Here’s a puzzle: You can sue FDA to challenge a decision on a Citizen Petition, because it is final agency action. See 21 C.F.R. § 10.45(d). Courts have held that you ordinarily cannot sue FDA to challenge Warning Letters, because they generally do not rise to the …
As prosecutions for manufacturing and distributing counterfeit drugs continue to rise with enhanced investigatory tools and federal statutes (see DEA’s recent announcement on “Operation Meltdown”), courts are grappling with how to fashion appropriate sentences. Last week, the Sixth Circuit Court of Appeals affirmed the 90-month …
Monday was an eventful day for the parties and practitioners alike who are closely following the ongoing legal challenges to FDA’s attempt to impose civil penalties on businesses alleged to be selling unauthorized e-liquid tobacco products. The day included oral arguments at the Fifth Circuit …
On January 27, 2026, the Department of Health and Human Services (“HHS”) Office of Inspector General (“OIG”) issued a Special Advisory Bulletin addressing direct-to-consumer (“DTC”) prescription drug programs. These DTC programs allow cash-paying patients, including those enrolled in Federal health care programs such as Medicare …
Hyman, Phelps & McNamara, P.C. Director Kalie E. Richardson will be moderating a Food and Drug Law Institute webinar this coming Wednesday on Ensuring Effective Responses to FDA 483s and Warning Letters. This webinar will cover fundamental considerations for responding to FDA 483s and Warning …
On December 18, 2025, the U.S. Food and Drug Administration (FDA or the Agency) published clarification on its enforcement approach under the Modernization of Cosmetics Regulation Act of 2022 (MoCRA) with the release of a draft guidance titled “Questions and Answers Regarding Mandatory Cosmetics Recalls: …
On December 16, CDRH issued 12 Warning Letters to manufacturers and retailers of breast binders. The Warning Letters were posted on FDA’s website 2 days later. According to the Warning Letters, the products offered by these companies are intended to compress breast tissue and create …
At this point in 2024, there were countless unknowns about how the medical device industry would be impacted in 2025. Did the year unfold as you expected? Did your company prepare for impacts to the foreign supply chain? Did you predict the government was going …
A few months ago, we blogged about a Texas U.S. District Court’s Wulferic ruling that FDA’s civil monetary penalty (CMP) provision for tobacco products contained at 21 U.S.C. § 333(f)(9) is unconstitutional under the Seventh Amendment and SEC v. Jarkesy, 603 U.S. 109 (2024). Wulferic, LLC …
Hyman, Phelps & McNamara, P.C. (HPM) is hosting a complimentary webinar, titled “Medical Device Update, 2025 Year in Review.” The webinar is scheduled for December 10, 2025 (11:00am to 12:00pm ET). Don’t miss this essential briefing. Our experts will unpack the year’s top FDA regulatory changes, …
Hyman, Phelps & McNamara, P.C. (“HPM”) Director Larry Houck will moderate “New Rules, New Risks: Inside the Changing World of Federal Inspections” at the Food and Drug Law Institute’s Enforcement, Litigation, and Compliance Conference in Washington, D.C., December 4-5, 2025. The session will explore the …
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 …
On October 3, 2025, FDLI published an article analyzing Warning Letters (WLs) issued since January 9, 2020 by Hyman, Phelps & McNamara P.C.’s Véronique Li and Jeff Gibbs. The in-depth analysis identified posting and issuance patterns, the length of time between milestone activities such as the …
On September 26, 2025, the Department of Commerce published a notice requesting public comment on “an investigation to determine the effects on the national security of imports of personal protective equipment (PPE), medical consumables, and medical equipment including devices.” 90 Fed. Reg. 46383 (Sept. 26, …
In a case involving international horse-doping conspiracies, racetracks, and state horse racing regulators, the Second Circuit expanded the application of the FDC Act’s felony provisions. There are two forms of criminal penalties for violations of the FDC Act contained in 21 U.S.C. § 333(a): a strict …
