FDA Regulatory Insights & Compliance Guides

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 facility registration under MoCRA is a prerequisite — and it's actively enforced. This is the step-by-step path, plus the mistakes that most often delay foreign registrants. Step 1: Confirm you're required to register MoCRA requires facilities that manufacture or process cosmetic produc

If you manufacture or process cosmetics outside the United States and sell them in the U.S. market, the answer is almost certainly yes — MoCRA requires foreign cosmetic facilities to designate a U.S. Agent as part of FDA facility registration. Here's exactly who needs one and why it matters. Who is Required to Have a U.S. Agent? Under MoCRA, any foreign facility that manufactures or processes cosmetic products for the U.S. market and must register with FDA is required to desi

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, and many companies need