News & Analysis as of

Enforcement Actions Federal Food Drug and Cosmetic Act (FFDCA) Regulatory Requirements

Troutman Pepper Locke

Are State ENDS Directories Preempted? Federal Courts Are Split

Troutman Pepper Locke on

Over the past two years, at least 15 states have enacted laws requiring manufacturers of electronic nicotine delivery systems (ENDS) to certify the status of their federal premarket tobacco product applications (PMTAs) in...more

Gardner Law

LDT Rule Vacated: FDA Backs Down, but Uncertainty Remains

Gardner Law on

In December 2024, we published an alert highlighting the FDA’s final rule on Laboratory Developed Tests (LDTs) and the compliance countdown to May 2025. The rule, issued in May 2024, sought to phase out the agency’s...more

Proskauer - Health Care Law Brief

DOJ Targets Gender‑Affirming Care under FDCA and FCA: Scrutinizes Off‑Label Drug Use and False Diagnosis Codes

Last month, the United States Department of Justice (“DOJ”) issued its “Civil Division Enforcement Priorities” memorandum, memorializing a shift from its predecessor administration’s policy on gender‑affirming healthcare...more

Troutman Pepper Locke

FDA and CBP Seize Nearly $34M Worth of Illegal E-Cigarettes in Joint Operation

Troutman Pepper Locke on

In the first major enforcement action involving the importation of illegal tobacco products by the new administration, and on the heels of the appointment of the new acting director of the U.S. Food and Drug Administration...more

Beveridge & Diamond PC

FDA Food Chemical Regulation: Understanding Pesticide Action Levels

The U.S. Food and Drug Administration’s (FDA) March 2025 publication of its new “Chemical Contaminants Transparency Tool” spotlighted a lesser-known aspect of FDA’s regulation of pesticide residues on food: action levels....more

Axinn, Veltrop & Harkrider LLP

Compounding Problems: Recent Decisions on Tirzepatide Highlight Interplay Between FDA Anti-Compounding Enforcement and Private...

Earlier this month, a federal district court denied the Outsourcing Facilities Association’s preliminary injunction motion, which sought to preclude FDA from taking enforcement action against compounded tirzepatide...more

Morgan Lewis - Well Done

The Future of Artificial Colors in the US Food Supply Is Not So Bright

Only weeks after being confirmed, the Department of Health and Human Services (HHS) secretary has advised food companies to remove artificial colors from their food products. He recently met with several major food brand...more

Harris Beach Murtha PLLC

GLP-1 Weight-Loss Drugs Off Shortage List; Deadlines to Stop Compounding

Glucagon-like peptide-1 agonists, a class of medications known as GLP-1s, have grown in popularity, initially for the treatment of type 2 diabetes and more recently for obesity and other labeled and off-label indications for...more

Sheppard Mullin Richter & Hampton LLP

FDA’s Semaglutide Shortage Resolution: Legal Implications and Risks for Compounding Pharmacies

Last month, the U.S. Food and Drug Administration (the “FDA”) announced in a Declaratory Order the resolution of the shortage of semaglutide injection products Wegovy and Ozempic (the “February Declaratory Order”). On March...more

Mintz - Health Care Viewpoints

FDA’s Backup LDT Enforcement Method: Specimen Collection Kits

We have written at length about the U.S. Food and Drug Administration’s (FDA’s) actions to promulgate regulations specifying the agency’s authority to regulate laboratory developed tests (LDTs) as medical devices and to phase...more

Foley & Lardner LLP

Compounded GLP-1 Drugs: Texas Judge Denies PI Motion and Request for Stay of FDA’s Declaration that Tirzepatide Shortage is...

Foley & Lardner LLP on

On March 5, 2025, one U.S. District Court ruled unequivocally in the Food & Drug Administration’s (FDA) favor in the case, Outsourcing Facilities Ass’n, et. al. v. U.S. Food and Drug Admin., et. al., 4:24-cv-0953-P, slip op.,...more

Fox Rothschild LLP

End of Semaglutide Shortage Means Big Changes for Prescribers and Compounders

Fox Rothschild LLP on

On February 21, the FDA announced that the shortage of semaglutide injection products has been resolved. Semaglutide has appeared on the FDA’s Drug Shortage List since 2022 because demand for the drug exceeded the available...more

DLA Piper

FDA Bans Red Dye No. 3 Under the Delaney Clause

DLA Piper on

The US Food and Drug Administration (FDA) has revoked its authorization for the use of FD&C Red No. 3, also known as Red Dye No. 3. Issued on January 15, 2025, the ban will go into effect for food (including dietary...more

Ropes & Gray LLP

2024 FDA Enforcement Review: Quality and Transparency Remain Critical Concerns

Ropes & Gray LLP on

The U.S. Food and Drug Administration (“FDA”), in partnership with the Department of Justice (“DOJ”), pursued significant and, in some cases, precedent-setting enforcement actions in 2024. The government continued to...more

Clark Hill PLC

Red Dye No 3: Old Data Induces New Ban

Clark Hill PLC on

On January 16, 2025 the federal Food and Drug Administration (FDA) issued notice requiring manufacturers to reformulate their products removing Red Dye No. 3 by January 15, 2027 for food (21 CFR §74.303) and January 18, 2028...more

DLA Piper

Certain DSCSA Deadline Extensions Set to Eclipse in 2025

DLA Piper on

The Drug Supply Chain Security Act (DSCSA) (section 582 of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 USC §360eee – 1) was introduced in response to several drug contamination, counterfeiting, and diversion...more

Sheppard Mullin Richter & Hampton LLP

FDA Gets Technical on HCT/P Rules in Warning Letter to Human Tissue Company

On May 21, 2024, the Center for Biologics Evaluation and Research (CBER) at the U.S. Food and Drug Administration (FDA) published a warning letter issued to Akan Biosciences, Inc. (Akan) for unresolved inspection observations...more

Hogan Lovells

First company receives FDA violation notice for ClinicalTrials.gov submission omission

Hogan Lovells on

On April 27, 2021, the U.S. Food and Drug Administration (FDA) issued its first Notice of Noncompliance to a company for failing to submit required clinical trial summary results information to ClinicalTrials.gov. In...more

Hogan Lovells

Recent FDA Warning Letters focus on inadequate allergen controls following undeclared allergen recalls

Hogan Lovells on

The U.S. Food and Drug Administration (FDA) recently issued a fifth Warning Letter related to allergen labeling, continuing a series of Warning letters in the past six months that cite companies for failing to “identify and...more

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