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  • Foods and Dietary Supplements

    • Enhanced Criminal Penalties for Food Safety Violators?February 1st, 2011

      By Ricardo Carvajal – Senator Patrick Leahy (D-VT) reintroduced legislation to strengthen criminal penalties for food safety violators in the form of the Food Safety Accountability Act of 2011.  As with the version of the bill introduced last year, the current version would amend Title 18 …

    • FDA Announces Withdrawal of Draft Guidance on Implementation of PPACA Menu Labeling ProvisionsJanuary 25th, 2011

      By Susan J. Matthees – FDA is withdrawing its draft guidance titled “Draft Guidance for Industry:  Questions and Answers Regarding Implementation of the Menu Labeling Provisions of Section 4205 of the Patient Protection and Affordable Care Act of 2010,” which was published in August 2010.  As …

    • Salmonella and Undeclared Allergens Get Starring Roles in FDA’s First Reportable Food Registry Annual ReportJanuary 24th, 2011

      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 …

    • GAO Recommends that FDA Tighten its Grip on Structure/Function Claims in Food LabelingJanuary 23rd, 2011

      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 …

    • Are Dietary Ingredient Facilities Subject to Mandatory HACCP Requirements?January 13th, 2011

      By Ricardo Carvajal & Wes Siegner – As we would wager is true of all major pieces of legislation, the Food Safety Modernization Act (“FSMA”) can be expected to have significant unanticipated consequences.  By way of background, the FSMA requires all food facilities subject to registration …

    • Industry Asks FDA to Extend the Compliance Period for Change in Enforcement Discretion Policy with Regard to Phytosterol Health ClaimJanuary 13th, 2011

      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 …

    • ABA Section of Litigation to hold its First Annual Workshop on Food and SupplementsJanuary 11th, 2011

      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 …

    • 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, …

    • 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 …

    • Surprise, Surprise. . . Food Safety Legislation Roars Back to LifeDecember 20th, 2010

      By Ricardo Carvajal – Capping a week-long flurry of legislative activity, the Senate reportedly passed the Food Safety Modernization Act by a voice vote Sunday night.  The legislation now returns to the House, where approval is likely.  Given that the President’s signature is certain, it now appears …

    • FDA Steps Up Efforts Against “Tainted” Products Masquerading as Dietary SupplementsDecember 19th, 2010

      By Riëtte van Laack – On December 15, 2010, FDA took several steps to increase its enforcement against products that are marketed as dietary supplements but contain analogs of, or the same active ingredients as, FDA-approved drugs, or other substances that do not qualify as dietary …

    • Food Safety Legislation on Life SupportDecember 17th, 2010

      By Ricardo Carvajal – The massive spending bill to which food safety legislation was attached (and that also includes provisions on rare and neglected diseases) – the Fiscal Year 2011 Omnibus Appropriations Act – has been pronounced dead.  Although Congress may yet find another vehicle for …

    • HPM Attorney to Present at FDLI’s Food Law and Regulation ConferenceDecember 17th, 2010

      Hyman, Phelps & McNamara, P.C.’s Ricardo Carvajal will be presenting "Food Safety: Unintended Components/Contaminants of Food" at the Food and Drug Law Institute's ("FDLI’s") January 24-25, 2011 conference, "Introduction to Food Law and Regulation: How the Government Regulates the Food Industry," which is part of FDLI’s Food Week …