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FDA and USDA Call for a Definition of Ultra-Processed Foods

On July 23, 2025, the U.S. Food and Drug Administration (FDA) and U.S. Department of Agriculture (USDA) announced a joint Request for Information (RFI) to gather information and data to help establish a federally recognized...more

FDA Regulatory Updates for Summer 2025: Food, Supplements, and Cosmetics

Recent actions by the Food and Drug Administration (FDA or Agency) reflect a sharpened scrutiny in areas where public health and safety may be critical, but a more relaxed approach in areas where it views innovation may be...more

Get Ready for New York's June 1 Registration Deadline for Certain Aerosols

By June 1, all entities that supply, manufacture, produce, or distribute aerosol products that contain fluorinated greenhouse gases with a GWP20 greater than 10 (regulated substances), for sale or use in New York, must...more

FDA Launches Operation Stork Speed to Make Infant Formula Healthy Again

On March 18, the U.S. Department of Health and Human Services (HHS) and the Food and Drug Administration (FDA) announced the launch of Operation Stork Speed “to enhance [FDA’s] efforts to ensure the ongoing quality, safety,...more

Red Dye No. 3 Ban at FDA and What's Next

On January 15, 2025, the Food and Drug Administration (FDA or Agency) issued an order to revoke the authorization for the use of FD&C Red No. 3 (Red No. 3) in food and ingested drugs in response to a 2022 color additive...more

Food and Color Additives - Is the Patchwork Here?

State legislatures are actively pursuing bans on food and color additives.  California’s landmark Food Safety Act (Act), effective January 2027, bans the manufacture and sale of products containing brominated vegetable oil...more

Event in Review: The Modernization of Cosmetics Regulation Act of 2022

The Modernization of Cosmetics Regulation Act of 2022 (MoCRA) is the biggest change to the scope of the U.S. Food and Drug Administration's (FDA) regulatory authority over cosmetics since 1938. ...more

New York Court Denies Dietary Supplement Trade Association's Motion for a Preliminary Injunction - The New State Law Is in Effect

As we have previously discussed, a new law from New York State will require companies selling dietary supplements for weight loss or muscle building to pay close attention to consumers' age. This law went into effect on...more

FDA Finalizes Section V of the 2016 Revised Draft NDI Guidance

On March 4, FDA announced the availability of a final guidance, Dietary Supplements: New Dietary Ingredient Notification Procedures and Timeframes – Guidance for Industry. The guidance finalizes Section V: NDI Notification...more

FDA Launches Cosmetics Direct, Issues Final Guidance on Registration and Listing of Cosmetic Product Facilities and Products Under...

Last week, the U.S. Food and Drug Administration (FDA) launched Cosmetics Direct, a new electronic submission portal for the registration and listing of cosmetic product facilities and products under the Modernization of...more

New York State Prohibits Sales of Diet Pills and Dietary Supplements for Weight Loss and Muscle Building to Minors

A new law from New York State will require companies selling certain dietary supplements in the state to pay close attention to consumers' age. Last week, Governor Kathy Hochul signed into law Assembly Bill A5610D, which...more

Prepare Now for the New FDA Requirements for Cosmetics Companies

Thanks to the Food and Drug Omnibus Reform Act (FDORA), cosmetic companies will soon be subject to new requirements for registration, product listing, disclosure of ingredients, adverse event reporting, safety substantiation,...more

FDA Medical Device Updates to Emergency Use Authorizations and Enforcement Discretion Issued During the COVID-19 Public Health...

On March 24, 2023, the Food and Drug Administration (FDA) finalized two transition plan guidance documents for medical devices that either 1) were issued Emergency Use Authorizations (EUAs), or 2) received enforcement...more

What Companies Regulated by the FDA Need to Know About the Consumer Product Safety Commission

The U.S. Consumer Product Safety Commission (CPSC) is an independent federal agency that regulates the manufacture, distribution, and sale of consumer products in the United States. Specifically, the Commission is tasked with...more

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