Tobacco control groups condemn the FDA’s Vuse approval.
WASHINGTON — Tobacco control groups including the Campaign for Tobacco Free-Kids announced that it still condemns the approval of a vaping product despite the federal Food and Drug Administration’s (FDA) endorsement for such a product type.
“While it is a positive step that FDA denied applications for 10 flavored Vuse e-cigarettes, it is concerning that a product that has three times the nicotine concentration as legally permitted in Canada, the UK, and Europe was authorized,” said Matthew L. Myers, the president of the Campaign For Tobacco-Free Kids.
“Vuse products with this level of nicotine leave our nation’s youth at an undue risk of addiction,” Myers said added in the statement.
Vaping Post previously reported that the PMTA approval of the Vuse vaping platform and its e-liquids was first for the industry.
“We must remain vigilant with this authorization and we will monitor the marketing of the products, including whether the company fails to comply with any regulatory requirements or if credible evidence emerges of significant use by individuals who did not previously use a tobacco product, including youth. We will take action as appropriate, including withdrawing the authorization,” said FDA Center for Tobacco Products director Mitch Zeller in a press release published on Oct. 12.
“The American Lung Association is dismayed that FDA will permit three Vuse products to remain on the market in the U.S., including products that contain almost 5% nicotine,” adds Jill Dale, a spokesperson for the American Lung Association. “The harm these products cause to youth shows that they fail to meet the Tobacco Control Act’s public health standard.”
Karen E. Knudsen, the chief executive officer of the American Cancer Society Cancer Action Network, issued similar remarks.
“While we acknowledge the rigorous scientific process undertaken by the Food and Drug Administration to evaluate these products against the public health standard, we remain concerned about the potential implication for youth initiation and lifelong tobacco addiction to high nicotine concentration products,” Knudsen said.
“While the FDA has issued strict marketing restrictions in an effort to prevent youth exposure, the manufacturer of these authorized products, R.J. Reynolds, has an established track record of circumventing regulation to addict generation after generation of new customers,” she added in the same statement. “Continued post-market surveillance will be imperative to ensure the company complies with the regulation and further monitoring of extended use of these nicotine-containing products will be crucial to understand potential long-term health implications.”
Here’s a list of other groups reacting negatively to the Vuse approval:
- Gerald E. Harmon, American Medical Association President: “The AMA is deeply disappointed by the FDA’s action yesterday authorizing the marketing of RJ Reynolds e-cigarette products with high nicotine levels. With this action, the FDA risks hooking another generation of young people on tobacco products. Since declaring e-cigarette use and vaping an urgent public health epidemic in 2018, the AMA has pushed for more stringent policies to protect young people from the harmful effects of tobacco and nicotine use, and we will not stop. With that clear danger front and center, the solution is simple, and that is why we have called for an immediate ban on all e-cigarette and vaping products from the market. Allowing this product into the marketplace signals that it’s safe, and nothing could be further from the truth.”
- Steve Weiss, American Heart Association spokesperson: “The FDA’s authorization of Vuse Solo in tobacco flavor will require continued vigilance on purchasing patterns and youth uptake and utilization. We must ensure youth don’t gravitate to tobacco-flavored e-cigarettes, enabling the tobacco industry to sustain the nicotine epidemic.”
- Lee Savio Beers, American Academy of Pediatrics President: “The Food and Drug Administration’s (FDA) decision yesterday to authorize the Vuse Solo e-cigarette to be legally sold in the United States is highly concerning. It is the first e-cigarette product authorized by FDA and is alarmingly the second most popular e-cigarette brand used by children. It’s [the] FDA’s job to protect the health and safety of children, but with products such as this on store shelves, pediatricians are greatly concerned that young people will continue to fall victim to nicotine addiction.”