A Texas judge for the U.S. District Court for the Eastern District of Texas issued a ruling on March 31, 2025, to vacate and set aside, in its entirety, the U.S. Food and Drug Administration’s (FDA) Final Rule titled Medical...more
4/3/2025
/ Administrative Procedure Act ,
Centers for Medicare & Medicaid Services (CMS) ,
CLIA ,
Federal Food Drug and Cosmetic Act (FFDCA) ,
Final Rules ,
Food and Drug Administration (FDA) ,
Judicial Authority ,
Medical Devices ,
Regulatory Authority ,
Regulatory Requirements ,
Vacated
On February 20, 2025, U.S. Senators Dick Durbin (D-IL) and Roger Marshall, M.D. (R-KS) introduced bipartisan legislation, the Protecting Patients from Deceptive Drug Ads Act (the Act), which closes perceived “legal loopholes”...more
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
3/13/2025
/ Appeals ,
Drug Compounding ,
Enforcement Actions ,
Federal Food Drug and Cosmetic Act (FFDCA) ,
Food and Drug Administration (FDA) ,
Life Sciences ,
Pharmaceutical Industry ,
Pharmacies ,
Preliminary Injunctions ,
Prescription Drugs ,
Regulatory Requirements
The U.S. Food and Drug Administration (FDA) began 2025 with a resolution to make food “healthy” again by announcing a trio of new final and proposed rules that are intended to make it easier for consumers to identify healthy...more
2/21/2025
/ Compliance ,
Department of Health and Human Services (HHS) ,
Final Rules ,
Food and Drug Administration (FDA) ,
Food Labeling ,
Food Safety ,
Product Packaging ,
Proposed Rules ,
Public Health ,
Regulatory Agenda ,
Regulatory Requirements
The U.S. Food and Drug Administration (FDA) recently announced final guidance for firms in the medical device and product industry titled, “Communications From Firms to Health Care Providers Regarding Scientific Information...more
1/8/2025
/ Compliance ,
Enforcement ,
Federal Food Drug and Cosmetic Act (FFDCA) ,
Final Guidance ,
Food and Drug Administration (FDA) ,
Health Care Providers ,
Labeling ,
Life Sciences ,
Medical Devices ,
Pharmaceutical Industry ,
Prescription Drugs ,
Regulatory Requirements
On December 4, 2024, the U.S. Food & Drug Administration (FDA) released its Marketing Submissions for a Predetermined Change Control Plan (PCCP) for Artificial Intelligence-Enabled Device Software Functions (AI-DFS) final...more
On December 19, 2024, the U.S. Food and Drug Administration (FDA) issued a Declaratory Order reevaluating and re-confirming that the tirzepatide drug shortage has been resolved. This order revoked and replaced FDA’s October...more
On December 17, the U.S. Food and Drug Administration (FDA) issued Warning Letters to five companies offering various GLP-1 products, including Semaglutide, Tirzepatide, Retatrutide, Cagrilintide, Mazdutide, Survodutide, and...more
Brand companies who own GLP-1 products have been pushing the Food and Drug Administration (FDA) to limit their compounding. On August 28, 2024, Eli Lilly and Company submitted a nomination to request that its GLP-1 product,...more
Less than a week after the U.S. Food & Drug Administration (FDA) determined that the shortage of the tirzepatide injection, a glucagon-like peptide 1 (GLP-1) medication, has been “resolved” and removed from the FDA’s shortage...more
On October 2, 2024, the U.S. Food and Drug Administration (FDA) determined the shortage of the tirzepatide injection, a glucagon-like peptide 1 (GLP-1) medication, has been “resolved”. The tirzepatide injection had appeared...more
The enforcement trends of 2023 have continued into 2024, especially with respect to the U.S. Consumer Product Safety Commission (CPSC or Commission) and the U.S. Food and Drug Administration (FDA or Agency). Both have ramped...more
8/30/2024
/ Consumer Product Safety Commission (CPSC) ,
Consumer Product Safety Improvement Act (CPSIA) ,
E-Commerce ,
Enforcement ,
Food and Drug Administration (FDA) ,
Inspections ,
Litigation Strategies ,
Policies and Procedures ,
Regulatory Agenda ,
Regulatory Requirements ,
Reporting Requirements
The Supreme Court’s decision in June 2024 in Loper Bright Enterprises v. Raimondo and Relentless Inc. v. Department of Commerce to overrule the Chevron doctrine has major implications for every administrative agency,...more
On May 6, 2024, the U.S. Food and Drug Administration (FDA) issued its final rule significantly modifying FDA’s approach to oversight of laboratory developed tests (LDTs). The final rule is effective July 5, 2024....more
The U.S. Food and Drug Administration (FDA) recently doubled down on its January 26, 2023 position that existing regulatory pathways for foods and dietary supplements are not appropriate to manage the risks of cannabidiol...more
After formulating an exciting new healthy food or beverage, the packaging it comes in may feel like an afterthought. It should not be. Food packaging has become an increasingly hot topic among federal and state regulators,...more
3/15/2024
/ Beverage Manufacturers ,
Code of Federal Regulations (CFR) ,
Federal Food Drug and Cosmetic Act (FFDCA) ,
Food and Drug Administration (FDA) ,
Food Manufacturers ,
GRAS ,
Green Guides ,
PFAS ,
Product Packaging ,
Recycling ,
Sustainability
Healthy food and beverage (“F&B”) companies frequently use social media to advertise. When used appropriately, social media campaigns can be incredibly effective tools to help emerging F&B companies reach target consumers,...more
2/29/2024
/ Advertising ,
Corporate Branding ,
Disclosure Requirements ,
False Advertising ,
Federal Trade Commission (FTC) ,
Food and Drug Administration (FDA) ,
FTC Endorsement Guidelines ,
Influencers ,
Marketing ,
Popular ,
Risk Management ,
Scientific Evidence ,
Social Media ,
Targeted Digital Advertising ,
Transparency
Whether formulating a new food or developing a novel ingredient, a critical first step is understanding the regulatory framework for bringing a new ingredient (or a food containing a new ingredient) to the market. This...more
In the effort to enhance product quality and the integrity of the infant formula supply chain after contamination resulted in the 2022 baby formula shortage, Congress and the FDA took steps to ensure that infants and parents...more
In the world of healthy food and beverages, a crucial first step towards bringing a new product to the crowded U.S. market is identifying and understanding the regulatory authorities that oversee your product. This is not...more
11/30/2023
/ Advertising ,
Alcohol Beverage Control ,
Beverage Manufacturers ,
Federal Food Drug and Cosmetic Act (FFDCA) ,
Federal Meat Inspection Act (FMIA) ,
Federal Trade Commission (FTC) ,
Food & Drug Regulations ,
Food and Drug Administration (FDA) ,
Organic ,
TTB ,
USDA
On October 10, 2023, the U.S. Food and Drug Administration (FDA) issued a public warning regarding the potential health risks associated with compounded ketamine products. This warning follows a February 16, 2022 alert...more
After years of enforcement discretion, the U.S. Food and Drug Administration (FDA) published a proposed rule on October 3, 2023 under which the agency articulated its intent to increase regulatory oversight of laboratory...more
10/11/2023
/ Centers for Medicare & Medicaid Services (CMS) ,
CLIA ,
Emergency Use Authorization (EUA) ,
Federal Food Drug and Cosmetic Act (FFDCA) ,
Food and Drug Administration (FDA) ,
Healthcare ,
Laboratory Developed Tests ,
Medicaid ,
Medicare ,
Proposed Rules ,
Shareholders
In June 2023, the U.S. Food and Drug Administration (FDA) published final guidance (Guidance) on presenting risk and efficacy information for direct-to-consumer (DTC) promotional labeling and advertisements for prescription...more
9/12/2023
/ Advertising ,
Compliance ,
Direct to Consumer Sales ,
Final Guidance ,
Food and Drug Administration (FDA) ,
Labeling ,
Marketing ,
Over The Counter Drugs (OTC) ,
Pharmaceutical Industry ,
Prescription Drugs ,
Risk Factors
Industry insiders can all agree that the U.S. Food & Drug Administration (FDA) regulates the use of medical devices. Most insiders agree that a medical device is any instrument, apparatus, implement, machine, contrivance,...more
Decentralized Clinical Trials (DCTs) are clinical trials where some or all trial-related activities occur at locations other than traditional clinical trial sites, such as via telemedicine or in a clinical trial participant’s...more