The Daily Intake

Legal and Regulatory updates for the food and supplement industry

FDA has published two draft guidance documents to assist processors and farmers in complying with product safety requirements under the Food Safety Modernization Act (FSMA). The FSMA final rule on Current Good Manufacturing Practice (CGMP), Hazard Analysis, and Risk-Based Preventive Controls (HARPC) for Human Food (the Preventive Controls Rule) was published on September 17, 2015 (80 FR 55907). In January 2018, FDA published a Draft Guidance to explain the Agency’s current thinking on how to…
As reported by multiple outlets, Stephen Ostroff, FDA’s Deputy Commissioner for Food and Veterinary Medicine, will retire January 5. Ostroff assumed the role of Deputy Commissioner in 2016, previously serving as the acting FDA Commissioner on two occasions. Walmart’s Vice President for Food Safety and Health, Frank Yiannas, is set to replace Ostroff. Yiannas will have a different title, Deputy Commissioner for Food Policy and Response, reflecting FDA’s ongoing efforts to reorganize the agency.…
The Executive Office of the President recently released its Fall 2018 Unified Agenda of Regulatory and Deregulatory Actions. Twice a year, federal agencies publish this comprehensive report describing regulations currently under development or recently completed. The agenda provides stakeholders with a preview of agencies’ top regulatory priorities for the coming months. This fall’s agenda highlights significant regulatory undertakings by the U.S. Department of Agriculture (USDA) and the U.S. Food and Drug Administration (FDA). Of…
A California appeals court stayed a trial that had been scheduled for this week, to determine penalties in the Proposition 65 case against Starbucks and other defendants for failure to warn for acrylamide in coffee under Proposition 65.  It is the latest in the eight year saga of the case, which was filed by Center for Education and Research on Toxics (CERT). The defense successfully argued that the trial should be delayed, pending the outcome…
The Center for Food Safety (CFS) and the Center for Environmental Health (CEH) filed suit against the FDA on October 15 for failure to implement provisions of the Food Safety Modernization Act (FSMA).  CFS and CEH assert FDA has failed to meet several important FSMA action deadlines related to FDA’s mandate to classify and designate certain foods as “high-risk” for foodborne illness purposes, and to create additional recordkeeping requirements for facilities handling such foods. These…
Washington State Initiative 1634 would ban local taxes on groceries. The initiative defines groceries as “any raw or processed food or beverage, or any ingredient thereof, intended for human consumption except alcoholic beverages, marijuana products, and tobacco. The ban would not apply to existing taxes, including Seattle’s sweetened-beverage tax (see our January 2, 2018, blog for more information on the Seattle tax). Washington’s Initiative 1634 will be on the November 6 ballot. (Proposed initiatives needed…
As previously reported in The Daily Intake, FDA has requested comments pertaining to consumer awareness and understanding of the use of milk and other dairy terms on plant-based alternatives.  Depending upon the feedback received, FDA could then potentially revisit its policy of not enforcing the standard of identity for milk as it pertains to labeling plant-based products like almond milk, soy yogurt, and vegan cheese. FDA’s Standards of Identity define milk in part as…
As previously reported in The Daily Intake, on August 10, 2018 Dewayne Johnson was awarded $289 million in his case against Monsanto, maker of the popular herbicide Roundup, by a San Francisco jury.  The award, which included $250 million in punitive damages, was to compensate Mr. Johnson for the lymphoma that he alleged was caused by exposure to professional strength Roundup.  Monsanto has vowed to appeal. As reported in Law360 (subscription) and various other…
As previously reported on this blog, the U.S. Department of Agriculture (USDA) and the Food and Drug Administration (FDA) announced that they will hold a joint meeting on October 23-24, 2018, to discuss the use of cell culture technology to develop products derived from livestock and poultry. The meeting will focus on potential hazards, regulatory issues, and labeling issues. There has been an ongoing debate as to whether USDA or FDA should have regulatory jurisdiction…
A class action lawsuit filed by Lenora Rice in Cook County, Illinois alleges that LaCroix manufacturer, National Beverage Corp, falsely markets its popular flavored sparkling water as “all natural.” The complaint states that LaCroix sparkling waters are “manufactured using non-natural flavorings and synthetic compounds,” but are labeled as “all natural” and “always 100% natural.” Specifically, LaCroix is alleged to contain ethyl butanoate, limonene, linalool, and linalool propionate.  According to FoodNavigator  the substances named in the …