On April 16, 2024, the Food and Drug Administration (FDA), the American regulatory agency, surprised more than one by publishing a new opinion on vaping and its risks… which appeared rather positive. For the first time, she acknowledges, albeit half-heartedly, the relative risks surrounding electronic cigarettes compared to combustion cigarettes. So, should we see this as evidence of a desire to change course or is it a simple smoke screen?
What to remember from the new FDA publication on vaping and risk reduction:
- On April 16, 2024, the Food and Drug Administration (FDA), the American regulatory agency, published a new page on its website: “The relative risks of tobacco products” (1)
- For the first time, it recognizes the importance of distinguishing smoked cigarettes and non-combustion products in what it calls the “continuum of risks”
- It thus defines vaping as generally being able to constitute a lower-risk alternative to smoking.
- Under the guise of educating the population on risk reduction, the FDA continues to play on several fronts, blurring certain boundaries and always using misinformation
- Far from the health considerations it sets out, the FDA only seems to be trying to justify its decision to keep only 23 vaping products on the market, thus absolving itself of responsibility for the increase in the black market and denying any bias in its choices (which American justice rightly blames him)
The FDA and vaping: put into context
In the United States, each vaping product is subject to control and approval by the Food and Drug Administration, or FDA, the American health regulatory agency.
However, since it has taken control of the market, the latter continues refusal after refusal, considering that the marketing requests sent to it by manufacturers do not present sufficient evidence as to the reduction of risks enabled by these products, and the benefits that they could provide to adult smokers. The FDA also does not hide its disapproval of flavors, immediately refusing any vaping product with a taste other than tobacco in its composition.
Also, currently, of the hundreds of thousands of vaping products concerned, less than thirty are officially authorized by the FDA. Result : Unapproved products or products awaiting approval still continue to arrive on American soil, the black market is growing by the hour and the FDA is accumulating lawsuits.
In this more than chaotic context for the vaping market and smokers in withdrawal, even the American Courts of Justice side with the manufacturers, judging the agency “capricious” And “arbitrary”. The problem is such that an investigation has even been launched at the government level by the Committee on Oversight and Accountability, to ensure that the agency is able “to carry out its core functions and ensure that Americans have access to products that can reduce the rate of tobacco-related illness and death”.
Criticized from all sides, the FDA is therefore not unaware of this: it must quickly find a pirouette to defend itself against its accusations of bias, it which wants to be the guarantor of public health. And it seems that this is precisely what she wanted to do this April 16, 2024, through her new internet page: “The relative risks of tobacco products”…
The FDA: a less divided opinion on vaping and its risks?
Through its branch specializing in the regulation of tobacco products, the Center for Tobacco Products (CTP), the FDA has launched a new web page on its website, entirely dedicated to the issue of reduction of risks of non-combustion products.
From the introduction, we can read:
“FDA’s Center for Tobacco Products (CTP) is committed to protecting the health of all people in the United States through a comprehensive approach to reducing the burden of tobacco use […] The CTP strives toeducate adults who smoke about the relative risks of tobacco products »
– FDA, April 16, 2024“The relative risks of tobacco products”, 2nd and 3rd paragraph
With this in mind, the agency thus indicates, for the first time:
“Burned or smoked tobacco products, such as cigarettes, are the most harmful type of tobacco product. Unburned products – such as Electronic cigarettes and other smokeless tobacco products – present generally less health risk than cigarettes and other combustible tobacco products »
– FDA, April 16, 2024“The relative risks of tobacco products”, 4th paragraph
Also, according to her, a request to market a tobacco product as a modified risk tobacco product (MRTP) is successful if the manufacturer manages to “ demonstrate that the product will significantly reduce the harm and risk of tobacco-related disease for consumers and benefit the health of the population as a whole ». This is why, after a “careful scientific scrutiny”she specifies, she chose to authorize only 23.
Clive Bates’ point of view
For this public policy advisor, who undertook to analyze in detail the FDA’s opinion in an article dated April 25, 2024, published on his blog The Counterfactual (2)the health regulatory agency deliberately conceals certain crucial information, leaving a certain doubt:
“The expression “present generally fewer health risks” poorly characterizes the very large differences in risk between combustible and non-combustible products”
– Clive Bates, April 25, 2024The Counterfactual
By literally playing on words, the FDA would thus seek to justify its decisions in terms of market regulation. However, as Clive Bates reminds us:
“Relative risks are determined by physics, chemistry and biology, and not by a bureaucratic assertion. There are many reasons why products much safer than cigarettes have not been approved by the FDA – chief among them: the FDA has erected insurmountable, opaque and shifting barriers that drain the resources of all companies, with the exception of the largest »
– Clive Bates, April 25, 2024The Counterfactual
Behind the smokescreen
By focusing on the construction of the article and the choice of words, we can clearly see that this new FDA publication is far from being informative. If it half recognizes the contribution of the electronic cigarette in the fight against smoking, it continues to participate in the propagation of false ideaslike using fake debates to try to reassure the population about its ethics:
“The concept of relative risk is complex and it is important to ensure that efforts to educate adults who smoke on this topic are evidence-based and likely to achieve the desired results, while minimizing the impact non-targeted audiences, particularly young people”
– FDA, April 16, 2024“The relative risks of tobacco products”, last paragraphs
In addition to relying on the shaky argument of the lack of scientific perspective – which is now increasingly difficult to support given the 15 years of already existing evidence – the FDA does not hesitate to ride the famous controversy of vaping among young people, once again sowing doubt about the intentions of the vaping industry.
“Many things in life are complex. The role of expert agencies is to distill and communicate important and actionable information from complexity, while remaining truthful, ethical and respectful of citizens and their autonomy.
In this formulation, it is suggested that different risk information be presented to different audiences – young people and adults. This seems like a code intended to mislead young people about the comparative risks of smoking and vaping and to ensure that adult needs do not get in the way of scaring young people with lies”– Clive Bates, April 25, 2024The Counterfactual
Personal interests, far from an objective of protection and collective well-being
Thus, if the primary objective of the FDA is truly to communicate the right information to the general public in order to support them with complete clarity in choosing a safer alternative, it should allow them to have a real state of the places of knowledge about vaping. Method, remember, considered at least 95% less harmful than smoking cigarettes (without “generally” or “could”), more effective than most nicotine substitutes (3) and without link to any gateway effect towards smoking, quite the contrary (4).
It seems rather that here, the FDA has issued a more “positive” opinion on vaping and its risks in order to try to allay the accusations hovering over it.
To quote George Orwell, very aptly used by Clive Bates in his article: “ The great enemy of clear language is lack of sincerity. When there is a gap between one’s real goals and one’s stated goals, one turns, so to speak, instinctively to long words and exhausted idiomatic expressions, like a cuttlefish throwing ink »…
