By Diane B. McColl & Ricardo Carvajal – On December 28th, FDA reopened the public comment period for its 1997 proposed rule that outlined the voluntary GRAS notification process intended to replace the voluntary GRAS affirmation petition process. FDA stopped accepting GRAS affirmation petitions and implemented …
By Cassandra A. Soltis – The Food and Drug Administration (“FDA”) posed that question in 2005, when it issued an advance notice of proposed rulemaking concerning the serving sizes of products that could reasonably be consumed at one eating occasion. 70 Fed. Reg. 17010 (Apr. 4, …
By Ricardo Carvajal - Although many of the Food Safety Modernization Act's ("FSMA's") major provisions have a delayed effective date (including the requirement to develop and implement a HACCP plan), some significant provisions will take immediate effect, including: Stronger records access authority (FSMA § 101). FDA gains authority …
As expected, the U.S. House of Representatives passed the Food Safety Modernization Act (H.R. 2751) as passed by the Senate. The bill now goes to the President, who is expected to sign it into law. A copy of the bill is available here (scroll down to …
By Ricardo Carvajal – A class action lawsuit has been filed in California alleging that the McDonald’s Corporation engages “in the unfair, unlawful, deceptive and fraudulent practice of promoting and advertising McDonald’s Happy Meal products to very young California children, using the inducement of various toys.” The …
The Washington Legal Foundation recently published an article written by HPM attorneys, Ricardo Carvajal and Nisha P. Shah, on the February 2010 Government Accountability Office ("GAO") report that criticized FDA's general oversight of uses of ingredients that are generally recognized as safe (“GRAS”) and the agency's …
Hyman, Phelps & McNamara’s Paul Hyman and Ricardo Carvajal recently published an article in Food Chemical News on the cost of inadequate substantiation of health-related claims made in the labeling and advertising of foods. Although FDA appears reluctant to take an aggressive stance with respect …
By Ricardo Carvajal – In a strongly worded opinion, a federal judge has ordered that genetically modified sugar beet stecklings (seedlings) planted pursuant to permits issued by USDA be pulled from the ground. As we noted in a prior blog posting, USDA/APHIS was found in violation …
By Ricardo Carvajal No sooner had we blogged on Senate passage of the Food Safety Modernization Act than Roll Call reported that the bill might be doomed by a constitutional flaw – namely that § 107 of the bill proposes fees, and Article I, section 7 …
By Ricardo Carvajal - FDA announced that its Food Advisory Committee will meet on March 30 and 31, 2011, “to discuss whether available relevant data demonstrate a link between children’s consumption of synthetic color additives in food and adverse effects on behavior.” Earlier this year, the European …
By Ricardo Carvajal – By a vote of 73 to 25 (see the roll call here), the Senate has passed S. 510, the Food Safety Modernization Act. As we noted in a prior posting, the Senate HELP Committee released a compromise agreement in August that would …
By Ricardo Carvajal – It’s the time of year for holiday food safety alerts. The home kitchen has long been recognized as a significant source of foodborne illness. Reliable data are hard to come by, but a recent survey and study suggest that consumer awareness and …
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 …
