Beshear gets bill to limit vaping products to those OKd by FDA; Ky. Youth Advocates calls for enforcement of underage-sales law

By Melissa Patrick
Kentucky Health News

A bill to reduce underage vaping by limiting legal sales to products approved by the U.S. Food and Drug Administration, and creating a database of retailers that sell the products, passed the legislature in its closing minutes Thursday night and was delivered to Gov. Andy Beshear for his signature or veto. 

Opponents of the bill say it would not curb underage use of vape products, but will hurt small businesses and help large companies that lobbied for it. 

Rep. Rebecca Raymer

House Bill 11, sponsored by Rep. Rebecca Raymer, R-Morgantown, was amended in the Senate to include parts of Senate Bill 344, sponsored by Sen. Brandon Storm, R-London. 

"Both he and I shared the goal of getting these vape products off the market that were being geared toward our children," Raymer said at the Senate Judiciary Committee meeting held hours before it passed the Senate and won concurrence in the House. 

The bill passed the Senate 29-7-1 on Thursday, March 28. Sen. Karen Berg, D-Louisville, cast the "pass" vote. Voting no were Republicans Shelley Funke Frommeyer of Alexandria, Jimmy Higdon of Lebanon, Robby Mills of Henderson, Adrienne Southworth of Lawrenceburg and Stephen West of Paris, and Democrats Robin Webb of Grayson and David Yates of Louisville. 

The House agreed to the changes and sent the amended bill to Beshear on a 64-27 vote, ending a day of debate that began in the Senate Judiciary Committee.

Committee discussion

Raymer said HB 11 simply lines up Kentucky's law with what the FDA says is legal, noting that the majority of vaping products being confiscated in schools are flavored disposable products form China. 

"And they are illegal in China, and they're only being made for sale in the U.S.," she said, adding later, "We are not making anything illegal. We are simply following what the FDA has put in place." 

Troy LeBlanc, a retailer and manufacturer of vape products, spoke against the bill, stating  that it is "essentially creating a monopoly for Juul. It's one of the very few products that would be left." Juul is a Japanese company in which Altria Group, formerly Philip Morris Cos., owns a 35% stake.

"I  would have to close my stores, and closing my stores means I fire 50 people here in the state," LeBlanc asserted. "And we simply can't compete having vape stores have the exact same 15-20 products as every gas station," which he said are the biggest source of vapes for underage people. 

He said transcripts from an earnings calls with Altria show that if electronic cigarettes are restricted, the company's earnings per share will go up because they will sell more tobacco. "It's the reason why they're pushing this bill so hard," he said. Kentucky Lantern reports that Altria is pushing similar bills in other states. 

Greg Troutman, a lawyer for the Kentucky Smoke-Free Association, and LeBlanc urged the committee to hold the bill until January 2026 to give the U.S. Supreme Court time to review how the FDA regulates vaping products. "This bill is going to shut everybody down," said Troutman.

He added, "This bill is not going to keep them out of the hands of kids" because they will buy them online. "Do we want our kids ordering in bulk from China? . . . these are going to order them in bulk and take them to school and use them and sell them." 

Senate debate

Yates said he didn't think the bill would protect minors. He called for future bills to limit the sale of vape products in places that only serve those 21 and older and to put more money into enforcement. This bill, he said, will put "mom and pop" vape shops out of business. 

"Against the best efforts, we are creating a monopoly for one particular brand," he said. "We are getting rid of the other brands that even have lower nicotine products in them." 

Berg said castign a "pass" vote was difficult because she supports efforts to decrease underage vaping but there are issues with how the products are approved by the FDA and the exorbitant cost to get a product approved that have led to "only one product can be sold in the state."  

While voting "no," Funke Frommeyer called the bill "very disruptive to many small businesses in my Senate district. I need to stand up for them."
 

Sen. Reginald Thomas, D-Lexington, acknowledged the hardship for small vape shops, but said when it comes down to it he had to vote "yes" and vote "on the side of our young people and their health and their concern."

House debate

Rep. Savannah Maddox, R-Dry-Ridge, said she voted against the bill because it is already illegal to sell these products to minors. "What this is, is big government, nanny-state overreach," she said. "Today it's  these products; what is it tomorrow?" 

Rep. Richard White, R-Morehead, said he supported the bill because of the dangers these products pose to young people. He told a story of a 15-year-old who was on one of his church's vans who had to be taken to a hospital after he overdosed on a vape that someone gave him.

"These things are so unregulated and been brought in from places that are not legal," he said. "I urge everybody to vote yes to help protect our kids." 

Rep. Ken Upchurch, R-Monticello, said he has a son who will soon turn 15 that he worries about every day. He said he would be voting "yes" to protect him and "I don't care who gets put out of business."

In its final form, the bill was not a big hit with Kentucky Youth Advocates. 

“We had hoped to celebrate HB 11 as a win for kids this legislative session, but at this point, it looks as if adult special interests are winning the day,” KYA Executive Director Terry Brooks said in a press release. 

“What’s clear is that Kentucky’s kids are facing a vaping epidemic, orchestrated by ‘big vape’ companies through marketing and sweet flavors. What’s also clear is that kids are getting their hands on vapes through local retailers despite state and federal tobacco-21 laws prohibiting selling to those underage. What is unclear is why the Kentucky General Assembly continues to move the focus away from enforcing underage sales law and taking meaningful steps to reduce youth initiation of these addictive nicotine products.”

What's in the bill? 

The final version of the bill defined "authorized vapor product" to only include vapor products and added online retailers. It did not include the product directory from Storm's original bill, and it kept the stiffer penalties from Raymer's bill. 

Asked about the online sale of these products, Storm told reporters, "If you're an online retailer and you're going to do business in Kentucky, you need to make sure that your items are compliant. And if not, you're gonna be held accountable."

HB 11 would only allow FDA-approved vaping products to be sold in Kentucky, along with those that have received a "safe harbor certification" for products that fall under several qualifications, including those that remain under review, but has not yet been denied or approved for sale.

It would also require businesses that sell vaping products to acknowledge that in their annual business filings with the secretary of state, who would send a list monthly to the Department of Alcoholic Beverage Control and the Department of Revenue. ABC, which is already responsible for enforcing laws aimed at limting youth smoking, would be responsible for creating a system that identifies and publishes the retailers who violate the law.

If the bill becomes law, it 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  or subsequent 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.

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.

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."

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.

Electronic cigarette sales are way up, and so are calls to poison-control centers about children's exposure to the devices

Truth Initiative photo

By Melissa Patrick

Kentucky Health News

Electronic cigarette sales are up, and so are calls to poison control centers, according to two new reports from the Centers for Disease Control and Prevention. 

E-cigarette sales increased by nearly 47% over the past three years, increasing from 15.5 million units per four-week period in January 2020 to 22.7 million in December 2022, according to a CDC market analysis published in the agency's June 23 Morbidity and Mortality Weekly Report. 

The data includes sales from brick-and-mortar retailers only and does not include sales data from vape shops and internet retailers.

The study also found that during the three-year period, the number of brands increased by 46%, from 184 to 269 brands. Sales of re-filled devices decreased (75% of total sales to 48%), while disposable devices increased (25% to 52% of sales); while sales of youth-appealing flavors—such as fruit, candy, and desserts—increased.

"The surge in total e-cigarette sales during 2020-22 was driven by non-tobacco-flavored e-cigarette sales, such as menthol, which dominates the prefilled-cartridge market, and fruit and candy flavors, which lead the disposable e-cigarette market," Fatma Romeh, lead author of the study, said in a news release. " Data from the 2022 National Youth Tobacco Survey also highlight the popularity of these flavored e-cigarettes among U.S. middle and high school students.”

The good news is that sales slowed down in the later months of the study, with overall monthly sales of e-cigarettes showing a decline from May to December 2022. The report says this decrease could be attributed to several factors, including local and state restrictions on sales of flavored tobacco products,  Food and Drug Administration regulatory actions, potential Covid-19 supply chain disruptions, inflation and a change in the products that allow more "puffs" and stronger doses of nicotine. 

In December 2022, the five top-selling e-cigarette brands were Vuse, Juul, Elf Bar, Njoy and Breeze Smoke, respectively, with Elf Bar (now marketed as EBDesign) emerging as the top-selling disposable brand in the United States. 

According to the 2021 Youth Behavioral Risk Factor Surveillance System data, 45% of Kentucky's high-school students said they had ever 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, 11.7% of them said they usually got their electronic vapor products by buying them themselves in a convenience store, supermarket, discount store or gas station. 

All of these rates are higher than the national average. 

The FDA is working to address e-cigarettes that have high youth appeal, including flavored disposable products. On June 22 it issued a warning letter to 189 retailers it said were selling unauthorized tobacco products, specifically Elf Bar and Esco Bar, which are disposable products that come in flavors known to appeal to youth. 

“All players in the supply chain—including retailers—have a role in keeping illegal e-cigarettes off the shelves,” Brian King, director of the FDA’s Center for Tobacco Products, said in a news release. “This latest blitz should be a wake-up call for retailers of Elf Bar and Esco Bars products nationwide. If they’re waiting for a personal invitation to comply with the law, they might just get it in the form of a warning letter or other action from the FDA.”

Poison control calls doubled

In a separate CDC report, researchers from the FDA found that nationwide, from April 2022 to March 2023, poison-control centers received 7,043 e-cigarette exposure calls, representing a 32% increase, from 476 in April 2022 to 630 in March 2023. And, they had nearly doubled in 2018. 

The report says about 88%, or nearly nine in 10 cases, involved exposures to children under 5. Most of the calls involved inhalation (61%) and ingestion (40%). 

Overall, the study found that 43 cases of exposure resulted in hospital admission and 582 of them required treatment in a healthcare facility. One case resulted in death, a suspected suicide of a person 18 years or older. 

Among the limited number of cases with brand information reported from April 2022 to March 2023, the researchers found that  Elf Bar was cited more than all other brands combined, with nearly all Elf Bar cases occurring among children younger than 5 years old. 

According to data provided by the Kentucky Poison Control Center, housed at Norton Children's Hospital in Louisville, Kentucky saw a 93% increase in reported electronic cigarette exposures during that time frame, with 92 reports of e-cigarette exposure reported in 2018 and 178 reported from April 2022 and March 2023. 

"In general, during those years, 77% of the cases were under the age of 6, 10% were ages 6-18, and the rest were adults," Joe Hall, manager, Norton's public-relations manager, said in an email. 

That said, Hall offered a word of caution about the data: "Reporting is voluntary, and while the data may be representative of the trend in the general population, we do not know the true numerator, and many exposures are not reported. Additionally, exposure does not mean severe poisoning," he said. 

The researchers closed the CDC report by saying that continued surveillance is critical to prevent e-cigarette exposure, particularly among young children. 

The FDA explains in a consumer update about the report that e-liquids with even small amounts of nicotine can be dangerous to children if they touch or drink it. They stress that adults who use e-cigarettes should store them and e-liquids in a safe , elevated location, out of children's reach and view.

"Young children can be severely hurt by drinking e-liquids," the update says. "Harmful effects can include seizure, coma (long period of unconsciousness), respiratory arrest (which happens when a person stops breathing), and death. Children may also accidentally be exposed to e-liquids and their contents, including nicotine, through contact in the mouth, contact on the skin (i.e., spilled e-liquid), or by inhaling the e-liquid aerosol. It’s important to remember that containers for e-liquids can seem tempting to children of all ages for many reasons. But these products are not meant for children, teens, or young adults."

FDA orders Juul products off the shelves, and firm asks court to block it; rule to limit level of nicotine in cigarettes is coming

Photo from Juul Labs

UPDATE, June 27: A federal judge blocked the order pending proceedings in Juul's lawsuit.

By Melissa Patrick
Kentucky Health News

The federal government has ordered Juul Labs to stop selling and distributing its products in the United States after denying the company's application to keep selling them, saying the company did not provide adequate data to determine "relevant health risks." 

Meanwhile, the Food and Drug Administration is planning to establish a maximum nicotine level in cigarettes and other combustible tobacco products to reduce the addictiveness of the products, which claim the lives of 480,000 Americans each year, with more than 8,000 in Kentucky.

"While we welcome the ban on Juul -- we think that's a good thing -- it is not nearly enough, and until they actually come to grips with the nicotine problem, they're not going to solve this," said Ben Chandler, president of the Foundation for a Healthy Kentucky. "The central problem here is that we are addicting an entire new generation of young people to nicotine."

The FDA issued marketing denial orders against Juul that require the company to remove its electronic-cigarette products from the U.S. market, or risk enforcement action. 

“Today’s action is further progress on the FDA’s commitment to ensuring that all e-cigarette and electronic nicotine delivery system products currently being marketed to consumers meet our public health standards,” FDA Commissioner Robert M. Califf said in the release. He also noted the role of e-cigarettes in the rise of youth vaping.

The 2020 National Youth Tobacco Survey found Juul was the most popular e-cigarette brand used by adolescents with 25.4% of high school e-cigarette users and 35.1% of middle school users saying Juul was their most used brand.

According to the latest 2019 Youth Risk Behavior Surveillance System report, 26% of Kentucky's high school students had used an electronic vapor product on at least one day in the 30 days prior to the survey, while just 8.9% had smoked cigarettes. A national survey found youth vaping rates have declined during the pandemic, but a separate survey taken in late 2020 found that 34% of the 400 Kentucky youth surveyed believed there had been an increase in tobacco use due to the pandemic.

The FDA said the company's marketing applications “lacked sufficient evidence regarding the toxicological profile of the products to demonstrate that marketing of the products would be appropriate for the protection of the public health.” 

A key public-health issue the FDA looks for in reviewing electronic cigarettes is whether the potential benefit to adult smokers who may be using them to quit smoking is greater than the risks to youth. 

The agency said it didn't see clinical information suggesting there is an immediate risk to using Juul products, but "Some of the company’s study findings raised concerns due to insufficient and conflicting data– including regarding genotoxicity and potentially harmful chemicals leaching from the company’s proprietary e-liquid pods – that have not been adequately addressed."

Joe Murillo, chief regulatory officer at Juul Labs, issued a statement saying the company had "provided sufficient information and data based on high-quality research to address all issues raised by the agency" and that the data meets the standard of being "appropriate for the protection of the public health." He added, "We intend to seek a stay and are exploring all of our options under the FDA’s regulations and the law, including appealing the decision and engaging with our regulator."

UPDATE, June 24: Juul asked a federal court in Washington to block the order.

Juul, which has long been blamed for the surge in teen vaping, had already stopped selling its sweet-flavored e-cigarette pods, but had continued selling tobacco- and menthol-flavored cartridges while it waited on the FDA to review its marketing application. The company had also worked on efforts to stop teens from buying its products, like halting television, print and digital advertising. ”

Anti-smoking advocates praised the FDA's ruling. 

Ellen Hahn, a University of Kentucky nursing professor and the director of the Bridging Research Efforts and Advocacy Toward Healthy Environments (BREATHE) initiative, said in an email that the decision "is long overdue. This move is particularly important [for] our ability to breathe in Kentucky. Kentucky youth smoke e-cigarettes, or vapes, over twice the rate of high school students in the U.S. (26.1% vs. 11.3%). E-cigarette aerosol contains highly addictive nicotine that damages the lungs and the developing brain. Vaping is a cause of serious lung injury and makes it harder for the user to fight infection. Lung damage from vaping is comparable to conventional cigarette use." 

That said, Hahn cautioned that since the FDA's decision to limit flavorings in Juul products, other "disposable" vapes have become more popular because they continue to offer a variety of flavors. "So while today’s decision shows the power of FDA’s premarket review, there are plenty of other e-cigarette products still on the market," she said. 

Matthew L. Myers, president of the Campaign for Tobacco-Free Kids, said the decision "represents the most significant action the FDA has taken to reverse the youth e-cigarette epidemic." 

Harold Wimmer, president and CEO of The American Lung Association, commended the FDA for "following the science and denying Juul the ability to sell its products that are clearly marketed to addict a new generation of youth to tobacco."

Limiting nicotine: The FDA's goal in limiting nicotine in cigarettes and other combusted tobacco products is to reduce youth use, addiction and death, says the FDA news release announcing the effort. 

The FDA notes that while nicotine is not what makes cigarettes so toxic, it is the ingredient that makes it hard to quit. And says if the proposed reduction is successful, it "would make those products minimally- or non-addictive." 

"The U.S. Surgeon General has reported that 87% of adult smokers start smoking before age 18, and about two-thirds of adult daily smokers began smoking daily by 18 years of age. Lowering nicotine levels to minimally addictive or non-addictive levels would decrease the likelihood that future generations of young people become addicted to cigarettes and help more currently addicted smokers to quit," Califf said in the release. 

Inside Health Policy reports that the FDA is expected to publish its proposed rule in December. It was originally scheduled for July.

The sooner you quit smoking, the better off your lungs will be; but the sooner you start, the higher will be your risk of cancer death

Photo: Getty Images/Wavebreakmedia

Smoking's negative health consequences are well known, but smokers can reduce―or even erase―their risk of dying from lung cancer by quitting at a young age, and the younger the better.

A new study led by the American Cancer Society analyzed data on more than 410,000 Americans participating in an ongoing federal health survey between 1997 and 2014, and the researchers found that quitting by age 35 can effectively eliminate the risk of dying from lung cancer and quitting by 45 can lower the risk by 87%. Even middle-age smokers between 55 and 64 can can cut their risk in half by quitting.

"Smoking definitely has a cumulative effect,” said Dr. Patrick Ma, an oncologist at Penn State Cancer Institute. “Of course, the best advice is never start smoking, but this study shows it’s never too late to quit and see some benefit."

On the flip side, the sooner one starts smoking, the higher their chances of dying from cancer. People who started smoking before age 10 are four times more likely to die from cancer than lifelong nonsmokers, and people who started before age 18 are three times more likely.

The good news overall is that lung cancer-related deaths are on a downward trend, Ma said. Lung cancer mortality among men has decreased by 51 percent since 1990 and by 26 percent among women since 2002.

Annual scans for lung cancer are recommended for adults ages 50 to 80 who have smoked at least one pack of cigarettes for 20 years and currently smoke or have quit within 15 years.

November is Lung Cancer Awareness Month.