FDA Expands Oversight with Launch of Post-Market Chemical Assessment Program
On May 12, 2026, FDA announced a comprehensive process for the post-market assessment of food additives and initiated the post-market assessment of azodicarbonamide (ADA), a food additive used...
View ArticleCalifornia Attorney General Issues Enforcement Advisory on Prohibited Foam...
On December 2, 2025, the California attorney general issued a formal enforcement advisory letter to producers of food-service ware made from expanded polystyrene foam (EPS). The letter reminds...
View ArticleWhat’s on the Menu for 2026: Legal Trends in the Food & Beverage Industry
Federal, state, and private actions are accelerating across color additives, labeling and packaging, heavy metals, ultraprocessed foods, and insurance preparedness. As the regulatory landscape...
View ArticleNew Texas Legislation on Color Additives – Takeaways for Industry
As we have previously discussed, state and federal government authorities are turning their attention toward artificial coloring in foods. Most recently, Texas Governor Greg Abbott signed into law SB...
View ArticleOrphan Drugs, Big Breaks: The Quiet Carve-Out in the 'One Big Beautiful Bill...
The One Big Beautiful Bill Act takes a big step in the rare disease space by expanding the contours of the orphan drug exclusion, a once narrow exception that permitted manufacturers of rare disease...
View ArticleProcessed Food Industry in the Crosshairs: FDA and USDA’s Ultra-Processed...
Last week’s issuance of a request for information (RFI) in the Federal Register by the FDA and the US Department of Agriculture (USDA) marks the first step in the administration’s effort to address...
View ArticleFDA Updates Food Labeling Compliance Program: What It Means for Food...
In June 2025, the US Food and Drug Administration (FDA) announced a major update to its General Food Labeling Requirements Compliance Program—the first overhaul of this program since 2010. This program...
View ArticleFDA Proposes New Tool for Post-Market Scientific Assessment of Food Ingredients
On June 18, 2025, FDA announced for public comment a Post-market Assessment Prioritization Tool (Prioritization Tool) as an enhanced systematic process for post-market scientific assessment of...
View ArticleFood for Thought Implications of FDAs New Chemical Review Program
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...
View ArticleState Legislation on Color Additives in Food: Takeaways for Industry
Both state and federal government authorities have recently turned their attention toward artificial coloring in foods. The Food and Drug Administration (FDA) announced a series of measures in April...
View ArticleFrom Offshore to Onshore: Considerations for Pharmaceutical Industry...
The White House on May 5, 2025 issued an executive order requiring the US Food and Drug Administration to find ways to facilitate the opening of new drug manufacturing sites in the United States while...
View ArticleProposed Nutrition and Allergen Labeling Changes for Alcoholic Beverages: Key...
The Alcohol and Tobacco Tax and Trade Bureau (TTB) has published a pair of proposed rules that if finalized could significantly reshape alcohol beverage labeling in the United States. In a move aimed...
View ArticleFDA Drug Inspections Post–Workforce Reductions: Potential Implications and...
The US Food and Drug Administration (FDA) is confronted with significant challenges in its inspection processes due to recent layoffs. Among other effects, the latest reduction in force of full-time...
View ArticleHHS Signals GRAS Reform: How Food Manufacturers Can Prepare Now
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...
View ArticleFDA Regulatory Uncertainty Calls for Strategic Decision-Making by Drug...
The recent reductions in the US Food and Drug Administration’s workforce are poised to have a substantial impact on drug and biologic development programs. This LawFlash discusses strategies to...
View ArticleKey Considerations for Foreign Clinical Trials When Looking Abroad for...
With the continuing cuts to US Food and Drug Administration (FDA) staffing, the pharmaceutical and biotechnology industries are communicating increasing concern about potential product development...
View ArticleThe Future of Artificial Colors in the US Food Supply Is Not So Bright
Only weeks after being confirmed, the Department of Health and Human Services (HHS) secretary has advised food companies to remove artificial colors from their food products. He recently met with...
View ArticleNavigating FDA from 2024 into 2025 Human Foods Program
FDA Restructures its Food Resources Although there were a number of significant new regulations, the most significant food industry change in 2024 was the overhaul of how FDA structures itself to...
View ArticleFDA Cosmetic Updates: New Q&As for MoCRA Facility Registration, Product...
FDA continues to construct its regulatory program for cosmetic products, albeit at a slower pace than the congressional timelines provided in the Modernization of Cosmetics Regulation Act of 2022...
View ArticleHow the US Election May Affect the FDA Regulation of Life Sciences Products –...
The reelection of former President Donald Trump, coupled with Republicans gaining the Senate majority and poised to gain the House majority, has prompted many in the life sciences industry to question...
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