Health providers and consumers increasingly rely on the internet for health and medical-related information, but not all such information is reliable, and many statements are downright false. The proliferation of social media...more
7/15/2024
/ Draft Guidance ,
Enforcement ,
False Statements ,
Federal Food Drug and Cosmetic Act (FFDCA) ,
Food and Drug Administration (FDA) ,
Internet ,
Medical Devices ,
Pharmaceutical Industry ,
PHSA ,
Policy Statement ,
Prescription Drugs ,
Regulatory Reform
On February 2, 2024, FDA finalized its nearly two-year-long process to harmonize QS regulations with ISO standards. As we mentioned when FDA proposed the harmonization in 2022, this update represents the first update to the...more
On December 26, 2023, the Food and Drug Administration (FDA) released a Small Entity Compliance Guide Final Guidance Document: Direct-to-Consumer Prescription Drug Advertisements: Presentation of the Major Statement in a...more
I. WHY THIS CASE MADE THE LIST -
A highly publicized and long-running multi-agency action against the former Chief Executive Officer and the former Chief Operating Officer of Theranos Inc. resulted in criminal convictions...more
5/24/2023
/ Centers for Medicare & Medicaid Services (CMS) ,
CEOs ,
CLIA ,
COOs ,
Corporate Crimes ,
Corporate Executives ,
Corporate Governance ,
Corporate Misconduct ,
Corporate Officers ,
Criminal Conspiracy ,
Criminal Prosecution ,
Department of Justice (DOJ) ,
FBI ,
Federal Food Drug and Cosmetic Act (FFDCA) ,
Food and Drug Administration (FDA) ,
Fraud ,
Health Care Providers ,
Patients ,
Regulatory Agenda ,
Securities and Exchange Commission (SEC) ,
Wire Fraud
The Food and Drug Administration (FDA) now has additional regulatory authorities over cosmetics, thanks to the Food and Drug Omnibus Reform Act (FDORA). FDORA was a part of the Consolidated Appropriations Act, 2023 (the...more
1/19/2023
/ Cosmetics ,
Federal Food Drug and Cosmetic Act (FFDCA) ,
Food and Drug Administration (FDA) ,
Manufacturers ,
New Regulations ,
Personal Care Products ,
Product Labels ,
Product Safety Labels ,
Proposed Legislation ,
Registration Requirement ,
Regulatory Oversight ,
Reporting Requirements
The Food and Drug Administration (FDA) issued a consumer alert related to Delta-8 tetrahydrocannabinol (Delta-8 THC), following a recent increase in adverse event reports to FDA and poison control centers. Although Delta-8...more
9/20/2021
/ Cannabis Products ,
Centers for Disease Control and Prevention (CDC) ,
Drug Safety ,
Enforcement ,
Federal Food Drug and Cosmetic Act (FFDCA) ,
Food and Drug Administration (FDA) ,
Healthcare ,
Hemp ,
Life Sciences ,
Misbranding ,
Public Health ,
Risk Factors ,
THC
More than two years have passed since hemp-derived cannabidiol (CBD) was legalized in the United States under the Agriculture Improvement Act of 2018 (also known as the “Farm Bill”). The Food and Drug Administration (FDA) has...more
On August 2, 2021, the Food and Drug Administration (FDA) published its final intended use rule (the “Final Rule”). The Final Rule amends FDA’s regulations describing the types of evidence relevant to determining a product’s...more
8/6/2021
/ Enforcement Actions ,
Federal Food Drug and Cosmetic Act (FFDCA) ,
Final Rules ,
First Amendment ,
Food and Drug Administration (FDA) ,
Intended Use ,
Manufacturers ,
Off-Label Use ,
Pharmaceutical Industry ,
Product Labels ,
Regulatory Oversight