Imperial Tobacco: Disappointed by FDA's decision to reject Myblu e-cigarettes, disagrees with conclusion
The FDA's rejection of a premarket tobacco product application (PTMA) for several pod-based tobacco e-cigarette products sold by Fontem US doesn't bode well for other e-cigarette marketers.
The FDA's April 8 marketing denial order for Fontem's Myblu product was the first denial of an application issued to Big Tobacco.
Fontem is owned by UK-based Imperial Brands plc, one of the largest tobacco companies in the world.
Under FDA rules, marketers of electronic nicotine delivery systems must submit PMTAs by September 2020 so the agency can determine their suitability to protect public health.
The FDA designation primarily considers whether the devices will help convert adult smokers to safer alternatives, but will not introduce tobacco to new users.
The latter concern is the most complicated for tobacco companies, given the popularity of teen vaping in recent years.
In rejecting PMTAs for seven Myblu products, the FDA determined that the applications lacked sufficient evidence that permitting marketing of these products is appropriate to protect public health.
"Furthermore, these applications do not demonstrate that the potential benefits to smokers of complete or significant reductions in smoking outweigh the risks to young adults."
U.S.-based ITG Brands LLC, the subsidiary of Imperial that sells Myblu, issued a statement saying it was disappointed by the FDA's decision and disagreed with the agency's scientific assessment and conclusions.
“We believe our product complies with regulatory requirements and plan to use the administrative appeals process to convince the agency that approval should be granted. Based on past practice, we do not expect the FDA to seek to enforce an MDO during an appeal, so we expect the product to remain in place during this period. will remain in the market.”
In a lawsuit settlement on Tuesday, tobacco giant Juul Labs Inc. agreed to pay $22.5 million to Washington state while agreeing to various marketing reforms to prevent the sale and use of its e-cigarettes by minors.
Allegations in the state's consumer protection lawsuit, filed in September 2020, included Juul inappropriately targeting teens on social media.
As previously reported, two years ago this month, the Federal Trade Commission filed a lawsuit against Juul and its major shareholder Altria, alleging that the companies violated antitrust laws by trying to eliminate competition in the e-cigarette space.
In February, an administrative law judge dismissed the FTC's antitrust charges. The FTC is appealing the decision.
Juul and British American Tobacco's Vuse brands have a combined dollar share of about 70 percent of e-cigarettes in U.S. retail stores tracked by Nielsen, while Imperial has about 3 percent.
Juul, British American Tobacco and NJOY Holdings Inc.'s NJOY brand are still awaiting PMTA decisions on pod-based e-cigarettes currently under consideration by the FDA.
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