This Newsletter Is Not "FDA Approved"
The confusion over bureaucratic terms *might* actually help the US vapor industry.
A Quick Programming Note
In addition to every Friday, I’ve decided that I’ll be publishing this newsletter whenever news breaks, and when I’m not on the clock for Filter. I think it’s important that as the news progresses on the Food and Drug Administration (FDA) and the US vapor market that I’m able to report on it as quickly as possible.
Moving on …
The FDA Is Not "Approving" E-Cigarettes
On Thursday, a reporter asked Jen Psaki, the White House press secretary, about President Joe Biden’s opinion on taxing e-cigarettes like other tobacco products. She essentially punted the question, but did mention how one e-cigarette was recently “approved” by the FDA.
That statement is not true.
This week, the FDA “authorized” a marketing order for how the Vuse Solo and two of its original, tobacco-flavored cartridges could specifically be advertised and sold. The agency determined that these products are “appropriate for the protection of the public health” — which has come to be understood as helping adult smokers switch and not introducing a new generation to nicotine. In the letter to the R. J. Reynolds Vapor Company, which produces Vuse, the agency states none of these products can say that they are “FDA approved.”
The bureaucratic language is so unclear that someone who speaks on behalf of the president of the United States does not seem to comprehend what’s happening. But who can really blame her?
FDA’s marketing order “does not allow the e-cigarettes to be marketed with any modified risk claims, explicit or implicit (although FDA has not been that diligent in enforcing against unauthorized implicit modified risk claims),” Eric Lindblom, a senior scholar at Georgetown’s O’Neill Institute for National and Global Health Law and a former director of the FDA’s Center for Tobacco Products Office of Policy, told me in an email. “To be allowed to market with any such claims [R . J Reynolds] would have to seek an MRTP [modified risk tobacco product] order from FDA giving permission to market the e-cigs with reduced-risk or reduced-exposure claims.”
He added: “The Tobacco Control Act also explicitly states that manufacturers are not allowed to advertise their products by saying that FDA has approved them or certified them or anything like that, just because they received a PMTA [premarket tobacco product application] order allowing their marketing.”
Still, imagine what will occur if the agency decides to “authorize” JUUL’s PMTA — which the company, like all the others, had to submit by last September so their products could keep being sold. Much of the population, who does not spend their afternoons culling through the hazy vernacular of tobacco control, is likely going to believe an “authorization” is a tacit stamp of approval. For comparison’s sake, look at the uncertainty that clouds the agency “authorizing” and “approving” COVID vaccinations. (David Lim, a Politico reporter, recently conducted a Twitter poll about which FDA actions sound the least rigorous.)
Just glance at these headlines, the extent of most people’s reading of the news.
From the BBC:
From CNBC:
There’s an irony here. Vapor companies are explicitly barred from stating that their products are “approved” — and by extension, “safer than smoking.” But politicians, the media, and the public at-large are already doing it for them. By failing to grasp the distinction, they are among the chosen few who’ll be able to shift the broader culture and discourse around vaping and tobacco harm reduction (THR). It’s easy to fathom that their mistakes, and the desire of THR proponents to let them live with those mistakes, can lead the general populace to assume the obvious: vaping is much safer than smoking. It has to be easier than trying to explain all of this. Though, of course, I’m not implying the above strategy makes any sense.
But the confusion, for once, might actually work in vape advocates’ favor.
Some more reporting this week in Filter
FDA’s First-Ever Vaping Product Authorization Brings Mixed Feelings
Michigan Drops Its Vape Flavor Ban, But Advocates Wary What’s Next