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The U.S. Food and Drug Administration (“FDA”) published marketing denial orders on June 23, 2022, effectively calling for the halt of sales and the removal of Juul vaping products from American shelves. Juul will likely appeal the order, and it remains to be seen as to whether the company or its retail partners will voluntarily remove Juul products from store shelves during the appeal process, which could take several months or longer.
Pursuant to the Family Smoking Prevention and Tobacco Control Act (“Act”), the FDA, through the Center for Tobacco Products, has the authority to regulate tobacco products. The definition of tobacco products expanded as vaping has become more popular, initially changing to capture vaping products and the devices, while more recently brining synthetic nicotine under the FDA’s regulatory purview. While the Act preserves some state regulatory powers over tobacco products, one of the Act’s provisions requires the FDA to perform premarket review for new and modified risk tobacco products to protect the public health.
The standard under which the FDA evaluates tobacco products differs from the FDA’s traditional “safe and effective” evaluation standard used in the medical context, as there are no “safe” tobacco products. Instead, the FDA evaluates tobacco products by using a public health standard that balances the risks and benefits of the product. Generally, vaping products, classified as electronic nicotine delivery systems, or “ENDS”, attempt to gain FDA approval by claiming that the ENDS product improves smoking cessation and does not increase youth tobacco product use. Currently, the FDA uses the Premarket Tobacco Product Application (“PMTA”) as the vehicle to determine whether a tobacco product satisfies the FDA’s public health concerns.
In October 2021, the FDA issued authorized the marketing of one set of ENDS products through the PMTA process, the Vuse unit and its tobacco flavored e-liquid pods, determining that the product may benefit adult smokers who switch to the Vuse product. The FDA denied the PMTA of other flavors of e-liquids. The Juul denial demonstrates a shift in FDA policy amid calls for tighter regulation of tobacco products, particularly focused youth use of ENDS. Given the recent approval of the Vuse system, the Juul Order may have come as a surprise to the industry.
The Juul Order is issued in the wake of increased regulation at the state level. While some states have outright banned the sale of flavored e-liquids, in Florida, similar bills have failed to pass the Legislature. Instead, Florida recently required retailers to either hold a Retail Tobacco Product Dealer permit or a Retail Nicotine Product Dealer permit by amending chapter 569, Florida Statutes, to define nicotine products and nicotine dispensing devices, require the regulation of such products by the Division of Alcoholic Beverages and Tobacco, and to preempt the ability to regulate the marketing, sale, or delivery of such products to the State.