United States: On Monday, the U.S. Supreme Court discussed whether the Food and Drug Administration (FDA) wrongly denied approval for flavored e-cigarettes because of health concerns. The court’s justices debated if the FDA had unfairly changed its rules while reviewing the products. Two companies are challenging the FDA’s decision, saying they were not treated fairly during the process.
But it is still possible the court could find fault in the agency’s approach.
There is currently a conservative bench of six in the Supreme Court that has doubts more often than not regarding decisions made by federal agencies.
However, the court was deeply divided, and in another good omen for the FDA, the newest of the conservatives, Kavanaugh, appeared to side with the agency.
As reported by the NBC News, others were more cautious, questioning whether the FDA never made it clear to companies what kind of evidence would pass their muster when it comes to flavored vapes.
The case raises questions about the FDA’s oversight of new tobacco products just when vaping devices, or e-cigs, have proliferated in society.
Manufacturers of flavored vapes have filed several cases across the country against the FDA’s decisions.
While the FDA was involved in most of these trials, it went to the Supreme Court after it lost one of the trials in the 5th U.S. Circuit Court of Appeal, New Orleans.
The legal problem in front of the justices: Whether the FDA erred in the way it considered the companies’ petitions, contrary to the APA?
The case describes difficulties being encountered by Triton Distribution, an e-liquid manufacturer for vape pens with the flavored names such as Signature Series Mom’s Pistachio and Suicide Bunny Mother’s Milk and Cookies and Vape Stasia who applied for approval for Iced Pineapple Express, Killer Kustard Blueberry, among others.
The FDA has time and again rejected and/or has not approved flavored vapes since the same could potentially cause harm to the public’s health through its influence on the youth to take to tobacco. The products nevertheless have not disappeared and can be found on the market.
The companies that could be liable to civil and criminal fines for marketing products without the FDA okay, said the agency is wrong saying that flavored vape products should not be marketed because they have not received approval arguing that they can be used to quit smoking.
Their lawyers say that the FDA offered its procedure of reviewing the peach and applicable flavors then altered the manner by halting consideration of added taste halfway through the application process.