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Regulatory Oversight Federal Food Drug and Cosmetic Act (FFDCA) Enforcement Actions

Beveridge & Diamond PC

FDA Food Chemical Regulation: Understanding Pesticide Action Levels

The U.S. Food and Drug Administration’s (FDA) March 2025 publication of its new “Chemical Contaminants Transparency Tool” spotlighted a lesser-known aspect of FDA’s regulation of pesticide residues on food: action levels....more

Foley Hoag LLP

New Intended Use Rule Finalized

Foley Hoag LLP on

On August 2, 2021, the Food and Drug Administration (FDA) published its final intended use rule (the “Final Rule”). The Final Rule amends FDA’s regulations describing the types of evidence relevant to determining a product’s...more

Hogan Lovells

FDA cracks down on pharmaceutical firm for misbranding drug as COVID-19 treatment

Hogan Lovells on

Last week, the U.S. Food and Drug Administration (FDA) Office of Prescription Drug Promotion (OPDP) posted two more warning letters for 2020, bringing the tally to five warning and untitled letters for the year. These...more

King & Spalding

FDA Releases Progress Report Regarding Enforcement Discretion Policy on Hemp-Derived Cannabidiol (CBD)

King & Spalding on

Last week, FDA submitted a report to Congress detailing the Agency’s progress on developing an enforcement discretion policy (i.e., a policy of not taking enforcement action) on hemp-derived cannabidiol (CBD). At the same...more

Stinson LLP

CBD Industry Experiences Wave of New Consumer Lawsuits

Stinson LLP on

The cannabidiol (CBD) industry has been on the receiving end of over a half dozen new consumer class actions in recent weeks, which is likely only the beginning for the emerging industry....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

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