By Ricardo Carvajal – When FDA issued a report on the Reportable Food Registry ("RFR") 7 months after the RFR’s implementation, the agency cautioned that it was “too early to draw inferences concerning patterns of food and feed adulteration.” Not so in the agency’s first annual …
By Ricardo Carvajal – The Government Accountability Office ("GAO") issued a report recommending in part that FDA “identify and request from Congress the authorities needed to access evidence from food companies regarding potentially false or misleading structure/function or other claims on food that would allow the …
By Riëtte van Laack – As previously reported here, on Dec. 8, 2010, FDA issued a proposed rule to amend the interim final rule (“IFR”) for the phytosterol health claim. In the preamble to that proposal, the agency stated its intent to discontinue its policy of …
By Ricardo Carvajal – The American Bar Association’s Section of Ligation (specifically the Food and Supplements Subcommittee of the Products Liability Committee) is presenting its First Annual Workshop on Food and Supplements on February 17 in Atlanta. Hyman, Phelps & McNamara, P.C.’s Ricardo Carvajal will be …
By Riëtte van Laack – More than 9 years after issuing a proposed rule, the Food Safety and Inspection Service (“FSIS”) published the final rule for nutrition labeling of single-ingredient meat and poultry products, as well as ground and chopped meat and poultry products. Starting January …
By Ricardo Carvajal – The Food Safety Modernization Act ("FSMA") is now law. We previously blogged on some provisions that take immediate effect (namely stronger records access authority under FDC Act § 414, mandatory recall authority, whistleblower protection, and authority to refuse admission of imported food …
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 …
