By Ricardo Carvajal – FDA released a report summarizing the first seven months of the agency’s experience with its Reportable Food Registry (for more on recent developments pertaining to the RFR, see our prior posting here). The data summarized by FDA show how the potential …
By Alexander J. Varond* & Diane B. McColl – As noted in our blogpost less than two months ago, the U.S. District Court for the District of Columbia held that FDA acted unconstitutionally in Alliance for Natural Health, US v. Sebelius when the agency limited qualified …
By Ricardo Carvajal – As we discussed in a prior posting, Section 4205 of the Patient Protection and Affordable Care Act requires the display of certain nutrition information by chain restaurants and retail food establishments with 20 or more locations doing business under the same …
By Susan J. Matthees – FDA recently announced that the Agency is seeking public comments on how to implement section 4205 of the Patient Protection and Affordable Care Act of 2010 (“PPACA”), which requires certain restaurants and vending machines to disclose nutrition information. The docket opened on …
By Peter M. Jaensch – On July 14, 2010, the Federal Trade Commission (“FTC”) announced an agreement with Nestle HealthCare Nutrition, Inc. (“Nestle”) to settle an FTC investigation with regard to alleged false and misleading health claims. The FTC's Complaint arose from claims made by …
By Ricardo Carvajal – The Supreme Court overturned a district court decision, affirmed by the 9th Circuit Court of Appeals, that enjoined the USDA Animal and Plant Health Inspection Service ("APHIS") from partially deregulating Roundup Ready Alfalfa ("RRA") and prohibited the planting of RRA until …
By Susan J. Matthees – USDA and HHS have announced the availability of the final Report of the Dietary Guidelines Advisory Committee (“DGAC”). The agencies are required by law to jointly update and publish the Dietary Guidelines for Americans at least every 5 years, and …
By Diane B. McColl & Ricardo Carvajal – It’s here! FDA’s Center for Veterinary Medicine (“CVM”) finally implemented a "generally recognized as safe" (“GRAS”) notification program for use of ingredients in animal feed or pet food. We have waited for this program since 1997, when it …
By Ricardo Carvajal – Kellogg Company has agreed to FTC’s expansion of the settlement order that the company entered into in July 2009 regarding false claims that Frosted Mini-Wheats improve children’s attention (see our prior post here). At issue now are “dubious health claims” that Rice …
By Ricardo Carvajal & Diane B. McColl – The Alliance for Natural Health (“ANH”) has prevailed on summary judgment in its court challenge to FDA’s denials of, and restrictions on, certain qualified health claims regarding selenium and cancer. The decision marks the latest chapter in …
By Ricardo Carvajal – FDA has revised its draft guidance on the Reportable Food Registry (“RFR”) to address the new electronic portal for submission of reports, and in response to recent questions that the agency received from industry. Among the more significant changes and additions: A …
By John R. Fleder & Ricardo Carvajal – The Federal Trade Commission ("FTC") has announced a second opportunity for public comment on its proposed issuance of compulsory process orders to 48 food and beverage firms. If those orders are issued, the FTC will demand information …
By Ricardo Carvajal – FDA announced that Reportable Food Registry ("RFR") reports can now be submitted through the new FDA-NIH Safety Reporting Portal, which will also accept reports about problems with pet food, animal drug adverse event reports, and human gene transfer clinical trial adverse …
By Riëtte van Laack – In 2005, the Sanitary Food Transportation Act of 2005 (“SFTA”) was enacted. This law shifted responsibility for safe transportation of food from the U.S. Department of Transportation to FDA. Among other things, the SFTA amended the FDCA to include section …
By Cassandra A. Soltis – That’s what the Food and Drug Administration (“FDA”) is hoping anyway. In a notice expected to be published in the Federal Register on Thursday, April 29, 2010, FDA will announce that it is requesting data and information from “all interested parties,” …
