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 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.
Read moreThe 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.
Read moreKey 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.
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.
Read moreThe 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.
Read moreThe 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.
Read moreThe 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.
Read moreIn 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.
Read moreThe 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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