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Public Health › Final Rules › Federal Food Drug and Cosmetic Act (FFDCA)

Hogan Lovells

HHS Secretary Directs FDA to Explore Rulemaking to Eliminate Self-GRAS Pathway

Hogan Lovells on

The Secretary of the U.S. Department of Health and Human Services (HHS), Robert F. Kennedy, Jr., recently issued a press release directing the Food and Drug Administration (FDA) to take steps to explore possible rulemaking to...more

DLA Piper

FDA Bans Red Dye No. 3 Under the Delaney Clause

DLA Piper on

The US Food and Drug Administration (FDA) has revoked its authorization for the use of FD&C Red No. 3, also known as Red Dye No. 3. Issued on January 15, 2025, the ban will go into effect for food (including dietary...more

Venable LLP

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

Venable LLP on

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

Husch Blackwell LLP

FDA Bans the Use of Red No. 3 in Food and Ingested Drugs

Husch Blackwell LLP on

On January 16, the U.S. Food and Drug Administration (FDA) announced that it is revoking the authorization for use of FD&C Red No. 3 in food (including dietary supplements) and ingested drugs. The dye is commonly used in...more

Akin Gump Strauss Hauer & Feld LLP

In Waning Days of the Current Administration, FDA Announces Red No. 3 Ban

Akin Gump Strauss Hauer & Feld LLP on

On January 15, 2025, FDA announced an order revoking the listings providing for the use of the color additive FD&C Red No. 3 in both foods (including dietary supplements) and ingested drugs. The order is in response to a 2022...more

Hogan Lovells

FDA Issues Final “Healthy” Rule

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On December 19, 2024, the U.S. Food and Drug Administration (FDA) issued its long-awaited final rule updating the requirements for when the term “healthy” can be used as an implied nutrient content claim in food labeling. ...more

McDermott Will & Schulte

FDA’s Fresh Take on Use of “Healthy” in Food Labeling

McDermott Will & Schulte on

On December 19, 2024, the US Food and Drug Administration (FDA) issued a new final rule titled “Food Labeling: Nutrient Content Claims; Definition of Term ‘Healthy.’” The rule revises regulations that govern when food...more

Maron Marvel

Will EPA’s Recent Ban on Methylene Chloride Uses Result in Exponential Litigation Similar to Asbestos?

Maron Marvel on

Methylene chloride, also known as dirchloromethane [osha.gov], is a volatile, colorless liquid with a chloroform like odor. Historically, it has been used in various industrial processes, such as pharmaceutical manufacturing,...more

King & Spalding

LDT Final Rule: Shifting the LDT Battlefield

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On April 29, 2024, the Food and Drug Administration (“FDA” or “the Agency”) released a pre-publication version of the highly anticipated laboratory developed test final rule (“LDT Final Rule”). The LDT Final Rule is...more

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