Posts by Marc Sanchez
New FSMA Rule; FDA Proposed Rule: Focused Mitigation Strategies to Protect Food Against Intentional Adulteration
The US Food and Drug Administration (FDA) announced a new rule today under the Food Safety Modernization Act (FSMA).
Read MoreFDA Annouces Significant Overhaul of Proposed Produce Safety Rule
The US Food and Drug Administration (FDA)
Read MoreTwo New Studies Debunk Benefits of Multivitamins; What is the Impact on Industry?
Two studies released on Monday gained national headlines for their findings on the effectiveness of multivitamins.
Read MoreExemptions to the Proposed Rule for Preventative Controls for Animal Food
The charts below do not contain all of the information necessary to determine the proposed requirements for compliance in a particular circumstance. Consult the proposed rule for specific requirements. Proposed Exemptions From the New Requirements for Hazard Analysis and Risk-Based Preventive Controls Proposed Exemptions From the New Requirements for Hazard Analysis and Risk-Based Preventive Controls…
Read MoreTrans Fat Banned Under New FDA Rule
The US Food and Drug Administration announced today it will take steps to curb the use of partially hydrogenated oils from processed foods. The Agency proposed a new rule that would deem PHOs, a primary source of trans fat, no longer generally recognized as safe (GRAS). GRAS is a legal standard to determine the safety…
Read MoreProposed Preventative Controls and GMP Rules for Animal Food and Feed: Overview
The pet food and animal feed industry is set to make sweeping changes under the newly proposed Preventative Controls and GMP rules. The U.S. Food and Drug Administration (FDA) announced the new rule late Friday. It is part of a suite of proposed rules issued this year under the Food Safety Modernization Act (FSMA). At…
Read MoreFDA/USDA Shutdown Ending, Expect Lengthy Delays
The government shutdown that shuttered the doors of the USDA and FDA has ended. The Agencies are expected to return back to normal operations on Thursday. For a few weeks, however, nothing will be normal about the Agencies. The nearly three week long shutdown will continue to impact industry even with the Agencies now open.…
Read MoreShutdown Delays Medical Device Approvals (510(k)s)
As the shutdown continues the impact continues to be felt.
Read MoreGovernment Shutdown; Update on Impact on USDA & FDA
The US federal government is shutdown. The impact will be felt by all areas of FDA and USDA regulated industry. The FDA will cease all non-emergency services not funded by user fees. During the shutdown, FDA operations will be limited to work that involves the safety of human life, the protection of property and criminal…
Read MoreRare Recall Arrest: Jensen Farms Cantaloupe Owners Arrested, Charged
A rare and stunning arrest was made this week by the FDA and the US Attorney’s Office. Eric and Ryan Jensen, the owners of the now bankrupt Jensen Farms that was the source of a contaminated cantaloupe that caused a nationwide outbreak, were arrested
Read MoreEmerging Growth Companies
Our firm offers works with companies of all sizes and at all different stages of growth. Emerging growth companies in regulated industry can need special guidance on corporate matters. Issues ranging from formation, questions about investing regulations, distribution agreements and agreements with contract manufacturers. We can discuss a broad range of corporate issues and develop…
Read MoreReview of FSVP Part 2: The Basic Mechanics of a FSVP
Food Court continues its series discussing the new Foreign Supplier Verification Program (FSVP) rule issued by the US FDA under the Food Safety Modernization Act (FSMA). To read the two previous posts click
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