E-cigarette companies have until Dec. 12 to respond to issues raised by the Food and Drug Administration (FDA) or be forced to stop selling sweet electronic cigarette flavored tobacco pods, which are alternatives to cigarettes called E-cigarettes or “vapes.”
Regulators claim they contain addictive nicotine and can have negative effects on brain development on youth.
The FDA gave a 60-day deadline on Sept. 12 to five major e-cigarette manufacturers: figure out how to limit advertising and sales of flavored tobacco pods to minors or be forced to take them off the market.
The products being targeted are JUUL, Altria Group Inc.’s MarkTen, Fontem Ventures BV’s blu, British American Tobacco Plc’s Vuse and Logic. These companies make up more than 97 percent of the U.S. market for e-cigarettes, the FDA reports.
The FDA ultimatum comes after it focused on the sale of JUUL this spring. JUUL, a pocket-sized device that looks like a USB drive, is popular among minors.
The FDA issued 56 warning letters and six civil monetary penalties to retailers selling JUUL. And it “sharply expanded our enforcement against retailers who illegally sell e-cigarettes to kids,” FDA Commissioner Scott Gottlieb said.
The FDA maintains that products initially designed to help adults ease off of smoking cigarettes has become “an epidemic” among minors and youth. In response, it launched a Youth Tobacco Prevention Plan earlier this year focusing on three key objectives: preventing youth from accessing tobacco products, curbing the marketing of tobacco products aimed at youth, and educating teens about the dangers of using any tobacco products.
In the meantime, convenience stores and gas stations are banned from selling flavors other than tobacco, mint and menthol, and stricter age-verification requirements for online e-cigarette sales have been implemented.
Those that don’t comply will come under the scrutiny of “the largest single enforcement action in agency history,” Gottlieb said, which is aimed at retail and online sales of e-cigarettes to minors.
The FDA has already sent more than 1,100 warning letters to stores for the illegal sale of e-cigarettes to minors and 131 civil money penalties to stores that continue to violate the restrictions on sales to minors.
The FDA’s 499 page rule regulating the use and sale of tobacco products “is a death sentence to the vaping business and [isn’t something] the vaping business can work with,” Jim McDonald at Vaping360.com said. The advocacy organization calls the FDA rule “an attack on what we do and who we are, and vapers are right to feel mad and betrayed.”
The Truth Initiative, a tobacco-control group based in Washington, D.C., says the rule doesn’t go far enough. It wants flavored e-cigarettes immediately pulled from the market, according to statements made by its CEO Robin Koval.
Regulators made clear the purpose of the new restrictions on alternative tobacco devices is to reduce smoking rates and prevent minors from smoking through the enticing entry point of vaping.
The restrictions do not apply to vape shops or other specialty retail stores, which are more often used by adults who vape as a way to quit smoking. However, Liz Mair, a spokeswoman for Vapers United, called the plan an "ill-conceived and exceptionally dangerous move."
According to the FDA, the percentage of people who smoke cigarettes in the U.S. dropped to 14 percent in 2017, the lowest it’s ever been since records have been kept. Vaping was up by 75 percent over the last year, the FDA reports.
Still, Gottlieb’s challenge to e-cigarette manufacturers “to take equally bold action to reform their own practices” is a death knell, McDonald argues. “If your company’s name is Pfizer or Johnson & Johnson, your tobacco-derived nicotine is a safe, non-addictive medicine. If your name is Joe’s Vape Juice, you’re a producer of deadly addictive poison that is a menace to society.”