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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

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

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

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

FTC Brings the Heat on Pyrex Manufacturer’s “Made in USA” Claims for Products Made in China

Last week the Federal Trade Commission (FTC) announced it had issued a complaint and proposed consent order against Instant Brands LLC for allegedly marketing products as “Made in the USA,” when they were actually made in...more

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