E-cigarettes have been on the market for almost a decade, but controversy continues to surround the devices, which were first pitched as a smoking cessation tool but eventually led to an epidemic level of use among underage consumers. Now, the FDA has given the first market authorization to an e-cigarette—R.J. Reynold’s Vuse—as a way to help smokers quit. But the agency, which says this does not mean the product is “FDA-approved,” also denied a request to sell flavored pods for the device. And it imposed strict marketing regulations on the company, including digital advertising restrictions in order to greatly reduce the potential for youth exposure to these products. Industry leaders say this is a good sign that the FDA doesn’t intend to drive e-cigarette makers out of business, while also being careful about allowing products that target young people, amid an epidemic of youth vaping. The FDA hasn’t yet ruled on products from former market leader Juul, and continues to deny pre-market requestions from thousands of applications from potential c-cigarette makers.
Meanwhile, the American Heart Association is not mincing words about its position on e-cigarettes: it calls on the FDA to reject all the remaining pre-market tobacco applications for flavored products, regulate synthetic nicotine, and prohibit the sale of any flavored tobacco product. It also called on states to pass laws and policies that remove flavored tobacco products, including menthol, from the market. The Heart Association was responding to a recent survey that found that more than 80 percent of high school and middle school students who vape prefer flavored products, as well as a preference for disposable products that those with synthetic tobacco—both of which are not under FDA jurisdiction.
And finally, a clinical trial has begun of the first potential opioid vaccine in humans. The trial, at Columbia University, will first test the safety and efficacy of a vaccine designed to trigger the patient’s own immune system to develop antibodies to the target: if the individual uses opioids, for example, the antibodies would bind to it and prevent it from getting to the brain. The vaccine would not prevent cravings for the drug, but it could serve as an added layer of protection for people at high risk.