By Wes Siegner – In April 2005, FDA published guidance for industry on dietary supplement labeling, “A Dietary Supplement Labeling Guide.” As we wrote in 2009, an error in this guidance, stating that the term “dietary supplement” was not an acceptable statement of identity on its …
By Ricardo Carvajal – The prompt was an invitation to speak at the 21st Annual Tulane Environmental Law and Policy Summit on the pros and cons of genetically engineered food animals, in the wake of FDA’s approval of AquAdvantage salmon as a new animal drug (a topic we’ve …
By Ricardo Carvajal & Jay W. Cormier – In response to a Congressional directive buried in the 2016 Consolidated Appropriations Act (“the Appropriations Act”), FDA issued an Import Alert targeting “[a]ny shipment of suspected or known GE salmon or product composed in whole or in part of GE …
By Ricardo Carvajal & JP Ellison – According to public communications by the restaurant chain Chipotle, the company has been served with subpoenas in a federal criminal investigation apparently arising out of one or more outbreaks of foodborne illness that appear to implicate certain of the …
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 …
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 …
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 …
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 …
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 …
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 …
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 …
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 …
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 …
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 …
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 …
