Fed Up with the FDA, Big Tobacco Goes Nuclear

Altria Group vape subsidiary NJOY has filed a federal lawsuit alleging the FDA has violated the Tobacco Control Act by delaying marketing decisions on NJOY vape products. 

The lawsuit, filed Aug. 21 in the U.S. District Court for Western Louisiana by NJOY and three local businesses, charges the FDA has allowed an appeal for supervisory review of marketing denial orders (MDOs) for flavored NJOY DAILY products to hang in limbo for nearly three years---even after Altria addressed a major deficiency listed in the denial. 

On the same day the lawsuit was filed, Altria announced it would launch a new nicotine pouch brand without first receiving FDA authorization. Rival tobacco company R.J. Reynolds has also launched flavored disposable vapes without prior marketing authorization from the FDA.

Altria calls FDA refusal to act on NJOY’s PMTA a “pocket veto”

On June 10, 2022, the FDA granted marketing authorization for the NJOY DAILY in Rich Tobacco flavor (both 4.5 and 6 percent nicotine strength). On the same day, the agency denied authorization for the DAILY in Blue + Black Berry (4.5 and 6 percent), Watermelon (4.5 percent), and Tropical Twist (4.5 percent) flavors. (The FDA left PMTAs for menthol-flavored DAILY products pending at that time, but granted marketing authorization for them on June 21, 2024.)

The Tobacco Control Act—-which Altria (then known as Philip Morris) had a major hand in crafting—-mandates that premarket tobacco applications (PMTAs) receive an FDA decision within 180 days. NJOY’s supervisory appeal of the flavored DAILY denial was filed nearly three years ago. Many other companies’ PMTAs have remained in review even longer, including since before the Sept. 9, 2020 PMTA filing deadline.

NJOY says the failure to resolve the appeal “might reflect” the FDA’s “unlawful de facto product standard banning flavored products.” The company also notes that the FDA ignored the company’s marketing plans and extensive scientific evidence when rendering its original decision to reject PMTAs for the flavored products.

The company supplied the FDA with a longitudinal cohort study showing that its flavored DAILY products promote complete switching by adult smokers at greater frequency than its tobacco- and menthol-flavored products. NJOY says FDA documents obtained in a Freedom of Information Act (FOIA) request show that the Center for Tobacco Products (CTP) “Office of Science’s epidemiology staff concluded that NJOY had adequately addressed the flavor-specific deficiency, finding that the Blue + Black Berry-, Watermelon-, and Tropical Twist-flavored products were associated with higher rates of smoking cessation.”

According to NJOY, the FOIA documents also indicate that the FDA Office of Health Communication and Education “concluded that the measures in NJOY’s marketing plans exceeded measures used in recent marketing granted orders and would mitigate concern about the potential for youth initiation.”

NJOY says it has requested updates from the FDA without success, and received no response when it asked the agency if it was allowed to continue marketing the flavored products while the appeal was in progress.

“Unless this Court orders FDA to issue a decision, some decision, on NJOY’s supervisory appeal,” says NJOY’s brief to the court, “Plaintiffs will continue to incur ongoing harm from FDA’s attempted pocket veto. Because FDA cannot use internal review to forever trap manufacturers in regulatory limbo, Plaintiffs are entitled to relief from this Court.”

The NJOY lawsuit was presumably filed in Louisiana because the appeals court which would hear any challenge to a district court ruling would be the Fifth Circuit Court, which has been largely sympathetic to vaping plaintiffs. 

Altria and Reynolds launch new products without FDA consent

The Altria lawsuit was filed almost simultaneously with decisions by Altria and rival tobacco company R.J. Reynolds to launch new nicotine products without prior FDA authorization. The Big Tobacco firms are apparently daring the regulatory agency to take action by engaging in the very same conduct they call “unlawful” when done by rival Chinese vape manufacturers.

In early August, Reynolds (a division of British American Tobacco) announced it would test-market flavored disposable vapes acquired from longtime independent vape company Charlie’s Holdings. The new products, developed by Charlie’s under the PACHA brand, will be marketed by Reynolds under the VUSE ONE name. They are currently being sold in limited locations, according to Tobacco Insider.

Reynolds claims that because Charlie’s Holdings filed PMTAs for the products before the May 14, 2022 PMTA deadline for synthetic nicotine-based products, they are legal to market while the agency reviews the applications. That isn’t true, however. 

The 2022 law giving the FDA authority over synthetic nicotine specifically granted a 60-day grace period (until July 13, 2022) during which products could remain on the market without authorization. After that, marketing any synthetic nicotine product without prior authorization is illegal. Reynolds is aware of that. Its ongoing campaign to eliminate Chinese disposable competitors from the American marketplace has included numerous demands that the FDA enforce against PMTA scofflaws.

In an FDA citizen petition filed in February 2023, Reynolds specifically demanded the FDA enforce against “Any flavored disposable ENDS (except for tobacco- or menthol-flavored products)” and “Any disposable ENDS containing nicotine derived from any source other than tobacco that lacks premarket authorization.” (The five VUSE ONE disposables—-in Berry Melon, Raspberry Chill, Strawberry Kiwi, Tropical Chill and Watermelon Chill flavors—-contain synthetic nicotine in 5 percent strength.) 

In October 2023, Reynolds filed a complaint with the U.S. International Trade Commission (ITC), asking the trade regulator to prevent the importing, distributing or selling of “illegal disposable vapes.”

Now Reynolds has executed a 180-degree turn and claims that, because the FDA has exceeded the statutory 180-day limit for reviewing the PACHA PMTAs, the products are legal to market.

Altria subsidiary Helix Innovations, meanwhile, is using the same legal logic to bring new nicotine pouches to market. PMTAs for the pouches, branded as on! PLUS and available in three flavors and three nicotine strengths, were submitted in June 2024, according to Altria—-which, under the new Big Tobacco PMTA standard, makes them legal.

“While the FDA’s review timelines have extended far beyond the 180-day statutory requirement,” Altria said in an Aug. 21 X (Twitter) post, “Helix has complied with all regulatory requirements to bring on! PLUS to market—disclosing ingredients, opening facilities for inspection, and submitting marketing materials for review.”