US FDA OTC regulations

Life After “De Minimis”: What Importers of Cosmetics, Food, and Supplements Must Know

US FDA Dietary Supplements, US FDA food regulations, US FDA OTC regulations, USA Cosmetic Regulations / By

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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Adverse Event Reporting for Cosmetics | MOCRA Compliance with Cosmereg

Adverse Event Reporting for Cosmetics | MOCRA Compliance with Cosmereg

US FDA Dietary Supplements, US FDA food regulations, US FDA Medical Devices, US FDA OTC regulations, USA Cosmetic Regulations / By

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

Understanding the Role of a US FDA Agent for Cosmetics, OTC, and Drug Products

US FDA OTC regulations, USA Cosmetic Regulations / By

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

Step-by-Step Guide: Obtaining a DUNS Number for FDA Food Facility Registration

US FDA Dietary Supplements, US FDA food regulations, US FDA OTC regulations, USA Cosmetic Regulations / By

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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FDA Withdraw The New OTC Monograph User Fee for FY 2021

FDA Withdraw The New OTC Monograph User Fee for FY 2021

US FDA OTC regulations / By

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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FDA Imposes New Yearly Charges for OTC Monograph Drug Establishment

US FDA OTC regulations / By

FDA Imposes New Yearly Charges for OTC Monograph Drug Establishment   This article has been updated on the 5th of January 2021 https://cosmereg.com/fda-withdraw-the-new-otc-monograph-user-fee-for-fy-2021/   In the past March, President Trump had signed a pandemic aid act named “CARES”. This act featured a measure that reshapes and upgrades the manner specific OTC and non-prescription drugs are

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