In September 2021, the Office of Scientific Investigations of the Center for Drug Evaluation and Research of the U.S. Food and Drug Administration (FDA) issued a Warning Letter to dietary supplement company RAAS Nutritionals,...more
Recently, the U.S. Food and Drug Administration (FDA) issued a statement and proposed rule clarifying the types of evidence that the FDA considers when determining the "intended use" of a product. Intended use is important...more
Recently, a New York-based dietary supplement manufacturer (and its subsidiaries) issued a nationwide recall of all lots of dietary supplement products manufactured and sold between January 2013-November 2019. Because the...more
2/12/2020
/ CGMP ,
Consent Decrees ,
Department of Justice (DOJ) ,
Dietary Supplements ,
Drug Compounding ,
Due Diligence ,
Enforcement Actions ,
FDA Warning Letters ,
Federal Food Drug and Cosmetic Act (FFDCA) ,
Federal Trade Commission (FTC) ,
Food and Drug Administration (FDA) ,
Inspections ,
Manufacturers ,
Patent Infringement ,
Product Recalls
With its recent issuance of additional warning letters and the release of a consumer update, the Food and Drug Administration (FDA) appears to be signaling that it will continue its deliberate approach in determining an...more
11/27/2019
/ Cannabidiol (CBD) oil ,
Cannabis Products ,
Dietary Supplements ,
FDA Warning Letters ,
Federal Food Drug and Cosmetic Act (FFDCA) ,
Food and Drug Administration (FDA) ,
Health and Safety ,
Hemp ,
Hemp Cultivation ,
Interim Final Rules (IFR) ,
Regulatory Agenda ,
USDA
Introduction: Citizen Petitions in the News -
Citizen petitions and stay of action petitions (collectively, citizen petitions or petitions) are in the news. Formally, citizen petitions are a mechanism for "interested...more
11/7/2019
/ Abbreviated New Drug Application (ANDA) ,
Administrative Proceedings ,
Anti-Competitive ,
Biosimilars ,
Citizen Petitions ,
Dietary Supplements ,
Federal Food Drug and Cosmetic Act (FFDCA) ,
Final Guidance ,
Food and Drug Administration (FDA) ,
Noerr-Pennington Doctrine ,
Public Health ,
Sham Citizen Petitions
Dietary supplements are big business. Three out of four Americans take a dietary supplement, and the rate rises to four out of five among older Americans. Dietary supplements are a $40 billion dollar industry, with between...more
A number of important changes have occurred in the cannabis, hemp, and cannabidiol (CBD) spaces. This alert presents a snapshot of significant developments and selected future predictions....more
2/7/2019
/ Amended Legislation ,
Amended Regulation ,
Cannabidiol (CBD) oil ,
Controlled Substances Act ,
DEA ,
Decriminalization of Marijuana ,
Department of Justice (DOJ) ,
Dietary Supplements ,
Farm Bill ,
FDA Approval ,
Food and Drug Administration (FDA) ,
Food Manufacturers ,
Hemp ,
Marijuana ,
Marijuana Related Businesses ,
Patents ,
Utility Patents
Dietary supplements are big business. A recent estimate pegs the U.S. market for dietary supplements at over $35 billion annually. The U.S. Food and Drug Administration (FDA) estimates the number of dietary supplements to be...more