FDA recently issued final guidance regarding the initiation of voluntary product recalls and its related suggestions on how to be “recall ready.” The guidance – covering voluntary recalls of food, drugs, devices, biological products, cosmetics, and tobacco – emphasizes the importance of a company’s recall readiness at all stages of a product’s distribution chain and provides companies with suggested measures to prepare for and implement voluntary recalls. It also advises companies on best practices for working with FDA to initiate a timely voluntary recall.
On October 12, 2021, the U.S. Food and Drug Administration (“FDA”) issued orders granting R.J. Reynolds (RJR) Vapor Company approval to market three of its electronic nicotine delivery system (ENDS) products – the Vuse Solo ENDS e-cigarette and accompanying tobacco-flavored pods. In issuing the orders, FDA found “that the marketing of these products is appropriate for the protection of public health.” However, FDA also stated that its orders do not mean “these products are safe or ‘FDA approved.’” See FDA Permits Marketing of E-Cigarette Products, Marking First Authorization of Its Kind by the Agency | FDA.
Although ENDS products, such as e-cigarettes, have been on the market since the mid-2000s, this is the first time FDA has authorized the marketing of specific ENDS products through the Premarket Tobacco Product Application pathway.
While various states and municipalities grapple with how to address the proliferation of e-cigarette or vaping product use associated lung injury (EVALI) and the related uptick in e-cigarette use among young people, Massachusetts has taken a drastic measure to protect its residents. On September 24, 2019, Massachusetts became the first state to ban the sale of all vaping products after Governor Charlie Barker issued an emergency order that took effect immediately and would remain in effect for four months. The Order states:
“The sale or display of all vaping products to consumers in retail establishments, online and through any other means, including all non-flavored and flavored vaping products, including mint and menthol, including tetrahydrocannabinol (THC) and any other cannabinoid, is prohibited in the Commonwealth.”