Constructive engagement

Following meetings with the leadership of Altria, Juul, Reynolds American, Fontem Ventures, and JTI, U.S. Food and Drug Administration (FDA) Commissioner Scott Gottlieb said the companies had presented thoughtful proposals to reverse the trend in youth use of e-cigarettes. The proposals, he said, consisted not only steps the companies would take to restrict youth access and appeal, but also steps that they think the FDA and other policy-makers can take.
Suggestions for the agency included:

• Restricting distribution of certain flavored products to channels with enhanced age-verification processes
• Requiring certain products that are more appealing to underage users to come off the market until these products receive premarket authorization from the FDA
• Raising the minimum age to purchase tobacco to 21 years to reduce the problem of older purchasers selling products to underage friends.

Gottlieb said the agency will be looking at data as it develops policy, including on how different types of electronic nicotine delivery systems products are used by kids; the popularity of various products, such as cartridge-based e-cigarettes; the popularity of non-tobacco flavors; and the strength of various distribution methods in ensuring robust age verification.
In balancing the trends of youth initiation against adult smokers using e-cigarettes to quit, Gottlieb concluded, “We may need to take actions that might narrow the off-ramp from smoking for adults in order to close the on-ramp to nicotine addiction to kids.”
Responding to the statement, Wells Fargo analysts wrote that they were struck by the commissioner’s collaborative tone toward the top tobacco/e-cigarette manufacturers. Changes were likely in the next few weeks, they added.
Changes could include some combination of bans/restrictions on sales of certain e-cigarette flavors. The agency could also look to regulate distribution channels and Juul-like cartridge-based e-cigarettes could be on the chopping block, according to the analysts.
The commissioner’s comments on the importance of nicotine to adult smokers transitioning to e-cigarettes could suggest that the FDA may not seek to cap nicotine levels, the analysts speculated.
to reverse the trend in youth use of e-cigarettes. The proposals, he said  consisted not only steps the companies would take to restrict youth access and appeal, but also steps that they think the FDA and other policy-makers can take.
Suggestions for the agency included:

• Restricting distribution of certain flavored products to channels with enhanced age-verification processes
• Requiring certain products that are more appealing to underage users to come off the market until these products receive premarket authorization from the FDA
• Raising the minimum age to purchase tobacco to 21 years to reduce the problem of older purchasers selling products to underage friends.

Gottlieb said the agency will be looking at data as it develops policy, including on how different types of electronic nicotine delivery systems products are used by kids; the popularity of various products, such as cartridge-based e-cigarettes; the popularity of non-tobacco flavors; and the strength of various distribution methods in ensuring robust age verification.
In balancing the trends of youth initiation against adult smokers using e-cigarettes to quit, Gottlieb concluded, “We may need to take actions that might narrow the off-ramp from smoking for adults in order to close the on-ramp to nicotine addiction to kids.”
Responding to the statement, Wells Fargo analysts wrote that they were struck by the commissioner’s collaborative tone toward the top tobacco/e-cigarette manufacturers. Changes were likely in the next few weeks, they added.
Changes could include some combination of bans/restrictions on sales of certain e-cigarette flavors. The agency could also look to regulate distribution channels and Juul-like cartridge-based e-cigarettes could be on the chopping block, according to the analysts.
The commissioner’s comments on the importance of nicotine to adult smokers transitioning to e-cigarettes could suggest that the FDA may not seek to cap nicotine levels, the analysts speculated.
Read Gottlieb’s full statement here.