The Food and Drug Administration and the Alcohol and Tobacco Tax and Trade Bureau (TTB) have both recently issued guidance documents to allow for the increased production of alcohol-based hand sanitizer during the COVID-19...more
On March 17, 2020, the U.S. Food and Drug Administration (FDA) issued guidance to food manufacturers and importers in response to the COVID-19 pandemic. In the guidance, FDA stated it will temporarily not enforce supplier...more
Companies directly and indirectly regulated by the U.S. Food and Drug Administration (FDA) face specific challenges separate from other businesses in dealing with the recent outbreak of coronavirus disease 2019 (COVID-19). ...more
We have blogged, most recently on January 3, 2020, about the status of so-called “ag-gag” laws. These laws are designed to prevent undercover scrutiny of agricultural operations to uncover cruelty to animals, food safety...more
The U.S. Food and Drug Administration (FDA) issued a press release on the evening of Monday, November 25 concerning its recent enforcement actions and a regulatory decision concerning products that contain cannabidiol (CBD)....more
Beginning this summer, the Food and Drug Administration (FDA) through its Office of Criminal Investigations, launched a criminal probe to investigate the vaping-related lung illnesses that have affected over five hundred...more
The U.S. Food and Drug Administration (“FDA”) issued a Warning Letter, dated July 22, 2019, to Curaleaf, Inc. (“Curaleaf”), a multi-billion dollar market cap company that is publicly traded on the Canadian Securities...more
Friday, the U.S. Food and Drug Administration held a meeting to discuss its regulatory approach to products that contain cannabis and cannabis-derived compounds, including cannabidiol (CBD). The public hearing was intended to...more
On Monday, the United States Supreme Court found that a judge is better suited than a jury to decide if consumers’ tort claims are preempted by federal regulations. In the case, Merck Sharp & Dome, Corp. v. Albreecht, the...more
5/24/2019
/ Agency Disapproval ,
Clear Evidence Standard ,
Failure To Warn ,
FDA Approval ,
Federal v State Law Application ,
Food and Drug Administration (FDA) ,
Judicial Authority ,
Jury Trial ,
Manufacturers ,
Merck Sharp & Dohme Corp. v. Albrecht ,
Preemption ,
Prescription Drugs ,
Question of Fact ,
Question of Law ,
Remand ,
SCOTUS ,
State Law Claims ,
Vacated ,
Warning Labels
The Alcohol and Tobacco Tax and Trade Bureau (TTB) recently issued an industry circular which makes clear that cannabidiol (CBD), a product derived from hemp, is not permitted in alcohol beverages.
TTB generally consults...more
On Wednesday, April 3, 2019, the U.S. Food and Drug Administration (FDA) announced plans to hold a meeting to discuss its regulatory approach to products that contain cannabis and cannabis-derived compounds, including...more