The United States is currently facing a flood of unauthorized, often flavored, disposable e-cigarettes, with the vast majority originating from manufacturing hubs in China. Despite a regulatory framework designed to control the market and protect youth, a complex and often brazen supply chain has emerged, leveraging a network of U.S.-based middlemen – including customs brokers and obscure distribution companies – to navigate import hurdles and place these illegal products onto store shelves nationwide. A deep dive into customs data, regulatory filings, and industry insights reveals a shadow economy operating in plain sight, posing significant challenges for federal enforcement agencies and public health officials alike.
Read moreTag Archive for: FDA
The U.S. Food and Drug Administration (FDA) has released six updated or new forms required for submitting new tobacco product applications through the Premarket Tobacco Product Application (PMTA) and Substantial Equivalence (SE) pathways. Effective July 6, 2025, all applicants must use these revised forms for their submissions. The agency stated that failure to use the latest versions or complete them properly will generally result in the FDA refusing to accept the application.
Read moreFDA Admin. Makary’s comments on youth vaping clash with data & Trump’s pledge to “save vaping,” raising doubts about flavored e-cigarette policy.
Read moreThe U.S. Food and Drug Administration (FDA), in collaboration with U.S. Customs and Border Protection (CBP), announced the seizure of nearly two million units of unauthorized e-cigarette products in Chicago, carrying an estimated retail value of $33.8 million. The operation, which took place in February of this year, aimed to intercept and prevent illegal e-cigarettes from entering the U.S. market.
Read moreAcross the country, flashy and highly publicized conventions are showcasing an endless array of products that are not only illegal under federal law but also dangerous, addictive, and targeting America’s youth. At a recent expo in Miami, a dazzling display of e-cigarettes, or vapes, featured a wide range of enticing flavors, from Banana Taffy and Blueberry Milk to Gummy Rush and Tropical Gush.
Read moreOn Wednesday(April 03/2025), the U.S. Supreme Court largely supported the Food and Drug Administration’s (FDA) decision to deny two e-cigarette companies, Triton Distribution and Vapetasia, the right to sell flavored vape products that regulators consider a health risk to youth. The unanimous ruling, authored by Justice Samuel Alito, overturned a lower court’s decision that the FDA had failed to follow proper legal procedures under the Administrative Procedure Act when rejecting the companies’ applications.
Read moreThe FDA’s recent leadership overhaul continues to send shockwaves through the agency, leaving a critical leadership vacuum and raising concerns about its ability to fulfill its mission of ensuring public health. On April 01, the FDA’s chief tobacco regulator, Brian King, was placed on administrative leave, marking the latest chapter in a sweeping purge that has affected multiple departments within the agency. The restructuring has particularly targeted the FDA’s tobacco division, which has been a focal point of debate over policies regarding vaping and e-cigarette regulation.
Read moreA recent study co-authored by the U.S. Food and Drug Administration (FDA) has revealed a remarkable decline in e-cigarette use among American youth, with the number of middle and high school students currently using e-cigarettes falling to its lowest level in a decade. The study, published in the peer-reviewed scientific journal “American Journal of Preventive Medicine,” found that the FDA’s youth e-cigarette prevention campaign, “The Real Cost,” played a significant role in this reduction.
Read moreThe United States Food and Drug Administration (FDA) has made significant strides in the fight against tobacco-related harm by authorizing the marketing of various smoke-free alternatives to conventional cigarettes. In January 2025, the FDA authorized 20 ZYN nicotine pouch products, recognizing their potential to present a lower risk of cancer and other health conditions compared to traditional cigarettes.
Read moreThe U.S. Food and Drug Administration (FDA) has updated Import Alert 98-06 for the year 2025. This update emphasizes that all new tobacco products, particularly snus and nicotine pouches, that have not undergone the required premarket review process may be detained without physical examination upon entry into the United States.
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