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    • Nutritional Labeling for Raw Meat and Poultry Products Coming to you January 1, 2012January 6th, 2011

      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 …

    • With New Food Safety Law, Significant Burdens on Industry (and on FDA)January 5th, 2011

      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 …

    • A Holiday Present to the Human and Animal Food Industries: FDA Reopens Comment Period on 1997 GRAS Notice Proposed RuleJanuary 4th, 2011

      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 …

    • Will Increasing Beverage Serving Sizes Send the Wrong Message to Consumers?January 3rd, 2011

      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, …

    • With the Food Safety Modernization Act Set to Become Law, Certain Provisions Will Take Immediate EffectDecember 23rd, 2010

      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 …

    • House Passes Food Safety LegislationDecember 21st, 2010

      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 …

    • Would You like a Parenting Class with that Happy Meal?December 16th, 2010

      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 Value of GRASDecember 9th, 2010

      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 …

    • The Cost of Inadequate SubstantiationDecember 7th, 2010

      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 …

    • Federal Judge Orders that Genetically Modified Sugar Beet Seedlings be Pulled from the GroundDecember 6th, 2010

      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 …

    • Food Safety Legislation Hits a RoadblockDecember 2nd, 2010

      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 …

    • Color Warnings on Hyperactivity Coming to a Food Near You?December 1st, 2010

      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 …

    • U.S. Senate Advances Food Safety LegislationNovember 30th, 2010

      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 …

    • Have a Happy (And Safe) ThanksgivingNovember 24th, 2010

      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 …

    • FDA and FTC Target Caffeinated Alcoholic Malt BeveragesNovember 23rd, 2010

      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 …