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Show: results per page Sort by:  | FDA Deploys Section 301(ll) in Battle against DMAA
Ricardo Carvajal, A. Wes Siegner; Hyman, Phelps & McNamara, P.C.;
Legal Alert/Article May 17, 2013, previously published on May 16, 2013 A year ago, FDA issued a warning letter to USPlabs alleging that certain products containing dimethylamylamine ("DMAA") that were marketed as dietary supplements were adulterated because (1) DMAA is a new dietary ingredient ("NDI") for which no notification had been submitted as...
| | FDA Held In Violation of APA for Delay in Issuing FSMA Regulations
Ricardo Carvajal; Hyman, Phelps & McNamara, P.C.;
Legal Alert/Article April 25, 2013, previously published on April 24, 2013 The U.S. District Court for the Northern District of California granted summary judgment to the Center for Food Safety and Center for Environmental Health in their lawsuit alleging that FDA’s delay in issuing regulations to implement the Food Safety Modernization Act ("FSMA")...
| | When is a Website Considered Labeling?
Ricardo Carvajal; Hyman, Phelps & McNamara, P.C.;
Legal Alert/Article April 18, 2013, previously published on April 16, 2013 Our colleagues at the Drug and Device Law Blog recently blogged on the decision in Wilson v. Frito-Lay North America, Inc., a false advertising case out of the Northern District of California in which the court held that statements on a food company’s website did not constitute labeling even...
| | Food Traceability: Recordkeeping Without Regard to Risk?
Ricardo Carvajal; Hyman, Phelps & McNamara, P.C.;
Legal Alert/Article April 11, 2013, previously published on April 9, 2013 Section 204 of the Food Safety Modernization Act ("FSMA") directed FDA to establish pilot projects “to explore and evaluate methods to rapidly and effectively identify recipients of food to prevent or mitigate a foodborne illness outbreak and to address credible threats of serious...
| | FSMA Preventive Controls and OMB: No Cloak or Dagger
Ricardo Carvajal; Hyman, Phelps & McNamara, P.C.;
Legal Alert/Article April 3, 2013, previously published on April 2, 2013 When FDA published its proposed rule on preventive controls as authorized by FSMA, we noted that FDA requested comment on a number of important issues that were not addressed in the text of the regulation itself, namely product testing, environmental monitoring, and supplier approval and...
| | On FSMA’s Second Anniversary, FDA Releases Two Major Proposed Rules
Ricardo Carvajal; Hyman, Phelps & McNamara, P.C.;
Legal Alert/Article January 8, 2013, previously published on January 6, 2013 FDA released two long-awaited proposed rules to implement key provisions of the Food Safety Modernization Act ("FSMA"): Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Human Food and Standards for the Growing, Harvesting, Packing, and Holding...
| | Are Food Allergen Thresholds on the (Far) Horizon?
Ricardo Carvajal; Hyman, Phelps & McNamara, P.C.;
Legal Alert/Article December 28, 2012, previously published on December 27, 2012 Signaling potential movement on an issue that has bedeviled industry, FDA published a notice requesting comments “relevant to conducting a risk assessment to establish regulatory thresholds for major food allergens.” Undeclared major food allergens continue to be one of the two...
| | In a Milestone for Regulation of Imported Foods, New Zealand and U.S. Food Safety Systems are Deemed Comparable
Ricardo Carvajal; Hyman, Phelps & McNamara, P.C.;
Legal Alert/Article December 19, 2012, previously published on December 18, 2012 FDA announced that it executed a Food Safety Systems Recognition Arrangement ("RA") with its counterpart in New Zealand, the Ministry for Primary Indsutries ("PMI"). The RA is the culmination of an assessment that began in 2010 and included both paper and on-site reviews. Based...
| | In Litigation, FDA Explains and Defends FSMA Efforts
Ricardo Carvajal; Hyman, Phelps & McNamara, P.C.;
Legal Alert/Article December 12, 2012, previously published on December 11, 2012 We previously reported on a lawsuit that seeks to compel OMB and FDA to accelerate the implementation of FSMA. Now the government has filed a motion to dismiss the case and for summary judgment. The motion provides a full accounting of FDA’s efforts to implement FSMA, and is worth reading for...
| | In a FSMA First, FDA Suspends a Food Facility’s Registration
Ricardo Carvajal, John R. Fleder; Hyman, Phelps & McNamara, P.C.;
Legal Alert/Article November 30, 2012, previously published on November 29, 2012 On November 26th, Commissioner Hamburg issued an order suspending the registration of the Sunland Inc. food manufacturing facility alleged to be at the heart of the ongoing recall of peanut products potentially contaminated with Salmonella. Until the order is vacated and the registration is...
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