Sunday, March 10, 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.

The bill would ban retailers from selling unauthorized products to any person, and set fines of $1,000 for the first violation, $5,000 for the second violation, and loss of "the ability to sell Tobacco Control Act covered products for one year" for a third violation. A banned retailer who had another violation would be fined $10,000 per transaction.

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.

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