Citing “epidemic levels of youth use of e-cigarettes and the popularity of certain products among children,” the US Food and Drug Administration (FDA) banned fruit- and mint-flavored vaping products yesterday. The rule, known as Enforcement Priorities for Electronic Nicotine Delivery Systems (ENDS), is due to go into effect within 30 days. This comes on the heels of the new Tobacco 21, legislation raising the minimum age of sale of tobacco to 21.
Factors Leading to FDA Flavored Vape Ban
Spurring this move by the FDA were results from the 2019 National Youth Tobacco Survey (NYTS) revealing that more than five million US middle and high school students are e-cigarette users “with a majority reporting cartridge-based products as their usual brand.”
The health impact on youth who vape is vast. Rose Marie Robertson, MD, group deputy chief science and medical officer of the American Heart Association (AHA), told the Journal of American Medical Association (JAMA), “We’ve known for a long time that combustible cigarettes are bad for your health, and it’s not just lung cancer and chronic obstructive pulmonary disease and other kinds of pulmonary problems. It is, in fact, heart disease as well—atherosclerosis, arrhythmias, sudden cardiac death, atrial fibrillation. Many cardiovascular problems are related to the use of combustible cigarettes. We now have three Surgeon General’s reports that make that case very clearly.”
Menthol and Tobacco Flavors to Follow?
Mitch Zeller, director of the FDA’s Center for Tobacco Products, addressed concerns over youth possibly migrating to menthol and tobacco flavors that are not under the ban on CNBC’s Squawk Box today. Zeller stated that the FDA will revisit the ENDS policy’s inclusion of these products in the future.
At a recent congressional hearing, the Centers for Disease Control and Prevention’s (CDC) Principal Deputy Director, Dr. Anne Schuchat, said a flavor ban should include menthol.
US Department of Health and Human Services (HHS) Secretary Alex Azar said in a statement, “By prioritizing enforcement against the products that are most widely used by children, our action today seeks to strike the right public health balance by maintaining e-cigarettes as a potential off-ramp for adults using combustible tobacco while ensuring these products don’t provide an on-ramp to nicotine addiction for our youth.”
What ENDS Means for Tobacco Distributors
The FDA put e-cigarette distributors on notice with these stipulations:
“Beginning 30 days from the publication of the notice of availability of this guidance in the Federal Register, the FDA intends to prioritize enforcement against these illegally marketed ENDS products by focusing on the following groups of products that do not have premarket authorization:
- Any flavored, cartridge-based ENDS product (other than a tobacco- or menthol-flavored ENDS product);
- All other ENDS products for which the manufacturer has failed to take (or is failing to take) adequate measures to prevent minors’ access; and
- Any ENDS product that is targeted to minors or likely to promote use of ENDS by minors.
Cartridge-based ENDS products are a type of ENDS product that consists of, includes, or involves a cartridge or pod that holds liquid that is to be aerosolized when the product is used. For purposes of this policy, a cartridge or pod is any small, enclosed unit (sealed or unsealed) designed to fit within or operate as part of an ENDS product.”
FDA Commissioner Stephen M. Hahn, MD said in a statement, “As we work to combat the troubling epidemic of youth e-cigarette use, the enforcement policy we’re issuing today confirms our commitment to dramatically limit children’s access to certain flavored e-cigarette products we know are so appealing to them – so-called cartridge-based products that are both easy to use and easily concealable. We will continue to use our full regulatory authority thoughtfully and thoroughly to tackle this alarming crisis that’s affecting children, families, schools and communities.”