Category Archives Food and Drug Administration

The Food and Drug Administration (FDA) and U.S. Department of Agriculture’s Food Safety Inspection Service, (FSIS) will convene a joint meeting to address ways of enhancing current product tracing systems for food intended for humans and animals. FDA and FSIS reportedly intend for the December 9-10, 2009, event to stimulate ideas on improving their ability to “increase the speed and accuracy of traceback investigations and traceforward operations.” More specifically, the agencies want to “identify the source of contamination during outbreaks of foodborne illness and to improve the ability of all persons in the supply chain to more quickly identify food that is (or potentially is) contaminated and remove it from market during traceforward operations.” Public comments will be accepted until March 3, 2010. See Federal Register, November 3, 2009.

Pine nuts imported from China have reportedly left some Americans with a bitter, metallic aftertaste, prompting the Food and Drug Administration (FDA) to investigate the claims. According to a news source, FDA has received about two dozen complaints of “pine mouth” in recent months, but no illnesses have been reported. “Should the FDA find a public health hazard, then we will advise consumers accordingly,” an agency press officer said. The United States reportedly imports some 25 million pounds of pine nuts annually, 90 percent of which comes from China. A Richmond, Virginia, importer of Chinese pine nuts has scoffed at the pine mouth phenomenon, calling it an “Internet sensation” on food websites and blogs. He said he first heard reports of pine mouth a few years ago and had his product tested for heavy metals, Salmonella, yeast, and mold, but that testing revealed nothing unusual. See The Baltimore Sun, October…

The food industry has reportedly halted a new front-of-packaging (FOP) labeling campaign pending Food and Drug Administration (FDA) guidance. According to an October 23, 2009, press release, the Smart Choices Program™ voluntarily postponed active operations after FDA Commissioner Margaret Hamburg indicated “that the agency intends to develop standardized criteria on which future front-of-package nutrition or shelf labeling will be based.” While awaiting FDA guidance, the program will no longer enroll new companies or encourage use of the logo. “We welcome the FDA’s interest in developing uniform front-of-package and shelf-labeling criteria,” said program chair Mike Hughes. “The Smart Choices Program shares that exact goal, and was designed to provide a voluntary front-of-package labeling program that could promote informed food choices and help consumers construct healthier diets. We continue to believe the Smart Choices Program is an important step in the right direction.” See Reuters, October 23, 2009; FoodNavigator-USA.com and UPI.com, October…

The Food and Drug Administration (FDA) has issued a letter to the food industry to provide guidance on front-of-package (FOP) labeling and warn that the agency “will consider using our regulatory tools” if the industry fails to provide “a common, credible approach to FOP and shelf labeling.” According to FDA, consumers are less likely to read the nutrition facts label on the back or side of a food package and thus rely on information appearing on the front of the package. Acknowledging that food companies have begun relying on “symbol programs” to convey nutritional information, FDA states that it is assessing the criteria established by food manufacturers and comparing them with its regulatory criteria. FDA Commissioner Margaret Hamburg stated during a conference call with journalists that the agency plans to “take enforcement for egregious examples,” observing that “[s]ome nutritionists have questioned whether this information is more marketing oriented than nutrition…

Led by a University of Massachusetts biology professor, more than 30 scientists have reportedly written to the Food and Drug Administration (FDA) to express concern about the agency’s plans to further study the health effects of bisphenol A (BPA), a plasticizer ubiquitous to food packaging that has apparently been subject to more than 900 studies. According to the researchers, many of whom have participated on government BPA health-effects panels, “FDA’s plans to spend significant time and money on a very well researched chemical are disturbing.” The agency has indicated that it will issue a new opinion on the chemical’s safety by November 30, 2009, and the scientists note that FDA plans to spend $7 million on new BPA research in the interim. Not only are they concerned about the quality of the planned research, which calls for BPA to be tested on a rat strain insensitive to BPA at low levels,…

The Food and Drug Administration (FDA) has announced a public hearing for November 12-13, 2009, to discuss issues related to ways the internet and social media tools are used to promote FDA-regulated medical products, including prescription drugs for humans and animals. Comments from “consumers, patients, caregivers, health care professionals, patient groups, internet vendors, advertising agencies, and the regulated industry” are requested by October 9, 2009. FDA is “particularly interested in hearing views from the public as to how expanding Web 2.0 technologies may be used to promote medical products to both health care professionals and consumers in a truthful, non-misleading, and balanced manner.” Emerging internet technologies such as blogs, microblogs, podcasts, social networks and online communities, video sharing, widgets, and wikis have prompted questions from regulated companies and other interested parties regarding advertising and labeling provisions, regulations and promotion policies. See Federal Register, September 21, 2009.

The Food and Drug Administration (FDA) has opened the Reportable Food Registry (RFR) as a new way to head off potential cases of foodborne illness. The system requires food companies that manufacture, process or hold food for consumption in the United States to report potentially dangerous products to FDA within 24 hours “if they find a reasonable probability that an article of food will cause severe health problems or death to a person or an animal,” according to an agency news release. The reporting requirement applies to all foods and animal feed regulated by FDA except infant formula and dietary supplements, which are covered by other regulatory requirements. Under rules governing the RFR, the responsible party charged with reporting to FDA must investigate the cause of the adulteration, submit initial information and supplemental reports, and follow up with FDA as needed. The responsible party is not required to report if…

The Food and Drug Administration (FDA) has announced two public meetings to discuss the prevention of Salmonella enteritidis (SE) during the production, storage and transportation of shell eggs. Slated for September 30, 2009, in Chicago, Illinois, and November 5, 2009, in Atlanta, Georgia, the meetings will explain an FDA final rule that requires shell egg producers “to implement measures to prevent SE from contaminating eggs on the farm and from further growth during storage and transportation, and requires these producers to maintain records concerning their compliance.” The agency has anticipated that the rule will prevent 79,000 illnesses and 30 deaths attributed to SE, a leading bacterial cause of foodborne illness in the United States. See Federal Register, August 31, 2009.

The Food and Drug Administration (FDA) has reportedly declined to send an objection letter to Arizona-based Wisdom Natural Brands™ concerning its request for generally recognized as safe (GRAS) status for its stevia sweetener, SweetLeaf®. Considered the gold standard in GRAS rulings, the lack of an FDA objection has confirmed earlier determinations by two independent scientific panels that reviewed SweetLeaf’s® GRAS status in March 2008. The company first lodged a notification of GRAS status with FDA for a “general purpose sweetener in various food categories” in March 2009. See FoodNavigator-USA.com, September 2, 2009. In a related matter, a Los Angeles Times article titled “Sweet stuffed: We eat lots (and lots of kinds) of sweeteners. What’s in them?” offers a primer of common and not-so-common sweeteners such as sucrose, glucose, fructose, corn syrup, high fructose corn syrup, lactose, honey, and agave syrup. “America’s sweet tooth is growing,” writes Wendy Hansen. “Like many other…

The Food and Drug Administration (FDA) has issued a request for “comments and scientific data and information on acrylamide in food,” noting that the agency is considering industry guidance on this issue. Describing acrylamide as “a chemical that can form in some foods during certain types of high-temperature cooking,” the agency is seeking information from manufacturers on how to measure and reduce acrylamide levels in food. The agency has also asked responders to provide detailed feedback about: (i) techniques for acrylamide mitigation; (ii) best monitoring practices; (iii) standard practices for the delivery, storage, temperature control, reconditioning, and screening of potatoes; (iv) changes to food packaging instructions and other measures that can reduce acrylamide levels during a product’s final preparation by consumers; (v) food types for which the agency could recommend target acrylamide levels; and (vi) achievable acrylamide levels for french fries, potato chips, breakfast cereals, coffee, cookies, and other baked goods…

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