Feb 9, 2023 | FDA and USDA Regulatory Update, Foods
FDA has indicated enforcement discretion for certain qualified health claims regarding the consumption of cocoa flavanols in high flavanol cocoa powder and a reduced risk of cardiovascular disease for conventional foods. With “very limited credible scientific...
Feb 1, 2023 | FDA and USDA Regulatory Update, Foods
In a January 31, 2023 announcement, FDA proposed a vision to restructure the oversight of food safety and informed consumer choices into a new organization which will be known as the Human Foods Program. As part of this restructuring, the Center for Food Safety and...
Jan 30, 2023 | FDA and USDA Regulatory Update, Foods
The U.S. Food and Drug Administration (FDA) has issued a final guidance titled Best Practices for Convening a GRAS Panel. Although in most cases general recognition of safety can be supported without convening a GRAS panel, this guidance provides information to those...
Jan 4, 2023 | Drugs, FDA and USDA Regulatory Update
What You Need to Know The U.S. Food and Drug Administration has issued a final guidance on Homeopathic Drug Products describing the agency’s approach to prioritizing regulatory actions for homeopathic products posing the greatest risk to patients. The agency...
Aug 31, 2022 | EASeNews, FDA and USDA Regulatory Update, Foods
FDA recently released an updated 2022 edition of the Voluntary National Retail Food Regulatory Program Standards (Retail Program Standards) for both food service and food retail establishments. These standards give recommendations for designing, managing and...
Aug 18, 2022 | Drugs, FDA and USDA Regulatory Update
The much anticipated Proposed Rule on Revising the National Drug Code Format was announced in the FR Vol 87, No. 141 Revising the National Drug Code. The FDA is proposing a 12 digit uniform NDC number to replace the current format of 10 digits, which when exhausted...