The U.S. FDA’s Claims on Vaping Contradict the Agency’s Own Scientific Findings

Government watchdog group Protect the Public’s Trust, whose mission is monitoring and highlighting any improper and illegal behavior of senior government officials, has just filed a complaint with the Department of Health and Human Services against the U.S. Food and Drug Administration (FDA).

The complaint accuses the FDA of promoting misinformation on vaping products, more specifically of warning against the products’ safety and effectivity, contradicting its own data and scientific findings in doing so.

Protect the Public’s Trust highlighted that in line with countless other peer reviewed studies, an FDA report found that “only a subset” of the many harmful compounds found in cigarettes are found in vapes and at significantly lower levels. The same FDA report  also revealed that menthol vapes were more effective at helping adult smokers quit cigarettes than their fruit, candy or tobacco flavoured counterparts.

In fact, in line with predictions by tobacco harm reduction experts, the survey results published in Tobacco Control last year, reported that following the flavour ban set by the US FDA in 2020, most respondents switched to other flavours or tobacco products. The study found that less than 5% of the 3,500 adult respondents had actually quit vaping in response to the flavour ban.

Flavour bans do not decrease teen vaping
Similarly, extracting data from the Population Assessment of Tobacco Health (PATH) survey, another study exploring the impact of non-traditional vape flavours on e-cig addiction and harm perception, found that flavour bans do not necessarily decrease teen vaping rates.

Titled, “E-cigarette addiction and harm perception: Does initiation flavor choice matter?,” the study analysed data from 1,043 teens aged between 12 and 17 years. The research team found that there was actually no significant difference in addiction levels between those initiating with traditional versus non-traditional flavours.

The FDA’s trend of ignoring science
Meanwhile, Protect the Public’s Trust stated that there has been a pattern of government officials failing to follow “the science.” In line with these accusations, when last year the first low-nicotine cigarettes gained the authorization from the FDA to be sold as reduced risk products, professor of medicine and renowned tobacco harm researcher in tobacco harm reduction research at the University of Louisville, Dr. Brad Rodu had highlighted that many experts are questioning how the products managed to meet the FDA’s tough MRTP standard.

The authorization requires products to “significantly reduce harm and the risk of tobacco-related disease to individual tobacco users and benefit the health of the population as a whole taking into account both users of tobacco products and persons who do not currently use tobacco products.”

This is because, he explained, reducing nicotine does not reduce risk at all, as nicotine does not cause cancer or any of the other diseases associated with smoking. On the other hand, the chemicals which do have not been reduced at all. Similarly, tobacco harm reduction expert Clive Bates had called this move the FDA’s “most ill-judged moves to date,” as these products still produce all of the smoke and thousands of carcinogens.

Court of Appeals rules against FDA
Additionally, only last month in a legal action against the FDA, a panel of Fifth Circuit judges ruled that the agency has created road block after road block for the legal vape industry, in what is being considered an abuse of its power. In 2016, it deemed that vapes are tobacco products, despite the fact that they contain no tobacco, and harshly regulated them as such.

Irrespective of the data and testimonials indicating their benefit as tobacco harm reduction and quit smoking tools, the FDA first set up the very complicated, lengthy and expensive Pre Market Tobacco Application (PMTA) process that most vape companies would not be able to complete. Then the agency started “inexplicably shifting its criteria for approval and moving its goalposts, suggesting an abuse of administrative procedures.”

Such patterns have attracted multiple complaints and lawsuits, and some cases, US courts have ruled against the agency. “The FDA admits that it ‘has yet to grant’ a single application to market non-tobacco-flavored e-cigarettes. This means it has denied over 355,000 such applications, which amount to 99% of all timely-filed (applications),” said the Fifth Circuit ruling in its reading.

In fact, the agency has recently sent shockwaves across the safer alternatives’ industry when it refused a marketing authorisation for around 17m individual e-liquid products from the same company. The FDA announced that it had issued a refusal to accept (RTA) letter to the company over its grouped PMTA which included e-liquids in varying sizes, nicotine strengths and flavours. It justified the RTA by alleging that the said company failed to provide required environmental assessments, which is meant to determine whether the approval of a product would affect the environment.