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, …
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Dietary Supplements
- Diamond Jubilee: The Federal Food, Drug, and Cosmetic Act Turns 75!June 25th, 2013
- NIH Launches Database of Dietary Supplement LabelsJune 24th, 2013
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 …
- House Appropriations Committee Report Expresses Concerns About FDA; Would Require a Slew of New Action DeadlinesJune 13th, 2013
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 …
- FDA Deploys Section 301(ll) in Battle Against DMAAMay 16th, 2013
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 …
- Using Scientific Literature in Food or Dietary Supplement Marketing? Proceed with CautionMay 1st, 2013
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 …
- FTC Loses Again; Court of Appeals Affirms Lower Court’s Determination that Garden of Life’s Expert Opinion Constitutes Competent and Reliable EvidenceApril 18th, 2013
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 …
- GAO Suggests Ways to Improve FDA’s Oversight of Dietary Supplement SafetyMarch 26th, 2013
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 …
- Citizen Petition Asks FDA to Restrict Availability of St. John’s WortJanuary 28th, 2013
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] …
- HHS OIG Reports Take Aim At Weight Loss and Immune Support Dietary SupplementsOctober 3rd, 2012
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 …
- FTC Settlement with Medifast: Weight Loss and Maintenance Claims Must be Supported by One (Not Two) Well-controlled StudySeptember 13th, 2012
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 …
- The POM Wonderful Case Enters the PlayoffsAugust 24th, 2012
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 …
- Court Rejects FTC’s Effort to Require Two StudiesJune 13th, 2012
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 …
- U.S. Senate Slogs Through Amendments and Passes FDA Safety and Innovation Act; Onward to the House BillMay 25th, 2012
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, …
- District Court Decides that Garden of Life’s Expert Opinion Constitutes Competent and Reliable EvidenceMarch 8th, 2012
By Riëtte van Laack – The United States District Court for the Southern District of Florida recently denied a motion by the Federal Trade Commission (“FTC”) to hold Garden of Life and its founder, Jordan S. Rubin (collectively “GOL”) in contempt for allegedly violating a court-issued …
- Senators Hatch and Harkin Request that FDA Withdraw Draft NDI GuidanceJanuary 10th, 2012
By Riëtte van Laack – In a strongly worded letter to FDA Commissioner Hamburg dated December 22, 2011, the principal authors of the Dietary Supplement Health and Education Act of 1994 (“DSHEA”), Senators Orrin Hatch (R-UT) and Tom Harkin (D-IA), requested that FDA immediately withdraw the …