By John R. Fleder, Douglas B. Farquhar & Ricardo Carvajal – The U.S. Attorney for the Eastern District of California (Sacramento) has announced guilty pleas by two individuals for fraudulent activities in connection with their distribution of tomato products. Allegedly at the direction of her superiors …
By John R. Fleder, Douglas B. Farquhar & Ricardo Carvajal – FDA has obtained summary judgment and an order of permanent injunction against a Minnesota seafood supplier that was found to have had an inadequate HACCP plan for more than three years, in violation of FDC …
By Ricardo Carvajal The Second Circuit Court of Appeals has rejected the New York State Restaurant Association’s (NYSRA’s) challenge to a New York City Board of Health (NYC) regulation requiring all menu boards and menus in chain restaurants with 15 or more establishments nationally to bear …
By Ricardo Carvajal – Disagreeing with an earlier New Jersey district court decision, a California district court has ruled that there is no federal preemption of an unfair competition claim against the manufacturer of a food that contains high fructose corn syrup ("HFCS") and is labeled …
By Ricardo Carvajal – FDA has approved the biological product ATryn, an anticoagulant derived from the milk of genetically engineered ("GE") goats. The approval follows on the heels of the agency’s issuance of long-awaited guidance on its regulatory approach to GE animals, which we discussed …
By Ricardo Carvajal & Susan J. Matthees – The FDA Globalization Act (“FDAGA”) of 2008 was “meant to stimulate discussion about how to provide adequate funding and authority for FDA to ensure safety” of products over which the agency has jurisdiction. When we commented on …
By Ricardo Carvajal – USDA has suspended, and proposes to debar, Peanut Corporation of America ("PCA") from “participating in government contracts or subcontracts, as well as federal non procurement programs,” among other activities. The suspension is for one year and is effective immediately. The proposed debarment …
The latest issue of the Food and Drug Law Institute’s “Update” magazine features articles written by four Hyman, Phelps & McNamara, P.C. attorneys. The first article, titled “Imported Products – FDA Is Not Fooling Around,” was written by Dara Katcher Levy and John R. Fleder. It …
By Wes Siegner & Ricardo Carvajal – Last August, FDA published data that the Agency had gathered on the content of lead in 324 vitamin products labeled for use by women or children. FDA made clear that its estimates of lead exposures for all of …
By Diane B. McColl & Ricardo Carvajal – In an attempt to improve import safety and further implement its Food Protection Plan, FDA has issued a Guidance for Industry titled “Voluntary Third-Party Certification Programs for Foods and Feeds.” The guidance recognizes that independent certification of …
By Kurt R. Karst – Those following the subject of preemption of conflicting state laws have speculated for months whether the Obama Administration might undo the position FDA has advanced in Federal Register announcements and in court filings in which the Agency has generally staked …
By Diane B. McColl & Ricardo Carvajal – In response to a citizen petition filed on behalf of a pharmaceutical company, FDA has determined that products containing pyridoxamine (a form of vitamin B6) are not dietary supplements within the meaning of FDC Act § 201(ff) and …
By Riëtte van Laack & Ricardo Carvajal – On January 15, the Center for Veterinary Medicine ("CVM") published its final guidance on “Regulation of Genetically Engineered Animals Containing Heritable Recombinant DNA Constructs.” The final guidance describes CVM’s application of the FDC Act’s new animal drug provisions …
Ricardo Carvajal of Hyman, Phelps & McNamara, P.C. will be moderating panels or speaking in two upcoming conferences that address dietary supplement and food regulatory issues. The first is a Food and Drug Law Institute conference titled “What you Need to Know Now about Emerging …
By Ricardo Carvajal – FDA has issued a proposed rule that would amend the standard of identity for yogurt and revoke the regulations on standards of identity for lowfat and nonfat yogurt. Under § 401 of the FDC Act, FDA has the authority to establish a …
