On May 1, 2026, the House Committee on Appropriations submitted House Report 119-632 to accompany H.R. 8646—the Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act for Fiscal Year 2027, which passed on June 4, 2026. The report serves as the Committee’s …
On June 15, 2026, the U.S. Food and Drug Administration (FDA) issued a Warning Letter to Happiest Baby, Inc., the manufacturer of the SNOO Smart Sleeper bassinet system, following a July 2025 inspection of the company’s Los Angeles facility. The Warning Letter highlights several key …
We have written on this blog about FDA’s modernization agenda from several angles lately—from the psychedelics Executive Order to the peptide compounding landscape (part 1, part 2)—but here is a storyline that cuts to the operational heart of regulated industry (or at least appears to): FDA …
It’s been a month since DOJ announced the “first-ever Department-wide corporate enforcement policy” for criminal matters. Touted as a means of “promoting uniformity, predictability, and fairness” in how DOJ pursues white-collar cases against corporate defendants, the new “Corporate Enforcement and Voluntary Self-Disclosure Policy” (CEP) sets …
If you’ve been tracking FDA’s international presence, you know FDA has been through a bit of a roller coaster over the past decade. After consolidating from 13 foreign offices down to 8 between 2012 and 2014—and losing its Pretoria, South Africa office in 2015—the Agency …
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, …
