The U.S. Food and Drug Administration (FDA) has published the results of its investigation into an outbreak of E. coli in November and December 2019 caused by romaine lettuce and other leafy greens from the Salinas Valley area of California. FDA found that nearby land used for cattle grazing was the most likely contributing factor associated with three outbreaks that stemmed from three distinctly different strains of E. coli.
Category Archives Food and Drug Administration
The U.S. Food and Drug Administration (FDA) has published a food-safety checklist for retail food establishments that have been closed or operating in a limited capacity during shelter-in-place orders. The list covers issues that may arise if a facility has been closed, such as ensuring water and sewage lines or coolers and freezers are working, and approaches to slowing the spread of COVID-19, such as social distancing measures and increased outdoor air circulation. Checklist sections include facility operations; water, plumbing and ice; cleaning, disinfecting and sanitizing for food contact and non-food contact surfaces; food temperature control; product inspection and rotation; warewashing equipment; handwashing stations; employee health; and social distancing.
The World Health Organization (WHO) has issued “COVID-19 and food safety: guidance for food businesses,” which provides information on the risks of transmission of COVID-19 in the food and beverage industry. “It is highly unlikely that people can contract COVID-19 from food or food packaging,” the guidance states. “Coronaviruses cannot multiply in food; they need an animal or human host to multiply.” Instead, it urges industry to “reinforce personal hygiene measures and provide refresher training on food hygiene principles to eliminate or reduce the risk of food surfaces and food packaging materials becoming contaminated with the virus from food workers.” The guidance provides specifics on hygiene standards, such as open food displays and the use of disposable gloves. The U.S. Food and Drug Administration has also provided several resources for food and beverage companies, including a list of frequently asked questions. The website features regularly updated questions on a number…
The U.S. Food and Drug Administration has urged several sellers of products with cannabidiol (CBD) to stop marketing their products as able to treat or prevent COVID-19. The letters, sent by the Center for Drug Evaluation and Research (CDER), emphasize that “FDA is taking urgent measures to protect consumers from certain products that, without approval or authorization by FDA, claim to mitigate, prevent, treat, diagnose, or cure COVID-19 in people.” The targeted CBD Sellers—including Indigo Naturals, Native Roots Hemp, CBD Online Store and Nova Botanix LTD—market their products with claims ranging from “boosting the immune system” to providing stress relief “when everyone else is panicking.” The letters urge the companies to respond within 48 hours to a CDER COVID-19 Task Force email address.
The U.S. Food and Drug Administration has released its plan to combat outbreaks of Shiga toxin-producing E. coli (STEC) carried by leafy greens. "Due to the reoccurring nature of outbreaks associated with leafy greens, FDA has developed this commodity-specific action plan," the announcement states. "Expediting the improved safety of leafy greens will require collaboration between FDA and stakeholders in the public and private sectors, including industry and our regulatory partners. This plan is designed to help foster a more urgent, collaborative, and action-oriented approach." The plan details actions on prevention, response and addressing knowledge gaps.
The U.S. Food and Drug Administration (FDA) has released the third and final installment of its draft guidance on intentional adulteration of food under the Food Safety Modernization Act. The guidance focuses on food defense corrective actions, food defense verification, reanalysis and recordkeeping. The rule applies to domestic and foreign companies required to register with FDA as food facilities.
A U.S. federal court entered a consent decree of permanent injunction prohibiting Home Style Foods, Inc., and its owner and quality manager from selling food products until the company complies with federal regulations. U.S. Food and Drug Administration (FDA) inspections reportedly found Listeria monocytogenes in the company's food preparation area and documented violations of seafood safety regulations. “After repeated food safety violations, the FDA worked with the U.S. Department of Justice to obtain this injunction in order to prevent potentially contaminated food from reaching consumers. The company failed to take the appropriate corrective actions resulting in this action,” an FDA official said in a press release. “When a company fails to follow the law, the government will take action to protect the food supply."
The U.S. Senate has voted to confirm Stephen Hahn as the commissioner of the U.S. Food and Drug Administration (FDA). Hahn, an expert in radiation oncology, reportedly promised to prioritize science, data and public health over political interests when directing the agency's policy.
The U.S. Food and Drug Administration (FDA) has issued a consumer update on cannabidiol (CBD) products and other products containing ingredients derived from cannabis. The update clarified that FDA "is concerned that people may mistakenly believe that trying CBD 'can't hurt'" because the agency has "seen only limited data about CBD's safety and these data point to real risks that need to be considered." FDA warned that CBD may have potential to injure the liver, cause negative drug interactions and affect male reproductive health, safety risks the agency identified during its review for the drug form of CBD. FDA's update coincided with the release of several warning letters to CBD companies from the agency's Center for Drug Evaluation and Research. The letters warned companies that the language used to describe the benefits of CBD amounted to adulterated foods and misbranded drugs. Following the November 25, 2019, update, consumers filed several…
The Government Accountability Office (GAO) has released a recommendation that the U.S. Food and Drug Administration (FDA) establish a process that ensures the agency tests at least one shipment of imported seafood before removing it from alert status. GAO reviewed 274 removal decisions between 2011 and 2018 and found that FDA did not conduct audits for 260, or 95%, of the decisions. "FDA officials said they conducted limited sampling because many import alert removal decisions can be supported by documentary evidence provided by firms," GAO announced. "Additionally, for certain violations that indicate a firm failed to meet regulatory or administrative requirements and may pose a public health hazard, an FDA directive establishes a goal for FDA staff to conduct a follow-up inspection within 6 months. However, GAO's review of removal decisions found that for 31 of the 32 firms that received such a finding, FDA did not conduct a follow-up…
