Washington A case concerning the Food and Drug Administration’s denial of approval for flavored e-cigarettes due to public health concerns will be heard by the Supreme Court on Monday.
At a time when e-cigarettes, or vapes, have taken over the market, the case calls into question the FDA’s authority to approve new tobacco products.
Flavored vaporizer manufacturers have challenged FDA rulings in a number of cases across the nation.
The FDA won the majority of those cases, but after losing one in the 5th U.S. Circuit Court of Appeals in New Orleans, it filed an appeal with the Supreme Court.
The judges are debating whether the FDA violated the Administrative Procedure Act, a federal law, by failing to appropriately evaluate the company’s requests.
The case centers on issues raised by Vapestasia, which has applied for approval for flavors like Iced Pineapple Express and Killer Kustard Blueberry, and Triton Distribution, which produces e-liquids for vape pens with vibrantly named flavors like Signature Series Mom’s Pistachio and Suicide Bunny Mother’s Milk and Cookies.
Because they may encourage youth tobacco use, the FDA has repeatedly refused to approve flavored vapes, citing potential health risks. Despite this, the items are nonetheless widely accessible.
The companies claim the FDA made a mistake and that flavored vapes can help people quit smoking. They might face civil and criminal fines for promoting products without clearance.
Their attorneys contend that without providing applicants with sufficient notice, the FDA altered its criteria for evaluating flavored vapes in the middle of the procedure.
According to the organization, each application is assessed based on its merits. “They failed to support their claims with sufficient evidence in any form,” Solicitor General Elizabeth Prelogar wrote in court documents condemning the two corporations’ motions.
The FDA has the authority to regulate tobacco products under the Tobacco Control Act, with a particular emphasis on youth. However, it didn’t start regulating vape products until 2016, after they were already available for purchase. At the time, the FDA stated that it would refrain from pursuing enforcement measures while businesses applied for approval.
It later came to the conclusion that the possible advantages of aiding adult smokers in quitting do not exceed the possible health hazards to youth, who are especially drawn to vapes with non-tobacco flavors.
E-cigarettes with menthol and tobacco flavors have both received FDA approval.
When President-elect Donald Trump begins his second term in office, the agency will be well-known. Robert F. Kennedy Jr., a vaccine skeptic, has been nominated by Trump to lead the Department of Health and Human Services, which includes the FDA, as part of his commitment to overhaul the healthcare system.
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