FDA News Update
FDA QMSR Is Now in Effect: What Medical Device Companies Should Do Next
If you are a medical device company and you are still preparing for FDA inspections using the old Quality System Inspection Technique guide — stop….
FDA General Wellness Guidance 2026: What Wearable and Digital Health Companies Can and Can’t Do Now
If you’re building a wearable, wellness app, smart ring, recovery tracker, or connected health platform, FDA just updated the playbook — and the changes matter….
Will the FDA Eliminate Self-Affirmed GRAS? What the Proposed Rule Could Mean
The conversation around self-affirmed GRAS is evolving quickly, with lawmakers and regulators signaling potential changes that could reshape how food ingredients are evaluated and brought…
FDA GRAS Reform in 2026: What Food and Ingredient Companies Need to Know
The landscape of food ingredient safety is entering a period of significant transition in 2026. For decades, the “Generally Recognized as Safe” (GRAS) pathway has…
The FDA’s Quality Management System Regulation (QMSR): What the New Inspection Framework Means for Medical Device Companies
The medical device industry is currently navigating one of its most significant regulatory shifts in decades. For nearly thirty years, the Food and Drug Administration…
The FDA’s New Approach to “No Artificial Colors” Claims: Compliance Risks and Legal Considerations
The U.S. Food and Drug Administration has announced a new enforcement approach to products labeled “no artificial colors,” signaling heightened scrutiny for food and beverage…
503A vs 503B Compounding Pharmacies: Compliance Risks That Can Pull Products from the Market
Compounding pharmacies play a critical role in patient care, especially when commercially available drugs cannot meet specific clinical needs. However, the regulatory distinction between traditional…
Congress Targets the GRAS Process: Four Bills That Could Fundamentally Change FDA Food Ingredient Oversight
GRAS Loophole For more than two decades, the FDA’s “generally recognized as safe” (GRAS) framework has allowed food ingredients to enter the U.S. market either…
Importing Dietary Supplements into the U.S. in 2025: FDA, USDA, and Customs Pitfalls
The U.S. market for dietary supplements continues to expand in 2025, with global manufacturers eager to meet consumer demand for vitamins, minerals, and herbal products….
What the Shutdown-Ending Bill Means for Hemp, CBD, and Cannabinoid Products
The Hemp Provision in H.R. 5371: What the Shutdown-Ending Bill Means for Hemp, CBD, and Cannabinoid Products Congress quietly enacted one of the most sweeping…
The FDA’s Latest Warning Letters: What They Reveal About Cosmetic and Supplement Claims
In recent months, the U.S. Food and Drug Administration (FDA) has issued a series of warning letters that highlight recurring problems in how cosmetic and…