Posts by Marc Sanchez
FDA Uses FSMA Suspension Authority; Second Suspension Under New FSMA Powers
The U.S. Food and Drug Administration (US FDA) suspended the registration of a food facility at Roos Foods in Kenton, Delaware. Facility registration is required by all food companies in order to distribute their products. The suspension follows a widening investigation by the FDA, the Centers for Disease Control (CDC), and state and local officials…
Read MoreFDA Proposes New Nutrition Label
The US Food and Drug Administration announced today dramatic new changes to the food nutrition label. The proposed label is open for comment over the next 90-days. Following the comment period the final rule would be issued likely a year later.
Read MoreFY 2013 483 Data Released; Top Ten Observations Unchanged
The US FDA released enforcement data from fiscal year 2013. The data provides the total number of Form 483 Inspectional Observations, the most common pre-enforcement tool used by the agency, for the prior year. Comparing the new data to fiscal year 2012 provides insight into the Agency’s enforcement priorities. The informal review below again shows…
Read MoreFDA Publishes Draft Approach to Identifying High Risk Foods Under FSMA
The US Food and Drug Administration announced its
Read MoreNew FSMA Rule; Proposed Rule on Sanitary Transportation of Human and Animal Food
The US Food and Drug Administration announced a new rule to prevent food safety risks during the transport. This is the seventh and final major rule under the Food Safety Modernization Act (FSMA). The rule is open to public comment through May 31, 2014, but like many of the recent rules the comment period will…
Read MoreFDA Issues Two New Guidance Documents; Energy Drinks and Liquid Dietary Supplements Under New Scrutiny
The US FDA issued two new guidance documents focused on energy drinks following a Congressional call for action.
Read MoreMarijuana, THC, and the US FDA – What Does Increasing Legalization Mean for Food, Drugs, and Dietary Supplements?
Colorado made headlines this past week when its decriminalization of marijuana went into effect. Since that time an increasing number of calls and e-mails rushed in to ask what the FDA position was and if foods, dietary supplements or drugs could contain cannabis. The short answer is no. For federal purposes marijuana remains a schedule…
Read MoreFDA Form 483 Response Strategy – FY 2012 Inspectional Observation Summaries
FDA Form 483 Response Strategy FY 2012 Inspectional Observation Summaries FDA Form 483 response strategy – perhaps the best strategy to both prepare for a
Read More“Can a Dietary Supplement Treat a Concussion? No”; Stretching the Reach of Dietary Supplement Claims
The US Food and Drug Administration (FDA) announced through a consumer advisory on the danger of using a dietary supplement to treat concussions or traumatic brain injuries (TBI). The announcement follows a series of Warning Letters issued in 2012 and a new warning letter to Star Scientific of Virginia. There are two components to the…
Read MoreSNAP Trafficking Charge Letter
SNAP Trafficking Charge Letter Overview of USDA/FNS Charge Letter Response and Appeal SNAP Trafficking charge letter act as the official notification from the USDA FNS (United States Department of Agriculture Food and Nutrition Service) to a SNAP retailer. It will indicate the nature of the trafficking violations, the time-frame to respond, which is incredibly short,…
Read MoreNew 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)
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