By Riëtte van Laack – This case dates back to November 2004, when the FTC filed a complaint in the United States District Court for the Northern District of Georgia, alleging that defendants, including the National Urological Group, Inc., Hi-Tech Pharmaceuticals, Inc., Jared Wheat and Stephen …
By Wes Siegner – Just in time for the windup to ad campaigns for the fall/winter cold/flu season, FDA has sent Zarbee’s, Inc. a Warning Letter alerting the company that its dietary supplement products are in fact illegal drugs, some prescription drugs, given the claims that the …
By Kurt R. Karst – On May 29th, the U.S. House of Representatives Committee on Appropriations voted 31-18 during a mark-up session to send to the House floor its version of the Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2015, along …
By Riëtte van Laack – The FDC Act, as amended by the Dietary Supplement Health and Education Act (“DSHEA”) of 1994, excludes from the definition of dietary supplement any article that is approved as a new drug and any article “authorized for investigation as a new …
By Wes Siegner – Dan Fabricant has now left FDA. In his short tenure as FDA division head and spokesperson on dietary supplement matters, the agency devoted more resources to dietary supplement enforcement matters. Moreover, the industry was routinely criticized for failing to file new …
By Jennifer M. Thomas & James P. Ellison – Hyman, Phelps & McNamara, P.C. (HP&M) filed comments on April 7 concerning FDA’s Guidance document, Investigational New Drug Applications (INDs) — Determining Whether Human Research Studies Can Be Conducted Without an IND (the “Guidance”). HP&M has previously blogged …
The American Bar Association’s Section of Ligation (specifically the Food and Supplements Subcommittee of the Products Liability Committee) just announced its Fourth Annual Food & Supplements Workshop, scheduled for June 5 in the Minneapolis area. Among the topics to be addressed: Emerging Issues: Surveying the Regulatory …
By Riëtte van Laack – Last week, FDA announced the long awaited proposal for revisions to the regulations (here and here) for the format and mandatory information included in the Nutrition Facts Box (“NFB”) and the Supplement Facts Box (“SFB”), and for the calculation of the …
By Ricardo Carvajal – The Institute of Medicine (“IOM”) published a summary report of the workshop on caffeine in food and dietary supplements that IOM convened last August at FDA’s request. As noted in the introduction to the summary, the summary presents statements, recommendations, and opinions …
By Riëtte van Laack – On January 13, FDA announced the availability of two guidances concerning beverages and liquid dietary supplements: “Distinguishing Liquid Dietary Supplements from Beverages” and “Considerations Regarding Substances Added to Foods, Including Beverages and Dietary Supplements.” Both guidances are derived from FDA’s 2009 …
Next Wednesday, December 12th, the ABA Section of Litigation, Products Liability Committee is sponsoring a live audio program titled “Understanding criminal prosecution of food and supplement companies (and their corporate officers) under the Food Drug and Cosmetic Act: Best practices to avoid becoming the next …
By Ricardo Carvajal & Kurt R. Karst – According to contingency plans drawn up by the Department of Health and Human Services, 45% of FDA’s nearly 15,000 staff were to be furloughed in the absence of enacted annual appropriations – popularly referred to as a …
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, …
