After a few months of relative quiet when the Trump administration took office, there have been significant developments at the Food and Drug Administration (FDA) and the Center for Tobacco Products (CTP) since Department of Health and Human Services (HHS) Secretary Robert F. Kennedy Jr. and FDA Commissioner Dr. Marty Makary were confirmed by the Senate. Shortly after President Trump took office, the FDA withdrew two proposed rules that would have banned the sale of menthol cigarettes and flavored cigars.
CTP Changes
In late March, the administration made sweeping changes at the CTP, removing the director and gutting many other departments. At almost the same time, the U.S. Supreme Court unanimously (9-0) ruled largely in favor of the FDA in the FDA v. Wages and White Lion case. The case examined whether the FDA unlawfully denied product premarket tobacco product applications (PMTAs) for flavored e-cigarette products because the agency had changed its standard for evaluating such products in the middle of the review process. In its opinion, the Supreme Court said the FDA did not act arbitrarily and capriciously in its review of the manufacturers’ PMTAs because the marketing denial orders (MDOs), citing a failure to include comparative efficacy data, were sufficiently consistent with FDA’s previous guidance regarding the scientific evidence needed for authorization. However, the court sent the case back to the U.S. Court of Appeals for the 5th Circuit to reevaluate, under the correct standard, whether FDA’s failure to review the marketing plans in the PMTA “for the sake of efficiency” was harmless error.
Smokeless, Harm Reduction
With these developments, there is an opportunity for the FDA’s CTP to reset and streamline its operations. Rather than focus on banning certain tobacco products, the agency should implement more effective tobacco harm reduction policies, by authorizing more non-combusted nicotine products to provide adult smokers with expanded choices and by educating smokers about the continuum of risk. With hundreds of thousands of nicotine product PMTAs still pending before the agency, particularly in the vapor and nicotine pouch space, the FDA has an opportunity to provide adult cigarette consumers with more authorized product choices that potentially present less risk.
Illicit Vapor
Coupled with PMTA authorizations, the agency should provide retailers with more transparency, specifically with respect to information on illicit products in the vapor and nicotine pouch categories. Currently, the illicit vapor product market is at least 60% of sales with many of these products imported from China. To help address this growing problem, the FDA needs to provide more detailed information on the products that are clearly illegal and increase enforcement against these products.
In 2009, Congress granted the FDA authority to regulate tobacco and nicotine products. The time is now to reform the CTP by embracing innovation and science to support tobacco harm reduction, while simultaneously taking effective action against bad actors who have exploited the lack of enforcement from the agency.
Members help make our journalism possible. Become a CSP member today and unlock exclusive benefits, including unlimited access to all of our content. Sign up here.