Latest news with #SignatureSeriesMom'sPistachio
Yahoo
02-04-2025
- Business
- Yahoo
Supreme Court rules for the FDA in flavored vapes dispute
WASHINGTON — The Supreme Court on Wednesday handed a win to the Food and Drug Administration over its refusal to approve flavored e-cigarettes. The court threw out an appeals court ruling that found the agency unlawfully changed the rules in the middle of proceedings when it was deciding whether to approve various products. With e-cigarettes, or vapes, more popular than ever, the case put the FDA's role in the approval process under scrutiny. Despite the agency's refusal to approve many products, flavored vapes have remained widely available. Writing for a unanimous court, conservative Justice Samuel Alito stopped short of ruling definitively that the FDA had acted unlawfully on one particular aspect of the case: whether the agency should have considered the companies' marketing plans as part of the approval process. That issue will now be decided by the lower court. But Alito said that the FDA's decisions were otherwise sound, noting that the companies' own applications are "strong evidence that regulated entities had adequate notice of the sort of comparative analysis the FDA anticipated." The FDA, then under the Biden administration, appealed to the Supreme Court after the New Orleans-based 5th U.S. Circuit Court of Appeals ruled that it had incorrectly handled the approval requests made by manufacturers, thereby violating the federal Administrative Procedure Act. The agency has won similar cases in other courts. Triton Distribution, which makes e-liquids for vape pens with flavors like Signature Series Mom's Pistachio and Suicide Bunny Mother's Milk and Cookies, is one of the companies involved. The other is Vapestasia, which has sought approval for Iced Pineapple Express, Killer Kustard Blueberry and other flavors. The FDA has said flavored vapes pose a health risk because they could encourage young people to use tobacco. The companies could face potential civil and criminal penalties for marketing products without approval. They argued the FDA got it wrong in denying the approvals, saying that flavored vapes can be used to help people stop smoking. Their lawyers said the FDA changed its standard for considering flavored vapes in the middle of the process without giving applicants adequate warning. The agency responded in court that it evaluates each application on its merits and that the companies had failed to provide sufficient evidence for their claims. The FDA began regulating vape products in 2016 after they were already on the market. At the time, the agency said it would not take enforcement actions while companies sought approval. It subsequently concluded that the potential benefits of helping adult smokers quit do not outweigh the potential health risks to young people, who are most attracted to nontobacco-flavored vapes. The FDA has given its approval to menthol-flavored e-cigarettes, as well as some that are tobacco-flavored. This article was originally published on
New York Times
02-04-2025
- Business
- New York Times
Supreme Court Rules Against Makers of Flavored Vapes Popular With Teens
The Supreme Court ruled on Wednesday that the Food and Drug Administration had acted lawfully in rejecting applications from two manufacturers of flavored liquids used in e-cigarettes with names like Jimmy the Juice Man Peachy Strawberry, Signature Series Mom's Pistachio and Suicide Bunny Mother's Milk and Cookies. In a unanimous decision written by Justice Samuel A. Alito Jr., the justices upheld an F.D.A. order that prohibited retailers from marketing flavored tobacco products. The court rejected claims that the agency had unfairly switched its requirements during the application process. Justice Alito wrote that the agency's denials of the applications were 'sufficiently consistent' with agency guidance on tobacco regulations. The justices rejected a ruling by the U.S. Court of Appeals for the Fifth Circuit that the agency had acted arbitrarily and capriciously, finding that the F.D.A. had not tried to change the rules in the middle of the approval process. A 2009 law, the Family Smoking Prevention and Tobacco Control Act, requires makers of new tobacco products to obtain authorization from the F.D.A. According to the law, the manufacturers' applications must demonstrate that their products are 'appropriate for the protection of the public health.' The agency has denied many applications under the law, including the two at issue in the case before the justices, saying the flavored liquids presented a 'known and substantial risk to youth.' The appeals court ruled last year that the agency had changed the rules in the middle of the application process, accusing it of 'regulatory switcheroos' that sent the companies 'on a wild-goose chase.' More formally, the court said the agency's actions had been arbitrary and capricious. In asking the Supreme Court to hear the case, Food and Drug Administration v. Wages and White Lion Investments, No. 23-1038, the agency's lawyers cited another appeals court that had reached the opposite conclusion. The Fifth Circuit's decision 'has far-reaching consequences for public health and threatens to undermine the Tobacco Control Act's central objective of 'ensuring that another generation of Americans does not become addicted to nicotine and tobacco products,'' they wrote, quoting from the other appeals court's decision.
NBC News
02-04-2025
- Business
- NBC News
Supreme Court rules for the FDA in flavored vapes dispute
WASHINGTON — The Supreme Court on Wednesday handed a win to the Food and Drug Administration over its refusal to approve flavored e-cigarettes. The court threw out an appeals court ruling that found the agency unlawfully changed the rules in the middle of proceedings when it was deciding whether to approve various products. With e-cigarettes, or vapes, more popular than ever, the case put the FDA's role in the approval process under scrutiny. Despite the agency's refusal to approve many products, flavored vapes have remained widely available. Writing for a unanimous court, conservative Justice Samuel Alito stopped short of ruling definitively that the FDA had acted unlawfully on one particular aspect of the case: whether the agency should have considered the companies' marketing plans as part of the approval process. That issue will now be decided by the lower court. But Alito said that the FDA's decisions were otherwise sound, noting that the companies' own applications are "strong evidence that regulated entities had adequate notice of the sort of comparative analysis the FDA anticipated." The FDA, then under the Biden administration, appealed to the Supreme Court after the New Orleans-based 5th U.S. Circuit Court of Appeals ruled that it had incorrectly handled the approval requests made by manufacturers, thereby violating the federal Administrative Procedure Act. The agency has won similar cases in other courts. Triton Distribution, which makes e-liquids for vape pens with flavors like Signature Series Mom's Pistachio and Suicide Bunny Mother's Milk and Cookies, is one of the companies involved. The other is Vapestasia, which has sought approval for Iced Pineapple Express, Killer Kustard Blueberry and other flavors. The FDA has said flavored vapes pose a health risk because they could encourage young people to use tobacco. The companies could face potential civil and criminal penalties for marketing products without approval. They argued the FDA got it wrong in denying the approvals, saying that flavored vapes can be used to help people stop smoking. Their lawyers said the FDA changed its standard for considering flavored vapes in the middle of the process without giving applicants adequate warning. The agency responded in court that it evaluates each application on its merits and that the companies had failed to provide sufficient evidence for their claims. The FDA began regulating vape products in 2016 after they were already on the market. At the time, the agency said it would not take enforcement actions while companies sought approval. It subsequently concluded that the potential benefits of helping adult smokers quit do not outweigh the potential health risks to young people, who are most attracted to nontobacco-flavored vapes. The FDA has given its approval to menthol-flavored e-cigarettes, as well as some that are tobacco-flavored.
