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 Facility registration gets the headlines, but product listing is where many brands stumble — because it's a separate, ongoing obligation tied to every individual product. Under MoCRA, the Responsible Person must list each marketed cosmetic with FDA and keep that listing current. Here's what's required. What is cosmetic product listing under MoCRA? Under Section 607(c) of the

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 If you make cosmetics outside the U.S. and want to sell them into the American market, FDA Cosmetics Direct is the filing path for facility registration. This is the step-by-step path, plus the mistakes that most often delay foreign registrants. Step 1: Confirm the facility is in scope for the FDA registration process FDA Cosmetics Direct is the process for facility registrat