Trump Administration Supports a Ban on Flavored Vape Products
On September 11th, 2019, the Trump Administration announced that, after six deaths and 450 vape related illnesses, it intends to issue a finalized guidance in the coming weeks which will amend the FDA’s enforcement policies regarding flavored vape products. The guidance would remove unauthorized flavored vape products from the market.
Health and Human Services Secretary Alex Azar noted, “[t]he Trump Administration is making it clear that we intend to clear the market of flavored e-cigarettes to reverse the deeply concerning epidemic of youth e-cigarette use that is impacting children, families, schools and communities….We will not stand idly by as these products become an on-ramp to combustible cigarettes or nicotine addiction for a generation of youth.”
The administration’s announcement comes on the heels of recent survey data from the National Youth Tobacco Survey which show a substantial rise in the rates of youth e-cigarette use. According to the FDA’s announcement, “the preliminary data show that more than a quarter of high school students were current (past 30 day) e-cigarette users in 2019 and the overwhelming majority of youth e-cigarette users cited the use of popular fruit and menthol or mint flavors.”
Until now, FDA has not been enforcing pre-market tobacco product authorization requirements for vape products which were already on the market when the “deeming rule” was issued on August 8th, 2016. This new finalized guidance would change that enforcement policy. Thus, the new policy would clear “the market of unauthorized, non-tobacco-flavored e-cigarette products.”
What the guidance would not do is issue a tobacco product standard under Section 907 of the Food Drug and Cosmetic Act. Under Section 907, the FDA can issue specific standards for tobacco products. For instance, FDA issued a tobacco product standard under Section 907 for flavored cigarettes, eliminating them from the market. This is not to say FDA will not issue a tobacco product standard for flavors in vape products in the future. In 2018, FDA issued a request to relevant stakeholders to provide information on flavors in tobacco products, including vape products.
Vape product manufacturers who produce flavored products should expect the FDA to enforce its premarket tobacco product rules from the date of the issuance of a new policy guidance. However, this does not mean that vape product manufacturers are prohibited from submitting a PMTA for a flavored tobacco product in the future.
What is not clear, however, is the link between the recent health scare and flavors in tobacco products. On September 6th, FDA issued an announcement to consumers that they should avoid THC containing vape products – which may be the cause of recent health problems. In response to the confusion over whether vape products containing THC or nicotine were causing illness, Gregory Connolly, President of the American Vaping Association stated, “[e]ach day of this crisis brings more evidence that street vapes containing THC or other illegal drugs are responsible for these illnesses, not nicotine vaping products.” Connolly went on to note that “[i]t is incredibly irresponsible for media outlets and health authorities to continue to focus on vaping products generally when we know that tainted, black market THC products remain on the streets. We continue to call on the CDC and FDA to not only promptly investigate these incidents, but also act to ensure that adult smokers know that nicotine vaping products remain a far safer alternative to smoking.”
If you currently market flavored vape products or would like additional information about how to respond to the recent announcement, feel free to contact us for a free consultation at (909)635-6588.