News & Analysis as of

Enforcement Actions › Public Health › Federal Food Drug and Cosmetic Act (FFDCA)

Troutman Pepper Locke

Are State ENDS Directories Preempted? Federal Courts Are Split

Troutman Pepper Locke on

Over the past two years, at least 15 states have enacted laws requiring manufacturers of electronic nicotine delivery systems (ENDS) to certify the status of their federal premarket tobacco product applications (PMTAs) in...more

Morgan Lewis - Well Done

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

Morgan Lewis - Well Done on

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

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

Ropes & Gray LLP

2024 FDA Enforcement Review: Quality and Transparency Remain Critical Concerns

Ropes & Gray LLP on

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

Clark Hill PLC

Red Dye No 3: Old Data Induces New Ban

Clark Hill PLC on

On January 16, 2025 the federal Food and Drug Administration (FDA) issued notice requiring manufacturers to reformulate their products removing Red Dye No. 3 by January 15, 2027 for food (21 CFR §74.303) and January 18, 2028...more

Alston & Bird

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

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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

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

Epstein Becker & Green

After Decades of Broad Enforcement Discretion, FDA Signals New Approach to Homeopathic Drugs

Epstein Becker & Green on

Two announcements made by FDA in late October signal a marked change to FDA’s regulatory approach to “homeopathic” drugs. On October 25, 2019, FDA withdrew the 1988 Compliance Policy Guide (“CPG”) 400.400 Conditions Under...more

Shook, Hardy & Bacon L.L.P.

Dietary Supplement & Cosmetics Legal Bulletin | April 2018

Shook, Hardy & Bacon L.L.P. on

FDA Issues Guidance on Concentrated Caffeine - The U.S. Food and Drug Administration (FDA) has released guidance clarifying that "dietary supplements containing pure or highly concentrated caffeine in powder or liquid...more

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