On March 9, 2026, the FDA’s Center for Tobacco Products issued new draft guidance for flavored ENDS PMTAs. The directive mandates a higher evidentiary burden for fruit and dessert flavors, requiring manufacturers to definitively prove adult cessation benefits outweigh youth initiation risks to secure legal US market authorization.
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The U.S. Food and Drug Administration continues its cautious approach to the vaping market by licensing a new age-gated device while maintaining strict limits on non-tobacco flavors.
Read moreThe Food and Drug Administration (FDA) has officially signaled a strategic shift in its vaping enforcement, opening the door for e-cigarette flavors that appeal specifically to adults. In a document released Monday, the agency proposed authorizing vapes in mint, coffee, tea, and spice profiles (such as cinnamon or clove), while maintaining a strict ban on the fruit and candy flavors that fueled the youth “epidemic.” This move aims to provide “safer nicotine alternatives” for adult smokers while addressing the 70% market share currently held by illicit, unregulated Chinese suppliers.
Read moreThe U.S. Food and Drug Administration (FDA) has released a new two-page handout designed to clarify the oversight process for e-cigarette and vape products introduced to the U.S. market on or after February 15, 2007. Acknowledging the complexity of these regulations, the FDA emphasizes that the primary responsibility lies with manufacturers and importers to secure authorization before selling their products.
Read moreOver the last decade, the U.S. Food and Drug Administration (FDA) has faced mounting criticism for its regulatory stance on vaping, particularly its aggressive policing of flavored products. Critics argue this approach has created a “regulatory moat” that inadvertently protects the combustible cigarette market while leaving adult smokers with fewer, less appealing alternatives to quit. The result, they say, is a thriving gray market for unregulated vapes and a missed opportunity for public health.
Read moreThe U.S. Food and Drug Administration (FDA) has introduced fully web-based versions of four key regulatory forms for premarket tobacco product applications (PMTAs) and Substantial Equivalence (SE) Reports. This update to the CTP Portal Next Generation (CTP Portal NextGen) allows manufacturers to complete, validate, and submit Forms FDA 4057, 4057a, 3965, and 3965a entirely online.
Read moreA new law banning the sale of non-FDA approved vaping products went into effect across Mississippi on December 1st. Following the passage of House Bill 916, all vape shops and retailers were required to remove unauthorized products, primarily targeting disposable vapes and flavored juices, from their shelves. Retailers had been given a 60-day grace period since October to comply.
Read moreAs part of a continuing resolution passed by Congress and signed by President Donald Trump on November 12th, the U.S. Food and Drug Administration (FDA) is now mandated to allocate at least $200 million towards enforcing regulations on electronic nicotine delivery systems (ENDS). This funding, drawn from the FDA’s user fees, aims to significantly bolster efforts against illegal vape products, particularly those imported from China and other countries.
Read moreThe Acting Director of the U.S. Food and Drug Administration’s (FDA) Center for Tobacco Products (CTP), Bret Koplow, has signaled a potential shift in the agency’s approach to tobacco control, expressing support for a “tobacco harm reduction” strategy to lower cigarette smoking rates. Speaking at the Food and Drug Law Institute (FDLI) conference, Koplow stated he “carefully supports” the potential for expanding the range of authorized flavored e-cigarettes.
Read moreThe U.S. Food and Drug Administration (FDA) has launched a new nationwide initiative aimed at compelling hundreds of thousands of retailers to stop selling illegal vaping products. The campaign is designed to combat the youth vaping crisis and increase “voluntary compliance” among businesses like vape shops, convenience stores, and gas stations by providing clear information on which products are legal to sell.
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