On March 24, 2022 FDA authorized the sale of three electronic nicotine delivery systems distributed by Japan Tobacco’s US company Logic Technology Development, – two conventional e-cigarettes and one heated tobacco product. FDA withheld the Technical Project Lead (TPL) report that provides the scientific justifications for its decision.
Thanks to my colleague Lauren Lempert filing a Freedom of Information Act request, we now have the TPL. It shows even more serious problems than when FDA bent over backwards to authorize RJR’s Vuse Solo. Specifically, to justify authorizing the Logic products, FDA advanced arguments that JT/Logic didn’t make itself, most notably:
- While JT/Logic specifically says “that the new products are ‘designed for adult combusted tobacco smokers, and their user guides state that the new products are not smoking cessation products [emphasis added]” and makes no such claims in the application, FDA concludes that the products are “appropriate for protection of public health” because they will help some smokers to quit.
- While JT/Logic does not address youth use at all even though the law specifically requires FDA to consider effects on nonusers, FDA did it for them, concluding that because tobacco flavor e-cigs are not as popular as flavored e-cigs (ignoring menthol), youth use was not a problem.
As with Vuse Solo, FDA concludes, “The potential of the new products to benefit smokers who significantly reduce their CC [combusted cigarette] use (or who switch completely and experience CC cessation) outweighs the risk to youth …” but, as with Vuse Solo, does not give any numbers about just how many kids FDA is willing to sacrifice per adult beneficiary.
FDA argues the Logic products will help smokers quit even though Logic makes no such claims
This is all the more stunning because JT/Logic does not present information in its application to make this case, something FDA recognizes:
Because reductions in CC [conventional cigarette] consumption are other found [sic] to increase the likelihood of successful CC cessation (Hughes & Carpenter, 2006), decreases in CPD [cigarettes/day] associated with the use of the new products may promote CC quit attempts and lead to successful CC cessation among CC smokers who are interested in quitting; however, these outcomes are not assessed in the current PMTAs.” (page 6)
FDA repeats this argument many times in its report, never citing any specific evidence presented in the application or the current scientific literature to support its conclusion. For example, “Thus, CC smokers who choose to use the new products may experience the benefits of significantly reducing their nicotine exposure, reducing their exposure to BOE (see Section 3.5.1.2.), reducing their nicotine dependence, and facilitating smoking quit attempts and success” (page 23).
FDA’s speculation that Logic users reduced CPD will lead to cigarette cessation is based on a single literature review based on research published as of November 2004, 18 years ago and years before e-cigarettes were on the market.
More important, FDA continues to ignore the fact that much newer studies in the real world based on actual effects of e-cigarette use on cigarette cessation among consumers show no population cessation benefit of e-cigarettes. Without a real cessation benefit there is no benefit to trade off against the millions of kids e-cigarettes recruit to nicotine addiction.
To be clear, it is FDA, not JT/Logic making this argument and it is FDA that is substituting its generic “belief” that these products reduce a person’s use of cigarettes instead of following the statutory requirement that places the burden on the manufacturer to provide scientific evidence that the particular product when used in the marketplace does produce that result. FDA leaps to this unfounded conclusion despite the fact that the TPL recognizes that “dual use of the new products with CC is the most likely use behavior” (page 23) and “It is unclear from the information provided how many participants completely switched (i.e., completely quit CC use) to the new products in the applicant submitted 60-day clinical studies” (page 24).
FDA also overstates the drop in the number of cigarettes smoked. The TPL says:
In the applicant-submitted 60-day clinical studies (L0004 and LP005), a large majority of participants in the full analysis set decreased self-reported CPD by 80%:
* Logic Vapeleaf Regular (PM0000529.PD1): 73%-77%
* Logic Pro Tobacco (PM0000535.PD1): 70%-80%
* Logic Power Tobacco (PM0000540.PD1): 63%-72%
However, the extent to which participants maintained their reduced CPD outside of the clinical study setting or completely switched from CC in these studies (i.e., CC cessation) was not described based on the study design (page 24).
This is an important limitation because 60 days is a short-duration study. In addition, most of the reductions were less than 80%.
FDA claims dual use is safer than smoking
- FDA assumes that dual use (smoking cigarettes and using e-cigarettes at the same time) will be substantially lower risk than cigarette smoking because fewer cigarettes are consumed and levels of some biomarkers of exposure are lower. As with Vuse Solo, FDA ignored the evidence that dual use is as dangerous or more dangerous than smoking.
FDA ignored the fact that it doesn’t take many cigarettes to cause significant cardiovascular and stroke risk. In particular, FDA did not cite a highly relevant 2018 meta-analysis of 55 publications containing 141 cohort studies that found that men who smoked just one cigarette per day had 53% of the excess relative risk of coronary heart disease as for smoking 20 cigarettes per day and women had 38% of the excess risk. The excess risks for stroke associated with one cigarette per day was 64% for men and 36% for women.
Indeed, like its authorization of Vuse Solo, FDA’s discussion of health effects was shallow, focusing on the fact that e-cigs deliver lower levels of some toxins and ignoring or downplaying the large body of evidence of substantial specific harms.
As with Vuse Solo, FDA mentions but does not act on its own study showing no all-cause mortality benefit of smoking reduction. In particular, the TPL says “reductions in CC smoking have not been found to lower the risk of all-cause mortality, all-cancer risk, or other smoking/tobacco related cancers (Chang et al., 2021)” (page 43). This FDA study blows away its assumption that cigarette reduction will have significant health benefits at a population level.
JT/Logic ignores effects on youth, so FDA makes the case for them
The law requires FDA to consider effects on non-users. The FDA reported that the PMTA application did not include this information: “The applicant did not provide studies from the peer-reviewed literature containing information on the likelihood that adult or young adult nonusers of tobacco will start using the new products …” and “The applicant did not provide information on use of the new products among vulnerable populations” (page 29).
Rather than seeing these omissions as a fatal flaw in the applications, FDA simply made JT/Logic’s case for them (page 27-28). FDA argued that tobacco flavor ENDS are not popular with kids and that Logic devices are not (currently) popular with kids. FDA simply sidestepped the fact that FDA menthol is popular with kids by ignoring it.
FDA de facto authorized a modified risk claim without JT/Logic even asking for it
The FDA PMTA Guidance recommends that applicants submit consumer perception evaluations that report consumer perceptions of the proposed labeling or advertising: “Consumer perception evaluations should address how consumers perceive product harms and include consideration of packaging and labeling.” The law requires separate specific FDA authorization for tobacco companies to make modified risk claims.
This is another place that FDA gave JT/Logic a pass:
The leaflet/user guide submitted with the Logic Vapeleaf products described the product as “A unique combination of vapor technology and real tobacco provides satisfying taste with no smoke smell and no ash.” In addition, the Point-of-Sale advertisement for the Logic Vapeleaf Regular products included a similar statement: “Real Tobacco. No Smoke Smell. No Ash.” Also, the cartridge and capsules shelf carton show a statement “No Ash, No Smoke Smell” on one side of the package, above the image of the device. (page 32)
These are all statements that could be understood by consumers as unauthorized modified risk claims that a product “contains a reduced level of a substance or presents a reduced exposure to a substance” or “does not contain or is free of a substance” (TCA 911(b)(2)(i)(II) and (III)). Such statements are only permitted after a company has been authorized to make specific modified risk claims about a specific product, something JT/Logic did not request.
Rather than requiring evidence to show that consumers did not read these statements as modified risk or health claims or prohibiting them, FDA just looked the other way:
Based on the information [JT/Logic] presented at this time, there is insufficient information to conclude that the above statements on the Logic Vapeleaf materials submitted with the application, or any other information in the applicant’s other labeling/advertising for Logic Vapeleaf products do in fact convey modified risk. Accordingly, Social Science does not conclude that this labeling/advertising would cause the new tobacco products to be modified risk tobacco products. (page 32)
The message to tobacco companies: Don’t give FDA any research on consumer perception of your marketing claims that might complicate your getting your PMTA approved.
Other problems with FDA’s discussion of JT/Logic marketing
FDA notes, “the applicant did not describe its plans for marketing the products the first year after receiving an order [authorizing selling their products] in the subject applications” (page 30-31). JT/Logic did not even display the required warning labels on sample packaging it submitted to FDA (page 32).
FDA also cites JT/Logic’s support of the tobacco industry’s “We Card” program as evidence of a good faith effort to reduce youth sales, despite the fact that previously secret internal tobacco industry documents show that “We Card’s” true purpose is “to improve the tobacco industry’s image and to reduce regulation and the enforcement of existing laws.”
And, of course, FDA implied that menthol flavor is not a problem, leaving the menthol Logic products on the market through inaction.
A copy of the TPL with my notes on it is available here and the FDA marketing order is here.
The bottom line: FDA’s marketing authorizations for these 3 JT/Logic products are even more flawed than the FDA’s Vuse Solo decision.
FDA did not remedy previously identified problems with its earlier Vuse Solo authorization
Together with colleagues at UCSF and elsewhere, in December 2021, we wrote Acting FDA Commissioner Janet Woodcock outlining serious scientific issues with the Vuse Solo decision in the hopes that subsequent decisions would become more scientifically rigorous.
Things have gone in the opposite direction. It is time for Congress or other authorities to force FDA to pay attention to the current science.
Stanton Glantz blog 