ST. GEORGE – The owner of a local e-cigarette store fears his business will be wiped out if new regulations proposed by the Utah Department of Health come into effect.
In a letter sent to e-cigarette retailers in early June, the Health Department said it plans to regulate packaging labeling requirements as well as limit the percentage of nicotine in disposable e-cigarette products.
The state also plans to begin enforcing federal regulations regarding tobacco products not registered and approved for sale by the U.S. Food and Drug Administration through its Tobacco pre-market application process, which could come into effect later this year.
Brendon Gunn, owner of Cloud 9 Vapor in Washington City, told St. George News he was concerned about the proposed rules because of the potential impact they could have on his business.
“Our business may not survive this,” he said.
Speaking on behalf of the Utah Department of Health, Ryan Bartlett, of the Department of Health’s Tobacco Prevention and Control Program, said vaping retailers should not be afraid of the proposed regulations and that the The state was not trying to shut them down.
“It’s not something the Utah Department of Health is doing to harm the vape industry in the state,” Bartlett said.
The proposed rules are currently on public comment until July 15, with a public hearing in Salt Lake City that will also be shared online Wednesday afternoon.
So what are the specifics of these proposed rules and why are they of concern to a local vape store owner?
Percent Nicotine Content in Disposable Vapor Products
According to the letter sent to vapor retailers across the state, the Department of Health proposes to restrict the sale of disposable vape products with a nicotine content greater than 5% w / v, or exceeding 59 milligrams, from July 22. following a content not exceeding 3%, or 36 milligrams, on September 1.
“In our experience, what we’ve found is that most companies don’t produce lower milligram nicotine,” Gunn said, adding that a shift from 5% to 3% of Nicotine content would wipe out much of its activity.
There are popular e-cigarette brands that sell lower concentrations of nicotine, such as Juul, which is among the most popular e-cigarette product brands in Utah, Bartlett said. The Department of Health has already put in place a content limit of 2%, 26 milligrams, on non-disposable vape products, he added.
Gunn and Vincenzo Porter, regional director of Cloud 9 Vapor, said the company “has a bad taste in its mouth” towards Juul products because it is owned by Phillip Morris International, the company behind Marlboro cigarettes.
While Vapor 9 has some Juul products on offer, sales are microscopic compared to the rest of what the store sells, Gunn said.
A large majority of the store’s disposable vape offerings are also in the 5% nicotine content range. Limiting that to 3% will negatively impact not only them, but the vape industry across the state, Porter said.
“The majority of products in all Utah stores would be drastically diminished,” Porter said, adding that this would severely limit adults’ freedom of choice regarding alternatives to smoking.
As an example of the impact the proposed regulation could have, Porter said it would be like going from hundreds of product options to fewer than 10 for customers to choose from.
“It imposes products on them,” he said.
Pre-MApplication of tobacco in the market worries
According to the FDA, a PMTA must be submitted to the FDA when a new tobacco product is created and must provide scientific data relating to current regulatory standards, how the product is manufactured, that the product does not pose an overall threat to the public health, etc.
The rule focuses primarily on manufacturers of new or modified tobacco products, such as the “vape juice” used in electronic cigarettes. Producers who are able to obtain application approval and registration for their product have FDA approval to continue selling and marketing them. Vape companies that have not submitted a PMTA – in this case by September 9, 2020 – may be considered in violation of the rule.
However, enforcement of the PMTA rule has been delayed for various reasons, with a court-ordered moratorium on enforcement in place until early September. Recently, the US Small Business Administration asked the FDA to continue delaying the application. In a letter sent to the FDA, the Small Business Administration argues that the agency is not giving itself enough time to review the application it has already received.
In its letter to vaping retailers, the Utah Department of Health said it will apply FDA enforcement rules to non-compliant products once the federal agency chooses to enforce them itself. . The FDA is expected to begin implementing the PTMA process by September 9.
“This will immediately make the majority of these products illegal,” Gunn said. He said he believed the state could go ahead and seek to enforce PMTA rules before the FDA. “They are trying to enforce federal laws that the federal government is not even enforcing right now.”
There are many producers of tobacco products that are not verified by the PTMA, said Gunn, who understands Cloud 9 Vapor because it produces internal vape brands for customers.
Although the FDA seeks to verify the safety of tobacco products through the PMTA process, this can also be quite expensive.
Requests should be sent regarding the nicotine content of the product, the size of the bottle it is to be sold in, the type of flavor it is, among other details, Porter said. When Cloud 9 looked at the total costs of the PMTA process, it was found to be prohibitive, he said.
The cost of PMTA compliance, according to the FDA, can cost manufacturers between $ 117,000 and $ 466,000 per application.
If the state chooses to enforce the PMTA rules before the FDA, as Gunn claims, the additional rules the Department of Health seeks to put in place won’t matter much because the PTMA rule would negatively impact the vape industry in Utah as a whole, he said. .
St. George News contacted the Utah Department of Health for clarification on the matter and received the following response via email on Tuesday:
Local health departments will have the authority to apply the FDA’s PMTA process, when the FDA determines which ENDS (Electronic Nicotine Delivery System) products can no longer be sold in the market; it could be as early as 9/9/21, but it could also happen at a later date.
However, for e-cig products with already pending PMTA applications, the proposed rule amendment allows Utah retailers to continue to sell those products until the FDA determines whether they can or. not be sold under the PMTA process, if the products meet all other criteria in the rule, the manufacturer has submitted a PMTA or equivalent application to the FDA by 9/9/20, and the FDA has not issued a written marketing order prohibiting the sale of the specific e-cig product.
Local health departments will not require Utah retailers to remove these vaping products, unless they meet the other requirements of R384-415, or do not meet all three requirements. for the exception proposed in R384-415-7 (3).
Additional details on the proposed amendment and Utah tobacco laws can be found here.
Public comment period and meeting
The proposed nicotine content regulations are currently undergoing a third public comment period, Bartlett said. This is because previous versions of the proposed rules have not been well received by the public, he said.
As for the proposed rules themselves, they are the result of recent legislation passed by state lawmakers that left the details of tobacco regulation in the hands of the state health department, said. Bartlett.
This is another point that bothers Gunn, as he has said he sees the Department of Health as trying to wipe out the vape industry rather than working with it the way the Legislature has done. State. Such cooperation has led the state to issue an accepted tax of 56% on all vaping products. If the vape shops are wiped out because of the proposed rules, it will also kill a potential source of revenue for the state itself, he said.
“They’re going to hurt their own wallet,” Gunn said.
Comments can be submitted to the Utah Department of Health until July 15 at [email protected].
The public meeting on the proposed rules – which will include a public comment period – will be held Wednesday from 2:30 p.m. to 4 p.m. and can be viewed online via Zoom.
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