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 …
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 …
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 …
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 …
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 …
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 …
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 …
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 …
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 …
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 …
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 …
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) …
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 …
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; …
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 …
