Tag Archive for: FDA

NJOY Sues FDA Over Flavored Vape Application Delays

NJOY LLC, a subsidiary of tobacco giant Altria Group, has filed a federal lawsuit against the U.S. Food and Drug Administration (FDA), accusing the agency of unlawfully delaying its review of applications to market flavored e-cigarettes. The lawsuit, filed on August 21, 2025, in the Western District of Louisiana, argues that the FDA’s inaction has effectively created a “de facto flavor ban” on NJOY’s products, hindering its ability to provide adult smokers with reduced-risk alternatives while allowing a flood of unauthorized, illicit flavored disposable vapes to dominate the U.S. market.

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FDA Denies Marketing for Blu Tobacco-Flavored Disposable Vape

The U.S. Food and Drug Administration (FDA) has denied marketing rights for the Blu disposable classic tobacco-flavored 2.4% nicotine e-cigarette, according to a recent agency announcement. The product, produced by Fontem US, cannot be legally marketed in the United States.

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FDA’s Failure on Vaping Fuels State-Level Confusion & Overreach

As state legislative sessions wind down for the year, adult vapers and users of other safer alternatives to combustible cigarettes are catching a brief respite from the relentless onslaught of new tax hikes and product restrictions. However, despite campaign-trail promises from figures like Donald Trump to protect flavored vapor products, the tools of tobacco harm reduction remain under increasing threat. This time, the primary driver is not just state-level action, but the U.S. Food and Drug Administration’s (FDA) persistent failure to regulate and authorize these products in a timely, transparent, and effective manner. This federal inaction has created a vacuum, leading to a chaotic patchwork of state laws that often undermine public health goals. What is urgently needed is a straightforward, science-based, top-down regulatory approach – starting with the FDA – to help the nearly 30 million American adults still using deadly combustible cigarettes transition to safer alternatives.

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FDA’s Juul Approval Sparks Outrage from Lawmakers

The U.S. Food and Drug Administration’s (FDA) recent decision to grant marketing authorization to several Juul Labs e-cigarette products has ignited sharp condemnation from leading Democratic lawmakers, who are calling the move a dangerous step backward in the fight against the youth vaping epidemic. U.S. Senate Democratic Whip Dick Durbin (D-IL) and Congressman Raja Krishnamoorthi (D-IL) both released scathing statements, accusing the FDA under the Trump administration of prioritizing “Big Tobacco” over children’s health and vowing to investigate the circumstances of the decision.

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FDA Authorizes Juul’s Tobacco and Menthol E-Cigarettes for US Market

The U.S. Food and Drug Administration (FDA) has officially authorized the sale of Juul Labs’ e-cigarette device and its tobacco and menthol-flavored refill cartridges, marking a significant reversal of its previous ban and a potential new lease on life for the once-dominant vape maker. The decision, announced on Thursday, ends a years-long regulatory battle that saw Juul accused of fueling a youth vaping epidemic and nearly pushed the company into bankruptcy.

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The Shadow Supply Chain: How Illegal Chinese Vapes Flood the U.S. Market

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.

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FDA Updates Tobacco & Vape Application Forms Starting July 6th

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.

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Trump Promised to ‘Save Vaping.’ Does His New FDA Head Agree?

FDA Admin. Makary’s comments on youth vaping clash with data & Trump’s pledge to “save vaping,” raising doubts about flavored e-cigarette policy.

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FDA & CBP Seize $34M Illegal E-Cigarettes in Chicago

The 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.

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Illegal Vapes Targeting Teens Openly Displayed at Public Expos

Across 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.

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