In the latest episode of Holland & Knight's Public Policy & Regulation Group "Eyes on Washington" podcast series, Healthcare & Life Sciences attorney Michael Werner and Sara Klock examine pivotal shifts in U.S. Food and Drug...more
The bipartisan leadership of the House Committee on Energy and Commerce and the Senate Committee on Health, Education, Labor and Pensions released a formal Request for Information (RFI) to the public on July 27, 2023, to...more
In the midst of expanded development and marketing of products containing cannabis and cannabis-derived compounds, President Donald Trump's FY 2021 proposed budget includes an additional $5 million for the U.S. Food and Drug...more
2/12/2020
/ Cannabidiol (CBD) oil ,
Cannabis Products ,
Congressional Committees ,
Dietary Supplements ,
Enforcement Programs ,
Federal Budget ,
Federal Funding ,
Food and Drug Administration (FDA) ,
Hemp ,
Information Reports ,
Marijuana-Infused Edibles ,
Regulatory Agenda ,
Trump Administration
• With the dramatic expansion of CBD products in the market, the U.S. Food and Drug Administration (FDA) is reviewing whether its current regulatory framework is appropriate, and if not, what modifications are needed.
• The...more
6/7/2019
/ Cannabidiol (CBD) oil ,
Cannabis Products ,
Dietary Supplements ,
Food and Drug Administration (FDA) ,
Health and Safety ,
Hemp ,
Labeling ,
Marijuana ,
Marijuana Cultivation ,
Marijuana Related Businesses ,
Public Hearing ,
Regulatory Oversight
On April 2, 2019, FDA outlined new steps to advance review of potential regulatory pathways for cannabis-containing and cannabis-derived products. In a statement issued by Commissioner Scott Gottlieb, released in conjunction...more
4/2/2019
/ Cannabidiol (CBD) oil ,
Cannabis Products ,
Dietary Supplements ,
Enforcement Actions ,
Food and Drug Administration (FDA) ,
Food Labeling ,
Food Marketing ,
Food Safety ,
Health and Safety ,
Hemp ,
Manufacturers ,
Marijuana ,
Marijuana-Infused Edibles ,
Product Labels ,
Public Hearing ,
Regulatory Oversight
FDA has announced plans to seek congressional and stakeholder input on "possible alternative approaches" to regulating cannabis and cannabis-derived products. The announcement came as Commissioner Scott Gottlieb spoke on the...more
3/4/2019
/ Cannabidiol (CBD) oil ,
Cannabis Products ,
Dietary Supplements ,
Enforcement ,
Food and Drug Administration (FDA) ,
Food Safety ,
Hemp ,
Marijuana ,
Marijuana Cultivation ,
Marijuana Related Businesses ,
Regulatory Agenda ,
Regulatory Oversight
With the enactment of the Agriculture Improvement Act of 2018 (Farm Bill) on Dec. 20, 2018, hemp and cannabis derivatives with extremely low concentrations of Tetrahydrocannabinol (THC)—less than 0.3 percent on a dry weight...more
1/4/2019
/ Agricultural Sector ,
Cannabidiol (CBD) oil ,
Cannabis Products ,
Controlled Substances Act ,
Decriminalization of Marijuana ,
Dietary Supplements ,
Farm Bill ,
Food and Drug Administration (FDA) ,
Hemp ,
Marijuana ,
Marijuana Cultivation ,
Marijuana Related Businesses ,
Regulatory Oversight
On Dec. 12, 2018, U.S. Food and Drug Administration (FDA) Commissioner Scott Gottlieb announced tougher compliance and enforcement policies for drug manufacturers, dietary supplement manufacturers, stem cell clinics and...more
12/17/2018
/ Clinical Laboratories ,
Data Integrity ,
Dietary Supplements ,
Drug Compounding ,
Enforcement Actions ,
Food and Drug Administration (FDA) ,
Health Care Providers ,
Manufacturers ,
New Guidance ,
Opioid ,
Pharmaceutical Industry ,
Pharmacies ,
Prescription Drugs ,
Regulatory Oversight ,
Stem cells