House Representatives Morgan Griffith (R-VA) and Brett Guthrie (R-KY) recently sent a letter to FDA Commissioner Robert Califf expressing “continued concerns involving systemic problems within the” Center for Tobacco Products (CTP). The first half of the letter asks FDA to explain its continued failure to issue meaningful regulations for CBD products, while the second half focuses on issues within CTP that have been echoed across the tobacco industry.
The letter criticizes FDA as having “deviated from its original mission in the regulation of tobacco products.” This mission, as outlined in the 2009 Tobacco Control Act (TCA), was to “focus on setting product standards, reviewing applications in a timely and fair fashion, and regulating tobacco products through the lens of a tobacco harm reduction framework.” Even though the TCA mandates that premarket tobacco product application (PMTA) decisions be issued in 180 days, the letter notes that it is taking years for FDA to act on PMTAs for electronic nicotine delivery systems (ENDS).
Reps. Griffith and Guthrie express frustration that, instead of focusing on the work before it (including hundreds of outstanding PMTA applications), FDA is proposing additional “massive undertakings” including a ban on menthol cigarettes, a ban on flavored cigars, and a nicotine cap for cigarettes.
The letter asks FDA to provide the following information by October 17, 2022:
- A detailed breakdown of how the CTP user fees are being spent across all statutorily permitted activities;
- A description of the recent timelines for PMTA authorizations and denials;
- How CTP’s work on PMTAs would be impacted by a menthol ban and nicotine cap;
- How the agency can develop a more effective plan to remove unauthorized synthetic products from shelves and a description of how it is prioritizing its enforcement resources in this regard;
- The agency’s plan to communicate to and educate the American people about the continuum of risk for tobacco products;
- The agency’s plan to educate Americans about the distinction between tobacco addiction and nicotine addiction.
Regarding the “continuum of risk” concept, there is widespread understanding (even with FDA) that noncombustible products present less risk to consumers. The ENDS industry has long been critical of how difficult it is to bring new ENDS products to market, even though FDA itself admits that these products play an important role in harm reduction. Reps. Griffith and Guthrie ask FDA to explain “[w]hat actions the CTP has undertaken to correct nicotine misperceptions among the general public, smokers, and the medical community.”
In July, FDA announced that it had engaged the Regan-Udall Foundation to conduct a comprehensive external review of the CTP’s activities. The Representatives question FDA’s choice to use the Reagan-Udall Foundation for this work, since the Foundation “was not designed to support the agency as a strategical and operational partner.” Nor, they state, “was it was ever intended to be an oversight body, which is the role of Congress.” The letter warns Commissioner Califf that “[r]egardless of the findings, [he] will still be responsible for addressing these issues within FDA and answering to Congress for the decisions being made at FDA under [his] leadership.”
Stay tuned to Tobacco Law Blog for further updates on this developing topic.