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FDA Sued By Another Vape Store Owner Over ‘Deeming Regulations’

FDA Sued By Another Vape Store Owner Over ‘Deeming Regulations’


FDA Sued By Another Vape Store Owner Over ‘Deeming Regulations’

Over the past year and a half, there have been numerous challenges mounted to the Food and Drug Administration’s “Deeming Regulations” which took effect in August 2016. The latest one comes from vape shop owner Kimberly Manor, proprietor of Moose Joose in Clare County, Michigan. She claims  that  the rule threatens to put her out of business due to the cost of compliance.

Manor, who just opened her second store in the county, claims that the regulations unfairly target vaping, which she along with many others believe is a powerful means for cessation from cigarettes. According to an interview she gave for the Clare County Review, she's helped about 500 people, including her family members, quit combustible cigarettes and move over to vaping.

The vape store owner claims that the regulations are unconstitutional because they treat non-tobacco products as if they actually contained tobacco.  

Deeming Regulations

The regulations themselves have had a few consequences that make many shop owners unhappy about the cost of compliance. But not all of it is negative. For one, it’s made some common-sense regulatory decisions, such as prohibiting the sale of vape products to anyone under the age of 18 and requiring sensible health warnings to consumers.

Unfortunately, this type of reasonable regulation is undercut by language in the rule that consistently equates the dangers of smoking combustible cigarettes with the dangers of vape products, which has led to a lot of the misinformation about the health dangers associated with vaping.

The rule, in its essence, adds vapor products to the Family Smoking Prevention and Tobacco Control Act. This act had previously just provided the FDA the ability to regulate cigarettes, cigarette tobacco, roll-your-own tobacco, smokeless tobacco, and any other tobacco products that the Agency, by regulation, deems to be subject to the law. Now it includes vaping too.

Moose Joose

For brick-and-mortar shops like Moose Joose, this could mean heavy prices that its independent funding can’t take on, although this won’t fully take effect until 2022. To get approval for sale, products like e-liquids made for vapor devices will have to go through an expensive pre-market application process, which Manor says could drive her out of business.

“No small business owner will be able to afford it,” Manor says. “Even though there is no tobacco in the e-liquid I manufacture, I was forced by the FDA to register as a ‘Tobacco Manufacturer,’” Manor said, adding that she will no longer be able to talk to her customers about possible benefits from switching from smoking combustible cigarettes to vaping.

“Vaping is a technology that’s proven to be more effective than gums, patches and cessation pills combined,” she said, citing a recent study by the Center for Disease Control which conceded that vaping is a more popular and effective tobacco harm reduction tool than any other nicotine replacement therapy.

“There has been literally thousands of studies on vaping – with no proof of any real, lasting damage. I’m living proof; my mother is living proof; my brother is living proof. And dozens of other friends and family members are living proof that vaping works and works tremendously fast.”