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Podcast - Developments in FDA & DOJ Regulation and Enforcement of Manufacturer Communications
As previously blogged about here, following notices of proposed rulemaking in 2022 and 2023, on August 22, 2024 the Federal Trade Commission finalized a rule that will impose monetary civil penalties false and misleading...more
Late last month, the U.S. Food and Drug Administration’s (FDA) Office of Prescription Drug Promotion (OPDP) issued its fourth Untitled Letter of the year to AbbVie, Inc. OPDP uses Untitled Letters to inform drug companies and...more
The US Securities and Exchange Commission (SEC) recently released two new sources of guidance for the Marketing Rule. On February 26, the SEC Division of Investment Management released an FAQ clarifying how to include gross...more
Plaintiff Says Splenda 100% Natural Ad Claims Leave a Bitter Taste - A class action lawsuit accuses the makers of Splenda Naturals Stevia, a sugar alternative, of misleading consumers with the claim that the product is...more
On April 17, 2024, the Division of Examinations (the “Division”) of the Securities and Exchange Commission (the “SEC”) published a Risk Alert entitled: “Initial Observations Regarding Advisers Act Marketing Rule Compliance”...more
Brand and influencer collaborations are a key component in marketing products and services, as highlighted in our article on Like & Follow! What to know when #advertising with #influencers. Ad Standards recently updated its...more
The lead-up to the July Fourth holiday was a busy time for endorsement and testimonial watchers—the FTC issued (i) its final, updated Guides to the Use of Endorsements and Testimonials in Advertising, (ii) an updated version...more
I. Advertising Rule Compliance Issues - On September 14, 2017, the staff of the SEC's Office of Compliance Inspections and Examinations (OCIE) issued a National Examination Program Risk Alert on the most frequent advertising...more
On May 27, 2014, an administrative law judge (ALJ) found ZPR Investment Management, Inc. (ZPRIM) and its former owner, Max Zavanelli, to have violated the Investment Advisers Act of 1940 for publishing misleading...more