News & Analysis as of

Warning Letters Food and Drug Administration (FDA) Rulemaking Process

Skadden, Arps, Slate, Meagher & Flom LLP

Joint FDA/HHS Initiative Targeting Direct-to-Consumer Pharmaceutical Advertising Garners Much Attention, but Legal Basis and...

On September 9, 2025, the Department of Health and Human Services (HHS) and Food and Drug Administration (FDA) announced a new initiative to close what the agencies describe as a “loophole” in requirements regarding the...more

Sheppard Mullin Richter & Hampton LLP

FDA’s Vast Ad/Promo Warning – Enforcement Ramp-Up or PR Nothingburger?

Late Tuesday, FDA issued a press release warning that it would be sending “thousands of letters warning pharmaceutical companies to remove misleading ads and issue approximately 100 cease-and-desist letters to companies with...more

Shook, Hardy & Bacon L.L.P.

Food & Beverage Litigation Update l October 2019 #2

LEGISLATION, REGULATIONS & STANDARDS - FDA Warns Company Selling CBD Oil - The U.S. Food and Drug Administration has published a warning letter it sent in September 2019 to a company selling cannabidiol (CBD) oil as a...more

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