FDA Regulatory Insights & Compliance Guides

By Alok Naik, R.Ph., M.S. Regulatory Affairs — Managing Partner, Axentra Global Pharma Compliance LLC If you're tracking PFAS in cosmetics by watching FDA alone, you're watching the wrong field. The immediate compliance pressure isn't coming from a single federal rule — it's coming from a fast-growing patchwork of state bans, while MoCRA directs FDA to study the issue. For brands selling nationally, that fragmented landscape is the real challenge. What are PFAS and why do the

By Alok Naik, R.Ph., M.S. Regulatory Affairs — Managing Partner, Axentra Global Pharma Compliance LLC MoCRA didn't replace existing cosmetic labeling rules — it added to them. On top of the long-standing requirements (identity, net quantity, ingredient declaration, Responsible Person name and place of business), there are new and forthcoming obligations every brand selling in the U.S. needs on its labels. Here's the current picture. The new MoCRA labeling requirements 1. Adve

By Alok Naik, R.Ph., M.S. Regulatory Affairs — Managing Partner, Axentra Global Pharma Compliance LLC One of MoCRA's most immediate, fully-enforced obligations is serious adverse event (SAE) reporting. The Responsible Person must report serious adverse events associated with a cosmetic product to FDA within 15 business days. Missing that window is a compliance failure — so every brand selling in the U.S. needs a system in place before an event ever occurs. What is a serious a

By Alok Naik, R.Ph., M.S. Regulatory Affairs — Managing Partner, Axentra Global Pharma Compliance LLC These two terms cause more confusion under MoCRA than almost anything else — and getting them wrong can leave gaps in your compliance. The short version: the Responsible Person owns the product's regulatory obligations; the U.S. Agent is the FDA's in-country point of contact for a foreign facility. They are different roles, with different requirements. What is the Responsible

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

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

By Alok Naik, R.Ph., M.S. Regulatory Affairs — Managing Partner, Axentra Global Pharma Compliance LLC One of the most consequential changes coming under the Modernization of Cosmetics Regulation Act (MoCRA) is mandatory fragrance allergen disclosure on cosmetic labels. For decades, brands have been able to list these substances collectively under the single word "fragrance." That is about to change — and the brands that prepare now will avoid a costly, last-minute labeling sc