August 05, 2021

Warren, Blumenthal Blast Juul’s Deceptive Practices, Call for Close FDA and FTC Scrutiny

Juul’s Purchase of Full Issue of Medical Journal Continues Big Tobacco’s Decades-Long Misinformation Campaign

Text of Letter to FDA (pdf) | Text of Letter to FTC (pdf)

Washington, D.C. - United States Senators Elizabeth Warren (D-Mass.) and Richard Blumenthal (D-Conn.) sent letters to Janet Woodcock, Acting Commissioner of the U.S. Food and Drug Administration (FDA), and  Lina Khan, Chair of the Federal Trade Commission (FTC), raising concerns over recent revelations that Juul Labs is mounting an all out campaign against any FDA action that would impact their profits, including purchasing an entire issue of the American Journal of Health Behavior to publish industry-funded studies under the guise of objective science. The senators call for action comes as the FDA reviews Juul’s Pre-Market Tobacco Application (PMTA), and nears a decision on whether Juul’s electronic cigarettes should remain on the market. 

“The tobacco industry has a decades-long history of misleading the public and public health officials about the dangers of its products, and this appears to be yet another example. The FDA and FTC should use their authority to swiftly investigate, and put an end to, the tobacco industry’s disturbing PR tactics and ensure that Juul can no longer deceive the public,” said Senator Warren. 

“Taking another page from Big Tobacco’s playbook, Juul has cravenly corrupted an academic journal to deceive and mislead. Its brazen purchase of supposed scientific studies is only the latest step in a craven, concerted campaign to profit from nicotine addiction. Protecting communities clearly requires that the FDA remove Juul from the market and FTC immediately pursue an investigation and enforcement measures,” said Senator Blumenthal. 

Juul’s efforts to influence the FDA include “pa(ying) $51,000 to have the entire May/June issue of the American Journal of Health Behavior devoted to publishing 11 studies funded by the company offering evidence that Juul products help smokers quit.” According to the “Conflict of Interest” statements associated with the 26 co-authors of the issue that Juul paid for, 18 of the co-authors are either current full-time employees of Juul, or were full-time employees at the time they conducted the research. Five others are consultants with Pinney Associates, working ‘on an exclusive basis to Juul Labs.’ And the final three, who co-authored one of the 11 studies, are employees of the Centre for Substance Use Research, an “independent” consultancy that designed that study under a contract with … Juul Labs.”

In the letter to the FDA, the lawmakers raise concerns about Juul’s deceptive behavior and the influence their behavior could have on regulators’ decisions. The lawmakers also ask whether the agency will review conflicts of interest in the “Deeming Rule” process, how studies with a conflict of interest are evaluated, and if the agency has had any communication with the companies regarding their activities to industry-funded pseudoscience studies and to subvert academic journals. 

In the letter to the FTC, the lawmakers question whether the Juul-funded studies are a form of advertising, if the studies are a potential deceptive practice, and if there is any precedent for the agency to take action. 

Last year, Senators Warren and Blumenthal led their colleagues in sending letters to British American Tobacco (BAT), Philip Morris International (PMI), the FDA, and the FTC questioning the tobacco companies' exploitation of the COVID-19 pandemic to market their e-cigarette products using abusive and misleading tactics aimed at youths and adolescents. The senators also sought information on the enforcement actions taken by the agencies to regulate these advertisements.