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 – The U.S. Court of Appeals for the District of Columbia Circuit recently declined to stop USDA/AMS implementation of the amended Country of Origin Labeling ("COOL") regulations for beef, pork, and poultry products requiring identification of the country where the animals are …
By Ricardo Carvajal – A putative class action targeting certain food products that declare “evaporated cane juice” (ECJ) as an ingredient was recently stayed based on the doctrine of primary jurisdiction. As noted by the Court, prior decisions have gone both ways on the question of …
GMA Science Forum 2014 kicks off on April 6 in Washington, DC. The Forum will feature numerous sessions addressing scientific and regulatory issues of interest to the packaged food industry. A complete agenda is available here. HPM attorneys will help present a half-day introduction to …
By Riëtte van Laack – Defendants Wellness Support Network, and co-owners Robert and Robyn Held, marketed two diabetes products – Diabetic Pack and Insulin Resistance – as medical foods. In 2005 and 2006, FDA issued two Warning letters to them (here and here), claiming the products …
By Ricardo Carvajal – Sabra Dipping Co., LLC ("Sabra") submitted a citizen petition (Dokcket No. FDA-2014-P-0259) asking FDA to establish a standard of identity ("SOI") for hummus. The proposed SOI would define hummus as “the semisolid food prepared from mixing cooked, dehydrated, or dried chickpeas and tahini” with …
By JP Ellison – We previously posted (here and here) about the Supreme Court case that will be argued next month in which the parties are debating the proper interplay between the Federal Food, Drug, and Cosmetic Act (“FDC Act”) and the Lanham Act. Briefly, the issue …
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 Wes Siegner – The following organizations filed joint comments on November 26, 2013 voicing strong opposition to the food provisions of FDA’s final IND Guidance and requesting that FDA reopen the comment period to permit comment on the food provisions of the guidance, which FDA …
By Ricardo Carvajal, Diane B. McColl & JP Ellison – The Center for Food Safety filed suit in the DC District Court challenging FDA’s allegedly “unlawful action of exempting substances that are [GRAS] from regulation as food additives under a proposed rule for more than fifteen …
By Ricardo Carvajal – FDA entered into a consent decree with the Center for Food Safety that specifies new deadlines for the agency’s submission of final rules implementing FSMA to the Federal Register for publication. The consent decree marks the latest chapter in a case that …
By Ricardo Carvajal – FDA published a notice announcing the availability of a Draft Approach for Designating High-Risk Foods, and asking for comments and information to help the agency refine that approach. Designation of a food as a High-Risk Food (HRF) would trigger additional recordkeeping requirements intended …
By Riëtte van Laack – On Friday, February 7, 2014, the FTC filed its long-awaited brief in the D.C. Circuit action concerning POM Wonderful LLC’s (“POM’s”) advertising for its pomegranate products (see our previous post here). Not surprising, the FTC asserts that POM’s ads were deceptive. First, …
By Riëtte van Laack – FDA published a proposed rule to implement the Sanitary Food Transportation Act of 2005 (“SFTA”) in the Federal Register on February 5. FDA also published Questions and Answers related to the sanitary transportation of human and animal food. Enacted in 2005, the …
