Oklahoma: Vape manufacturers need to prove PMTA applications are pending before selling them

Key points:

The Oklahoma State Senate in the United States has proposed requiring e-cigarette manufacturers to submit PMTA applications to the FDA.

The legislation could potentially impact the e-cigarette market, leading to potential store closures and a decrease in consumer choice.

Consumer groups warn that the new legislation could benefit tobacco companies and suppress small e-cigarette businesses.

According to a report by Journalrecord on April 9th, a new bill targeting e-cigarette manufacturers in Oklahoma, Senate Bill 1102, has passed review and entered the discussion stage in the regulatory committee.

On Wednesday (the 9th), Oklahoma Senator Bill Coleman introduced Senate Bill 1102, which calls for manufacturers to demonstrate timely submission of pre-market tobacco product applications (PMTAs) for e-cigarette products to the FDA, with the application currently under review, in order to avoid being subject to FDA or court-ordered suspensions. The FDA finalized the PMTA rule in 2021, requiring authorization for new tobacco products. Since 2016, the FDA has introduced regulatory requirements for products such as e-cigarettes. PMTAs include statements on product ingredients, additives, components, and characteristics.

The bill requires the submission of a proof form that details the brand, product name, flavor, and category of each e-cigarette product sold within the state. The annual report must include relevant documents and an initial payment of $5,000, followed by a yearly payment of $2,500.

The bill, co-sponsored by Cynthia Roe in the House of Representatives, is similar to measures that have been proposed in previous legislative sessions. She noted that this would allow e-cigarette products awaiting PMTA approval to be legally sold in Oklahoma. Roe stated that if the bill goes to the House Regulatory Committee, she plans to make amendments and remove the current title.

Although the FDA has received over 26 million pre-market tobacco product applications, Congressman Scott Fetgatter has reservations about the law because since 2016, the FDA has only approved less than 30 applications.

Luo pointed out that retailers only need to remove products that have not been approved and do not have pending PMTA applications. She also mentioned that some stores obtain supplies from the black market, which is the target of the bill to prevent non-compliant products from entering the market.

The bill was submitted to the regulatory committee for further discussion by a vote of 5 to 2 before it moves on to the House for further review.

The Consumer Advocates for Smoke-free Alternatives Association claims that the bill will make Oklahoma a "law enforcement agency" for tobacco companies, allowing state authorities to enforce anti-e-cigarette regulations.