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On October 1, 2024, the U.S. Food and Drug Administration (FDA or the Agency) implemented its unified Human Foods Program (HFP). The Agency established the HFP – which represented the single largest reorganization in FDA’s...more
Can food really be the prescription for better health? Discover how the “Food as Medicine” movement is reshaping health care and what it means for patients, providers, and the future of wellness. On this episode, special...more
Key Takeaways - What Happened: The U.S. Food and Drug Administration (FDA) released its draft post-market chemical review prioritization method for public comment. Public comments are due July 18, 2025....more
The US Food and Drug Administration recently announced a major initiative to strengthen oversight of food additives and other food-related chemicals. The agency described this as a “stronger, more systematic review process”...more
Ingredient suppliers and food manufacturers face an uncertain supply chain landscape in which “generally recognized as safe” (GRAS) self-determinations may be more closely scrutinized. The US Department of Health and Human...more
Through an Order that the Secretary of the U.S. Department of Health and Human Services (HHS) Robert F. Kennedy Jr. (RFK) called an act of “radical transparency,” the U.S. Food and Drug Administration (FDA) has been directed...more
On January 16, 2025, the U.S. Food and Drug Administration (FDA) announced a significant regulatory change by revoking the authorization for use of Red Dye No. 3 in food (including dietary supplements) and ingested drugs. As...more
Food chemical safety is among Food and Drug Administration ("FDA") top priorities as it rolls out a new Human Foods Program, amid a flurry of federal and state legislation addressing food additive safety, resulting in a...more
On October 30, 2024, the U.S. Food and Drug Administration’s (FDA) newly minted Human Foods Program (HFP) published a list of priority deliverables for Fiscal Year 2025. By way of brief background, FDA designed the HFP to...more
U.S. Food and Drug Administration (FDA) Commissioner Robert Califf on Jan. 31, 2023, announced a proposed restructuring of the agency's Human Foods Program in an effort to improve coordination among the FDA offices. These...more
As the United States’ primary public health and consumer protection agency, the US Food and Drug Administration (FDA) regulates at least one quarter of the nation’s economy and exerts significant influence over global...more
DA recently released Draft Guidance on the Agency’s expanded use of remote regulatory assessments (RRAs) to review regulated establishments and / or their records. FDA outlines how it intends this tool to be incorporated...more
The U.S. Food and Drug Administration (FDA) recently hosted a three-day virtual summit on e-commerce, which focused on food safety for foods ordered online and delivered directly to consumers. Because of the increasing...more
The European Union (EU) recently adopted a regulation requiring food business operators to establish and provide evidence of an appropriate food safety culture and detailing the steps they must take to satisfy this...more
On 5 March 2021, the U.S. Food and Drug Administration (FDA) issued a letter to baby and toddler food manufacturers and processors covered by the preventive control provisions of the Current Good Manufacturing Practice,...more
The Food Safety and Inspection Service (FSIS) has partially granted a Center for Science in the Public Interest (CSPI) petition regarding nitrate/nitrite claims on meat and poultry products produced using substances that...more
The United States Department of Agriculture's Food Safety and Inspection Service (FSIS) has issued an instruction to field personnel, FSIS Notice 49-20, to begin implementing the agency’s new Adulterated Product Monitoring...more
The United States Department of Agriculture’s (USDA) Food Safety and Inspection Service (FSIS or the agency) has issued a Proposed Rule to expand the circumstances in which FSIS will generically approve the labels of meat,...more
The U.S. Food and Drug Administration (FDA) recently provided an update from FDA Commissioner Stephen Hahn M.D. and Deputy Commissioner for Food Policy and Response Frank Yiannas on the forthcoming New Era of Smarter Food...more
What the FDA Requires for Food Safety During the COVID-19 Pandemic - The U.S. Food and Drug Administration’s (FDA) regulatory requirements for food companies, including manufacturers and importers, remain largely unchanged...more
LEGISLATION, REGULATIONS & STANDARDS - FDA Releases Guidance on Intentional Adulteration - The U.S. Food and Drug Administration (FDA) has released the third and final installment of its draft guidance on intentional...more
Once again there is a new attempt in Germany to introduce stricter requirements for food safety – despite the full harmonization approach in general EU food law...more
The U.S. Food and Drug Administration (FDA) has released the third and final installment of its Draft Guidance to support compliance with the Mitigation Strategies to Protect Food Against Intentional Adulteration (“IA rule”)....more
The United Kingdom (UK) left the European Union (EU) on 31 January 2020. While the EU and the UK lastly agreed on a withdrawal agreement and thus can avoid an unregulated Brexit, specific rules for trading UK goods on the EU...more
The U.S. Department of Agriculture’s (USDA’s) Food Safety and Inspection Service (FSIS) has issued an updated Labeling Guideline on Statements That Bioengineered or Genetically-Modified Ingredients or Animal Feed Were Not...more