Dive Brief:
- The Food and Drug Administration has ruled that the Blue disposable classic tobacco-flavored 2.4% nicotine e-cigarette cannot be marketed in the U.S., according to a Tuesday announcement from the agency.
- The FDA said the product, produced by Fontem US, did not adequately prove that granting its marketing rights would benefit public health
- While the FDA has noted that both e-cigarettes and nicotine pouches can be lower-risk alternatives for smokers, only a handful of products have successfully made their case to the agency.
Dive Insight:
Fewer than 30 vaping products have been approved for marketing in the U.S. The four brands with approved items are Juul, Altria’s Njoy, Reynolds American’s Vuse and Japan Tobacco’s Logic.
Blu ultimately did not convince the FDA that smokers would completely switch from cigarettes to its device. The FDA said Fontem’s application proved smokers were more likely to use both, which could cause additional health problems beyond those that come with cigarette use.
“While FDA-authorized e-cigarettes are a lower-risk alternative for adults who smoke cigarettes — especially if they completely switch — not all e-cigarettes are equal,” Bret Koplow, acting director of the FDA’s Center for Tobacco Products, said in a statement. “In this case, the company did not provide sufficient evidence of a benefit that outweighs the risk.”
The FDA has made several nicotine-related decisions this year, including withdrawing a proposed anti-menthol rule and approving its first nicotine pouches.
