U.S. Food and Drug Administration (FDA) Commissioner Scott Gottlieb has indicated that he will resign by the end of March 2019. Gottlieb reportedly said that he no longer wanted to commute between Washington, D.C., and Westport, Connecticut, where his family lives. Commentators have speculated that Gottlieb's departure may affect FDA initiatives, such as its planned review of the safety of cannabidiol as a food additive.
Tag Archives FDA
The U.S. Department of Agriculture (USDA) and Food and Drug Administration (FDA) have announced "a formal agreement to jointly oversee the production of human food products derived from the cells of livestock and poultry." The agreement "describes the oversight roles and responsibilities for both agencies and how the agencies will collaborate to regulate the development and entry of these products into commerce," according to a press release. "This shared regulatory approach will ensure that cell-cultured products derived from the cell lines of livestock and poultry are produced safely and are accurately labeled."
Class action litigation, the legal landscape for cannabis and the evolving implementation of the Food Safety Modernization Act (FSMA) were trending topics at the 2019 Grocery Manufacturers Association (GMA) Legal Conference. Numerous panels at the conference focused on emerging issues affecting the industry and anticipated trends moving forward, including implications of whole genome sequencing; how courts view the confluence of First Amendment rights and mandated advertising content; and standards-of-identity issues related to non-dairy milks, non-animal meats and cell-grown meats. Shook Partners Katie Gates Calderon, Phil Goldberg and Jim Muehlberger presented with Courtney Ozer, Assistant General Counsel – Litigation for Unilever United States, and Suzanne Werner, Litigation Counsel – The Coca-Cola Company, on strategies for avoiding and defending against claims involving product testing. The panel discussed (i) assembling a crisis-management team, which should include key company stakeholders, inside counsel, public-relations and governmental-relations personnel; (ii) understanding the pending lawsuit, which involves robustly…
U.S. Food and Drug Administration (FDA) Commissioner Scott Gottlieb reportedly said in a February 27, 2019, hearing before the House Appropriations Committee that the agency will hold public hearings on cannabidiol (CBD) in April 2019. Gottlieb reportedly told the committee that FDA is assembling a working group of senior officials to create rules that would govern CBD in food and other uses. According to CNBC, "Gottlieb floated what a possible framework might look like. He suggested high concentrations might be regulated as a drug that has more stringent oversight while lower concentrations could be categorized as food products that come with an easier review process." Meanwhile, a New York City crackdown on CBD in food products has reportedly been postponed. Beginning in October 2019, CBS reports, violators selling CBD food may be subject to fines of $200 and risk lower public health letter grades.
The U.S. Food and Drug Administration has released "Strategy for the Safety of Imported Food," which outlines methods the agency is using to ensure that it meets its four goals: (i) ensuring that imported food meets U.S. food safety requirements; (ii) preventing the entry of unsafe foods; (iii) rapidly responding to unsafe imported foods; and (iv) maintaining an "effective and efficient food import program."
The U.S. Food and Drug Administration (FDA) has announced the availability of "Public Warning and Notification of Recalls," final guidance that aims to "increase and expedite the appropriate and accurate use of public warnings and public notification and to increase public health protection by better informing the public about violative products being recalled." "We’re taking a new step to help ensure appropriate public warnings and notification of recalls when FDA-regulated products are involved," FDA Commissioner Scott Gottlieb said in a statement. "The final guidance we’re issuing today outlines circumstances when a company should issue a public warning about a voluntary recall, describes the general timeframe for companies to issue such a warning, discusses what information should be included in a public warning, and describes situations where the FDA may take action to issue its own public warning should a company’s warning be deemed insufficient."
The U.S. Food and Drug Administration (FDA) has released a report detailing its investigation into a 2018 outbreak of E. coli in romaine lettuce. The report describes the FDA traceback team's investigation into farms with potential links to the outbreak that culminated in a December product recall. "The FDA continues to recommend that leafy green growers, buyer/shippers and retailers be able to trace product back to the specific source in real time and make information about the source, such as harvest date and standardized growing regions, readily available for consumers on either packaging or point of sale signs, or by other means," FDA Commissioner Scott Gottlieb said in a press release. "We’re pleased to see many companies in the leafy green industry take voluntary steps to quickly respond to our previous recommendations. We believe this is the best approach to be able to inform consumers should there be any future…
In a series of tweets, U.S. Food and Drug Administration (FDA) Commissioner Scott Gottlieb announced that about 200 food investigators—of 550—for the agency's Office of Human and Animal Food Operations have been working during the federal government's partial shutdown, with additional staff possibly "on the way depending on needs." Gottlieb further noted which food operations have continued during the shutdown: (i) "[h]igh-risk domestic food surveillance inspections"; (ii) "foodborne illness surveillance and outbreak investigations"; (iii) "[e]xecution of high-risk food recalls"; (iv) "[i]nspection of foreign food facilities"; and (v) "[s]ampling of imported food samples (including sampling for antibiotic residue contamination and decomposition analysis." High-risk foods reportedly include seafood, dairy, fresh produce, spices, eggs, sandwiches and infant formula.
Sens. Ron Wyden (D-Ore.) and Jeff Merkley (D-Ore.) have sent a letter to the U.S. Food and Drug Administration (FDA) requesting an update to federal regulations on cannabidiol (CBD) to "give U.S. producers more flexibility in the production, consumption, and sale of hemp products." Wyden and Merkley urge FDA to answer a series of clarifying questions, including "What lawful pathways are currently available for those who seek approval to introduce Cannabis sativa L. and its derivatives as a food, beverages or dietary supplement, including into interstate commerce?" and "Are there circumstances in which Cannabis sativa L. and its derivatives may be permitted as a food, beverages or dietary supplement by the agency?" “Farmers in Oregon and nationwide are poised to make real economic gains for their communities once these regulations are updated,” a press release quotes Wyden and Merkley as saying. “We will be closely engaged in the ongoing implementation…
A consumer has alleged that Nuts 'N More LLC's White Chocolate Peanut Spread does not contain the amount of milkfat required to meet the U.S. Food and Drug Administration (FDA) definition of "white chocolate." Morrison v. Nuts 'N More LLC, No. 18-11192 (S.D.N.Y., filed November 30, 2018). According to the complaint, FDA requires white chocolate to contain "not less than 3.5 percent by weight of milkfat," but the white chocolate spread does not contain any dairy ingredients. "Because there is no additional milkfat to supplement the Product to meet FDA definition of white chocolate, the Product cannot be marketed as white chocolate and thus must be deemed imitation white chocolate," the plaintiff asserts. She alleges that she and other consumers paid a premium for what she believed to be white chocolate "and received an inferior Product than what was represented to them by Defendant." For alleged violations of New York…
