News & Analysis as of

Public Health Federal Food Drug and Cosmetic Act (FFDCA) Food Safety

Cozen O'Connor

FDA Encourages Food Manufacturers to Phase Out FD&C Red No. 3 Ahead of 2027 Deadline

Cozen O'Connor on

On July 14, 2025, the Food and Drug Administration (FDA) issued new guidance encouraging food manufacturers to phase out FD&C Red No. 3 ahead of the previous 2027 deadline and “as soon as is practicably possible.” Recall...more

Perkins Coie

Caffeine Safety Legislation Introduced in Congress

Perkins Coie on

On March 31, 2025, Congress saw the reintroduction of H.R. 2511, the Sarah Katz Caffeine Safety Act. The bill would amend the Federal Food, Drug, and Cosmetic Act to establish new regulatory requirements for labeling the...more

Kelley Drye & Warren LLP

MAHA Movement Continues to Invite Significant Change for Food Regulation at Federal and State Levels

Robert F. Kennedy Jr. promised big changes as Secretary of the Department of Health & Human Services, the sweeping agency that oversees FDA, NIH, CDC, and other divisions and agencies. Five months into his tenure, he has...more

Epstein Becker & Green

The End of the Self-Affirmed GRAS Pathway?

Epstein Becker & Green on

On March 10, 2025, Robert F. Kennedy, Jr., Secretary of the U.S. Department of Health and Human Services (“HHS”), in a seismic shift, announced that the U.S. Food and Drug Administration (“FDA”) would “explore potential...more

Morgan Lewis - Well Done

The Future of Artificial Colors in the US Food Supply Is Not So Bright

Only weeks after being confirmed, the Department of Health and Human Services (HHS) secretary has advised food companies to remove artificial colors from their food products. He recently met with several major food brand...more

Holland & Knight LLP

HHS Explores Stronger FDA Oversight for Food Ingredients

Holland & Knight LLP on

U.S. Department of Health and Human Services (HHS) Secretary Robert F. Kennedy Jr. announced on March 10, 2025, that he directed the acting commissioner of the U.S. Food and Drug Administration (FDA) to explore potential...more

Hogan Lovells

FDA Finalizes Two Food Allergen-Related Guidance Documents

Hogan Lovells on

On January 6, 2025, FDA published two final guidance documents related to food allergens: Questions and Answers Regarding Food Allergens, Including the Food Allergen Labeling Requirements of the Federal Food, Drug, and...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

Ropes & Gray LLP

2024 FDA Enforcement Review: Quality and Transparency Remain Critical Concerns

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The U.S. Food and Drug Administration (“FDA”), in partnership with the Department of Justice (“DOJ”), pursued significant and, in some cases, precedent-setting enforcement actions in 2024. The government continued to...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

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

Alston & Bird

$19 Million Criminal Penalty Levied Against Food Manufacturer Serves as a Stark Reminder of the Importance of Food Safety...

Alston & Bird on

A salmonella outbreak that sickened hundreds brought the largest criminal penalty ever imposed following a criminal conviction in a food safety case. Our Food & Beverage and White Collar, Government & Internal Investigations...more

McDermott Will & Schulte

Special Report - 2022 FDA Year in Review

As the United States’ primary public health and consumer protection agency, the US Food and Drug Administration (FDA) regulates at least one quarter of the nation’s economy and exerts significant influence over global...more

Morgan Lewis - Well Done

Anti-Spoil(er) Alert: FDA Issues Guidance on Antimicrobial Agents in Food

Morgan Lewis - Well Done on

FDA issued an updated Q&A guidance in September 2021, Microbiological Considerations for Antimicrobial Agents Used in Food Applications: Guidance for Industry (Antimicrobial Agents Guidance), which replaces a guidance...more

Morgan Lewis - Well Done

Sesame Becomes Newest Major Food Allergen

US President Joseph Biden signed into law the Food Allergy Safety, Treatment, Education, and Research Act (FASTER Act) in April, establishing sesame as the ninth major food allergen under the Federal Food ...more

Hogan Lovells

U.S. Congress passes the FASTER Act to require sesame allergen labeling

Hogan Lovells on

On 14 April 2021, the U.S. Congress passed the Food Allergy Safety, Treatment, Education, and Research (FASTER) Act of 2021 (S. 578), which now heads to the White House for signature. ...more

Hogan Lovells

FDA issues draft guidance on voluntary disclosure of sesame when added as flavoring or spice

Hogan Lovells on

On 10 November 2020, the U.S. Food and Drug Administration (FDA) announced the availability of a draft guidance recommending that companies voluntarily declare sesame in the ingredient list when it is used as a “flavor” or...more

Hogan Lovells

Recent FDA Warning Letters focus on inadequate allergen controls following undeclared allergen recalls

Hogan Lovells on

The U.S. Food and Drug Administration (FDA) recently issued a fifth Warning Letter related to allergen labeling, continuing a series of Warning letters in the past six months that cite companies for failing to “identify and...more

Sheppard Mullin Richter & Hampton LLP

The Farm Bill’s Impact on Hemp and CBD – and How Some States are Reacting

While the legal landscape continues to evolve in the cannabis industry, making entry into the space a potentially risky proposition, the passage of the Agriculture Improvement Act of 2018 (the “Farm Bill”) can be a real game...more

Hogan Lovells

FDA Deauthorizes Seven Synthetic Flavorings and Adjuvants as Food Additives

Hogan Lovells on

On October 9, 2018, the U.S. Food and Drug Administration (FDA) issued a final rule revoking authorization for seven synthetic flavorings and adjuvants as food additives. Notably, FDA’s rigorous scientific analysis determined...more

Shook, Hardy & Bacon L.L.P.

Food & Beverage Litigation Update | August 2018 #3

LEGISLATION, REGULATIONS & STANDARDS - ASA Upholds Complaints Against Ads Targeting Children - The U.K. Advertising Standards Authority (ASA) has upheld the Obesity Health Alliance’s complaints against advertisements...more

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