03.21.18 – For anyone following FDA tobacco regulations, the past week has been a busy one. On March 15th, the agency released its advanced notice of proposed rulemaking (ANPRM) for regulating the nicotine content in cigarettes. Today, the FDA is publishing another ANPRM regarding standards for flavored vapor and tobacco products in the Federal Register. As the name suggests, an ANPRM seeks input from consumers, scientists, and industry that assists an agency in crafting a final rule. And much like draft guidance, an ANPRM often represents regulators’ current thinking on a particular topic.
To the uninitiated, this announcement might sound reasonable. Product standards can be helpful in protecting consumers from poorly manufactured products and ingredients that are found to be harmful. But Tuesday’s announcement–and questions posed in the ANPRM–suggest that FDA is also specifically looking at limiting the flavors that would be allowed on the market.
In his announcement for the ANPRM, FDA Director, Scott Gottlieb notes that vaping’s popularity among young people is concerning. “No child should use any tobacco products, including e-cigarettes,” he said. “At the same time, we’re aware that certain flavors may help currently addicted adult smokers switch to potentially less harmful forms of nicotine-containing tobacco products.” The phrase “certain flavors” is repeated throughout the announcement and the ANPRM itself, which suggests that the agency is setting the stage for dramatically reducing the variety of flavored vapor products available to consumers. This would be consistent with the FDA’s thinking in regards to the effect of the deeming rule, published in 2016, which would remove more than 98% of vapor products from the market.
There is little comfort to be found in Director Gottlieb mentioning the importance of individual experiences with switching to non-combustible, low-risk forms of tobacco and nicotine. His acknowledgement that some have had success in quitting smoking by switching to such products is followed closely by the statement that “anecdotes aren’t the same as data.” And just that simply, he dismisses the experiences of millions who have completely eliminated or dramatically reduced their smoking habit thanks to vapor products.
In the coming weeks, CASAA will be providing guidance to comment on the ANPRM regarding flavors and other opportunities to engage with the FDA. Our initial advice to members is to share your personal story about vaping. Specifically, comments should include which flavors you use to stay smoke-free and how many different flavors you use in a given day. If you wish to comment now, the docket can be accessed by clicking here.
Now more than ever, consumer voices are needed to demonstrate how important access to a diverse vapor market is in reducing the early death and disease attributed to smoking.