By Ricardo Carvajal & Diane B. McColl – The Alliance for Natural Health (“ANH”) has prevailed on summary judgment in its court challenge to FDA’s denials of, and restrictions on, certain qualified health claims regarding selenium and cancer. The decision marks the latest chapter in …
By Ricardo Carvajal – FDA has revised its draft guidance on the Reportable Food Registry (“RFR”) to address the new electronic portal for submission of reports, and in response to recent questions that the agency received from industry. Among the more significant changes and additions: A …
By John R. Fleder & Ricardo Carvajal – The Federal Trade Commission ("FTC") has announced a second opportunity for public comment on its proposed issuance of compulsory process orders to 48 food and beverage firms. If those orders are issued, the FTC will demand information …
By Ricardo Carvajal – FDA announced that Reportable Food Registry ("RFR") reports can now be submitted through the new FDA-NIH Safety Reporting Portal, which will also accept reports about problems with pet food, animal drug adverse event reports, and human gene transfer clinical trial adverse …
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 …
