work? Vaping.”

“The whole point of electronic cigarettes” is to get people weaned off, he said, by tapering down their intake over time, eventually stopping.

“I cannot say that every person that walks into my store is doing it with this specific plan to quit vaping,” he said. But he has seen “multiple people quit vaping completely.”

LeBlanc told a legislative committee that the new law’s limits on vaping products “is essentially creating a monopoly for Juul,” an e-cigarette company. 

Will anti-vape bills help public health?

It remains to be seen what effect anti-vaping legislation like HB 11, which takes effect Jan. 1, will have on public health.

Some in the vaping industry say it will drive consumers back to traditional tobacco products — an assertion buttressed by reports from Altria, the parent company of tobacco giant Phillip Morris USA, the leading manufacturer of cigarettes in the United States.

Altria is lobbying legislatures around the country to enact laws like the one Kentucky just passed. Altria also has moved aggressively into marketing its FDA-approved e-cigarette products.

In a February earnings call. Altria CEO Billy Gifford said that “illicit e-vapor” sales last year reduced Phillip Morris cigarette sales by 1.5% to 2%.

The February earnings report said a successful clampdown on disposable e-cig growth could increase Altria’s earnings per share between 5 cents and 15 cents, according to an analyst for Barclays, “if cigarette volumes improve and e-cigs decline or remain steady.”

Since January 2022, Altria has spent more than $500,000 lobbying the Kentucky legislature, according to reports filed with the Legislative Ethics Commission.

“To the extent that this drives people back to smoking, how does this help public health?” said Greg Troutman, a lawyer for the Kentucky Smoke Free Association, which represents vape retailers.

Troutman said the new law will “blackmarket” vape products that have unknown ingredients.

People who smoke increase their risks of heart disease and strokes, according to the CDC. But it doesn’t hurt just them. Nonsmokers who breathe secondhand smoke are much more likely — 20% to 30% — to end up with heart disease or stroke, the CDC says. Kentucky already has dismal rates of heart disease mortality and stroke.

In 2021, a California-based study found that when flavored e-cigarettes were banned, minors turned to traditional cigarettes. At that time, researchers foundthat “reducing access to flavored electronic nicotine delivery systems may motivate youths who would otherwise vape to substitute smoking.”

At the time of publication, study author and assistant professor of health policy at Yale School of Public Health Abigail Friedman, urged caution when passing legislation attacking vapes only.

“While neither smoking cigarettes or vaping nicotine are safe per se, the bulk of current evidence indicates substantially greater harms from smoking, which is 
responsible for nearly one in five adult deaths annually,” said Friedman. “Even if it is well-intentioned, a law that increases youth smoking could pose a threat to public health.”

Thursday, April 11, 2024

Comer and committee grill FDA chief about handling of vapes

U.S. Rep. James Comer, R-Ky.
(AP photo by Alex Brandon)
Kentucky Health News

Rep. James Comer of Kentucky and other House members "grilled FDA Commissioner Robert Califf about why the agency has failed to swiftly assess product applications for e-cigarettes while illicit products from China flood store shelves," Luke Zarzecki reports for Inside Health Policy. "Califf defended FDA's approach by saying the agency is not resourced to deal with the flood of millions of applications for vaping products."

Califf appeared Thursday at a hearing of the Comer-chaired House Committee on Oversight & Accountability that last almost five hours. "We covered topics from seafood inspection, all the way to every other topic that I think could be imaginable," Comer told Zoey Becker of FiercePharma.

"Multiple lawmakers blamed FDA’s failure to quickly approve e-cigarette and vaping products from the United States for the proliferation of illegal imports, Zarzecki reports, quoting Comer: “FDA’s failure to regulate has allowed unsafe and illicit products to proliferate.”

"Califf said FDA would be more equipped to deal with illicit products if Congress approved the agency’s request to require e-cigarette manufacturers to pay user fees," Zarzecki reports. "He said FDA will not approve applications for vaping products unless they demonstrate the product will not contribute to nicotine addiction among children and youth." He said no one expected 26 million applications, and FDA has requested more staff to address the backlog.

The agency has asked the Supreme Court to review an appeals court’s ruling that it consider every marketing application for flavored e-cigarette products individually, "rather than rejecting them en masse because of their impact on youth smoking," Zarzecki notes.

"Public health groups have also sued the FDA and HHS over delaying a ban on menthol cigarettes and flavored cigars, and a spokesperson for FDA noted the rule is pending at the White House Office of Management and Budget."

FDA Commissioner Robert Califf (AP photo)
Califf said that in 2023, FDA “issued warning letters to more than 120 manufacturers and distributors and more than 400 retailers; filed over 40 civil money penalty complaints against manufacturers and over 65 against retailers; and collaborated with our federal partners at the U.S. Customs and Border Protection to seize approximately 1.4 million units of unauthorized e-cigarette products with an estimated retail value of more than $18 million; among other actions.”

"Comer criticized FDA for not seizing more illegal products from retailers," Zarzecki reports, and said the agency's approach to e-cigarettes is not what Congress had in mind. Comer said, “Those seeking to play by the rules don’t even know what the rules are because FDA won’t tell them, or FDA won’t put information out, or they will put information out, but they change it.”

Califf said vaping and electronic cigarettes came along after Congress passed the Tiobacco Control Act, under which the FDA operates.

Comer, who represents the state's First Congressional Distict, also criticized FDA for “failing to do the bare minimum to carry out its core mission” under the Biden administration. He said “a pattern of issues” show the agency “appears consistently unprepared for crises.”

He noted that FDA inspections of foreign manufacturing plants, where many drugs sold in the U.S. are made, haven't returned to pre-pandemic levels. He said the agency inspected 79 percent fewer foreign plants in 2022 than it did in 2019.

Califf conceded, “We need to pick up the pace.” He said the FDA recently “completely" reworked its inspection system in India to address problems there. The agency is converting its Office of Regulatory Affairs into an Office of Inspections and Investigations, "reassigning some 1,500 staffers to related roles."

Sunday, March 24, 2024

State Senate weakens bill to curb underage vaping and sends it to the House with just days left in the legislative session

By Melissa Patrick
Kentucky Health News

A bill set up a regulatory framework to curb underage vaping passed out of the Senate on Thursday, March 21, but hasn't yet been assigned to a committee in the House, with only a few days left in the legislative session.

State Sen. Brandon Storm
Senate Bill 344, sponsored by Sen. Brandon Storm, R-London, passed 29-8-1 with a floor amendment that reduced the civil penalties in the original bill and made some technical changes. 

Storm said the goal of the bill is to clean up the illicit market in electronic vaping devices. He said it would require an e-vapor manufacturer to certify to the state that the products it sells comply with federal regulations. 

It would also require the state to publish a list of compliant products in a directory, which would allow manufacturers, distributors and retailers to know exactly which products could be sold in Kentucky. "Today, there is ambiguity," he said.

"This solution will improve how these products are distributed and sold and will reduce underage exposure and use while also providing adult smokers access to less harmful smoke free alternatives," said Storm.

The bill also includes a list of terms that couldn't be used to "advertise, distribute, market, offer for sale, or sell a vapor product," including "cake," "candy," "cupcake," "pastry," or "pie." It also states that any "advertising, design, marketing, packaging, or trade dress" cannot include a food or symbol that is marketed to minors, or be advertised on school supplies primarily used by minors. 

As amended, the bill would impose a civil penalty of $250 for each product offered for sale in violation of the rules until the product is removed from inventory or until the offending product is properly listed in the directory. The second violation at the same location within a 12-month period would be $500 per product. The third violation would be $1,000 per product and the fourth or subsequent violation would be $1,500 per product.

The original bill included an initial penalty of $500 per day, with a second violation in a year bringing a 14-day suspension of the store's business license. The third violation would have resulted in a 60-day suspension subsequent violations would result in a one-year suspension. 

Sen. David Yates, D-Louisville, said the way to decrease e-cigarette access to young people is to restrict their sales in convenience stores and to only put it in stores that allow people who are 21 and older. And, he said, it's imperative to have strong enforcement laws. 

"If you do have someone that's selling to children, we hit them with these monster fines and penalties that have been recommended and couldn't pass today. You shut them down. You hold them accountable," he said. "But instead, what we're going to do is we're going to protect a monopoly and ultimately allow tobacco sales to increase." 

Yates also noted that the U.S. Court of Appeals for the Fifth Circuit has ruled that the FDA process in approving which products can be sold is "arbitrary and capricious," and the case is going to the U.S. Supreme Court.

"So with our passage today, we know if anything, we're going to cost our taxpayers a whole lot of money in litigation," he said. "But let's do that, because we're being lobbied by a very, very strong group." 

According to the 2021 Youth Behavioral Risk Factor Surveillance System data, 45% of Kentucky's high-school students said they had used an electronic vapor product, 22% were current users, 8% were frequent users, and 7% used the products daily. Asked how they got them, 12% said they usually bought them at a convenience store, supermarket, discount store or gas station.

Among Kentucky middle-school students, 24% said they had used an electronic vapor product, 11% said they were current users, nearly 3% said they were frequent users, and 2% said they used the products daily.

A floor amendment filed by Sen. Jimmy Higdon, R-Lebanon, that would have required retail establishments that sell vapor products to be licensed and much more stringent penalties for violations, among other things, was withdrawn. Higdon said he didn't have the votes to pass it. 

A floor amendment filed by Sen. Adrienne Southworth, R-Lawrenceburg, failed to pass. It would have exempted from the "vapor products" definition those with 20 milligrams of nicotine per milliliter or less and those used in an open vaping system.

A bill similar to SB 344, House Bill 11, passed the House on March 11 and has been assigned to the Senate Licensing and Occupations Committee, but has not yet been heard.

The legislature, which can meet for only 60 days, must finish by April 15, unless the governor calls a special session. This session has six days left: Monday through Thursday of this week for passage of bills, followed by a recess during which the governor can sign or veto bills, then two days for legislators to reconsider vetoed bills. Those days are Friday, April 12, and Monday, April 14.

Monday, March 11, 2024

Bill aimed at curbing Kentucky's youth 'vaping epidemic' passes House; Ky. Youth Advocates calls on Senate to make it stronger

By Melissa Patrick
Kentucky Health News

A bill to curb what its sponsor called the youth "vaping epidemic" in Kentucky passed the state House on Monday and is now in the Senate. 

Rep. Rebecca Raymer
Sponsor Rebecca Raymer, R-Morgantown, told her colleagues that she was inspired to work on the issue after hearing from school officials across the state about how "rampant the vaping is in our schools." 

Raymer said there is a "vaping epidemic," and most vape products being confiscated from students are not even authorized by the federal Food and Drug Administration.  

House Bill 11 passed on a 62-26 vote, with concerns voiced from members of both parties that it would do little to stop youth from vaping, but would harm small vaping businesses. 

The bill would require businesses that sell vaping products to acknowledge that in their annual business filings with the secretary of state, who would share it monthly with the Kentucky Department of Alcoholic Beverage Control and the state Department of Revenue.  ABC would then be responsible for creating a system that identifies and publishes the retailers who violate the law.

The bill would fine retailers $100 to $500 for a first offense of selling vaping products to anyone under 21, which is consistent with existing law. The penalty for a second offense would be $1,000 and $5,000 for a third violation. A retailer with a fourth violation in two years would be banned from selling vapes. The bill also sets fines for manufacturers and wholesalers. 

Terry Brooks, executive director of Kentucky Youth Advocates, lauded the bill's passage, saying it takes important steps to reduce youth access to addictive nicotine products. But he called for teh Senate to strengthen it. 

"Provisions of this bill will provide a more complete understanding of the retail landscape by creating a database of tobacco and nicotine product retailers, which is a critical first step to ensure that bad actors selling to underage kids are penalized," Brooks said in a news release. "But the ability to hold retailers accountable for responsibly selling tobacco and nicotine products relies on regular compliance checks for underage sales violations."

He added, "Youth have been targeted with flavored vape products and can quickly become dependent, but there are opportunities to stop this cycle. As HB 11 advances, we hope this bill can go even further by ensuring that regular compliance checks are included in statute." 

Legislators heard a similar plea from Mallory Jones, a junior at George Rogers Clark High School in Winchester, at the March 7 committee hearing. 

"Addressing the source of these products is critical to reducing youth access and initiation of nicotine, but the rules are only as good as the enforcement that we put behind them," she said. 

According to the 2021 Youth Behavioral Risk Factor Surveillance System data, 45% of Kentucky's high-school students said they had used an electronic vapor product, 22% of them were current users, 8% were frequent users, and 7% used the products daily.

Asked how they got them, 12% said they usually bought them at a convenience store, supermarket, discount store or gas station.

Among Kentucky middle-school students, 24% said they had ever used an electronic vapor product, 11% said they were current users; nearly 3% said they were frequent users, and 2% said they used the products daily. 

Opposition to the bill

During the House debate, Rep. Savannah Maddox, R-Dry Ridge, said she opposed the bill because it would ban products meant to be used by adults.

“This is being proposed as something that is designed to reduce harm in minor children, when in reality it will do no such thing. These products are already illegal,” she said. “What it will do is harm Kentucky’s businesses.”

Rep. Rachel Roarx, D-Louisville, brought up the concerns voiced by vape-shop owners to the committee, including documentation that showed convenience stores are the bad actors when it comes to selling vapes to minors, and their concerns that the only FDA-approved products have high nicotine levels. She also voiced her concerns that this bill is "granting a monopoly to certain companies." 

Rep. Daniel Grossberg, D-Louisville, said over 90% of his 4,000 emails and phone calls about the bill, many of them small business owners, had asked him to vote against it.

He said "The real problems [are] flavoring and marketing that target our kids," and called for "stricter controls and enforcement for those who sell to minors, and regulate both the potency and the purity of these products. Rather than us ceding control to the FDA, who has done nothing effective about this. I too want to protect our kids."

Raymer said several times that the FDA has been granted authority to regulate these products, and that this bill is simply following what the FDA says.

"I don't think the FDA has done a great job in going through this list, but that is what we have to work with," she said. " And this is how we get the products that are being geared towards these minors off the shelf and products that have gone through no safety checks, we don't know what's in them. . . . They're not just harmful for youth, they're harmful for all Kentucky consumers."

Saturday, March 9, 2024

Bill is moving to create database (but not licensing) of vape retailers, raise fines and bring state law in line with FDA rules

A customer vapes at a shop in Richmond, Va. (Associated Press file photo by Steve Helber)
By Melissa Patrick
Kentucky Health News

A bill to create a statewide database of retailers that sell vaping products, and align state law with federal restrictions on the products, is moving through the Kentucky General Assembly.

House Bill 11, sponsored by Republican Rep. Rebecca Raymer of Morgantown, was approved with a committee substitute by the House Health Services Committee on March 7 and was posted for possible action by the House starting Monday, March 11. 

After nearly an hour of discussion, HB 11 was approved 14-1-3, with Rep. Felicia Rabourn, R-Pendleton (Henry County), voting no and Democratic Reps. Adrielle Camuel of Lexington, Rachel Roarx of Louisville and Lindsey Burke of Lexington passing. 

Rep. Rebecca Raymer

Raymer said she began working on the bill after learning that most items confiscated in Kentucky schools are flavored and disposable vapes,and “I found out that these vapes are not even supposed to be offered for sale,” under rules of the U.S. Food and Drug Administration.

She said opponents would say that the bill will all such products off the shelf, but “That is simply not true. There are other states that have used the same definitions that we are using. I think Alabama is one of the states and they have about 1,600 products on their registry of things that can still be sold.”

Raymer said Congress is lobbying the FDA to create a concise list of what is legal and not legal, and “We are not the regulatory authority over these products. We don't get to decide what is legal and illegal.”

Dr. Britt Anderson, a pediatric emergency-medicine physician and vice-president of the Kentucky Chapter of the American Academy of Pediatrics, told the committee that she sees children come into emergency rooms addicted to nicotine and unable to stop vaping, which makes them cough and wheeze and be unable to exercise.

Vaping has become much more common among Kentucky schoolchildren than smoking. While the long-term effects of vaping on young people's health are unknown, Anderson said what we do know about vaping and nicotine use in youth is not "cutting-edge science." 

"We do know that they cause lung injury and changes to brain development during a crucial stage of life," she said. "And it's not just the nicotine. The complete ingredient list may contain fine particles and other carrier solvents that are unhealthy as well."

Mallory Jones, a junior at George Rogers Clark High School in Winchester, told the legislators that high schoolers can easily purchase vaping products despite the age restrictions.

"Once one person in a friend group starts using e-cigarettes, word gets around of where you can buy these products illegally, and it spreads like a domino effect," she said.

Jones lauded the bill, saying, "Addressing the source of these products is critical to reducing youth access and initiation of nicotine, but the rules are only as good as the enforcement that we put behind them."

Griffin Nemeth, coordinator of the #iCANendthetrend Youth Advisory Board at the University of Kentucky, noted that while HB 11 does not allow Kentucky to join the 40 other states that have some form of comprehensive tobacco retail licensure, it does allow the state to have a better understanding of the retail environment.

But he added that alone is not enough to make a difference: "It is with, and only with, the three combined elements of a retailer database, compliance checks and stiff penalties for violations that we can implement comprehensive prevention at the point of sale." 

Opponents of the bill

Troy LeBlanc, a retailer and manufacturer of vape products, said he supports efforts to decrease youth use of them, but said this bill won't do that because the bulk of the products approved by the FDA are sold in convenience stores and that's where most of the bad actors are when it comes to selling these products to youth.

"I urge you to change this bill to put these products in 21-and-over stores and have them policed by the ABC and have them fined with major fines . . . Make sure that the fine hurts enough to where people will not do it," he said. 

LeBlanc also said this bill would eliminate access to low-nicotine products while allowing sale of high-nicotine products made by large companies. 

He said the average nicotine level of products sold in vape shops is 3 milligrams per milliliter, while the large companies like Altria (formerly Philip Morris), make products with a much higher nicotine content.

"I don't believe it's the right bill because all it's going to do is to make sure that Altria is the main seller in every convenience store . . . . Juul is going to be all over the state," he said. "Juul also does not offer any nicotine product that's lower than 30 milligrams per milliliter." 

LeBlanc also pushed back on Raymer's claim that Alabama allows 1,600 products on their shelves, saying that after dissecting the list, "There are only eight brands on there of flavored nicotine." 

Mike Reichert of Campbell County, who said he owns two vape shops in Northern Kentucky, said this bill would likely cause his shops to close. 

"Most of the products that I sell would be banned as this bill is currently written," he said. "It would almost certainly cause my stores to close." 

Reichert said he got into the business to help people quit smoking, making that possible by selling the lower-nicotine products that can be tapered down to zero nicotine in his store. He agreed with LeBlanc that sales should be limited to 21-and-older stores, with higher fines to keep the bad actors out. 

Tommy Wilson of Pulaski County, who said he owns two vape stores, also pushed for such a move, which he said would likely make this issue go away. 

Wilson said he had helped thousands of people get off nicotine via combustible cigarettes and move to a lower-dose vaping product. 

“We too don't want youth vaping," he said. "But that said, we feel like it’s an adult’s choice to be able to find something that they deem is less harmful to their body. . . . Is it perfect? Maybe not, but is it better than 3,000 chemicals and burning smoke going into your lungs? I feel it is." 

The committee chair, Rep. Kim Moser, R-Taylor Mill, asked the opponents of HB 11 to keep talking to the bill sponsor to see if any tweaks can be made. 

"No one wants to do anything that is going to put anyone out of business," she said. "That's not our goal." 

Legislators' concerns

Rep. Josh Bray, R-Mount Vernon, asked the vape-shop owners if they're selling products that are not FDA-approved, prompting them to walk through the history of vaping products in the U.S., the ongoing methodology challenges to get products approved by the FDA and the legal challenges surrounding this issue. 

Earlier in her remarks, Raymer noted that she understands that those in opposition of this bill don't like the FDA process for regulating these products, but the bottom line is that the FDA has that authority. 

"And so we, as a state, have an obligation to offer some protection to our citizens," she said. "If we know these products are not authorized, they are not legal per the FDA, we shouldn't have them."

Roarx, one of the Louisville Democrats, said she appreciates the bill’s goal to keep Kentucky youth away from nicotine products, but said she has concerns that the bill might have unintended consequences on the tobacco and e-cigarette industry by creating a monopoly.

“I hope we can continue to make progress to make sure that we’re not just giving a couple of brands a monopoly on the entire industry,” Roarx said. 

The bill would take effect Jan. 1, 2025. Among other things, it would:
  • limit the sale of products to those authorized by the FDA and would punish retailers who sell unauthorized products to anyone under 21 years of age;
  • require businesses that sell vaping products to acknowledge that in their annual business filings with the secretary of state;
  • require the secretary of state to create a list of the businesses and share it monthly with the ABC and the state Department of Revenue;
  • require the ABC to create and maintain a tobacco database and reporting system, to be published monthly;
  • set rules around how manufacturers, wholesalers and retailers sell and distribute the products;
  • establish fines for manufacturers, wholesalers and retailers for noncompliance; and
  • allow police officers and ABC investigators to issue a uniform citation for any violation of the law. The citations would then be reported to and enforced by the ABC.
What are the fines? 

The bill would require any manufacturer of products covered by the federal Tobacco Control Act to sell authorized products to wholesalers and retailers. A manufacturer that violates this section would be subject to a fine of $25,000 for a first violation, $50,000 for a second violation and $75,000 for third and subsequent violations.

It would ban a wholesaler from selling unauthorized products and from selling authorized products to a retailer until it verifies that the retailer is not in the tobacco non-compliance database and reporting system. Violators would be subject to a $5,000 fine for the first violation, and $15,000 for the second and subsequent violations.

State law already bans sales to minors, with a fine of $100 to $500 for the first violation and $500 to $1,000 for the second violation. The bill would require the second-violation fine to be $1,000 and set a $5,000 fine for a third violation. A retailer with a fourth violation in two years would be banned from selling vapes. That would also apply to retailers who don't pay fines within 60 days.