Today, Reynolds American companies, R.J. Reynolds Vapor Company, Modoral Brands Inc. and American Snuff Company LLC, filed a complaint challenging the U.S. Food and Drug Administration’s (FDA) final rule governing premarket tobacco applications (PMTAs), a regulation that has allowed FDA to disregard Congress’s intent and mired the tobacco product review process in years of delay, uncertainty and unlawful agency action.
For Reynolds American and its subsidiary companies, our strategic aim is to migrate adult smokers from cigarettes to smokeless alternatives. We believe adult smokers should have access to alternative and less harmful products, such as vapor and nicotine pouches, for which substantial scientific evidence demonstrates a lower risk profile relative to cigarettes. For this to happen, a well-regulated marketplace – supported by timely, science-based premarket review, and approval of products is necessary to best serve public health.
With those beliefs and goals in mind, we filed to join litigation challenging FDA’s 2021 PMTA Rule, which requires FDA to grant or deny new product applications promptly and no later than 180 days after receiving an application. To date, FDA has never met this deadline, across all applicants, and created a regulatory purgatory for responsible companies that in turn opened the door for unscrupulous manufacturers to evade regulations and flood the U.S. market with illicit, unregulated vapor products that target youth.
The system as it stands today is not delivering the results Congress intended. Therefore, through our lawsuit, we are asking the court to vacate the PMTA rule and require FDA to adopt a review framework that complies with the law’s 180-day decision deadline. We believe adult nicotine consumers deserve access to regulated smokeless alternatives, not years of uncertainty; and responsible manufacturers that operate within the regulatory framework deserve certainty and consistency.
