House Oversight Committee Investigating FDA’s Center for Tobacco Products

The U.S. House of Representatives Committee on Oversight and Accountability has announced that it will investigate the U.S. Food & Drug Administration’s Center for Tobacco Products (CTP).

Yesterday, Rep. James Comer, R-Ky.—who chairs the committee—sent a letter to Dr. Robert Califf, the commissioner of FDA, announcing the investigation and requesting documents and communications from the agency. The four-page letter is focused primarily on the regulation of e-cigarettes and vaping products, which are referred to as ENDS, an acronym for electronic nicotine delivery system. The letter repeatedly mentions the recent report from the Reagan-Udall Foundation, which completed an external review of CTP and FDA’s food programs following negative headlines surrounding FDA in 2022.

The word “cigar” does not appear once in the letter.

Califf called for the Reagan-Udall Foundation investigation review after issues with the nationwide supply of baby formula, which is regulated by FDA, and a separate issue regarding the high-profile product review of Juul. Both of these controversies put FDA in the headlines of major news outlets and drew the ire of elected officials.

The Reagan-Udall Foundation report suggested several changes, some of which FDA said it intends to implement. Comer’s letter reiterates common complaints from the vaping industry about FDA such as the agency missing court-ordered deadlines regarding product review, a lack of transparency for the ENDS industry about how CTP operates, questions about how much the agency relies on science, potential political interference, a lack of enforcement for products that do not follow rules, etc.

Comer asked the agency to produce documents regarding the following topics by April 11:

1. All FDA staff comments submitted to the Reagan-Udall Foundation in conjunction with the Operational Evaluation of Certain Components of FDA’s Tobacco Program;
2. All communications between the White House, Department of Health and Human Services, and FDA, to include any office within the CTP, regarding tobacco or nicotine related policy decisions and evaluation of any application approval or denial decisions;
3. All documents and communications between FDA and the Centers for Disease Control and Prevention regarding CTP policies, application decisions, educational campaigns, or communications;
4. All documents and communications between FDA and public health advocacy groups regarding CTP policies, application decisions, educational campaigns, or communications;
5. All documents that describe the specific analytic process FDA uses to apply the “appropriate for the protection of public health” standard; and
6. All documents and communications related to FDA’s enforcement efforts to remove illegally marketed tobacco or nicotine products from retail locations.

Some of these communications might become of interest to the premium cigar industry both in its fight against FDA regulations and also in dealing with the regulations. Earlier this month, FDA announced that it is working on new regulations that would see the agency regulate places where tobacco products sold in the U.S. are made, i.e., regulating cigar factories in Latin and Central America.

In the meantime, the cigar industry continues to wait on a ruling from Judge Amit P. Mehta of the U.S. District Court for the District of Columbia. Last July, Mehta ruled against FDA as part of the Cigar Association of America et al. v. United States Food and Drug Administration et al. lawsuit filed by three cigar trade groups in 2016. In his ruling, Metha indicated that the agency failed to follow rules while creating regulations for products, specifically, ignoring comments regarding how “premium cigars” are consumed. Because of this, it is likely that the current set of regulations—many of which have already been overturned or delayed for “premium cigars”—will no longer apply and the agency will need to restart the rulemaking process for premium cigars.

Mehta’s ruling will apply to most cigars sold in American humidors but would not apply to some products, most notably large flavored cigars like ACID or Java.