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We were unable to process your request. Please try again later. If you continue to have this issue please contact customerservice@slackinc.com. Back to Healio Key takeaways: The FDA authorized the marketing of four non-tobacco vapes. The vapes require age verification that is \u201cexpected to effectively mitigate\u201d usage among youth. The FDA for the first time authorized the marketing of non-tobacco and non-menthol electronic nicotine delivery system products for adults, the agency announced. The two non-tobacco and non-menthol vape products are gold and sapphire. According to a press release from Campaign for Tobacco-Free Kids, gold is mango flavor and sapphire is blueberry.
The FDA authorized the marketing of four non-tobacco vapes. Image: Adobe Stock
The FDA also authorized two menthol vape products \u2014 classic menthol and fresh menthol. The vapes were authorized via the FDA\u2019s premarket tobacco product application pathway. They contain 50 mg\/mL, or 5%, of tobacco-derived nicotine, according to an FDA press release. \u201cBy helping to prevent youth use, device access restrictions are a potential game changer,\u201d Bret Koplow, PhD, JD, acting director of the FDA\u2019s Center for Tobacco Products, said in the release. \u201cThis technology is also an indication of the role innovation may serve in the effort to protect young people from threats posed by nicotine use and addiction while helping to enable availability of an expanded array of flavored options for adults who smoke who may use these products to completely switch away from regular cigarettes.\u201d The FDA said that its \u201crigorous, scientific review\u201d of the products manufactured by Glas, Inc. \u201cfound that the applicant sufficiently demonstrated that Glas\u2019s device access restriction technology, combined with FDA-required marketing restrictions, is expected to effectively mitigate the ability of youth to use the product.\u201d The manufacturer\u2019s technology \u201crequires the user to verify their age and identity with a government-issued ID and pair the device with a smartphone via Bluetooth,\u201d the release said. \u201cFollowing verification, the device will not operate if separated from the phone. The app also conducts random biometric check-ins to periodically confirm the registered user is the one using the device.\u201d The FDA also said that Glas was able to demonstrate that most adults aged 21 years or older successfully verified their age and found the vapes\u2019 instructions and age verification software easily understandable \u201cwhile youth and young adults could not.\u201d \u201cWith these orders, the FDA confirms the availability of an additional way for demonstrating that a non-tobacco flavored product meets the public health standard by using effective age-gating,\u201d the release said. \u201cIt remains the case that a non-tobacco flavored product may be authorized where the application demonstrates its benefit in helping adults quit cigarette smoking outweighs its potential risks.\u201d E-cigarettes are usually less harmful vs. cigarettes, the FDA previously told Healio. However, e-cigarettes have been tied to several conditions, including elevated BP and hypertension, peptic ulcer disease, lung cancer and asthma. The FDA said the authorization requires Glas to ensure the vapes\u2019 advertising, promotion and marketing is \u201ccarefully targeted\u201d at adults aged 21 years or older while also tracking, measuring and reporting to the FDA the effectiveness of its prevention measures aimed at youth. The agency said it could suspend or withdraw its authorization if the vapes\u2019 marketing is \u201cis no longer appropriate for the protection of the public health,\u201d which could include a rise in usage among youth or if the products\u2019 benefits no longer outweigh their risks. Steven Kelder, PhD, MPH, a professor of epidemiology at the University of Texas Health Houston School of Public Health, told Healio that \u201cone of things that\u2019s very clear is that teens like flavors. That\u2019s one of the primary causes about why they\u2019re curious about them, and when they\u2019re curious, they try them, and when they try them enough times, they get addicted. That\u2019s my concern.\u201d \u201cI\u2019ve been hearing for decades now that adults need fruit flavors or they\u2019re just not going to use vapes. The evidence doesn\u2019t support that. If someone\u2019s addicted to nicotine, they\u2019re going to use nicotine,\u201d Kelder said. \u201cPhysicians should know that there are risks in using vapes in terms of CVD and cancer. Vaping is less harmful, there\u2019s no doubt about it, but they\u2019re not harmless and the biggest harms fall on the kids. Why take a risk on these new flavors when its unnecessary.\u201d Editor\u2019s note: The story was updated on May 7 to clarify that the recently authorized vape products include two menthol products and two fruit-flavored products. Perspective Back to Top All tobacco products are harmful and can addict consumers, and it is important to emphasize that market authorization does not mean that these products are \u201csafe\u201d or even \u201cFDA approved.\u201d The FDA should consider stronger actions to reduce the accessibility, addictiveness and appeal of all tobacco and nicotine products \u2014 actions like a ban on non-tobacco flavors, including menthol, which would still enable access to tobacco-flavored vapes for adults who smoke and want to quit, while eliminating the wide variety of flavors, including fruit flavors, that we know appeal to young people. The FDA is clear that all tobacco products are harmful and have the potential to addict consumers, which is why kids and people who never used tobacco or nicotine should never start. Health care professionals have a unique role in educating individuals on the addictiveness of all tobacco products and the risks of tobacco use, regardless of whether a product has received authorization. It is critical that regulators, scientists and health care professionals remain vigilant and ensure that e-cigarettes are only used by adults who smoke and are trying to quit. Lauren Czaplicki, PhD, MPH Johns Hopkins Bloomberg School of Public Health
Disclosures: Czaplicki reports receiving research funding through the NIH and Bloomberg Philanthropies\u2019 Bloomberg Initiative to Reduce Tobacco Use.
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