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FDA Regulatory Insights & Compliance Guides
MoCRA Compliance in 2026: What's Enforced, What's Pending, and What to Do Now
By Alok Naik, R.Ph., M.S. Regulatory Affairs — Managing Partner, Axentra Global Pharma Compliance LLC Last reviewed: 2026 The Modernization of Cosmetics Regulation Act (MoCRA) is the biggest expansion of FDA's authority over cosmetics in roughly 80 years. But it's rolling out unevenly — some obligations are fully enforced, while several headline rules keep slipping. This is your plain-English status check for 2026, with a clear "what to do now" for each piece. What's enforced
Jun 203 min read
Structured Product Labeling: Ensuring FDA Compliance with fda labeling services
When you plan to export cosmetics, OTC drugs, pharmaceuticals, or food products to the United States, understanding FDA labeling requirements is critical. One of the most important aspects of compliance is Structured Product Labeling (SPL). This system ensures that your product information is submitted in a standardized, machine-readable format that the FDA can efficiently review and process. Navigating SPL requirements can be complex, but with the right knowledge and support
Jun 204 min read
MoCRA Cosmetic GMP Rule: Where It Stands in 2026 — and Why You Shouldn't Wait
By Alok Naik, R.Ph., M.S. Regulatory Affairs — Managing Partner, Axentra Global Pharma Compliance LLC MoCRA gave FDA the authority to establish, for the first time, federal Good Manufacturing Practice (GMP) requirements for cosmetics. Years in, that rule still isn't on the books — and the uncertainty is exactly why proactive manufacturers are building GMP-style systems now. What is the MoCRA cosmetic GMP requirement? Section 606 of the FD&C Act, as added by MoCRA, directs FDA
Jun 173 min read
FDA Approves Bemotrizinol (BEMT): What Sunscreen Brands Must Do to Sell in the U.S.
The FDA added bemotrizinol to the OTC sunscreen monograph. Here's the real timeline, the 18-month exclusivity catch, and the U.S. compliance steps brands need now.
Jun 154 min read
Navigating US FDA Registration with an FDA Registration Agent
Entering the US market with your cosmetic, OTC drug, pharmaceutical, or food product requires more than just compliance with product standards. One of the critical steps is registering your facility with the US Food and Drug Administration (FDA). For foreign companies, this process can be complex and requires a designated US-based representative known as an FDA registration agent. Understanding how to navigate FDA registration with an agent is essential to ensure your product
Jun 156 min read
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