On February 1, the Federal Trade Commission (“FTC”) announced its first enforcement action under the Health Breach Notification Rule (“HBNR” or “Rule”) against GoodRx, a direct-to-consumer digital healthcare and prescription...more
2/22/2023
/ Application Programming Interface (APIs) ,
Breach Notification Rule ,
Data Privacy ,
Enforcement ,
Federal Trade Commission (FTC) ,
Final Rules ,
FTC Act ,
Health Insurance Portability and Accountability Act (HIPAA) ,
Notification Requirements ,
Popular ,
Social Security Act
Signaling a renewed focus on consumer protection in the health claims space, the Federal Trade Commission (“FTC”) has revamped its 1998 guidance titled Dietary Supplements: An Advertising Guide for Industry and extended the...more
On December 1, the Office for Civil Rights (OCR) at the U.S. Department of Health and Human Services provided guidance on the intersection of the Health Insurance Portability and Accountability Act (HIPAA) and the use of...more
With two recent enforcement actions, the Federal Trade Commission (FTC) has shown that administering appropriate data security policies is an area of priority. On October 24, 2022, the FTC announced a Proposed Consent Order...more
On September 15, 2021, the Federal Trade Commission (“FTC”) issued a Policy Statement instructing health app and connected device companies to comply with the Health Breach Notification Rule (“the Rule”). The Rule, codified...more
11/2/2021
/ Breach Notification Rule ,
Data Breach ,
Electronic Devices ,
Federal Trade Commission (FTC) ,
Final Rules ,
Health Insurance Portability and Accountability Act (HIPAA) ,
HIPAA Breach ,
Mobile Apps ,
PHI ,
Popular ,
Security Breach
The Department of Health and Human Services (“HHS”) is continuing its focus on women’s health, this time through its research arm, the Agency for Healthcare Research and Quality (“AHRQ”). If the COVID-19 pandemic has shown us...more
On July 23, 2021, the U.S. Food and Drug Administration (“FDA” or “Agency”) rejected two New Dietary Ingredient (“NDI”) notifications to market full-spectrum cannabidiol (“CBD”) as part of dietary supplements. This move...more
The global cannabidiol (CBD) market size is expected to reach USD 13.4 billion by 2028. And yet a large part of that market—CBD-infused food, beverages, and dietary supplements—consists of unlawful sales. This article...more
Effective March 22, 2021, USDA’s Final Rule Sets Forth Regime for Producing Hemp Products in the United States, Superseding Interim Rule -
On January 9, 2021, the U.S. Department of Agriculture (USDA) issued a final rule...more
2/3/2021
/ Biden Administration ,
Cannabidiol (CBD) oil ,
Corrective Actions ,
DEA ,
Federal Food Drug and Cosmetic Act (FFDCA) ,
Final Rules ,
Food and Drug Administration (FDA) ,
Hemp ,
Hemp Cultivation ,
Notice of Violation ,
USDA
As our readers are well aware, in the past decade, food and beverage manufacturers have faced an unrelenting onslaught of putative class actions challenging allegedly false or misleading labels. In the January 2016 issue, we...more
In the last few days of the Obama Administration, the Food and Drug Administration (FDA or the Agency) issued a number of documents with implications for manufacturer communications with health care practitioners and payors. ...more
In Briseno v. ConAgra Foods, Inc., an opinion issued on January 3, 2017, the United States Court of Appeals for the Ninth Circuit held that Federal Rule of Civil Procedure 23 does not require plaintiffs challenging the...more