E-Cigarette Makers Face Looming Deadline To Obtain FDA Approval For Vaping Products
A deadline is fast-approaching for manufacturers of e-cigarettes to obtain FDA approval for their products, leaving a number of companies scrambling to keep their vaping products on the market, according to a new report by Convenience Store News.
In August 2016, the U.S. Food and Drug Administration (FDA) published their final e-cigarette guidance in the Federal Register, claiming regulatory responsibility of all Electronic Nicotine Delivery Systems (ENDS), which includes e-cigarettes, vaping products, and all liquids used with the devices.
The guidance classified ENDS devices as tobacco products, allowing the FDA to take control of an unregulated market, which gained national attention due to a series of problems including exploding lithium ion batteries and the illegal marketing of tobacco products targeting teens and adolescents.
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As a result of the action, the FDA mandated that all new nicotine based products go through premarket tobacco product applications (PMTAs) pursuant to the Tobacco Control Act that was passed in February 2007.
Manufacturers that fail to submit their PMTAs by the deadline will be prohibited from selling their products on the U.S. market, and be required to remove all of their vaping products from the market before this deadline. Manufacturers and stores that fail to comply with these standards will be subject to penalties assigned by the FDA.
In July 2019, a U.S. District Court in Maryland ordered that applications for deemed tobacco products, such as e-cigarettes, cigars, pipe tobacco, and hookah tobacco, that were on the market as of August 8, 2016, must be submitted to FDA no later than May 12, 2020. However, due to the ongoing COVID-19 pandemic, the deadline was extended in April through September 9, 2020.
By the deadline, manufacturers are required to submit for approval on how they intend to market their products in a way that discourages teen and underage use. The guidance also calls for manufacturers to provide details on how they intend to prevent lithium ion batteries used in e-cigarettes from exploding.
To date, several major ENDS manufactures have submitted their PMTAs, some for the second or third times, according to the CSNews.com report on August 17.
One of the largest brand names submitting for approval is JUUL Systems, which currently faces more than 600 lawsuits, some of which claiming the manufacturer mined the middle and high school environments with easily concealable USB-like vaping products containing a highly addictive nicotine salt formulation in an effort to make life-long customers out of children.
JUUL has reportedly submitted detailed scientific data from more than 110 studies that includes more than 125,000 pages evaluating the product’s impact on current users and those exposed to secondhand exposure. The research submitted also includes data and strategies oriented towards preventing youth and teenager first use.
Among other major retailers that have submitted PMTAs to the FDA are Reynolds American Inc., Fontem US LLC, E-Alternative Solutions, 511 Solutions LLC and Altria Group Inc.
The FDA announced it will evaluate the data and scientific information provided in the applications to determine whether the products are appropriate for the protection of public health. If approved the FDA will issue a Marketing Order Letter to authorize the continued marketing and sale.
The aggressive actions taken by the FDA over the last several years are in response to the rapid growth in e-cigarette use, with ENDS becoming the most popular form of tobacco, specifically among teens.
Recent data has shown youth nicotine use jumping 78% from 2017 to 2018, according to the FDA. In 2011, when the FDA first said it would regulate e-cigarettes, only 1.5 percent of teens vaped, but now more than one-third of teens use e-cigarettes as they have become increasingly popular among all age ranges.
The Centers for Disease Control and Prevention (CDC) found nearly 14% of middle school students, and 38% of high school students reported having used e-cigarettes. Among use in the last 30 days from when the survey was taken, five percent of middle schoolers and 16% of high school students reported having used vaping devices.
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