Juul Submits Comment to FDA’s ANPRM on Flavored Tobacco Products
Juul Labs has submitted its own comment to the U.S. Food and Drug Administration’s (FDA) Advance Notice of Proposed Rulemaking (ANPRM) issued on the regulation of flavors in tobacco products
In a press release, Juul Labs’ CEO Kevin Burns issued the following statement: “Smoking is still the leading cause of preventable death worldwide, with more than 480,000 deaths in the United States each year. Our mission is to eliminate cigarette smoking in the world by providing adult smokers with a true alternative to cigarettes. We believe flavors play an important role in helping adult smokers switch to vapor technology, which offers great potential.
“We fully support FDA’s efforts to curb underage use of tobacco products, and we believe restricting access to flavors will negatively impact current adult smokers in their journey to switch from combustible cigarettes. Appropriate flavors help adult smokers who do not want to be reminded of the tobacco-taste of a cigarette. We encourage FDA to allow for further scientific exploration on the role flavors play in helping adult smokers transition away from combustible cigarettes.
“As JUUL Labs works to support adult smokers in their efforts to switch, we also remain steadfast in our commitment to preventing underage use of vapor products. Both goals can be achieved through reasonable regulation to restrict advertising and naming of flavors such as cotton candy and gummy bear that are directed at children. We look forward to continuing to engage with FDA, policymakers, and community leaders on helping to reduce cigarette use while protecting young people.”
BENEFITS OF ENDS
Juul begins its comment submission by stating its support of the FDA’s effort to help existing smokers to reduce cigarette use, including the use of potentially less harmful products. Juul believes its product, considered to be an ENDS (electronic nicotine delivery system), can help achieve this and have a positive impact on public health overall but flavors play an important role in adult smokers making the switch from traditional cigarettes to devices like Juul which are sometimes touted as being a safer alternative for adult smokers.
“Although more research is needed, we believe the existing results demonstrate that an overly restrictive approach to flavors in ENDS, such as an across-the-board prohibition, would not serve public health. Instead, it would be a significant public health detriment because it would significantly undermine efforts to encourage switching by adults who are not yet ready, or have tried and failed, to quit use of tobacco products entirely,” the company wrote in its ANPRM submission to the FDA.
From there, Juul proceeded to describe how its device works and the potential health benefits it presents smokers who are looking for an alternative to combustible cigarettes. The company mentions how the FDA itself has acknowledged to some degree how ENDS are potentially less harmful than combusted cigarettes. It gets into how flavors have been shown to play a role in helping adult smokers switching to ENDS like Juul. The company references research that shows that adult smokers made the switch to e-cigarettes due to the variety of flavors available to them and how many opted for non-tobacco flavors to use with their ENDS. The variety of flavors prevented many smokers from going back to combustible cigarettes, the company says.
“Juul Labs is planning future research in this area, which will drill down on which user demographics favor certain flavors and provide a stronger understanding of whether any flavors might be particularly attractive to adult vs. non-adult users,” the company revealed in its submission.
Juul advises the FDA conduct more research on flavors before issuing a categorical restriction. It also warns that regulating or restricting flavors could have an negative consequence such as creating a gray market, as happened following Ontario’s menthol cigarette ban.
“If FDA chooses to restrict the use of menthol in combusted tobacco, in order to transition menthol smokers to potentially less harmful products, flavors should be continued to be allowed in alternative products as an “off-ramp,” as was seen after menthol cigarettes were banned in Ontario,” advised Juul in its submission.
Among Juul’s other suggestions were to use the premarket submissions and the ingredient listing process to evaluate flavors on a product-by-product basis, focus resources on youth access and youth-orientated marketing, and to consider science-based purity standards for ENDS flavor ingredients.