Tag Archive for: FDA

Supreme Court Backs FDA’s Denial of Flavored Vape Applications

On 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.

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FDA Faces Leadership Shake-Up: Major Staff Cuts and Departures Shake Health Agency’s Stability

The 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.

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Youth E-Cigarette Use Falls to Lowest Level in a Decade, FDA Study Reveals

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A 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.

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FDA Authorizations for Smoke-Free Alternatives Advance Tobacco Harm Reduction

The 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.

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FDA Updates Import Alert 98-06 for 2025: Reinforcing Restrictions on Unauthorized Tobacco Products

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The 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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Tennessee Vape Bill Proposing FDA Approval Requirement and 10% Tax Faces Industry Pushback

Tennessee legislators have introduced a bipartisan bill that would fundamentally transform the state’s vaping industry, sparking intense debate and forcing a one-week delay on the House committee vote originally scheduled for March 3rd.

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Tennessee Bill Requiring FDA Compliance for Vape Shops Passes Committee

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The Tennessee Legislature is considering a bill that would significantly impact vape shops across the state. The proposed legislation, sponsored by Representative David Hawk in the House and a corresponding bill in the Senate, would ban all non-Food and Drug Administration (FDA) compliant products. The bill recently passed a committee, moving it one step closer to becoming law.

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Supreme Court Weighs FDA’s Power to Regulate Vaping Products

Key Takeaways

  • The Supreme Court heard arguments on Monday regarding the FDA’s power to prohibit the sale of new candy-colored vaping products targeting teenagers.
  • Most justices, both conservative and liberal, indicated that Congress granted the FDA authority in 2009 to prevent the sale of new tobacco products, which the agency has recently used to reject new vaping flavors appealing to youth.
  • The vaping industry argued that the FDA overregulated and surprised companies by demanding new studies proving their products would persuade adult smokers to switch to e-cigarettes. However, several justices questioned this claim.

Background

In recent years, the FDA has used its authority to reject the sale of new vaping products with flavors like “Rainbow Road” and “Peachy Strawberry,” which are seen as particularly appealing to teenagers. The agency aims to balance persuading adult smokers to quit by switching to e-cigarettes while preventing millions of teenagers from starting to use nicotine products.

Supreme Court Arguments

During Monday’s Supreme Court hearing, most justices seemed to lean in favor of the FDA’s view. Justice Brett M. Kavanaugh questioned the vaping industry’s claim of FDA overregulation, suggesting that their objection lies with the law itself granting the agency discretion. Justice Elena Kagan agreed, stating that the dangers of these flavors for kids starting to use smoking products are well-known and the FDA has been transparent about this issue.

The Biden administration defended the FDA’s position, with Justice Sonia Sotomayor emphasizing that the statute is clear in requiring companies to demonstrate their product will help adults stop smoking cigarettes while not encouraging youth to start.

However, some conservative justices voiced support for the industry. Justice Clarence Thomas said the FDA’s regulations set a “moving target,” while Justices Samuel A. Alito Jr. and Neil M. Gorsuch expressed similar skepticism.

Potential Impact and Future Developments

It remains unclear if the court’s ruling in the coming months will settle the controversy. The attorney for the vaping companies pointed to the incoming administration of President-elect Donald Trump, who has stated his intention to “save flavored vapes,” adding uncertainty to the FDA’s future approach.

Justice Kavanaugh noted that the companies will be free to reapply for approval. Additionally, the practical impact of the FDA’s disapproval is questionable, as many unapproved e-cigarette flavors remain widely available.

Conclusion

The Supreme Court’s decision in this case will have significant implications for the FDA’s ability to regulate new vaping products and protect public health, particularly among teenagers. While the justices’ questions during the hearing seemed to favor the FDA’s position, the final ruling and its consequences remain to be seen. Businesses in the vaping industry and public health advocates alike will be closely watching the outcome of this case.

Vaping Industry Faces Turmoil Under FDA and Trump

The $22 billion global vaping industry is already embroiled in a complex battle involving regulators, Big Tobacco, and startups. With Donald Trump’s return to the White House, the market is poised to become even more chaotic. The industry, which thrives on innovation and consumer demand, faces increasing scrutiny from the FDA and state-level crackdowns on unauthorized products.

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Supreme Court Navigates Vape-Venue Dispute as Tobacco and Vape Manufacturers Challenge FDA

The Supreme Court recently heard arguments in a case involving tobacco and vape manufacturers battling the Food and Drug Administration (FDA) over the agency’s denial of marketing authorization for flavored e-cigarette products. While these companies have found little success in most appeals courts, they have enjoyed modest victories in the Fifth Circuit, which covers Louisiana, Mississippi, and Texas, and is widely regarded as the most conservative court in the country.

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