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
The U.S. Department of Health and Human Services (HHS) and the Drug Enforcement Administration (DEA) have postponed the effective date of the final rule regarding telemedicine prescribing of buprenorphine (the final...more
3/26/2025
/ Comment Period ,
DEA ,
Department of Health and Human Services (HHS) ,
Final Rules ,
Health Care Providers ,
New Legislation ,
Prescription Drugs ,
Proposed Legislation ,
Regulatory Requirements ,
Telemedicine ,
Trump Administration
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
In the final days of the Biden administration, the Drug Enforcement Administration (DEA) released a proposed rule that would allow practitioners with a Special Registration to prescribe Schedule III-V, and in limited...more
1/22/2025
/ Compliance ,
Controlled Substances ,
Controlled Substances Act ,
DEA ,
Health Care Providers ,
Healthcare ,
Prescription Drugs ,
Proposed Rules ,
Regulatory Agenda ,
Regulatory Requirements ,
Ryan Haight Act ,
Telemedicine
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
Artificial intelligence (AI) has the power to revolutionize health care. In oncology, there are now opportunities to apply AI to support diagnostics, predictive analytics, and administrative functions.
This hot topic was...more
9/26/2024
/ Analytics ,
Artificial Intelligence ,
Best Practices ,
Compliance ,
Contract Terms ,
Due Diligence ,
Governance Standards ,
Health Care Providers ,
Healthcare ,
Information Security ,
Insurance Industry ,
Machine Learning ,
Medical Devices ,
Policies and Procedures ,
Popular ,
Privacy Laws ,
Regulatory Agenda ,
Regulatory Oversight ,
Reimbursements
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
Trademark disputes can be time-consuming and costly. By proactively assessing risks and taking steps to avoid infringement, emerging companies save time and money. At the crux of most trademark disputes is the claim that...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
Venture capital can be a vital source of funding and support for emerging companies in the healthy food and beverage space. In addition to providing capital, venture capitalists may offer strategic guidance, networking...more
2/15/2024
/ Beverage Manufacturers ,
Business Plans ,
Corporate Governance ,
Early Stage Companies ,
Emerging Growth Companies ,
Food Manufacturers ,
Intellectual Property Protection ,
Investors ,
Private Equity ,
Restaurant Industry ,
Seed Financing ,
Startups ,
Venture Capital
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
A contract manufacturer (also known as a “co-man” or “co-packer” and for brevity, we’ll use “co-man” from here on out) is a critical partner for most emerging companies in the healthy food and beverage (F&B) space. The...more
Branding is critical for emerging companies in the healthy food and beverage (“F&B”) space. Strong brands can help companies stand out from competitors and build trust and loyalty with customers. For emerging companies, a...more