Washington, D.C. - Energy and Commerce Democratic leaders sent a letter to Food and Drug Administration (FDA) Commissioner Scott Gottlieb today seeking a more thorough explanation for the agency’s decision to delay much-needed public health oversight for newly deemed products, as well as other aspects of FDA’s recently announced regulatory framework for tobacco products. The letter was signed by Ranking Member Frank Pallone, Jr. (D-NJ), Health Subcommittee Ranking Member Gene Green (D-TX), and Oversight and Investigations Subcommittee Ranking Member Diana DeGette (D-CO).
“FDA’s decision will permit certain newly deemed products to stay on the market for as long as five years - until 2022 - with little oversight, and risks exposing a new generation to the health consequences of deadly tobacco products," the three lawmakers wrote to FDA. “These delays stand in stark contrast to the agency’s general mission of protecting public health and completely disregard the Tobacco Control Act’s requirement that FDA act in ways that are ‘appropriate for the protection of the public health."
Last year, FDA issued a final rule deeming all categories of tobacco products, including cigars, hookah and pipe tobacco, and electronic nicotine delivery systems (ENDS), such as e-cigarettes and vape pens, to be subject to its oversight authority under the Tobacco Control Act. In May, FDA postponed all future compliance deadlines for the requirements under the final deeming rule for three months, which prompted a letter from Pallone and Green urging FDA to implement the rule without further delay.
Pallone, Green and DeGette wrote that FDA’s action will allow manufacturers who market tobacco products featuring flavors like gummy bear, cotton candy, and peanut butter cup to continue with few restrictions for several more years. The three lawmakers wrote that based on these products’ names alone, it is not surprising that they are uniquely appealing to youth.
“We are deeply concerned that FDA’s decision will result in an increase in youth experimentation with tobacco and an increase in addiction to nicotine products in the future," Pallone, DeGette and Green continued in their letter to FDA Commissioner Gottlieb.
The lawmakers are requesting explanations from FDA by September 21st on several topics, including:
* FDA’s intended timeframe for lowering nicotine levels in combustible cigarettes to non-addictive levels and how FDA plans to timely and efficiently implement these measures.
* What new information FDA is seeking regarding the role flavors - including menthol - play in attracting youth and other users given the well-known evidence already available that flavors appeal to users and lead to increased usage.
* FDA’s plan to ensure that children and adolescents are not conveyed a message that ENDS products, such as e-cigarettes, are a “less dangerous" or “safer" alternative to traditional combustible cigarettes and thus an acceptable option for use.
* FDA’s reconsidering of the inclusion of premium cigars under the regulatory framework for the final deeming rule, despite previously acknowledging the public health justification for regulating premium cigars.
