A Seat at the Table

Serving the Latest in Food Law and Policy

The U.S. Food and Drug Administration (FDA) has released the second of three installments of its Draft Guidance to support compliance with the Mitigation Strategies to Protect Food Against Intentional Adulteration (IA) rule. Under the IA rule, the last of the major FDA Food Safety Modernization Act (FSMA) rules to be released, food facilities must develop and implement a food defense plan that identifies their significant vulnerabilities and mitigation strategies to address those vulnerabilities, and…
The U.S. Food and Drug Administration (FDA) recently released the “FDA Strategy for the Safety of Imported Food” (the Strategy), which outlines the agency’s approach to ensuring the safety of the ever-rising volume of imported foods. The Strategy sets out four food safety goals: 1) preventing food safety problems in the foreign supply chain prior to entry; 2) detecting and refusing entry of unsafe foods at the border; 3) quickly responding to unsafe imported…
The Food and Drug Administration (FDA) recently announced a plan for “policy advancements with the goal of implementing one of the most significant modernizations of dietary supplement regulation and oversight in more than 25 years.” FDA Commissioner Scott Gottlieb reflected on the 25th anniversary of the Dietary Supplement Health and Education Act, and stated his commitment to ensuring FDA achieves the right balance between consumer access to lawful supplements, while upholding the agency’s public health…
The U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) has issued a Draft Guideline detailing the Agency’s expectations of companies that identify foreign material in their meat and poultry products and more generally providing recommendations for how establishments should craft their complaint handling policies. FSIS states that it developed the document in response to an increase in the number of recalls of meat and poultry products adulterated with foreign materials, many of which…
Hogan Lovells will offer a free seminar on new U.S. food manufacturing, labeling, and inspection requirements that apply to any Mexican company exporting food to the U.S. These requirements cover both finished goods and ingredients. Hogan Lovells U.S. partners Maile Hermida and Elizabeth Fawell will be visiting from Washington, D.C. to discuss these latest U.S. food law developments and how they affect all foreign companies that sell food to the U.S. Who should attend? Regulatory, quality…
The U.S. Department of Agriculture’s (USDA’s) Food Safety and Inspection Service (FSIS) and the Food and Drug Administration (FDA) announced today a formal-agreement coordinating joint jurisdiction over the production of products derived from cell lines of livestock and poultry. This agreement marks the next significant step in establishing the regulatory framework for these products and delineates the general roles that FSIS and FDA will play in regulating the developing of cell lines, culturing cells, harvesting…
If you make a living producing and selling alcohol beverages, congratulations! You are beloved by many. As someone who manufacturers spirits, wine, beer, or other alcohol beverages, you not only address the high demand for your libations, but also the complex and often confusing regulations that affect your business. Now, however, you have the opportunity to participate in a major regulatory revision concerning your products. As you may know, the Alcohol and Tobacco Tax and…
U.S. Food and Drug Administration (FDA) Commissioner Scott Gottlieb recently issued a statement affirming that Produce Safety Rule inspections will begin this spring. Last year FDA chose to delay routine inspections to allow more time for farmers and state regulators to receive training on the rule. Routine inspections for large farms (i.e., farms with more than an average $500,000 in produce sales during the previous 3-year period) were delayed until spring 2019, and routine inspections…
The U.S. Food and Drug Administration (FDA) has issued final Guidance regarding Public Warning and Notification of Recalls Under 21 CFR Part 7, Subpart C. The document makes limited changes to the Draft Guidance that was issued in January 2018. The Guidance outlines circumstances when a company should issue a public warning about a voluntary recall, describes the general timeframe for companies to issue such a warning, discusses what information should be included in a…
What are the 3 letters that should strike fear into the heart of every food executive?  No, the 3 letters are not F-D-A.  Although the Food and Drug Administration is quite powerful, the agency can only wield that power against a particular food company ­­­­when it has the evidence to do so. The 3 letters we are referring to are W-G-S – which stands for Whole Genome Sequencing – because this new scientific tool can…