FDA Rejects PMTA for Tobacco-Flavored Bidi Stick

The FDA today issued a marketing denial order (MDO) for the tobacco-flavored Bidi Stick-Classic disposable vape. The decision comes while the agency continues a court-ordered second review of marketing applications for flavored Bidi Vapor products.

According to an FDA press release, Bidi’s premarket tobacco application (PMTA) “did not demonstrate an overall net benefit to people who use tobacco products and lacked sufficient evidence to address health risks.”

Bidi submitted PMTAs for multiple disposable vapes in 2020, and received MDOs for its flavored products in September 2021. Bidi immediately appealed the denial to the Eleventh Circuit Court, and in August 2022 the court ruled for Bidi (and five other vape manufacturers), ordering the FDA to re-review the denied Bidi PMTAs. Bidi’s flavored products remain under FDA review.

Previous FDA denials of tobacco-flavored closed-system products haven’t gone well for the agency. In April 2022, the FDA Center for Tobacco Products issued an MDO to Fontem US for its myblu device and multiple refill pods, including several tobacco-flavored pods. Last August, the District of Columbia Circuit Court of Appeals ruled for Fontem on the device and tobacco-flavored refills, but upheld the FDA’s denials of non-tobacco-flavored refills.

The FDA also issued an MDO to Juul Labs, ordering the company in June 2022 to remove all JUUL products from the market, including tobacco-flavored JUUL refill pods. However, soon after the D.C. Circuit Court of Appeals stayed the FDA denial, the agency backed down and voluntarily ordered a second scientific review.

The FDA Center for Tobacco Products has authorized just seven e-liquid-based vaping devices since it granted itself regulatory authority over e-cigarettes in 2016. All of the authorized products are tobacco-flavored, and none are refillable. All are made by manufacturers owned by three major tobacco companies—Altria Group (NJOY), Japan Tobacco International (Logic), and R.J. Reynolds/British American Tobacco (Vuse).

The FDA has not authorized any vaping products since current FDA Center for Tobacco Products Director Brian King was appointed in July 2022.

Dozens of vaping manufacturers have challenged FDA marketing denial orders in court. Two federal appeals courts have issued rulings against the agency, including the Fifth Circuit Court’s blockbuster Triton Distribution decision earlier this month.