By Susan J. Matthees – FDA is extending the deadline for comments to the proposed rule on menu labeling from June 6 to July 5, 2011 (see our previous post here). FDA states in a notice to be published in the Federal Register on May 24th …
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- FDA Extends Comment Period for Proposed Rule on Menu LabelingMay 23rd, 2011
- GAO Issues Critical Seafood Safety Report (and Domestic Catfish Farmers Rejoice)May 19th, 2011
By Ricardo Carvajal – In a report titled “Seafood Safety: FDA Needs to Improve Oversight of Imported Seafood and Better Leverage Limited Resources,” GAO found fault with many aspects of FDA’s imported seafood safety program. GAO set the stage for its review by noting that more …
- Imposing Needless Burdens on Small and Large Businesses, FDA’s Proposed Regulations on Menu and Vending Machine Labeling Requirements Need More WorkMay 5th, 2011
By Wes Siegner & Susan J. Matthees – On April 6, only 2 weeks behind schedule, FDA issued proposed rules (here and here) implementing section 4205 of the Patient Protection and Affordable Care Act of 2010 (“PPACA”), which requires certain restaurants and vending machines to disclose …
- FSMA Update: FDA Publishes Interim Final Rules to Amend its Administrative Detention and Prior Notice RegulationsMay 4th, 2011
By Ricardo Carvajal – As directed by the Food Safety Modernization Act (“FSMA”), FDA published interim final rules amending its administrative detention and prior notice regulations. Both rules (here and here) take effect July 3, 2011. Under the administrative detention regulations as amended, an FDA officer or …
- HP&M Attorney to Present at IFT Annual Meeting and Pre-Meeting Food Labeling Short CourseMay 4th, 2011
Hyman, Phelps & McNamara's Ricardo Carvajal will speak on the legal aspects of food allergen labeling and control at the Institute of Food Technologists’ 2011 Annual Meeting and Food Expo, taking place in New Orleans from June 11-14. He will also serve as co-instructor for …
- 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 …