The anti-vaping crusade has produced awful science and dishonest, vitriolic attacks on a nascent industry that is helping millions of people quit smoking. Case in point: the authors of a November 2022 study accused vaping company JUUL of altering the menthol content of one of its products to skirt Food and Drug Administration (FDA) regulation. Not only was the accusation false, the study authors knew it was false and published the paper anyway.
Brief background: In February 2020, the FDA banned all flavored, pod-based vapes, excluding tobacco and menthol. The study alleged that JUUL altered its menthol product to end-run the effects of the agency’s new flavor rule. This was a very serious allegation, as tobacco-control expert Clive Bates explained in a recent blog post:
… [F]or a vaping company to change the formulation of its products at the time would have been illegal and opened it up to enforcement action that could have removed some or all of its products from the market … [T]hey were not allowed to modify their products unless and until [an FDA authorization application] for the modified product had been successful.
The study very well could have swayed the FDA’s decision to deny marketing authorization for JUUL’s products. This is doubly so because the study was “supported by … the Center for Tobacco Products of the US Food and Drug Administration,” the regulatory authority tasked with reviewing the product in question. The bigger problem is that the company’s customers could have been left without access to the technology that helped them quit smoking.
There were numerous problems with the accusation. First, the researchers confused “the evaporation of the volatile menthol flavoring agent with a deliberate product modification,” Bates noted. The former is a well-known occurrence during storage; the latter is blatantly illegal. JUUL explained this to the researchers months before they published their study, then said the same publicly after the paper appeared online:
“The implications made about JUUL products in this study are contradicted by our own contemporaneous and detailed product and manufacturing records and are more readily explained by a methodological artifact that the authors have not fully reported, even after a direct prompt before submitting the manuscript.”
For almost six months, neither the study authors nor the journal that published their analysis responded to JUUL’s criticism. The text of the study was finally updated in April 2023 as follows:
Original: In conclusion, our findings suggest the possibility that the menthol content of JUUL pods changed in a manner that may have increased the appeal of these products when other flavoured pod-based products were no longer available. This work highlights the need to consider the menthol and other natural and synthetic coolants in e-cigarettes as a possible target for regulation, as well as the need for regular independent testing to assure that products remain compliant with regulation.
Revised: This study shows that concentrations of nicotine and menthol in JUUL products procured over a 3 year period decreased over time, possibly due to product degradation during storage. The findings highlight challenges of reconstructing product characteristics at the time of manufacture and time of consumption and suggests the utility of an ENDS product bank that could preserve samples for retrospective studies.
Did the authors apologize for making such an outrageous accusation? No. AVM’s Greg Conley filed a freedom of information request with the school that employs the study authors. “No author expressed an ounce of sympathy or embarrassment,” he observed after reviewing the researchers’ email exchanges about the study.
It actually gets worse. The authors not only refused to apologize, they doubled down. “Given the [tobacco] industry‘s long history of industry obfuscation, interference, and deception regarding research on tobacco products,” they wrote in response to JUUL’s criticism, “we decided … to report our results independently and respond to any public discussion of our work if and when it arose.”
Like the flawed studies I’ve discussed in past columns, this example sadly illustrates just how far tobacco control has fallen. Not only is junk science tolerated in this field, apparently so is outright deception—as long as your work is critical of e-cigarettes.
This sad state of affairs prompts an important question: if these scientists want smokers to quit, why do they dishonestly attack vaping, the most effective cessation tool that’s ever been developed? They’re either oblivious to the fact that they’re encouraging smokers to keep smoking, or they know and don’t care. Neither answer is acceptable.
