Over 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.
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The 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.
Read moreThe U.S. Department of Justice and the Food and Drug Administration (FDA) have announced the seizure of more than 2.1 million flavored e-cigarettes in a series of coordinated raids across seven states. This major operation is part of an intensified crackdown on unauthorized vaping products that are being sold without the required premarket authorization from the FDA.
Read moreThe U.S. Food and Drug Administration (FDA) is launching a new pilot program that will ease the research burden on nicotine pouch manufacturers, according to internal meeting transcripts reviewed by Reuters. This move is the first clear indication of a softer regulatory approach towards smoking alternatives under the Trump administration, potentially speeding up market access for major brands like Zyn, On!, and Velo.
Read moreFederal agents have conducted a nationwide series of raids on vape retailers and distributors, seizing over 4.7 million unauthorized e-cigarettes valued at more than $86.5 million. The operation, announced by Attorney General Pam Bondi and Health and Human Services (HHS) Secretary Robert F. Kennedy Jr., represents a significant escalation in the Trump administration’s crackdown on illegal vaping products.
Read moreThe U.S. Food and Drug Administration (FDA) is reportedly launching a pilot program to fast-track its review of nicotine pouches from four major tobacco firms: Philip Morris International (PMI), Altria, Reynolds American (part of British American Tobacco), and Turning Point Brands. According to meeting transcripts seen by Reuters, the program, which launched on Monday, aims to complete reviews of these products by December, a significant acceleration of a process that has previously taken years.
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