By Ricardo Carvajal – The would-be marketer of a probiotic suppository submitted a citizen petition (Docket No. FDA-2016-P-1133) to FDA asking the agency to “amend the definition of dietary supplement under the present statutory authority [of DSHEA] and to treat probiotic suppositories the same as oral probiotic …
By Riëtte van Laack – As we have reported on several occasions, “natural claims,” particularly when used in the advertising of food and dietary supplements, are frequently challenged by competitors and consumers. Neither the Federal Food, Drug, and Cosmetic Act (FDC Act), nor FDA regulations, nor …
By Riëtte van Laack – Last week, FDA issued the sixth of the seven major rules expected to issue under the authority of the Food Safety Modernization Act (FSMA), namely the final rule for Sanitary Transportation of Human and Animal Food. Although FSMA directed FDA to …
By Jay W. Cormier – Just a little more than four months after FDA approved AquAdvantage Salmon (AAS) – the first genetically engineered (GE) animal intended for food use – several organizations filed suit against FDA and the U.S. Fish and Wildlife Service (FWS) challenging that approval. Plaintiffs …
By Ricardo Carvajal – That’s our take-away from FDA’s recent public meeting on the implementation of FSMA’s import provisions and the associated regulations (FSVP, VQIP, and Accredited Third Party Certification). Several comments made at the meeting suggest that many importers may still be unaware of the advent …
By Ricardo Carvajal & JP Ellison – In a decision of significance in the realm of food additive regulation, the U.S. District Court for the Northern District of California dismissed a lawsuit targeting coffee-creamer products containing partially hydrogenated oil (PHO) on preemption grounds. The complaint – …
By Jenifer R. Stach & Wes Siegner – If you weren’t aware that the Department of Justice (DOJ) has unsafe dietary supplements on its list of enforcement priorities, you should take notice. On Tuesday March 8th, 2016 as part of National Consumer Protection Week, United States Attorney …
By Etan J. Yeshua – A regulation requiring restaurants in New York City to warn customers about menu items with high levels of sodium was set to take effect last week, but it is now the latest in a string of food labeling laws and regulations …
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 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 …
