AG/FDA Blog

The Relatively Unknown FSMA Rule – Foreign Supplier Verification Programs Rule

FSMA – The D.C. acronym for the Food Safety Modernization Act.  When I am working with clients or speaking with industry, everyone is familiar with FSMA.  But they think of FSMA as the Preventive Controls or Produce Safety Rules.  Some are also… Read More
Read More

Biotech Regulations Must be Based on Facts, Not Fears

By Dr. Nina Fedoroff, as published in Agri-Pulse The Coordinated Framework (CF) for the Regulation of Biotechnology was first implemented 30 years ago. The CF was developed by the White House Office of Science and Technology Policy (OSTP). OSTP broug… Read More
Read More

Priebus' January 20 Memorandum on Regulatory Freeze Pending Review

A memorandum from the President’s Chief of Staff, dated Friday, January 20, but released this afternoon via the Federal Register, directs all departmental and agency heads to forestall regulatory actions.  Previous administrations, including t… Read More
Read More

2016 – Gone But Not Forgotten

Happy 2017, everyone!  2016 has come and gone.  Looking at 2016 in my rear-view mirror, here are a few matters that caught my personal attention. As food and drug lawyers and corporate execs in regulated companies know (or definitely should know!),… Read More
Read More

What Is “Dietary Fiber”(for Purposes of Nutrition Labeling)?

FDA has issued two notices for publication in the Federal Register: A Request for Scientific Data, Information, and Comments (comments due within 45-days of publication); and A notice of availability about a draft guidance (comments due within 60-da… Read More
Read More

FDA Issues Final Guidance on VQIP

FDA today announced the availability of its finalized “FDA’s Voluntary Qualified Importer Program: Guidance for Industry.”  It also published a Fact Sheet on the Final Guidance, as well as Instructions for Submission of Voluntary Qualified Imp… Read More
Read More

Small Entity Compliance Guides on CGMP and Preventive Controls Final Rules for Human Food and Food for Animals

FDA has issued two Small Entity Compliance Guides (SECG) to enable domestic and foreign food facilities to better understand and comply with the requirements of two final rules implementing the FDA Food Safety Modernization Act.   See generally Foo… Read More
Read More

Draft FSMA Guidance for Industry: Describing a Hazard that Needs Control because Permissibly Not Controlled Upstream

FDA has made available for comment a draft guidance for industry that sets forth its current thinking about compliance with provisions of four FSMA final rules that require an entity (e.g., supplier) to include a disclosure statement, in documents ac… Read More
Read More

FDA Revises Food Product Categories for Food Facility Registrations

FDA has issued a revised guidance that explains the necessity of having food product categories in food facility registrations submitted to FDA under section 415 of the FD&C Act (21 U.S.C. 350d), and that updates the food product categories to be… Read More
Read More

“Healthy” Regulatory Definition To Be Revised?

FDA has defined the term, “healthy” (and related terms, including “health,” “healthful,” “healthfully,” “healthfulness,” “healthier,” “healthiest,” “healthily,” and “healthiness”), when used as an implied nutrient… Read More
Read More

Follow Blog Via Email

Enter your email address to subscribe to this blog and receive notifications of new posts by email.