FDA Faces the Opportunity to Embrace Innovation & Harm Reduction
After a few months of relative quiet following the Trump Administration taking office, there have been significant developments at the U.S. Food and Drug Administration (FDA) and the Center for Tobacco Products (CTP) since U.S. Department of Health and Human Services (HHS) Secretary Robert F. Kennedy Jr. and FDA Commissioner Dr. Marty Makary were confirmed by the U.S. Senate.
Shortly after President Donald Trump took office, the FDA withdrew two proposed rules that would have banned the sale of menthol cigarettes and flavored cigars. In late March, the administration made sweeping changes at the CTP, removing the director and gutting many other departments. These actions received a negative reaction from 18 Democratic U.S. senators who sent a letter to HHS Secretary Kennedy asking for specific details around the changes and what is the plan going forward for the CTP.
Around the same time as the changes at the CTP, the U.S. Supreme Court unanimously ruled (9-0) largely in favor of the FDA in the FDA v. Wages and White Lion case, which examined whether the FDA unlawfully denied 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.
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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 — citing a failure to include comparative efficacy data — were sufficiently consistent with the 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 the FDA's failure to review the marketing plans in the PMTA "for the sake of efficiency" was harmless error.
With these developments, there is an opportunity for FDA/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 noncombustible 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.
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% to 75% 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, the U.S. 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.
David Spross is executive director of the National Association of Tobacco Outlets (NATO), a national retail trade association that represents more than 66,000 stores throughout the country.
Editor's note: The opinions expressed in this column are the author's and do not necessarily reflect the views of Convenience Store News.