By Riëtte van Laack & John R. Fleder – In hockey parlance, a player gets a “hat trick” when the player scores three goals in one game. In the FDA enforcement world, a “hat trick” – and perhaps a “Gordie Howe hat trick” – would be the …
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- DOJ Makes History: On a Single Day It Files a Criminal Prosecution, a Consent Decree and a Criminal Forfeiture of Foods Involved in the Same IncidentJanuary 26th, 2016
- Soy Protein and Coronary Heart Disease Health Claim Stands – For NowJanuary 22nd, 2016
By Ricardo Carvajal - On January 4, FDA denied the Weston A. Price Foundation’s citizen petition seeking revocation of the health claim for soy protein and coronary heart disease (CHD). As reported in a prior blog posting, the Foundation filed the citizen petition in 2008, and sued the …
- NOP Clarifies What Substances Can Be Used in Post-Harvest Handling of Organic ProductsJanuary 20th, 2016
By Riëtte van Laack – On January 15, 2016, the National Organic Program of USDA's Agricultural Marketing Service (NOP) announced the availability of guidance on substances that may be used in the post-harvest handling of organic products and in facility pest management. Under the Organic Food Production …
- California Supreme Court Holds that the Organic Food Production Act of 1990 Does Not Preempt State Consumer Lawsuits Regarding Organic MislabelingDecember 17th, 2015
By Riëtte van Laack – The Supreme Court of California recently concluded that federal law does not preempt claims against allegedly intentional misrepresentations of organic status of a food. According to the Court, the Organic Foods Production Act of 1990 (OFPA) only preempts state law on …
- Question: What do Sodium Reduction, FOP Labeling, and Medical Foods Have in Common?December 16th, 2015
By Ricardo Carvajal – Answer: They were all designated as high priority items in a Nutrition Program Review (NRP) Report prepared by CFSAN staff for the Center Director in December 2014. (We compiled the report and its attachments into a single PDF, which we repaginated for …
- FSIS Finally Nets “Catfish”December 10th, 2015
By Riëtte van Laack – Although it has taken some time, the Food Safety and Inspection Service (FSIS) of the USDA published a final rule establishing a mandatory inspection program for “catfish (“fish of the order Siluriformes and products derived from these fish.”) This rule implements …
- Tastes Like Chicken: Second “BioPharm” Animal Approved to Produce Biological to Treat Orphan Disease Includes 6th Rare Pediatric Disease Priority Review VoucherDecember 8th, 2015
By Jay W. Cormier – On December 8, 2015, FDA issued a complex set of approvals for a unique product, Kanuma (sebelipase alfa). Kanuma is indicated for the treatment of a rare disease known as lysosomal acid lipase (LAL) deficiency. The list of distinguishing descriptors for the …
- Aloe Vera Extract and Goldenseal Root Powder Added to Proposition 65 List of “Known” CarcinogensDecember 7th, 2015
By Riëtte van Laack – On December 4, 2015, the California Office of Environmental Health Hazard Assessment (OEHHA) added Aloe vera, non-decolorized whole leaf extract and Goldenseal root powder to the list of “chemicals known to the State of California to cause cancer for purposes of …
- The Food Labeling Modernization Act Is BackDecember 3rd, 2015
By Riëtte van Laack - On November 23, an updated version of the Food Labeling Modernization Act (FLMA) of 2013 was introduced. Representatives Frank Pallone and Rosa DeLauro introduced the House bill (H.R. 4061) and a Senate version (S. 2301) was introduced by Senators Richard Blumenthal and …
- A Meeting on Listeria With Potentially High StakesDecember 2nd, 2015
By Ricardo Carvajal – FDA’s Food Advisory Committee (FAC) will meet on December 7-8 to discuss a number of issues related to Listeria monocytogenes (L. mono) in ready-to-eat (RTE) foods. As summarized in the supporting background document, the public health and regulatory challenges posed by L. mono have bedeviled FDA and …
- Something Old, Something New: FDA’s Guidance Documents on Labeling of Genetically Engineered Foods – Including SalmonNovember 24th, 2015
By Ricardo Carvajal – In tandem with its approval of genetically engineered (GE) salmon (see our previous post here), FDA issued two guidance documents on labeling of GE foods – a final guidance document applicable to foods derived from GE plants, and a draft guidance document specific to GE …
- Busy Day at FDA: Agency Approves the AquAdvantage Salmon Under Strict Conditions of Confinement, Rejects Two Related Citizen Petitions, and Issues Two GuidancesNovember 20th, 2015
By Jay W. Cormier – At long last, yesterday FDA approved AquaBounty’s AquAdvantage Salmon. The approval includes a number of related actions from FDA. As part of the approval, and as required by the National Environmental Policy Act (NEPA), FDA issued a Finding of No Significant Impact …
- FDA Proposes Compliance Criteria for Gluten-Free Hydrolyzed, Fermented and Distilled FoodsNovember 19th, 2015
By Riëtte van Laack – In 2013, FDA issued a final rule defining criteria for the term gluten-free for purposes of food labeling. The rule was “incomplete” because it did not address how to test fermented, hydrolyzed and distilled foods for compliance with the rule. In 2013, …
- FDA Rolls Out More FSMA RulesNovember 16th, 2015
By Ricardo Carvajal - FDA released pre-publication versions of the three final rules on foreign supplier verification program (FSVP), accredited third-party certification, and produce safety. As with the recently issued rules on CGMPs and preventive controls for human and animal food (see our previous post here), FDA …
- In Apparent Shift, FDA Engages on “Natural”November 11th, 2015
By Ricardo Carvajal – FDA is publishing a Federal Register notice asking for information and comments on the use of the term “natural” in human food labeling, “including when, if ever, the use of the term is false or misleading.” The notice purports to be based partly on …