News & Analysis as of

Regulatory Authority Federal Food Drug and Cosmetic Act (FFDCA) Food and Drug Administration (FDA)

McDermott Will & Emery

Loper Bright Could Shift Outlook for FDA Legal Challenges

The US Supreme Court has overruled the longstanding Chevron doctrine, an administrative law doctrine that required courts to defer to reasonable agency interpretations of ambiguous statutes. Loper Bright Enterprises v....more

Latham & Watkins LLP

Food and Drug Omnibus Reform Act Introduces Key Changes to FDA’s Authorities

Latham & Watkins LLP on

The legislation contains several reforms to FDA’s statutory authority and the regulatory framework that it administers. Key Points: ..Omnibus legislation appropriates new funds to FDA and reauthorizes certain FDA...more

Holland & Knight LLP

Court of Appeals Affirms Judgment that Struck Down Rule Mandating Price Disclosure in Pharmaceutical Ads

Holland & Knight LLP on

Holland & Knight's July 2019 Healthcare Law Update reported on a decision by the U.S. District Court for the District of Columbia that struck down a final rule promulgated by the U.S. Department of Health and Human Services...more

Proskauer - Advertising Law

Gin Manufacturer Bacardi Avoids Lawsuit for Its Use of “Grains of Paradise”

A federal judge in the Southern District of Florida recently dismissed an action alleging that Bacardi’s use of a botanical called “grains of paradise” in its gin was “harmful and illegal,” holding that the statute on which...more

Steptoe & Johnson PLLC

FDA Holds First Public Hearing on CBD Regulation

As the market for Cannabidiol (CBD) products continues to rapidly expand across the country, federal agencies are in the early phase of establishing regulations for the processing, dispensing, and ingestion of CBD products....more

King & Spalding

FDA Regulation of Cannabis

King & Spalding on

Agency Notice Touts Authority to Regulate Products Containing Cannabis and Cannabis-derived Compounds - On April 4, 2019, the U.S. Food and Drug Administration (FDA) published a notice in the Federal Register that it...more

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