The U.S. Department of Agriculture’s Food Safety and Inspection Service and the Food and Drug Administration have announced a February 8, 2010, public meeting to discuss draft U.S. positions for the 42nd Session of the Codex Committee on Food Additives (CCFA) slated for March 15-19, 2010, in Beijing, China. Co-sponsored by the U.S. Department of Health and Human Services, the meeting will include discussions concerning (i) “endorsement and/or revision of maximum levels for food additives and processing aids in [C]odex standards”; (ii) “draft and proposed draft food additive provisions of the General Standards for Food Additives (GSFA)”; (iii) “proposals for changes or additions to the International Numbering System (INS) for food additives”; (iv) “identification of problems and recommendations related to the inconsistent presentation of food additives provisions in Codex commodity standards; and (v) “the Codex standard for food grade salt.” See Federal Register, January 28, 2010.
Category Archives Food and Drug Administration
The Food and Drug Administration’s Science Board has announced a February 22, 2010, public meeting to discuss “an interim report from its subcommittee reviewing research at the Center for Food Safety and Applied Nutrition.” The advisory board is also slated to discuss “plans to establish another subcommittee to review research programs at the Center for Drug Evaluation and Research” and “updates on science programs at the Office of Regulatory Affairs and the National Center for Toxicological Research.” FDA plans to make background material available no later than two business days before the meeting. See Federal Register, January 27, 2010.
Scientists and others objecting to the use of recombinant bovine growth hormone (rBGH) to stimulate milk production in dairy cows have reportedly resubmitted a petition to the Food and Drug Administration (FDA) challenging the new animal drug application approval for an rBGH drug. FDA apparently failed to respond to the original petition, filed in 2007. The petition also requests that dairy products made from cows treated with rBGH be labeled with a health-hazard warning. The petitioners include Samuel Epstein, chair of the Cancer Prevention Coalition; Ronnie Cummins, national director, Organic Consumers Association; Arpad Pusztai, a consultant biologist from Scotland; and Jeffrey Smith, executive director, Institute for Responsible Technology. They claim that rBGH milk poses major cancer and other risks to the U.S. population and that the drug has toxic effects on cows. See World-Wire.com, January 15, 2010.
The American Council on Science and Health (ACSH) has responded to the Food and Drug Administration’s (FDA’s) recent review of bisphenol A in food contact applications, praising regulators for stopping short of a ban on the ubiquitous chemical but criticizing their concern for “hypothetical and non-existent health risks.” FDA has stated that it now shares the National Toxicology Program’s outlook on “the potential effects of BPA on the brain, behavior, and prostate gland in fetuses, infants, and young children,” and is considering a more aggressive oversight approach. To this end, the agency may seek new authority to govern BPA and its different formulations through the Food Contact Notification Program created in 2000. This regulatory framework not only requires manufacturers to provide detailed analysis on substance applications, but allows FDA to “quickly protect the public by revoking the use through a notice in the Federal Register.” Noting that BPA was first…
The Center for Science in the Public Interest (CSPI) has prepared a report for the Food and Drug Administration (FDA) that purportedly catalogs “some of the most egregious examples of false claims, ingredient obfuscations, and other labeling shenanigans” on the part of food manufacturers that make nutritional claims about their products. Titled “Food Labeling Chaos,” the report discusses health claims made by manufacturers of breakfast cereals, beverages, snacks, and baby food. CSPI praises FDA for taking more aggressive action under the Obama administration against food manufacturers that purportedly mislabel their products, but still calls for a significant overhaul of the nation’s food labeling regulations.
The Food and Drug Administration (FDA) has entered a memorandum of understanding (MOU) with Boston’s Northeastern University to “develop collaboration between the two parties in the areas of education, research, and outreach.” Focusing broadly on biotechnology and analytical chemistry, the MOU is intended to “provide opportunities for exchanging of graduate and undergraduate students, faculty, and personnel and for advanced training and outreach; stimulate cooperative research, and information exchange in biological product characterization and regulation with Northeastern University’s Barnett Institute of Chemical and Biological Analysis; and develop training programs for FDA and potentially other Government agencies and Industry.” Northeastern University is home to law professor and anti-tobacco activist Richard Daynard who also formed the Public Health Advocacy Institute to address food and obesity issues through legislation and litigation. The law school received a $2.7 million grant from the National Cancer Institute in 2009 to conduct a five-year research project, headed by Daynard,…
The Food and Drug Administration (FDA) has issued a warning letter to LSG SkyChefs, an airline catering company, to formally notify the company that its classification has been changed from “Approved” to “Provisional.” According to the December 10, 2009, letter, an FDA inspection revealed “significant deviations” from regulatory requirements, including insect infestations, standing water, debris accumulation, and swab samples that tested positive for Listeria monocytogenes. The company’s food processing facility will be re-inspected in 30 days, and if the conditions have not improved, “then your facility will be classified as ‘Use Prohibited’ or ‘Not Approved.’ ” FDA provided copies of its warning letter to the airlines that purchase food from SkyChefs; they will be unable to obtain food from the company if it fails the second inspection.
In a letter recently posted to its website, the Food and Drug Administration (FDA) has warned Nestlé USA that its Juicy Juice® products are misbranded because their labels include “unauthorized nutrient content claims.” According to FDA, the product labels include the claim “Helps support brain development . . . In children under two years old” and also states “no sugar added.” Under FDA regulations, these statements cannot be made on products for children younger than age 2. FDA also states that other Nestlé products have misleading labels because they imply that they contain 100 percent natural fruit juice when they actually contain “Flavored juice blend from concentrate with other natural flavors & added ingredients.” In a separate letter, FDA warns that the company’s BOOST Kid Essentials Nutritionally Complete Drinks® are also misbranded because they are promoted as a “medical food” to address conditions such as “failure to thrive” and “pre/post…
According to the Food and Drug Administration (FDA), a food importer from Virginia, who was sentenced to five years in prison for conspiring to import falsely labeled catfish from Vietnam to avoid paying import tariffs, has been barred from importing food into the United States for the next 20 years. This action apparently marks the first time the agency used its debarment authority under a law allowing the FDA to “debar a person from importing an article of food or offering such an article for import into the United States if that person has been convicted of a felony for conduct relating to the importation into the United States of any food.” The law also allows debarment in instances of the importation of adulterated food posing “a threat of serious adverse health consequences or death to humans or animals.” FDA reported that Peter Xuong Lam, president of Virginia Star Seafood…
The U.S. Department of Health and Human Services’ Office of Inspector General (OIG) has issued a report criticizing the U.S. Food and Drug Administration’s (FDA’s) food facility registry and traceability standards. According to the report, “FDA requires each domestic food facility to provide information for the registry,” including contact information for the facility, the owner or operator, and the parent company, and an emergency contact. After sampling 130 selected domestic food facilities, OIG concluded that (i) “Seven percent . . . either failed to register or failed to cancel their registration with FDA, as required”; (ii) “Almost half . . . failed to provide accurate information for the registry”; (iii) “FDA regulations do not ensure that the registry contains certain information that may be needed to locate a facility in an emergency”; and (iv) “Over half of the managers . . . were unaware of FDA’s registry requirement.” OIG has…
