Supreme Court affirms FDA's authority to review flavored e-cigarettes

Key points to focus on:

The Supreme Court sends SWT case back for retrial: The court made a summary judgment on the lawsuit between the FDA and SWT Global Supply Inc. and sent it back to the Fifth Circuit Court of Appeals, citing a ruling made three weeks ago in the FDA v. Wages and White Lion case. 

Court affirms FDA's authority to review flavored e-cigarettes: The court ruled that the FDA's stricter scrutiny of products that may appeal to minors, such as flavored e-cigarettes, based on a 2020 notice, is a legitimate exercise of administrative power. 

Three cases dismissed, FDA victorious: The Supreme Court declined to hear the cases of Magellan, Logic, and Lotus, upholding the decisions of the Second, Third, and Ninth Circuit Courts of Appeals, confirming the FDA's authority to reject relevant market applications. 

Companies involved in the SWT case: The case involves five companies: SWT Global Supply Inc., Cloud House LLC, Paradigm Distribution, SV Packaging LLC, and Vaporized Inc. Previously, the Fifth Circuit Court of Appeals ruled that the FDA's actions were unlawful, but that ruling has now been overturned. 

According to a report by Law360 on April 22, the U.S. Supreme Court made decisions on Monday, April 21, in five cases related to the entry of flavored e-cigarettes into the market: one case was sent back for retrial, three cases had their appeals dismissed, and the overall outcome favored the FDA, further confirming its authority to review applications for e-cigarette market approval.

The court issued an order stating that, in the case of FDA v. SWT Global Supply Inc., it has decided to grant a writ of certiorari and a summary disposition, and will remand the case to the Fifth Circuit Court of Appeals in accordance with the unanimous decision in the FDA v. Wages and White Lion Investments LLC case three weeks ago.

In its ruling, the Supreme Court determined that the FDA's rejection of e-cigarette product market applications that may appeal to minors did not constitute "arbitrary action," as it had already informed applicants in 2020 that flavored e-cigarettes would undergo stricter scrutiny.

Regarding the other three cases:

• Magellan Technology Inc. filed a case against the FDA in the Second Circuit Court of Appeals. 
• Logic Technology Development LLC filed a case against the FDA in the Third Circuit Court of Appeals. 
• Lotus Vaping Technologies LLC filed a case against the FDA in the Ninth Circuit Court of Appeals. 

The Supreme Court has decided not to hear the case, effectively upholding the original ruling and affirming that the FDA's actions were legal and that there was no "surprise switcheroo" in the review standards.

The FDA previously stated that among the numerous cases related to the review standards for flavored e-cigarettes, the Wages and White Lion case was most suitable as a representative case to handle legal disputes. The ruling in this case also served as a key basis for the remand of the SWT case for further review.

The SWT Global Supply case originated from a decision made by the Fifth Circuit Court of Appeals in 2023. The court ruled at that time that the FDA's rejection of market applications from five companies, including SWT, was "illegal." These five companies are:

• SWT Global Supply Inc.
• Cloud House LLC
• Paradigm Distribution
• SV Packaging LLC
• Vaporized Inc.

The FDA has requested the Supreme Court to review the ruling in October 2023. Following the judgment in the Wages and White Lion case, the FDA has asked the court to wait for the outcome of that case before deciding whether to accept the SWT case. The Supreme Court has ultimately accepted the FDA's request and will refer the case back to the Fifth Circuit Court of Appeals for further handling.