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FDA’s Proposed GRAS Rule: Mandatory Notifications, Expanded Scope, and Open Questions
Following through with long-stated intentions, FDA yesterday published a proposed rule that could fundamentally reshape how food substances reach the U.S. market under the Generally Recognized as Safe (GRAS) framework.…
FDA Advisory Committee Recommends Several Peptides for Compounding for Various Uses Despite Staff Opposition: What Stakeholders Need to Know
The explosive growth of the GLP-1 market has fueled demand not only for weight-loss therapies, but also for peptides marketed for wellness, fitness, and longevity purposes. As demand has increased, so too has the gray…
FDA Signals Increased Cosmetics Oversight through MoCRA Implementation and Other Regulatory Efforts
Last week, FDA touted its achievements in connection with implementing the Modernization of Cosmetics Regulation Act of 2022 (MoCRA) – noting that the agency had “worked tirelessly, mostly using existing resources, to…
FDA Turns Up the Heat on GLP 1 Dupes Sold “For Research Use Only,” Finds Intended Use Suggests Otherwise
Consumer demand for GLP‑1 drugs such as Ozempic and Zepbound continues to surge, fueling rapid growth in the market for GLP-1 drugs and compounded GLP-1 products, as well as supplements that are marketed to have…
From MAHA to Market: FDA and Some Retailers Announcing New Policies on Colors
The Make America Healthy Again (MAHA) movement has already prompted notable changes in federal and state food policy and has prompted regulators, plaintiff’s lawyers, manufacturers, retailers, and consumers to take a…