Leading Health Groups Urge FDA to Stop Major Tobacco Companies from Illegally Marketing New Products Without Authorization
WASHINGTON, D.C. – Six leading public health and medical organizations are urging the FDA to take immediate action to prevent tobacco giants R.J. Reynolds and Altria from illegally marketing new tobacco products in the United States without FDA authorization. Reynolds recently indicated that it plans to launch Vuse One, a disposable e-cigarette, without FDA authorization, while Altria has done the same about its on! PLUS nicotine pouch product.
“We urge the agency, with the necessary involvement of the U.S. Department of Justice, to take immediate and appropriate action to prevent Reynolds and Altria from their planned and intentional violation of the law,” the health groups wrote in a letter to FDA Commissioner Marty Makary. The letter was sent by the American Academy of Pediatrics, American Cancer Society Cancer Action Network, American Heart Association, American Lung Association, Campaign for Tobacco-Free Kids, and Truth Initiative.
The letter highlights that under the Family Smoking Prevention and Tobacco Control Act (TCA), no new tobacco product is permitted to be introduced for sale in the U.S. without first undergoing a thorough scientific evaluation and obtaining marketing authorization (called a marketing granted order or MGO) from the FDA. Although both companies have stated they have submitted an application for these products, none of the products in question has received marketing authorization.
“It is undeniable that Reynolds and Altria are planning to act in brazen defiance of the premarket provisions of the TCA, in the hope that FDA will allow them to get away with it in the name of ‘enforcement discretion.’ In both cases, this is a direct and very public challenge to FDA’s enforcement authority. FDA must respond in the strongest possible terms by making it clear that the marketing of these and other new tobacco products without MGOs violates the law,” the letter states. According to press reports, Reynolds plans to launch Vuse One during the fourth quarter of the year in Florida, Georgia, and South Carolina. The product has several features that appeal to youth. It is a disposable e-cigarette, which national data shows to be the most commonly used type of e-cigarette among U.S. youth. It will also be sold in fruit flavors appealing to young people, such as Raspberry Chill, Watermelon Chill, and Berry Melon.
Altria has announced the planned launch of its on! PLUS nicotine pouches in North Carolina, Texas, and Florida this fall. Nicotine pouches are the only category of tobacco product that saw an increase in youth use in recent years. These products are sold in flavors that appeal to youth, are heavily promoted on social media, and can expose users to high levels of nicotine.
The health groups’ letter reinforces that these companies are aware of the law, but are choosing to flagrantly violate it. Specifically, the letter cites previous statements by Reynolds and Altria recognizing that the marketing of new tobacco products without prior FDA authorization violates the Tobacco Control Act. It also cites repeated statements by the FDA that having a pending product application “does not create a legal safe harbor to sell a product.” Although the companies have asserted that their applications have been pending beyond the 180-day statutory review period, the letter notes that “nothing in the statute remotely suggests that surpassing the 180-day period confers a right to market a product without the issuance of a MGO.”