Tag Archive for: FDA

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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FDA Authorized E-Cigarette List: What’s Really Included?(Updated January 2025)

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The FDA recently released a downloadable one-page list of vaping products authorized for legal sale in the United States. Intended as a resource for retailers, the list purportedly includes “34 tobacco-flavored e-cigarettes and devices” granted marketing orders as of January 2025.

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FDA Proposes Reduction in Nicotine Levels for Cigarettes

The U.S. Food and Drug Administration (FDA) has issued a groundbreaking proposed rule that, if finalized, would significantly reduce the level of nicotine in cigarettes and certain other combusted tobacco products. The goal is to make these products minimally or nonaddictive, potentially saving countless lives and reducing the immense burden of smoking-related disease and death in the United States.

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Federal Agencies Seize $7M+ in Unauthorized E-Cigarettes in Miami

In a joint operation, the Food and Drug Administration (FDA), U.S. Homeland Security Investigations, and U.S. Customs and Border Protection seized more than 628,000 unauthorized e-cigarette products from a warehouse in Miami. The seized products, valued at over $7 million, primarily consisted of flavored, disposable e-cigarettes, including the popular Geek Bar brand.

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All Unauthorized E-Cigarettes May Be Detained Without Physical Examination

The U.S. Food and Drug Administration (FDA) has announced updates to two import alerts, 98-07 and 98-06, on January 3, 2025. These revisions aim to separate imported e-cigarette products from other tobacco products and provide more precise instructions to FDA staff, federal partners, and the trade community, including importers, customs brokers, and filers.

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FDA Adds 10 Chinese E-cigarette Companies to Import “Red List”

The U.S. Food and Drug Administration (FDA) has updated its import alert, known as the “Red List,” which empowers U.S. Customs and Border Protection to detain potential vaping products without physical examination. The updated list includes 13 additional e-cigarette manufacturers and distributors, with 10 of them being Chinese companies.

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FDA Warns 14 Online Retailers for Selling Illegal Flavored Vapes

In a recent development, the U.S. Food and Drug Administration (FDA) has issued warning letters to 14 online retailers for selling unauthorized vape products that have gained significant popularity among youth. The warning letters, announced on May 1, specifically target disposable e-cigarette products marketed under well-known brand names such as Elf Bar/EB Design, Esco Bars, Funky Republic, Hyde, Kang, Cali Bars, and Lost Mary.

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Florida Bill Requires Vape Makers to Note No FDA Approval

A new Florida bill (SB 1006) would mandate all nicotine product manufacturers clearly state on packaging that their vaping devices have not received regulatory approval from the U.S. Food and Drug Administration (FDA). The state Senate Appropriations Committee on Agriculture, Environment and General Government unanimously passed the proposed legislation on February 21st. Read more