AG/FDA Blog

What Would You Change About the Federal Government?

President Trump issued an Executive Order (Reorganization EO) on March 13 directing the Office of Management and Budget (OMB) to submit a comprehensive plan to reorganize Executive Branch departments and agencies.  OMB has now issued a Memorandum fo… Read More
Read More

Organic Reform

By Marshall Matz and Peter Matz, as published in Agri-Pulse The House of Representatives’ Freedom Caucus lists the USDA National Organic Program as one that should be a high priority for reform under President-elect Donald Trump. We agree. T… Read More
Read More

Adverse Event Information Now Available Online for CFSAN-Regulated Products

FDA has begun posting online (and intends to update quarterly) information derived from adverse event reports the agency has received about conventional foods (including food/color additives), dietary supplements, and cosmetics.  This information is… Read More
Read More

FDA Finalizes FSMA Third-Party Certification User Fee Program

Last week, FDA issued a final rule to establish a user fee program for a voluntary accreditation program under Section 808 of the Federal Food, Drug, and Cosmetic Act (added by Food Safety Modernization Act (FSMA)). In November 2015, the FDA promulga… 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

Food Regulation: A Changing of the Guard

Irrespective of whether you voted for or against Donald Trump, last night’s election results will lead to a significant changing of the guard in how food is regulated by FDA and USDA.  In his Contract with America, soon-to-be-President Trump promi… Read More
Read More

An Early Look at Some Congressional Changes Impacting Agriculture

With the House and Senate remaining under Republican majorities, it is very unclear what matters may be handled in the lame duck session, and which ones will be pushed into the 115th Congress.  Some will want to extend the Continuing Resolution fro… 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

Dr. Betsy Booren Joins OFW Law as Senior Policy Advisor

We are pleased to announce that Dr. Betsy L. Booren, who specializes in food safety policy development and analysis, has joined OFW Law as Senior Policy Advisor.  Most recently, Dr. Booren served as Vice President of Scientific Affairs for the North… 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.