By Etan J. Yeshua – Three months after announcing a strategic research plan to support its regulatory agenda, FDA's Center for Food Safety and Applied Nutrition ("CFSAN") this week announced its regulatory priorities for 2013 and 2014, giving those in the food, dietary supplement, and cosmetic …
By Joseph W. Cormier – Last week, the Administrative Conference of the United States ("ACUS") made four recommendations to the Executive Branch and independent agencies, three of which may be of interest to readers of this blog. Among its first recommendations this year, the ACUS …
By Kurt R. Karst – It was 75 years ago today, on June 25, 1938, that President Franklin Delano Roosevelt signed into law the Federal Food, Drug, and Cosmetic Act (“FDC Act”), which replaced the Pure Food and Drug Act of 1906, 34 Stat. 768, …
The National Institutes of Health ("NIH") recently launched a database of labels of dietary supplements being sold in the United States. The database includes, among other information, directions for use, ingredients, business contact information, and claims taken directly from product labels. The database can be …
By Kurt R. Karst – A Draft Committee Report made available by the U.S. House of Representatives Committee on Appropriations that would, once finalized, accompany the Fiscal Year 2014 Agriculture/FDA Apprropriations bill (currently available as a Full Committee Draft), lays out a laundry list of …
By Ricardo Carvajal & Wes Siegner – A year ago, FDA issued a warning letter to USPlabs alleging that certain products containing dimethylamylamine ("DMAA") that were marketed as dietary supplements were adulterated because (1) DMAA is a new dietary ingredient ("NDI") for which no notification had …
Recent actions by FDA and the FTC serve as reminders that both agencies will consider the use of scientific literature in determining whether marketing for a food or dietary supplement conveys disease treatment or prevention. FDA recently issued a warning letter to a company that …
By Riëtte van Laack – As previously discussed, in 2011, the FTC filed an action against Garden of Life and its owner (collectively “GOL”) asking the District Court to order GOL to show cause why it should not be held in civil contempt. The case stems …
By Riëtte van Laack – On March 18, 2013, the Government Accountability Office ("GAO") released a report addressing FDA’s use of Adverse Event Reports ("AERs") in overseeing dietary supplements. Specifically, GAO examined (1) the number and source and the types of dietary supplements identified in adverse …
By Ricardo Carvajal – Pharmacists Planning Service, Inc. ("PPSI"), a California-based “nonprofit public health, consumer, pharmacy education organization,” submitted a citizen petition asking FDA to make St. John’s Wort ("SJW") available only behind the counter. Specifically, the petition asks FDA “to remove sales of [SJW] …
By Ricardo Carvajal & Wes Siegner – The Department of Health and Human Services Office of Inspector General released two reports (see here and here) critical of dietary supplements in the weight loss and immune support categories. OIG focused on those categories because they were reported …
By Riëtte van Laack – Earlier this week, the Federal Trade Commission (“FTC”) announced the settlement of a $3.7 million civil penalty case against Jason Pharmaceuticals (“Jason”), a subsidiary of Medifast Inc., for allegedly violating a 1992 FTC Order regarding weight loss claims. According to the …
By John R. Fleder – We have previously reported about the Federal Trade Commission’s (“FTC”) case against POM Wonderful, the maker of pomegranate juice (here, here, here, and here). In the world of FTC advertising cases, this litigation is certainly “big league” litigation. On September 27, 2010, the …
By Riëtte van Laack – As we previously reported, the United States District Court for the Southern District of Florida denied the Federal Trade Commission’s (“FTC’s”) motion to hold Garden of Life and its founder, Jordan S. Rubin (collectively “GOL”) in contempt for allegedly violating a court-issued …
By Kurt R. Karst – After days of debate and a slew of proposed amendments, the U.S. Senate passed S. 3187, the FDA Safety and Innovation Act, on Thursday afternoon by a roll call vote of 96-1. Senator Bernie Sanders (I-VT), who cast the lone vote against passage, …
