By Riëtte van Laack – In 2005, the Sanitary Food Transportation Act of 2005 (“SFTA”) was enacted. This law shifted responsibility for safe transportation of food from the U.S. Department of Transportation to FDA. Among other things, the SFTA amended the FDCA to include section …
By Cassandra A. Soltis – That’s what the Food and Drug Administration (“FDA”) is hoping anyway. In a notice expected to be published in the Federal Register on Thursday, April 29, 2010, FDA will announce that it is requesting data and information from “all interested parties,” …
By Cassandra A. Soltis – In an advertising challenge brought by the Perrigo Company (“Perrigo”), the National Advertising Division (“NAD”) of the Better Business Bureau recommended that Pharmavite, LLC (Pharmavite) refrain from making several claims for its Nature Made® Prenatal + DHA Liquid Softgel Vitamins …
By Ricardo Carvajal – The Office of Inspector General ("OIG") of the U.S. Department of Health and Human Services released a report that finds fault with FDA’s inspection activities for food facilities and recommends several changes, including an expansion of FDA’s statutory authority. OIG reviewed FDA's food …
By Riëtte van Laack – On March 25, 2010, the Food Safety and Inspection Service (“FSIS”) of the USDA published a proposed rule requiring poultry and meat establishments subject to FSIS inspection to promptly notify the authorities when an adulterated or misbranded meat or poultry …
By Ricardo Carvajal – Earlier we blogged on the provisions of the Patient Protection and Affordable Care Act (“PPACA”) that most directly affect pharmaceutical and device manufacturers. The PPACA also contains a number of provisions that will directly and indirectly affect the food industry. Most …
By Peter M. Jaensch – On March 23, 2010, Congressman Jason Chaffetz (R-UT) introduced H.R. 4913 – the Free Speech About Science Act of 2010. The bill proposes several amendments to FDC Act § 403(r) concerning the misbranding of foods, which would have the effect …
By Ricardo Carvajal – In a recently issued guidance document, FDA makes clear that a company with a reportable food located in multiple facilities can submit a single report to the Reportable Food Registry (RFR) instead of individual reports for each facility (a reportable food …
By Riëtte van Laack – For several years, the Consumers Union and the Organic Consumers Association (“Petitioners”) have urged the U.S. Department of Agriculture (“USDA”) to require that personal care products that use the term “organic” in product labeling comply with the requirements of the Organic …
By Nisha P. Shah and Ricardo Carvajal – The title of a report issued by the U.S. Government Accountability Office (“GAO”) neatly sums up that agency’s perspective: “FDA Should Strengthen Its Oversight of Food Ingredients Determined to Be Generally Recognized as Safe (GRAS).” The report …
By Ricardo Carvajal – The ongoing recall of a widely used flavor enhancer known as hydrolyzed vegetable protein ("HVP") for possible contamination with Salmonella could mushroom to affect thousands of products. Although no illnesses have been reported thus far and FDA judges the risk to …
By Cassandra A. Soltis – Think twice before putting that claim on your food label – or on your website. Just last month, FDA issued 16 Warning Letters to food manufacturers regarding unauthorized nutrient content and health claims appearing in food labeling. In addition, some …
By Ricardo Carvajal & Diane B. McColl – In the fourth and most recent draft of the framework of its Animal Feed Safety System (“AFSS”), FDA provides a comprehensive overview of the system and of the significant gaps in that system that FDA intends to …
Hyman, Phelps & McNamara, P.C.’s Ricardo Carvajal will be speaking at FDLI’s upcoming Introduction to Food Law and Regulation: A Program on Understanding How the Government Regulates the Food Industry. Mr. Carvajal will be presenting on food safety and unintended components/contaminants in food. The conference …
By Ricardo Carvajal – While calling for further research on bisphenol A ("BPA"), a chemical used in the manufacture of some plastics, FDA has acknowledged that it has "some concern about the safety of BPA:" At this interim stage, FDA shares the perspective of the …
