Over 5,000 nicotine product retailers and distributors have received a letter from Minnesota Attorney General Keith Ellison threatening to prosecute them for selling vapes and nicotine pouches that have not received marketing authorization from the FDA.
“Our goal is voluntary compliance,” Ellison said at a press conference (and in a press release). “Most Minnesota business-owners are good people trying to do right by their communities, so I expect most will take swift action after receiving a reminder of the law.”
Ellison added that “distributors or retailers that choose to defy the law and not comply, however, should know that my office has a wide range of options to ensure that they stop harming our children. I cannot and will not sit by and allow people to turn a profit by pushing toxins on our children.”
Ellison claims in his letter that sellers of e-cigarettes and nicotine pouches "not authorized by the FDA" are "in violation of the federal Food, Drug and Cosmetic Act, as amended by the Tobacco Control Act.”
However, that isn’t entirely true. The FDA has not attempted to enforce those provisions against manufacturers with products still under review or manufacturers whose marketing denial orders (MDOs) have been stayed or overturned by federal courts.
If Ellison was correct, manufacturers currently selling Juul vapes or ZYN nicotine pouches would be subject to prosecution—even though both products remain under FDA review, and the FDA itself has taken no action against distributors or retailers selling those products.
Many vaping products (and all nicotine pouches) are still undergoing FDA review of their premarket tobacco applications (PMTAs). Dozens of other manufacturers have challenged FDA denial orders, and many have had the orders stayed or invalidated by circuit courts.
In fact, Ellison himself recently signed on to an amicus brief from a group of Democratic state attorneys general, urging the Supreme Court to overturn the Fifth Circuit Court of Appeals’ Triton Distribution decision, which invalidated MDOs for a large number of vape products sold by two manufacturers. The Court has agreed to hear the FDA’s Triton appeal during its next session. Meanwhile, those manufacturers are lawfully selling their products across the country—including in Minnesota.
Ellison (correctly) warns sellers not to violate a new Minnesota law that prohibits the sale of nicotine products that “are described or depicted as imitating candy, desserts, or beverages that are commonly marketed to minors” (the law also bans vapes that resemble school supplies). But that law doesn't prevent sales of other nicotine products pending FDA review.
His letter closes asking retailers to “confirm in writing that you will comply” with the mentioned laws, and will “only advertise, sell, or distribute e-cigarettes and oral nicotine pouch products that have been authorized by the FDA.”
Jim McDonald
Vaping for: 13 years
Favorite products:
Favorite flavors: RY4-style tobaccos, fruits
Expertise in: Political and legal challenges, tobacco control haters, moral panics
Jim McDonald
Smokers created vaping without help from the tobacco industry or anti-smoking crusaders, and I believe vapers have the right to continue innovating to help themselves. My goal is to provide clear, honest information about the challenges vaping faces from lawmakers, regulators, and brokers of disinformation. I’m a member of the CASAA board, but my opinions aren’t necessarily CASAA’s, and vice versa. You can find me on Twitter @whycherrywhy