Wisconsin Vape Distributor Sues State Over New Fines for Unauthorized Products

Key points:

·Lawsuit Focus: Distributors accuse new law of violating the Constitution's "Supremacy Clause" (federal exclusive drug regulation authority) and equal protection clause, demanding a halt to enforcement, claiming it is overreaching and will destroy their business. 

·Legal content: Requires e-cigarette products to be authorized by the FDA and listed in state registry, with unauthorized retailers fined $1000 per day, aiming to combat unapproved products. 

·Industry background: FDA has a backlog of authorization applications, 14 states have implemented similar registry systems, Iowa's related law has been halted due to lawsuits, industry may continue to challenge laws in other states. 

·Controversial balance: Experts believe it is necessary to balance "e-cigarette smoking cessation" with "preventing youth use," with the US youth e-cigarette use rate reaching a 10-year low by 2024, while nearly 16% of high school students in Wisconsin had used e-cigarettes in the last 30 days as of 2023.

【2Firsts News Flash】According to a report by the Milwaukee Journal Sentinel on July 9, a group of e-cigarette distributors is suing the state of Wisconsin over a new law that imposes fines on businesses that produce and sell products not authorized by the U.S. Food and Drug Administration (FDA).

Wisconsin passed this law at the end of 2023 to combat such products, but it did not take effect until July 1st. In a lawsuit filed on June 30th in federal court, the industry organization "Wisconsinites for Alternatives to Smoking & Tobacco" argued that the law would make many traditional cigarette alternatives produced, sold, and used by Wisconsin residents disappear. The organization is seeking a preliminary injunction to temporarily halt the enforcement of this law pending the outcome of the case.

Many e-cigarette products on the market are not authorized by the FDA. The FDA has accumulated a large number of applications for market authorization for such products in the United States, and lawmakers from both parties have criticized the agency for its lack of control over the market.

This law may cause all of our products in the nicotine and e-cigarette industry to disappear, which would result in our company going out of business.

David Beaupre, president of Supply Plus, stated that the company, a retailer of e-cigarettes with stores in Fond du Lac, Oshkosh, and Jackson, is one of the plaintiffs in the lawsuit.

In order to comply with a law set to take effect in 2023, manufacturers must provide proof to the state tax agency that their products have received FDA authorization. The tax agency plans to publish a list of these products starting in September, with retailers selling products not on the list facing potential daily fines of $1,000. According to the Public Health Law Center at Mitchell Hamline School of Law in Minnesota, 14 states have already enacted similar laws establishing such lists, with several others considering doing so, Wisconsin being the exception.

The lawsuit claims that this law violates the Supremacy Clause of the U.S. Constitution - according to this clause, the federal government has exclusive authority to regulate drug safety; it also violates the Constitution's equal protection clause, as it discriminates against specific types of products.

"I support regulation and approved products. However, I believe this is the responsibility of the FDA. Instead of allowing state governments to attempt to control, it's better to leave this work given by Congress to the FDA and give them time to regulate these products."

Bop Ray said.

In May, a federal judge halted Iowa's e-cigarette registry law following a similar lawsuit. The lead attorney for the plaintiffs, Eric Heyer, told the Milwaukee Sentinel that as laws in other states begin to take effect, the industry may challenge these laws.

A spokesperson for the tax authority declined to comment on the lawsuit.

Dr. Brian Williams, an associate professor of pediatrics and medicine at the University of Wisconsin-Madison School of Medicine and Public Health, stated that there is a delicate balance between helping traditional cigarette smokers quit by switching to e-cigarettes and not encouraging non-smokers, especially children, to use e-cigarettes.

Williams said that emerging research does suggest that e-cigarettes can play a role in smoking cessation, as they carry a lower toxin load compared to traditional cigarettes. A 2018 report from the National Academy of Sciences, Engineering, and Medicine found that if a person only vapes e-cigarettes and does not smoke traditional cigarettes, the harm from vaping may be less than smoking traditional cigarettes. However, Williams noted that even if unauthorized products disappear from the market, there are still authorized products available for those looking to quit smoking with e-cigarettes.

On the other hand, he said that many unauthorized products have certain qualities that appeal to teenagers, such as flavors. While there is still much to be understood about the short-term and long-term health effects of e-cigarette use on the general population, research clearly indicates that nicotine intake will alter the brains of adolescents.

Data from the Centers for Disease Control and Prevention in the United States shows that approximately 6% of adults and approximately 6% of adolescents use e-cigarettes nationwide. By 2024, the rate of e-cigarette use among adolescents has dropped to the lowest level in 10 years.

The latest youth risk behavior survey in Wisconsin in 2023 shows that nearly 16% of high school students have used e-cigarettes in the past 30 days, with 7% reporting frequent use of e-cigarettes.

He also pointed out that the youth e-cigarette usage rate is declining nationwide.