By Ricardo Carvajal & Diane B. McColl – FDA issued warning letters to the manufacturers of certain caffeinated alcoholic malt beverages contending that the products are adulterated under the Federal Food, Drug, and Cosmetic Act (“FDC Act”) because caffeine is not an approved food additive for …
By Ricardo Carvajal – An article in the current edition of the Food and Drug Law Institute’s Update discusses a recent development in the European Union's regulation on health claims used in food labeling that could have the effect of suppressing publication of scientific research on …
By Ricardo Carvajal – A California district court dismissed a class action lawsuit alleging that baked-goods products manufactured by Hostess Brands, Inc. are marketed in violation of California law because they are promoted as containing “0 grams of Trans Fat” despite containing partially hydrogenated oils. The …
By Ricardo Carvajal – FDA announced that its Pediatric Advisory Committee will meet on December 6 to “obtain and discuss information and data that will provide the Agency with a better understanding of current practices, and potential benefits and risks associated with the donation and banking …
By Ricardo Carvajal – The Committee on Examination of Front-of-Package Nutrition Rating Systems and Symbols (part of the Food and Nutrition Board at the Institute of Medicine of the National Academies) recently released a report on the first phase of its study of front-of-package ("FOP") nutrition …
By Ricardo Carvajal – No sooner did FDA hold its advisory committee meeting and public hearing on bioengineered AquAdvantage salmon than Congressional representatives made their displeasure known with the prospect of FDA approval. In addition to signing on to letters of protest to the Commissioner (here …
By Ricardo Carvajal – FDA announced the availability of a draft guidance on acidified food intended to help processors determine whether their products are subject to the current good manufacturing practice ("CGMP") requirements in 21 CFR part 114 and the “Specific Requirements and Conditions for Exemption …
By Ricardo Carvajal – A district court dismissed a complaint alleging consumer fraud in food labeling that highlights the presence of fiber. Plaintiff alleged that defendants violated state consumer fraud laws by failing to disclose that their products contain alleged “non-natural” fibers that “have not …
By Kurt R. Karst – Earlier this week, Senator Patrick Leahy (D-VT) introduced the Food Safety Accountability Act of 2010 (S. 3767). The bill, which follows Sen. Leahy’s Food Safety Enforcement Act of 2010 (S. 3669) introduced earlier this year and the recent egg …
By Ricardo Carvajal – In late August, FDA issued warning letters to Unilever and Dr. Pepper Snapple Group objecting to the use of unauthorized nutrient content claims for antioxidants in the labeling of certain products containing green tea. Similar warning letters addressing other types of …
By Riëtte van Laack – In anticipation of the possible approval of the New Animal Drug Application (“NADA”) for genetically engineered AquAdvantage Salmon (“GE salmon”), FDA announced a public hearing on September 21, 2010, concerning the labeling of food made from such salmon. This is …
By Ricardo Carvajal – In several cases that challenge food marketers’ use of the term “natural” in labeling and advertising, the presiding judges have recently opted to suspend proceedings and seek an administrative determination from FDA as to whether high fructose corn syrup ("HFCS") qualifies …
By Susan J. Matthees – FDA announced yesterday the availability of two new draft guidance documents regarding implementation of the menu labeling provisions of section 4205 of the Patient Protection and Affordable Care Act (“PPACA”). As we reported last month, FDA requested comments on how …
By Diane B. McColl – According to Sharon Benz, Ph.D., Director of the Division of Animal Feeds in FDA's Center for Veterinary Medicine ("CVM"), CVM is moving away from enforcement discretion for new animal feed/pet food ingredients. In a conversation with HP&M's Diane McColl, Dr. …
By Ricardo Carvajal – Late on August 12th, the U.S. Senate Committee on Health, Education, Labor, and Pensions (“HELP”) announced the release its 225-page compromise agreement of the Food Safety Modernization Act (S. 510). The Congressional Budget Office simultaneously released its estimate of the bill, …
