By John R. Fleder – In a stunning ruling on May 10, 2011, United States District Court Judge Roger W. Titus ruled from the bench in Greenbelt, Maryland, granting a Motion for a Judgment of Acquittal filed by the defendant, Lauren Stevens. Ms. Stevens was formerly …
By Jeffrey N. Wasserstein – As aficionados of all things social media (see our prior postings here, here, here, and here) (other than kitten videos, enough with those already!) we couldn’t help but notice a recent Untitled Letter to Warner Chilcott, LLC, relating to a YouTube video. A …
By Kurt R. Karst – On May 10th, the U.S. District Court for the District of Columbia ruled in FDA’s favor in a case filed last July by Graceway Pharmaceuticals, LLC (“Graceway”) stemming from the Agency’s January 2010 denial of a Graceway citizen petition and approval …
By Kurt R. Karst – On May 9th, FDA announced the May 10th publication of a Federal Register notice proposing and requesting comment on the structure of a user fee program for applications for biosimilar and interchangeable biological products submitted under section 351(k) of the Public …
By Jamie K. Wolszon – ReGen Biologics, Inc. (“ReGen”) has petitioned the U.S. Court of Appeals for the District of Columbia Circuit (“D.C. Circuit”) to review the Center for Devices and Radiological Health (“CDRH”)’s March 30, 2011 order that rescinded the company’s 510(k) clearance of a …
By Kurt R. Karst – While we were at the American Conference Institute’s conference on Paragraph IV Disputes last week, the Federal Trade Commission (“FTC”) announced the publication of its annual summary of agreements filed with the Commission during Fiscal Year 2010 – “Agreements Filed with …
By Wes Siegner & Susan J. Matthees – On April 6, only 2 weeks behind schedule, FDA issued proposed rules (here and here) implementing section 4205 of the Patient Protection and Affordable Care Act of 2010 (“PPACA”), which requires certain restaurants and vending machines to disclose …
By Ricardo Carvajal – As directed by the Food Safety Modernization Act (“FSMA”), FDA published interim final rules amending its administrative detention and prior notice regulations. Both rules (here and here) take effect July 3, 2011. Under the administrative detention regulations as amended, an FDA officer or …
Hyman, Phelps & McNamara's Ricardo Carvajal will speak on the legal aspects of food allergen labeling and control at the Institute of Food Technologists’ 2011 Annual Meeting and Food Expo, taking place in New Orleans from June 11-14. He will also serve as co-instructor for …
By Cassandra A. Soltis – The Interagency Working Group charged with drafting standards for marketing food to children has released draft nutrition principles, available here. The proposed principles are intended to help food companies determine which foods should be marketed to children as a way to …
By John R. Fleder – In 2004, the Federal Trade Commission (“FTC”) brought a civil action against the marketers of products sold as “Coral Calcium Daily” and “Supreme Greens with MSM.” The FTC challenged a number of claims, including that the products allegedly made express or …
By Carmelina G. Allis – Earlier this month, FDA updated the 1998 guidance document regarding changes to a PMA device that may or may not qualify for a 30-Day Notice. This updated document provides new examples of manufacturing changes that may be submitted under a 30-Day …
By Kurt R. Karst – FDA’s recent move to remove from the market hundreds of unapproved cough, cold, and allergy drug products has spawned two new lawsuits that might very well be one of the last hurrahs for court challenges to FDA Drug Efficacy Study Implementation-related …
By Riëtte van Laack – On Friday April 22, 2011, a customer slapped Bayer HealthCare LLC (“Bayer”) with a class action suit in California federal court accusing Bayer of falsely and deceptively advertising the benefits of its Phillips Probiotics Colon Health (“PPCH”) supplements. The complaint alleges …
By Cassandra A. Soltis – A recent case issued by the National Advertising Division (“NAD”) of the Better Business Bureau serves as a reminder to advertisers to clearly demarcate claims when multiple products are advertised in the same medium. In Case #5317, the NAD examined the advertisements …
