A marketing denial order (MDO) was issued by the FDA today regarding the tobacco-flavored Bidi Stick-Classic disposable vaporizer. The decision is made as the agency proceeds with a second review of marketing applications for flavored Bidi Vapor products, as mandated by court order.
Bidi's premarket tobacco application (PMTA) "lacked sufficient evidence to address health risks and did not demonstrate an overall net benefit to people who use tobacco products," according to an FDA press statement.
Bidi received MDOs for its flavored goods in September 2021 after submitting The court ordered the FDA to do a new review of the Bidi PMTAs that were refused. FDA regulates Bidi's flavored products still.
The FDA hasn't had any luck with its previous denials of closed-system goods with tobacco flavors. Fontem US received an MDO from the FDA Center for Tobacco Products in April 2022 for its myblu device and many refill pods, some of which had tobacco flavors. The District of Columbia Circuit Court of Appeals affirmed the FDA's denials of non-tobacco-flavored refills last August, but found in favor of Fontem regarding the device and tobacco-flavored refills.
Additionally, Juul Labs received an MDO from the FDA in June 2022, directing the firm to take all JUUL products—including tobacco-flavored JUUL refill pods—off the market. But shortly after the FDA's refusal was delayed by the D.C. Circuit Court of Appeals, the agency capitulated and willingly requested a second scientific review.
Only seven e-liquid-based vaping devices have been approved by the FDA Center for Tobacco Products since it assumed regulatory jurisdiction over e-cigarettes in 2016. The approved products are all flavored with tobacco, and none of them are refillable. All are produced by businesses that are owned by the three largest tobacco companies: R.J. Reynolds/British American Tobacco (Vuse), Japan Tobacco International (Logic), and Altria Group (NJOY).
Since the appointment of Brian King as the director of the FDA Center for Tobacco Products in July 2022, the FDA has not authorized any vaping products.
Numerous vaporizer producers have filed legal challenges against FDA marketing denial orders. The agency has been the subject of rulings from two federal appeals courts, one of which was the Fifth Circuit Court's landmark Triton Distribution case earlier this month.
