Utah will allow the sale of higher nicotine concentration products in the PMTA-based market

On June 18, Utah proposed to allow e-cigarette manufacturers to increase nicotine content in products sold in the state after a lawsuit settlement, according to kslnewsradio. Under the proposed rules, Utah retailers would be able to sell e-cigarettes with nicotine concentrations higher than current legal levels if the products go through the U.S. Food and Drug Administration’s (FDA) Premarket Tobacco Product Application Authorization (PMTA).


Utah Department of Health official Braden Ainsworth said the department has the authority under a 2020 law to amend the tobacco law to set nicotine limits for manufacturers of “sealed tobacco products (atomized products).


He said:


“While the Utah Department of Health is making this move to better align with the FDA’s premarket tobacco product application process and requirements, we still do not recommend the use and consumption of e-cigarettes and atomized products.”


Ainsworth said the department’s top priority is to develop policies that provide Utah residents with “a fair and equitable opportunity to live a safe and healthy life.”


In September 2021, the nicotine content of each container was limited to “3 percent of the weight of each container” and the concentration must not exceed 36 mg/mL, according to the regulation.


Ainsworth said the evaluation and decision regarding the regulation was made during the litigation and was part of a settlement agreement, “but whether or not a settlement is reached, the department will revise the regulation in some way to modify the nebulized product policy.”


Under the revised regulations, products sealed by the manufacturer may contain any amount approved by the FDA, but are limited to “5% by weight of each container” of nicotine and may not exceed “59 mg/mL” in concentration. The regulations state that the concentration range for products approved in 2022 is “1.5% to 6%.


Ainsworth said the use of e-cigarettes among Utah youth has declined. According to state data, 12.4 percent of teens used e-cigarettes in 2019, while the rate dropped to 7.8 percent in 2021. He also mentioned that several policy changes were made in 2020 aimed at addressing youth use of e-cigarettes, including limiting flavors.