Last week FDA publicly posted the first Quality Management System Regulation (QMSR) Warning Letter and this week it posted the second. The QMSR went into effect in February of this year. For months, we have seen the top 483 citations shift in FDA’s inspection database …
On June 24, 2026, the Fifth Circuit denied a petition brought by VDX Distro (VDX), an e-cigarette company, asking the court to review FDA’s decision to reject marketing authorization for its e-cigarette products. See VDX Distro, Inc. v. FDA, No. 24-60537 (5th Cir. 2026). By way …
No company wants to be on the receiving end of a Warning Letter, which is FDA’s primary tool for communicating to a company that it has been found to be in significant violation of regulatory requirements. Typically, a company who receives a Warning Letter must …
At the end of June, HHS Secretary Robert F. Kennedy told a House congressional committee that he would like to see all Americans make use of wearable products, such as Apple Watch, Oura Rings, Fitbits, and WHOOP, to “take control of their health.” Less than …
On May 6, 2025, FDA announced that it planned to conduct more surprise inspections at foreign manufacturing facilities that produce foods, essential medicines, and other medical products intended for U.S. consumers. The stated goals are to ensure that “foreign companies will receive the same level …
Last week, the Supreme Court issued a unanimous decision in FDA v. Wages & White Lion Investments, LLC, No. 23-1038 (Apr. 2, 2025) that affirms FDA’s denial of authorization to market flavored vape products. This opinion, which overrules a Fifth Circuit decision that FDA had …
On January 21, 2025, the Trump administration withdrew FDA’s proposed ban on menthol cigarettes, which the Biden administration initially introduced in 2022. This move is the latest step in FDA’s long, uncertain, and controversial journey to ban menthol cigarettes. For some background (which is covered in …
During the final week of the Biden administration, on January 15, 2025, FDA issued a proposed rule that, if finalized, would establish a maximum nicotine level in cigarettes and other combusted tobacco products, including most cigars and pipes, through its authority under Section 907 of …
