Jun 1, 2018 | EASeNews, Foods, FSMA Perspective
By Charles Breen, Independent Advisor for FSMA The explosion in the numbers of new breweries is a blessing for beer drinkers and their communities. In FDA’s eye, beer is food, and while exempt from preventive control requirements, brewers must comply with good...
Mar 1, 2018 | Foods, FSMA Perspective
In 1994 the Dietary Supplement Health and Education Act (DSHEA) created a new, legal class of food, called “dietary supplements,” which created a new subcategory of FDA-regulated foods. Many parts of the Food, Drug and Cosmetic Act (FD&C) still apply to dietary...
Mar 1, 2018 | EASeNews, Foods, FSMA Perspective
By Charles Breen, Independent Advisor for FSMA The next FSMA/FSVP compliance date is March 19, 2018. FDA enforcement activities begin with: Importers of human food whose Small Business Foreign Supplier is required to comply with Preventive Controls for Human Foods...
Feb 1, 2018 | EASeNews, Foods, FSMA Perspective
By Charles Breen, Independent Advisor for FSMA The December 2017 Department of the Inspector General report on FDA’s food recall process included some particularly harsh criticisms of the agency including inadequate authority, oversight and follow-up on voluntary food...
Jan 1, 2018 | EASeNews, Foods, FSMA Perspective
By Charles Breen, Independent Advisor for FSMA The coming year will be a busy one for food firms as the compliance date for 14 components of the FSMA Final Rule come into effect. FDA has published a helpful tool, Key Dates for Compliance, which runs through 2024 and...
Dec 1, 2017 | Foods, FSMA Perspective
In a nod to one of the more complex aspects of current food manufacturing and FSMA compliance, FDA recently published guidance that it will exercise enforcement discretion for two years over supply-chain requirements for domestic co-manufacturers of human and animal...
