Food, Drug & Agriculture

On December 6, FDA Commissioner Gottlieb announced in a press release the availability of a new draft guidance entitled, “Developing and Labeling In vitro Companion Diagnostic Devices for a Specific Group or Class of Oncology Therapeutic Products” (Draft Guidance). The agency also published the Draft Guidance announcement in the December 7 Federal Register. FDA issued the Draft Guidance in an effort to “make it easier to get class labeling on diagnostic tests for oncology…
As discussed in this blog two and three weeks ago, the Food and Drug Administration (FDA) and Centers for Disease Control and Prevention (CDC) have been investigating a multistate outbreak of E. coli O157:H7 illnesses that were likely linked to romaine lettuce.  On November 20, CDC advised consumers, retailers, and restaurants not to eat, sell, or serve any romaine lettuce until the source of the outbreak was better understood. On November 26, FDA announced that…
Vermont Packinghouse, LLC, located  in North Springfield, VT,  late Thursday recalled approximately 10,828 pounds of raw intact bone-in beef quarters from cattle identified as being over 30 months of age because the products may contain specified risk materials (SRM), specifically vertebral column, according to the U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS). Specified risk materials (SRM) refer to the  tissues of ruminant animals that cannot be inspected and passed for human food…
Our last post talked about carbohydrate-rich Thanksgiving food. Today, we are talking about a putative class action on the labeling of certain diet foods, particularly in regard to “net carbs” and sugar alcohols. This was not planned. Colella v. Atkins Nutritionals, Inc., No. 17-cv-5867 (KAM), 2018 WL 6437082 (E.D.N.Y. Dec. 7, 2018), on the other hand, has all the hallmarks of a case brought for no reason other than to reward the lawyer. The same…
The federal 2018 Farm Bill is likely to become law in the very near future. If it does, it will redefine the hemp industry nationwide. We intend on writing more in the near future as to the specifics of the 2018 Farm Bill, but one interesting question is what effect it will have on California’s industrial hemp and CBD policies. As anyone in the California hemp business knows, the Department of Public Health (“CDPH”) issued…
Analysis Public interest in the safety of romaine has increased during the past year as Canada and the United States have experienced three back-to-back outbreaks of E. coli O157:H7 tied to the leafy green.  Many people are surprised to learn that a bacteria generally thought of as beginning in the guts of cows is ending up in their salad bowls. But that’s what’s happening, with seven dead out of 350 sickened with E. coli infections. There…
Salmonella and Campylobacter infections were at a stable level during the past five years, but Listeria cases continue to rise in Europe, according to an annual report on trends and sources of zoonoses. The European Centre for Disease Prevention and Control (ECDC) and European Food Safety Authority (EFSA) report is based on 2017 data from all 28 European Union member states and nine other European countries that reported on some zoonotic agents. Listeriosis caused a…
CTI Foods LLC, an Owingsville, Ky. establishment, is recalling approximately 29,028 pounds of frozen, ready-to-eat (RTE) pork and poultry sausage links products that may be contaminated with extraneous materials, specifically pieces of metal, the U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) announced today. The frozen, ready-to-eat sausage links items were produced and packaged on Aug. 4, 2018. The following products are subject to recall: [View Label (PDF Only)] 23.4-oz. pouches of…
Vermont Packinghouse, LLC, a N. Springfield, Vt. establishment, is recalling approximately 10,828 pounds of raw intact bone-in beef quarters from cattle identified as being over 30 months of age because the products may contain specified risk materials (SRM), specifically vertebral column, the U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) announced today. The carcasses were slaughtered from Feb. 8, 2018 to June 8, 2018. The following products are subject to recall: White butcher…
They say the investigation is ongoing and more sources are possible, but as of this afternoon, the FDA is reporting traceback efforts in the ongoing E. coli outbreak linked to romaine lettuce has led to Adam Bros. Farm in Santa Maria, CA. The outbreak strain of E. coli O157H:7 has been confirmed in the sediment of an irrigation reservoir on the family-owned farm, according to officials from the Food and Drug Administration and the Centers…