Lisa Alsobrook

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As we previously reported, the United States Department of Agriculture (USDA) Food Safety and Inspection Service (FSIS) and the Food and Drug Administration (FDA) have issued a “Formal Agreement Between FDA and USDA Regarding Oversight of Human Food Produced Using Animal Cell Technology Derived from Cell Lines of USDA-amenable Species” (the press release can be found here).  The agreement provides helpful answers regarding many regulatory aspects of the cell-cultured food industry,…
  In 2014, the Food and Drug Administration (FDA) began random sampling and testing of a variety of commodities from domestic and foreign sources to learn more about the prevalence of disease-causing bacteria.  The first commodities sampled were sprouts, whole fresh avocados, and raw milk cheese (aged 60 days), followed by cucumbers and hot peppers.  Each commodity was tested for Salmonella, Listeria monocytogenes, and E. coli O157:H7.  Hot peppers were also tested for Shiga-toxin producing E.…
 Kavanaugh, Roberts In Crossfire of Battle Over ‘Auer’ (subscription to Law360 required) The U.S. Supreme Court heard arguments on March 27, 2019 about whether to overturn the principle of judicial review of federal agency actions that requires a federal court to yield to an agency’s interpretation of an ambiguous regulation that the agency has promulgated.  Under this policy, known as ‘Auer deference’ from the 1997 case Auer v. Robbins, a court must yield to…
  The California Office of Environmental Health Hazard Assessment (OEHHA) has tasked the Developmental and Reproductive Toxicant Identification Committee (DARTIC) of OEHHA’s Science Advisory Board with evaluating whether cannabis (marijuana), marijuana (cannabis) smoke, cannabis extracts, and Δ-9-Tetrahydrocannabinol (THC) have been shown to cause reproductive toxicity (developmental toxicity endpoint).  Chemicals identified as reproductive toxicants by the DARTIC are added to the Proposition 65 list. OEHHA is initiating the development of hazard identification materials on cannabis chemicals…
The U.S. Department of Agriculture’s (USDA) Food Safety and Inspection Service (FSIS) is concerned with an increase in recent years in the number of recalls of meat and poultry products contaminated with foreign materials.  Notably, in many cases, the recalling establishments had received multiple customer complaints before these recalls.  Customer complaints for meat and poultry products can often signal adulteration or misbranding issues that trigger regulatory requirements under 9 C.F.R. Part 416 – Sanitation,…
Amazon, Walmart, Costco Sued Over Fake ‘Kona’ Coffee (subscription to Law360 required) Section 43(a) of the Lanham Act (15 U.S.C. 1125) permits a civil action for, among other reasons, “false designation of origin.”  To prevail, a plaintiff must prove the designation of origin is false, that it is used in a commercial advertisement (e.g., a label) in interstate commerce, that it deceives or is likely to deceive in a material way, and it has caused…
  As reported here, the domestic and import inspection program for Siluriformes fish and fish products (including catfish) was transferred from FDA to USDA in response to a congressional mandate.  After September 1, 2017, only foreign countries that had submitted documentation showing the equivalence of their Siluriformes fish inspection system with that of the U.S. could continue exporting these products to the U.S.  Additionally, as of August 2, 2017, all shipments of imported Siluriformes…
  As covered on this blog, FDA has worked to strengthen the recall process for food, drugs, medical devices, and cosmetics in response to a report by the Office of Inspector General (OIG) of the U.S. Department of Health and Human Services concluded that FDA’s recall process can be too slow and puts consumers at risk.  21 CFR Part 7, Subpart C provides guidance on policy, procedures, and industry responsibilities for recalls (including product…
  As previously covered on this blog, the City of San Francisco passed legislation in June 2015 that required health warnings to be placed on advertising for sugar-sweetened beverages (i.e., nonalcoholic beverages with caloric sweeteners that contain more than 25 calories per 12 oz.). Specifically, the warning would have read: “WARNING: Drinking beverages with added sugar(s) contributes to obesity, diabetes, and tooth decay. This is a message from the City and County of San…
  FDA and USDA employees furloughed during the 35-day partial government shutdown have returned to work this morning after the President signed legislation on Friday to temporarily reopen the government for 3 weeks.  While this is very good news, it will take some time before all activities are running smoothly again. FDA Commissioner Dr. Scott Gottlieb’s recent tweets on starting back suggest that much of today will be spent on administrative issues. We expect that government…