The average nicotine concentration in e-cigarettes sold in U.S. The Vuse Solo authorized by FDA contains a 4.8% nicotine level similar to other popular brands among youth, including JUUL, and is more than double the level allowed in other countries like the UK, the EU, and Canada. The decision does not address nicotine levelsĭisappointingly, FDA’s decision on Vuse Solo keeps a high-nicotine product on the market and does nothing to address the issue of high nicotine content or nicotine delivery. Here is a closer look at key concerns about the FDA’s first e-cigarette authorization and the impact it may have on future decisions. Serious concerns also remain about youth use, which is still at epidemic levels, and the burden a new generation of nicotine users may face with the challenges of addiction, for themselves and society. However, the Vuse Solo authorization suggests the FDA considers the use of both e-cigarettes and combustible tobacco acceptable when we know that “cutting down” is not an effective harm reduction strategy and that dual use can inhibit attempts to fully quit smoking.
The Surgeon General has stated that there is no safe use of combustible tobacco. This is an important distinction: reduced exposure and reduced harms are not the same thing, meaning exposure to fewer toxic ingredients, especially in the context of dual use of both e-cigarettes and combustible products, does not necessarily mean lower levels of harm when people use the product. The decision, which does not mean the products are safe or “FDA approved,” indicates that the agency determined tobacco-flavored Vuse Solo has potential to benefit public health by helping smokers transition to a product that reduces their exposure to harmful ingredients. It is perplexing that FDA chose to issue its first authorization for a product with very minimal sales, but delayed taking action on a “sister” product with significant market presence. However, FDA has yet to complete PMTA reviews from the largest companies with the most popular products that make up over 75% of the e-cigarette market, including Vuse Alto. On Septemthe FDA finally faced a court-ordered deadline to review millions of premarket applications (known as PMTAs) from e-cigarette manufacturers to determine whether the products are “appropriate for the protection of public health.” The move to authorize Vuse Solo comes after the agency denied the applications of nearly a million flavored products. The authorization of Vuse Solo also permits it to be marketed fairly broadly, including via online sales, TV, digital and social paid advertising, the use of influencers and at youth-centric live events – tactics that are restricted for cigarette and smokeless tobacco brands.Į-cigarettes have been allowed to stay on the market for years without undergoing a review of their public health impact, sparking a sustained and ongoing epidemic of youth use. 2 e-cigarette brand used by high school students), high nicotine levels, and whether these products will help smokers quit combustible cigarettes.
The decision raises important concerns about continued youth use (Vuse, presumably the popular Alto version, is the no. Vuse Alto, the brand most competitive to market leader JUUL, accounts for nearly 95% of Vuse sales and remains on the market without FDA authorization. While this action marks a step forward in the long-delayed review of e-cigarettes, it’s important to note that Vuse Solo has no significant market share, according to Nielsen sales data as of June 2021. Reynolds, can continue to be sold in tobacco flavor, but it denied 10 unspecified Vuse Solo flavors and made no decision on its menthol e-cigarette.
In its first authorization of an e-cigarette product, the Food and Drug Administration announced that Vuse Solo, made by R.J.
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