Tag Archives FDA

The U.S. Food and Drug Administration (FDA) has deactivated an import alert that prevented the introduction of genetically engineered (GE) salmon into interstate commerce. The agency's statement indicates that it placed the ban in 2016 with the intention of lifting it when standards for labeling GE food were finalized. With the implementation of the National Bioengineered Food Disclosure Standard in late 2018, the authority to regulate GE food shifted to the U.S. Department of Agriculture (USDA), according to the statement, so the import ban deactivation will remove barriers for USDA regulation. "With the deactivation of the import alert, AquAdvantage Salmon eggs can now be imported to the company’s contained grow-out facility in Indiana to be raised into salmon for food. As was determined during the FDA’s 2015 review, this fish is safe to eat, the genetic construct added to the fish’s genome is safe for the animal, and the manufacturer’s…

Kind LLC has submitted a citizen petition urging the U.S. Food and Drug Administration (FDA) to require disclosure of added sugar and trans fat on food packaging and remove the required disclosures for total fat and cholesterol. In addition, the petition recommends that FDA "[r]evise its nutrient content claim regulations to only allow a food to bear a nutrient content claim highlighting the presence or absence of a nutrient if the food contains a meaningful amount of at least one health-promoting food, such as: vegetables, fruits (especially whole fruits), whole grains, legumes, nuts, and seeds, which are recommended in the most recent Dietary Guidelines for Americans."

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.

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.