FDA
Altria, Imperial, and PMI all Look to Dodge the Vapor Regulatory Bullet Major U.S. companies scramble to avoid the ire of an FDA that increasingly dislikes vaping. By Christopher Bickers n September, the U.S. Food and Drug Administration (FDA) announced a number of additional steps to address underage use of e-vapor products. These included asking several companies to provide plans to address underage use of e-vapor products. Altria said it was one of the targeted manufacturers and welcomed FDA’s action. In a letter to the F.D.A., Howard A. Willard III, chairman and chief executive of Altria Group, express alarm at the epidemic levels of youth e-cigarette use. “Although we do not believe we have a current issue with youth access to, or use of, our pod-based products, we do not want to risk contributing to the issue,” Willard wrote. But e-cigarettes are an important alternative for adults who want to stop smoking. “The current situation with youth use of e-vapor products, left unchecked, has the potential to undermine that opportunity,” Willard said. Representatives of Altria met with FDA Commissioner Gottlieb in October
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to discuss actions that could be taken. Then in late October, Altria announced its affiliate Nu Mark would: • Remove MarkTen Elite and Apex by MarkTen pod-based products until these products receive a market order from the FDA or the youth issue is otherwise addressed; • For the remaining MarkTen and Green Smoke cig-a-like products, Nu Mark will sell only tobacco, menthol and mint varieties. Nu Mark will discontinue the sale of all other flavor variants of its cig-a-like products until these products receive a market order from the FDA or the youth issue is otherwise addressed; and • Altria will support federal legislation to establish 21 as the minimum age to purchase any tobacco product. Approximately 80 percent of Nu Mark’s e-vapor volume in the third-quarter of 2018 will remain on the market after the announced market withdrawals. The company reiterat-
22 TOBACCO INTERNATIONAL OCTOBER/NOVEMBER 2018
ed that it has long supported efforts at retail to prevent youth access through identification checks, retailer training and other age verification practices. Similarly, it employs strong age-verification technologies and practices on our ecommerce sites to sell only to adult consumers age 21 and older. Altria stated it believes that the current youth issue is driven, in part, by “social access”—the purchase of tobacco products by consumers of legal age for use by minors. “We believe, in the face of these current e-vapor and youth-related concerns, now is the time to support federal legislation to increase the minimum legal age to purchase tobacco products to age 21 and to set a national standard.” Only the U.S. Congress can increase the minimum legal age nationally, and Altria said it will engroucage encourage Congress to consider the change as part of their tobacco-related
Altria has removed its MarkTen Elite (top) and Apex pod-based systems (above) from the U.S. market to await a market order from FDA.