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…
Category Archives Food and Drug Administration
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Regarding Substances Added to Foods, Including Beverages and Dietary Supplements,” the documents update 2009 draft guidance intended “to help dietary supplement and beverage manufacturers determine whether a liquid food product is properly classified as a dietary supplement or as a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 U.S. Food and Drug Administration (FDA) has announced plans to phase out the use of certain antibiotics in food animals as part of its effort to reserve medically important drugs for the treatment of human infection. Noting that voluntary participation “is the fastest, most efficient way to make these changes,” the agency will partner with industry to discontinue the practice of adding these drugs to animal feed and drinking water as a growth promoter. To this end, FDA has issued final guidance that urges animal pharmaceutical companies “to voluntarily revise the FDA-approved conditions on the labels of these products to remove production indications,” in addition to proposing an updated veterinary feed directive (VFD) “to facilitate expanded veterinary oversight by clarifying and increasing the flexibility of the administrative requirements for the distribution and use of VFD drugs.” “The plan also calls for changing the current over-the-counter (OTC) status to bring…
In response to a petition filed by the U.S. Pharmacopeial Convention, the U.S. Food and Drug Administration (FDA) has issued a final rule that amends select food-additive regulations referring to “food-grade specifications from prior editions of the Food Chemicals Codes (FCC) to incorporate by reference food-grade specifications from the FCC 7th Edition.” The rule took effect November 29, 2013, but objections and requests for hearing may be filed until December 30. See Federal Register, November 29, 2013.
Due to the recent government shutdown, the U.S. Food and Drug Administration (FDA) has extended the public comment period for several proposed rules related to the implementation of the Food Safety Modernization Act (FSMA). FDA has extended the deadline for comments on (i) “Notice of Intent to Prepare an Environmental Impact Statement for the Proposed Rule: Standards for Growing, Harvesting, Packing, and Holding of Produce for Human Consumption” until March 15, 2014; and (ii) “Foreign Supplier Verification Programs for Importers of Food for Humans and Animals” and “Accreditation of Third-Party Auditors/Certification Bodies to Conduct Food Safety Audits and to Issue Certifications,” until January 27.
The U.S. Food and Drug Administration (FDA) has issued the “Second BiennialReport to Congress on the Food Emergency Response Network (FERN)” as required under Section 202(b) of the Food Safety Modernization Act. Administered by FDA and the U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS), “FERN is an integrated, secure laboratory system for federal, state, and local government agencies engaged in food safety and food defense activities” responsible for detecting, identifying and responding to situations involving “biological, chemical, or radiological contamination of food.” Among other successes, FDA reports that FERN “has been vital in responding to major outbreaks of foodborne disease attributed to many products, including spinach, pet food, and peanut butter.” The network has also provided surge capacity for federal and state responses to both natural and industrial emergencies, in addition to handling large-scale, non-emergency projects, such as arsenic testing in fruit juices and rice products, and…
