By Riëtte van Laack – In April 2012, a California consumer filed a class action lawsuit against The Hershey Company alleging that Defendant’s Special Dark Chocolate Bars, Special Dark Kisses, Special Dark Cocoa and Cocoa were misbranded because they carried impermissible nutrient content claims, including nutrient …
By Ricardo Carvajal – The Center for Science in the Public Interest (“CSPI”) is taking on caffeination and fortification of foods with renewed vigor. In a letter to FDA/CFSAN’s Office of Compliance, CSPI alleges that certain foods to which caffeine is added “appear to violate [FDA’s] …
By Ricardo Carvajal – FDA published a draft Compliance Policy Guide ("CPG") that sets out enforcement criteria for ackee fruit products that contain hypoglycin A, a toxin that is naturally present in the fruit. Adverse effects of consuming the toxin can range from none to vomiting, …
By Ricardo Carvajal – The Government Accountability Office ("GAO") published a report that examines FDA’s progress in implementing provisions of the Food Safety Modernization Act ("FSMA") that direct the agency to establish a third-party certification system for imported foods. Among other things, that system is a …
By Ricardo Carvajal – As the November 6 election draws near, debate over California’s Proposition 37 is heating up. If the measure passes, genetically engineered ("GE") foods sold at retail in the state would have to be labeled as such – a requirement that would have …
The U.S. Pharmacopeial Convention (“USP”) recently announced at an Awards and Recognition Program for USP Expert Volunteers that the 2012 USP Award for an Innovative Response to Public Health Challenges went to the Food Ingredients Expert Committee. Hyman, Phelps & McNamara, P.C. Director Diane B. …
By Ricardo Carvajal – A federal district court dismissed a class action that took issue with a number of allegedly false and misleading claims made on the label of Benecol, a butter/margarine alternative. The claims at issue include “each serving contains .85g of plant stanol …
By Ricardo Carvajal – A federal court has ruled that the express preemption provisions added to the Federal Food, Drug, and Cosmetic Act (“the Act”) by the Nutrition Labeling and Education Act (“NLEA”) do not preempt Florida’s standard of identity for honey. Plaintiffs in the case, …
By Ricardo Carvajal – A consumer group, Citizens for Health, submitted a citizen petition (Docket No. FDA-2012-P-0904) to FDA asking the agency to “take action to protect the public from the illegal, mislabeled use of high fructose corn syrup (‘HFCS’) that is above 55 percent fructose” and …
By Ricardo Carvajal – The Center for Food Safety and the Center for Environmental Health filed suit in the Northern District of California to compel FDA and the Office of Management and Budget (“OMB”) to implement several major provisions of the Food Safety Modernization Act (“FSMA”). …
Hyman, Phelps & McNamara, P.C.’s Diane McColl will present at USP’s 2012 Science & Standards Symposium, which is dedicated to functional foods and dietary supplements. The conference will address scientific and regulatory issues from an international perspective, and will feature speakers from USP and NIH’s …
By Riëtte van Laack – The Organic Food Products Act of 1990 (“OFPA”) established national standards for the marketing of certain agricultural products marketed as organically produced. It directed USDA to issue regulations specifying the requirements for certification and labeling of organic agricultural products. In promulgating …
By Riëtte van Laack – The U.S. Government Accountability Office ("GAO") released a report on FDA’s food recall process prepared in response to a congressional directive in the Food Safety Modernization Act ("FSMA"), which provided FDA with mandatory recall authority for foods. In evaluating FDA’s implementation, the …
By Ricardo Carvajal – According to an informal policy, FDA considers the use of the term “natural” in food labeling to mean that nothing artificial or synthetic (including colors regardless of source) is included in, or has been added to, the product that would not normally …
By Riëtte van Laack – The Animal Drug User Fee Amendments of 2008 (“ADUFA”) directs FDA to prepare and publish annual summaries of antimicrobial animal drugs sold or distributed for use in food-producing animals. The data are derived from information submitted by sponsors of antimicrobial new …
