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Bemotrizinol joins the FDA sunscreen monograph — and why the pathway matters more than the molecule On 9 June 2026, the US Food and Drug Administration issued a Final Administrative Order adding bemotrizinol to the over-the-counter sunscreen monograph. Most of the coverage has framed this as a new ingredient arriving in America. For a regulatory […]
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OMUFA FY 2026: FDA OTC Drug User Fees, Rates & Key Deadlines The FDA has published the fiscal year 2026 fee rates under the Over-the-Counter Monograph Drug User Fee Amendments (OMUFA II). The headline changes: facility fees for OTC monograph drug manufacturers have dropped approximately 50% compared to FY 2025, while OTC Monograph Order Request
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Life After “De Minimis”: What Importers of Cosmetics, Food, and Supplements Must Know Introduction The elimination of de minimis import rules 2025 marks a turning point for global trade. The change rescinds previous rules allowing sub-$800. Shipments that once bypassed duties and simplified entry now require full customs clearance and compliance. For businesses importing cosmetics,
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FDA OTC Sunscreen Compliance: A Complete Guide for U.S. Market Registration Introduction Sunscreens are considered Over-the-Counter (OTC) drug products in the United States and are subject to strict regulatory oversight by the U.S. Food and Drug Administration (FDA). If you’re a cosmetic brand, private labeler, or manufacturer looking to sell sunscreen products in the U.S.,
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What is Adverse Event Reporting for Cosmetic Products? | MOCRA Compliance with Cosmereg With the Modernization of Cosmetics Regulation Act of 2022 (MOCRA), the U.S. FDA has strengthened regulatory requirements for cosmetic products, bringing them closer to the standards seen in food and drug industries. One of the most significant changes is the mandatory reporting
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The Role of the US FDA Agent for Cosmetics, OTC and Drug Products If you’re a foreign manufacturer of Cosmetics and OTC medications and prescription drug products, appointing a US Agent for FDA purposes is crucial. But what exactly does a US FDA agent do? First of all check here the difference between a cosmetic,
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How to get a DUNS number for food facility registration with the FDA In the United States, both domestic and foreign facilities engaged in the manufacturing, processing, packing, or storage of food intended for human or animal consumption are required by law to register with the U.S. Food and Drug Administration (FDA). This registration process
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Over the counter drug registration in the US An OTC drug or over-the-counter drug is a product that has generally been considered safe to use without a doctor’s prescription. Many people in the United States need drugs to treat certain ailments and at times when the condition being treated doesn’t necessarily require a visit
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US FDA OTC Monograph User Fee for FY 2021 Update The US Food and Drug Administration (FDA) announced new Over-the-Counter (OTC) Monograph consumer fees for fiscal year (FY) 2021 on March 26, 2021. The OTC Monograph User Fee Program (OMUFA), which was created by the passage of the March 2020 CARES Act, would require
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FDA Withdraw The New OTC Monograph User Fee for FY 2021 January 5, 2021 Update: FDA decided to withdraw their newly published OMUFA fees on December 29, 2020 Federal Register Notice entitled “Fee Rates Under the Over-the-Counter Monograph User Fee Program for Fiscal Year 2021″ till further notice. In the past March, President Trump
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