The U.S. Food and Drug Administration (FDA) has proposed a rule that would require certain shippers, receivers and carriers that transport food by motor or rail vehicles to take steps to prevent the contamination of human and animal food during transportation. Noting that the proposed rule will “help reduce the likelihood of conditions during transportation that can lead to human or animal illness or injury,” FDA Deputy Commissioner for Foods and Veterinary Medicine Michael Taylor said, “We are now one step closer to fully implementing the comprehensive regulatory framework for prevention that will strengthen the FDA’s inspection and compliance tools, modernize oversight of the nation’s food safety system, and prevent foodborne illnesses before they happen.” The proposed regulation aims to establish criteria for sanitary transportation practices, such as properly refrigerating food, adequately cleaning vehicles between loads and properly protecting food during transportation. The agency will accept comments until May 31,…
Category Archives U.S. Government and Regulatory Agencies
A recently released Natural Resources Defense Council (NRDC) report suggests that the U.S. Food and Drug Administration (FDA) has allowed 30 potentially harmful antibiotic additives to remain approved for use in food animals (cows, pigs and chickens), even though the agency’s own scientists found that “none of these products would likely be approvable as new additives for nontherapeutic livestock use if submitted today, under current FDA guidelines.” Titled “Playing With Chicken,” and based on a review of previously undisclosed FDA documents, the report notes that (i) 18 of the 30 antibiotic feed additives reviewed were assessed as posing a “high risk” to human health; (ii) drug manufacturers did not submit sufficient information on 12 of the additives to establish safety; (iii) despite the fact that 29 of the additives are not proven to be safe, no action has been taken to withdraw approval; and (iv) 26 of the additives have never…
The U.S. Food and Drug Administration (FDA) has announced two additional public meetings, February 27, 2014, in Chicago, Illinois, and March 13 in Anaheim, California, to discuss the Food Safety Modernization Act (FSMA) proposed rule for “Focused Mitigation Strategies to Protect Food Against Intentional Adulteration.” The meetings are the second and third in a series announced in the December 20, 2013, Federal Register and on FDA’s FSMA website. The first meeting is slated for February 20 in College Park, Maryland.
The U.S. Food and Drug Administration (FDA) has issued two final guidance documents for industry on distinguishing liquid dietary supplements from beverages. Titled “Distinguishing Liquid Dietary Supplements From Beverages” and “Considerations Regarding Substances Added to Foods, Including Beverages and Dietary Supplements,” the documents update 2009 draft guidance intended “to help dietary supplement and beverage manufacturers determine whether a liquid food product is properly classified as a dietary supplement or as a beverage, and to remind the industry of legal requirements regarding the substances that may be added to either type of product.” In “Distinguishing Liquid Dietary Supplements from Beverages,” FDA describes the factors characterizing liquid products deemed dietary supplements and those characterizing beverages deemed conventional foods. These include product claims, names, packaging, serving size, recommended daily intake, conditions of use, and product composition, as well as statements or graphic representations in labeling, advertising and other marketing practices, including promotional websites,…
The U.S. Food and Drug Administration (FDA) has announced a public meeting on February 20, 2014, in College Park, Maryland, to “discuss its proposed rule to require domestic and foreign food facilities that are required to register under the Federal Food, Drug, and Cosmetic Act (the FD&C Act) to address hazards that may be intentionally introduced by acts of terrorism.” The agency has proposed the requirement as part of its implementation of the Food Safety Modernization Act. FDA will accept comments until March 31. See Federal Register, December 24, 2013.
The U.S. Food and Drug Administration (FDA) has extended until March 3, 2014, the period for submission of comments, scientific data and other information related to its draft document titled, “Draft Risk Profile on Pathogens and Filth in Spices.” Originally published in the November 4, 2013, Federal Register, the draft risk profile identifies the most commonly occurring microbial hazards and filth in spices and quantifies, where possible, the prevalence and levels of these adulterants at different points along the spice supply chain. It identifies potential sources of contamination throughout the farm-to-table spice supply chain and evaluates the efficacy of current mitigation and control options designed to reduce the public health risk posed by consumption of contaminated spices in the United States. It also describes potential future mitigation and control options and identifies critical data gaps and research needs. FDA invites comments that can help improve the (i) data and information used;…
The U.S. Food and Drug Administration (FDA) has proposed a rule that will implement those provisions of the Food Safety Modernization Act addressing “hazards that may be intentionally introduced by acts of terrorism.” Under the rule, domestic and foreign facilities that manufacture, process, pack, or hold food would be required to register and implement certain measures to protect against the intentional adulteration of food. These facilities, with certain exemptions, would be required, among other things, to “prepare and implement a written food defense plan that includes actionable process steps, focused mitigation strategies, and procedures for monitoring, corrective actions, and verification.” The proposal is expected to be published in the December 24, 2013, issue of the Federal Register, and will have a 30-day public comment period. See FDA News Release, December 20, 2013. Issue 508
The Federal Trade Commission (FTC) recently hosted a workshop on digital native advertising as part its effort to ensure that “consumers can identify advertisements as advertising wherever they appear.” Titled “Blurred Lines: Advertising or Content?,” the workshop examined “the practice of blending advertisements with news, entertainment, and other content in digital media,” bringing together publishers, marketers, consumer advocates, academics, and self-regulatory organizations to discuss: (i) “the ways in which sponsored content is presented to consumers online and in mobile apps”; (ii) “consumers’ recognition and understanding of it”; (iii) “the contexts in which it should be identifiable as advertising”; and (iv) “effective ways of differentiating it from editorial content.” Building on recent updates to FTC’s guidance on search engine advertising, dot com disclosures, and endorsements and testimonials, the workshop is reportedly the latest step in the commission’s efforts to ensure that digital advertisers conform to rules intended to help consumers distinguish between…
Due to the recent government shutdown, the U.S. Department of Health and Human Services (HHS) and U.S. Department of Agriculture (USDA) have rescheduled the second meeting of the 2015 Dietary Guidelines Advisory Committee for January 13-14, 2014. Among those on the agenda are HHS, USDA and Institute of Medicine representatives, committee members and Food Systems Consultant Kate Clancy, who will address “Dietary Guidelines and Sustainability.” The public will have an opportunity to speak, and those who registered to do so before the originally scheduled October 3-4, 2013, meeting “will retain their designation.” Those choosing to participate by Webcast or in person must register by January 6, 2014. Comments are requested either by December 31, 2013, or throughout the committee’s deliberative process. See Federal Register, December 9, 2013.
The U.S. Department of Agriculture (USDA) has terminated proceedings on a proposed marketing agreement that sought to regulate the handling of fresh leafy green vegetables in the United States. Modeled after a 2006 initiative pioneered by California growers in the wake of an E. coli outbreak linked to fresh spinach, the National Leafy Green Marketing Agreement (NLGMA) would have authorized “the development and implementation of handling regulations (audit metrics) to reflect the United States Food and Drug Administration’s (FDA) Good Agricultural Practices, Good Handling Practices, and Good Manufacturing Practices.” According to the California LGMA, which participated in the NLGMA effort, the proposed program became redundant under the Food Safety Modernization Act (FSMA), which requires FDA to regulate produce farmers “to ensure their products are safe.” To this end, the California LGMA recently submitted comments on FSMA’s proposed Produce Safety Rule, asking the FDA to consider certified LGMA members as compliant…
