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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

Life in the Fast Lane! FDA Announces the Commissioner's National Priority Voucher Program

On June 17, the Food and Drug Administration announced the establishment of the Commissioner's National Priority Voucher (CNPV) program. Although initial details are sparse, the CNPV promises fast action, allowing drug...more

Leveraging Your Contracts to Address the Impact of Tariffs

Companies are facing a unique trade market. President Trump has announced various tariffs, including additional tariffs on China, the on-again, off-again tariffs on Canada and Mexico, auto tariffs, steel and aluminum tariffs,...more

Healthy or Not? FDA Explains New Standards in Latest Webinar

On April 10, 2025, the Food and Drug Administration (FDA) released a pre-recorded webinar outlining the updated "healthy" nutrient content claim rule. As we previously discussed, the rule will go into effect on April 28,...more

Regulatory Freeze: FDA Pushes Back Effective Date of "Healthy" Nutrient Content Claim Rule

On February 25, the Food and Drug Administration (FDA) announced a delay in the effective date for its final rule updating the criteria to use the "healthy" nutrient content claim on food labeling....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

FDA Issues Final Rule Updating the Criteria for Use of the "Healthy" Nutrient Content Claim

On December 19, 2024, the Food and Drug Administration (FDA) announced a final rule updating the definition of the term "healthy" as used in food labeling. Under the rule, manufacturers may use the term "healthy" and similar...more

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