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    • Feds Propose Voluntary Principles for Marketing Food to ChildrenMay 4th, 2011

      By Cassandra A. Soltis – The Interagency Working Group charged with drafting standards for marketing food to children has released draft nutrition principles, available here.  The proposed principles are intended to help food companies determine which foods should be marketed to children as a way to …

    • At the Atlantic Food Summit, Talk of Sustainability, Security, Nutrition Policy – and FDA PrioritiesApril 26th, 2011

      By Ricardo Carvajal -  The Atlantic’s second annual Food Summit in Washington, DC brought together speakers and attendees with divergent views on questions of how to ensure sustainability of the food supply, improve the availability and affordability of foods, and address the problem of obesity.  On one …

    • Food Safety Crime Bill Clears SenateApril 21st, 2011

      By Ricardo Carvajal – The Senate has adopted legislation that would strengthen criminal penalties "for any individual or corporation that knowingly endangers American lives by contaminating the food supply by distributing misbranded or tainted food products" (see Sen. Leahy's press release here).  The legislation provides for …

    • HPM Attorney to Speak at ACI Food Safety Regulatory Compliance ConferenceApril 11th, 2011

      Hyman, Phelps & McNamara's Ricardo Carvajal will be speaking on the Reportable Food Registry at the American Conference Institute’s 2nd Advanced Summit on Food Safety Regulatory Compliance, taking place in Chicago from June 15-16, 2011.  See here for a copy of the brochure and to register …

    • A Useful Resource on the Food Safety Modernization Act (and the Price is Right)April 7th, 2011

      By Ricardo Carvajal – FDA has a web page devoted to the Food Safety Modernization Act (“FSMA”) that provides ready access to useful information on the new law and on FDA’s implementation activities, including: the text of the law; Q&A’s; descriptions of the work groups charged with implementation; the text …

    • Challenges of Implementing FSMA Import Provisions Take ShapeMarch 30th, 2011

      By Ricardo Carvajal – At FDA’s public meeting on the food import safety provisions of the Food Safety Modernization Act ("FSMA") (see our prior blog posting here), the challenges posed by implementation of those provisions started to take shape.  Presentations by agency personnel, industry representatives, and …

    • Adverse Event Reports Might or Might Not be Material Information to InvestorsMarch 23rd, 2011

      By Ricardo Carvajal – The Supreme Court affirmed a 9th Circuit Court of Appeals decision that allows a securities fraud class action to go forward against Matrixx Initiatives, Inc. ("Matrixx") for allegedly violating § 10(b) of the Securities Exchange Act and Exchange Commission Rule 10b-5.  As …

    • FDA Publishes Q&A on Radiation Safety, Issues Import AlertMarch 23rd, 2011

      By Ricardo Carvajal – Last week FDA published a Q&A that explains steps the agency is taking to ensure that foods imported from Japan are safe.  Currently FDA does not believe there is any risk to the U.S. food supply, but is continuing to gather information …

    • Candy + Calcium = Warning LetterMarch 21st, 2011

      By Riëtte van Laack – On March 4, 2011, FDA issued a warning letter to Goetze’s Candy Co. Inc., because the addition of calcium to Goetze’s Caramel Cream Chocolate goes against FDA’s food fortification policy, 21 C.F.R. § 104.20.   Goetze marketed its product with the (impermissible) …

    • Failure to Launch: OIG’s Recommendations to HHSMarch 21st, 2011

      By Jennifer D. Newberger – One of the tasks of the Office of Inspector General (“OIG”) of the Department of Health and Human Services (“HHS”) is to make recommendations that will result in cost savings and/or improvements in program efficiency and effectiveness.  Unfortunately, as we are …

    • FDA Begins Implementing the Food Safety Modernization Act’s Import Safety ProvisionsMarch 11th, 2011

      By Ricardo Carvajal -  In an upcoming issue of the Federal Register, FDA is announcing a public meeting scheduled for March 29 to solicit comment on the import safety provisions of the Food Safety Modernization Act ("FSMA").  At the meeting, appropriately titled “Food Safety Modernization Act; …

    • The Jury Is Still Out on Impact of Menu LabelingMarch 9th, 2011

      By Susan J. Matthees – The USDA’s Economic Research Service (“ERS”) recently published an article titled “Will Calorie Labeling in Restaurants Make a Difference?” that considers the potential impact of the new menu labeling requirements for chain restaurants.  As we previously reported (here and here), § 4205 …

    • Sen. Leahy Asks DOJ for Update on Investigation of Peanut Corporation of AmericaFebruary 23rd, 2011

      By Ricardo Carvajal – In a letter directed to Attorney General Eric Holder, Senator Patrick Leahy (D-VT) asked the U.S. Department of Justice (“DOJ”) for an update on its investigation of the Peanut Corporation of America (“PCA”) and its president, Stewart Parnell.  According to the letter, FDA …

    • Food Design and the 2010 Dietary Guidelines: If Food Companies Comply, Will Consumers Buy?February 8th, 2011

      By Cassandra A. Soltis – The Dietary Guidelines for Americans, 2010 (the 2010 Dietary Guidelines), released by the federal government last week, were clearly drafted with the U.S. obesity epidemic in mind.  In addition to encouraging consumers to exercise more and reduce calorie consumption, the guidelines …

    • Health-Conscious Plaintiff Prefers the Ice Cream Bar: Makers of Nutella Sued for Allegedly False and Misleading “Balanced Breakfast” ClaimFebruary 8th, 2011

      By Peter M. Jaensch – In what appears to be yet another example of a consumer fraud class action that cites alleged  violations of the FDC Act and its implementing regulations, on February 1, 2011, Athena Hohenberg filed a class action lawsuit in U.S. District Court …