Altria, Imperial, and PMI all Look to Dodge the Vapor Regulatory Bullet

Altria has removed its MarkTen Elite (above) and Apex pod-based systems from the U.S. market to await a market order from 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

In 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 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 reiterated 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 e commerce 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 legislative priorities.

Altria has removed its MarkTen Elite and Apex pod-based systems (above) from the U.S. market to await a market order from FDA.

The company said it also supports requiring user fees for e-vapor products, banning vaping in schools and prohibiting self service displays at retail.

Imperial Brands, Fontem Ventures: “We aim to comply” Imperial and its Fontem Ventures subsidiary in the US, to support their insisted in October that it too would maintain compliance with FDA rules on the marketing, sale and distribution of vaping products in the US.

“We fully recognize the challenge faced by the FDA in balancing the positive public health potential of vapor products with legitimate concerns regarding youth access and responsible marketing,” Imperial and Fontem announced in a joint statement. ” Imperial Brands and Fontem are committed to creating something better for the world’s smokers. Vaping provides a unique opportunity to switch smokers to a healthier alternative, but this can only be achieved by responsible businesses operating in appropriately regulated markets.”

The statement concluded, “We will continue to engage with the FDA and other regulators around the world to shape the regulation that will encourage smokers to switch, focusing on issues including youth access prevention, product standards, harm reduction and responsible marketing.”

PMI LAUNCHES NEXT-GEN HEAT-NOT-BURN PRODUCTS: IQOS 3, IQOS 3 MULTI

While Altria adjusted its U.S. strategy in light of FDA scrutiny, Philip Morris International Inc. (PMI) went in another direction in October, launching a new generation of its heatnot-burn product, IQOS.

The new IQOS 3 and IQOS 3 MULTI integrate extensive consumer insights and feedback for improving design and user experience. At the same time, they retain the signature taste, sensory attributes and ritual of the original version, according to the manufacturer.

The new versions aim to encourage smokers to switch, to the benefit of their health, public health and, ultimately, society.

The new iterations were launched October 22 in Tokyo, Japan, the “birthplace” of IQOS. The iconic brand offers the best in taste and satisfaction in the category, and almost six million adult smokers (more than half in Japan) have already quit cigarettes.

“Our dream was to create a better alternative for smokers, and IQOS has made this dream a reality,” said André Calantzopoulos, PMI’s chief executive officer. “It’s a revolution for the 1.1 billion people who smoke. IQOS consumers know

that this product changes many things in their lives—we thank them, and we thank Japan for leading this positive change.”

André Calantzopoulos, CEO Philip Morris International, introduced PMI’s new IQOS 3 and IQOS 3 Multi in Tokyo, Japan—the world’s biggest market for heated tobacco. Improvements focused primarily on design and ergonomics.

IQOS 3, shown with the available range of case colors.

IQOS 3 Multi.

IQOS produces an aerosol that contains on average 90 percent lower levels of harmful chemicals than cigarette smoke. The totality of PMI’s preclinical and clinical evidence indicates that switching completely to IQOS presents less risk of harm than continued smoking. Evidence also shows that IQOS does not negatively affect indoor air quality. On average, 70 to 80 percent of IQOS users have quit cigarettes, which makes IQOS the most compelling smoke-free alternative today.

PMI has filed a Modified Risk Tobacco Product Application (MRTPA) for IQOS with the U.S. FDA, but the U.S. FDA has not yet completed its review of the company’s data. IQOS is currently not for sale in the United States.