Alternatives to traditional food products have increased in availability, number, variety and popularity over the last decade. So where does this leave consumers and the regulators who are tasked with ensuring food safety? The Ninth Circuit has held that the reasonable consumer can digest the differences between almonds and cows.
Category: Regulatory
Direct-to-Consumer Advertising and Promotional Labeling Transparency and Pricing Requirements for Pharmaceutical Manufacturers
Government and regulatory agencies have recently provided guidelines regarding the importance of transparency in Direct-to–Consumer (DTC) advertising through proposed regulation and guidance documents.
FDA Warns Against Sales Representative’s “False and Misleading” Oral Statements Regarding Prescription Medicine
The U.S. Food and Drug Administration’s Office of Prescription Drug Promotion (OPDP) sent an untitled letter to Eisai Inc. on October 11, 2018, based on a sales representative’s “false and misleading” oral statements during a lunch presentation about the safety of the antiepileptic medication Fycompa®, downplaying warnings, and engaging in off-label promotion of the product.