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Next Step for Cosmetic Products' Regulatory Makeover

On August 7, 2023, the U.S. Food and Drug Administration (FDA) issued draft guidance on new requirements for registration and listing of cosmetic product facilities and products. The draft guidance follows the signing of the...more

Biden Administration's End to COVID-19 Public Health Emergency to Impact Devices Under Enforcement Discretion

On January 30, 2023, the Biden administration announced its intent to end the national emergency and public health emergency (PHE) declarations on May 11, 2023. These emergency declarations have been in place since early...more

A Much-Needed Makeover: Congress Signs Updates to Cosmetic Regulations

The Modernization of Cosmetics Regulation Act of 2022 (MoCRA), signed into law on December 29, 2022, as part of the year-end Consolidated Appropriations Act, 2023, added significant new requirements for manufacturers,...more

FDA Cracks Down on Companies Listing CBD as an Inactive OTC Ingredient

On March 22, 2021, the U.S. Food and Drug Administration (FDA) issued warning letters to two companies, Honest Globe Inc. and Biolyte Laboratories LLC, for selling products labeled as containing cannabidiol (CBD) in ways that...more

FDA's COVID-19 Test Kit Policy Shortsighted and Creates Unacceptable Industry Confusion

In recent days, the U.S. Food and Drug Administration's (FDA's) policy granting authorization to manufacturers and laboratories for desperately-needed COVID-19 test kits has created mass confusion and even led to the...more

FDA Declares CBD Is Not GRAS and Signals That It Will Maintain Its Deliberate Approach

With its recent issuance of additional warning letters and the release of a consumer update, the Food and Drug Administration (FDA) appears to be signaling that it will continue its deliberate approach in determining an...more

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