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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.

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