Category Archives Food and Drug Administration

The Food and Drug Administration (FDA) held a public meeting May 1, 2009, designed to find ways to prevent, detect and address the adulteration of food, pet food, dietary supplements, medical devices, and cosmetics for economic reasons that pose the greatest public health risk. FDA invited testimony on Economically Motivated Adulteration (EMA) from industry representatives, organizations and stakeholders. The agency requests comments on EMA by August 1, 2009. See Federal Register, April 6, 2009.

The Food and Drug Administration (FDA) has prepared a summary of the comments and information provided during a 2007 hearing on the use of symbols to communicate nutrition information. Posted to the hearing docket on April 28, 2009, the document notes that significant gaps remain in research about consumer perception, understanding and use of symbols that convey information about nutrition claims on food products. According to the FDA, numerous nutrition symbol systems already exist, but because they “differ greatly,” “the ability of consumers to use these symbols to make nutritional comparisons between products or to determine how a food fits into a diet is uncertain.” FDA commissioned a focus group study and “is currently analyzing qualitative information collected from the study to explore varieties and ranges of consumers’ understanding of and reactions to a selected sample of existing and alternative nutrition symbols.” The agency also apparently needs more information about…

The Food and Drug Administration (FDA) has confirmed April 27, 2009, as the effective date for the final rule titled “Substances Prohibited From Use in Animal Food or Feed,” which establishes “measures to further strengthen existing safeguards against bovine spongiform encephalopathy (BSE).” The agency earlier this month considered delaying the rule for 60 days after industry stakeholders requested additional time to arrange alternative disposal methods for high-risk materials. In light of these requests, FDA has set an October 26, 2009, compliance date for renderers and other affected persons, but believes that “the rendering, livestock, meat and animal feed industries have addressed many of the compliance and carcass disposal challenges and are prepared to meet the April 27, 2009, effective date of the final rule.” See Meatingplace.com, April 23, 2009; Federal Register, April 24, 2009.

The Office of the Acting Deputy Undersecretary for Food Safety, U.S. Department of Agriculture and U.S. Food and Drug Administration have announced a public meeting on April 29, 2009, to discuss draft U.S. positions for the 18th Session of the Codex Committee on Residues of Veterinary Drugs in Foods (CCRVDF) slated for May 11-15, 2009, in Natal, Brazil. CCRVDF works to (i) establish “priorities for the consideration of residues of veterinary drugs in foods”; (ii) “recommend maximum levels of such substances”; (iii) “develop codes of practice as may be required”; and (iv) consider methods of sampling and analysis for the determination of veterinary drug residues in foods.” The session will include agenda items related to (i) the “registration of veterinary medicinal products”; (ii) “draft guidelines for the design and implementation of national regulatory food safety assurance programs”; and (iii) a “draft priority list of veterinary drugs requiring evaluation or reevaluation.”…

The Farm Foundation recently hosted a public forum titled “The Future of Food Safety Regulation” to discuss agricultural, food and rural policies designed to revamp the current regulatory system. Held April 7, 2009, at the National Press Club, the forum featured a panel of experts that included Jim Hodges of the American Meat Institute, Carol Tucker Foreman of the Consumer Federation of America’s Food Policy Institute; Scott Horsfall of the California Leafy Greens Marketing Agreement; and Margaret Glavin, an independent consultant and former Food and Drug Administration (FDA) official. Glavin reportedly identified the global food market as “the single biggest challenge” facing U.S. agencies and recommended modernizing laws to promote a uniform approach to food safety. Noting the high cost of legislative proposals that would create one umbrella agency, Glavin instead argued for increased FDA funding and the authority to enforce import requirements and conduct overseas inspections. “Our regulations and…

The Food and Drug Administration (FDA) has announced that U.S. marshals executed an inspection warrant at Westco Fruit and Nuts, Inc., in Irvington, New Jersey, after the company refused to recall its peanut products or provide access to distribution documents in the wake of the Salmonella outbreak involving peanuts from the Peanut Corp. of America (PCA). An FDA spokesperson said, “FDA’s enforcement action against Westco Fruit and Nuts is an appropriate step toward removing potentially harmful products from the marketplace, especially when, as in this case, a company is unwilling to share information FDA needs to ensure food safety. FDA uses all appropriate legal means necessary to obtain information and fully investigate firms or individuals who put the health of consumers at risk.” Apparently, Westco purchased oil-roasted and salted peanuts from PCA in November and December 2008. It sold them in various sizes and packages and used them as an…

The Food and Drug Administration (FDA) has proposed delaying for 60 days a final rule titled “Substances Prohibited From Use in Animal Food or Feed,” which establishes “measures to further strengthen existing safeguards against bovine spongiform encephalopathy (BSE).” Scheduled to take effect April 27, 2009, the rule includes provisions that prohibit the rendering of spinal cords and brains from cows older than 30 months. Industry groups have reportedly requested additional time to arrange for alternative disposal methods, prompting the agency to consider pushing back the implementation date to June 26. FDA will accept comments on the proposed delay until April 16, 2009. See Federal Register, April 9, 2009.

The Food and Drug Administration (FDA) has announced a public meeting slated for May 1, 2009, in College Park, Maryland, to discuss the economically motivated adulteration of foods and drugs, which the agency defines as the “fraudulent, intentional substitution or addition of a substance in a product for the purpose of increasing the apparent value of the product or reducing the cost of its production, i.e., for economic gain.” FDA is seeking public input on how the food, drug, medical device, and cosmetic industries, regulatory agencies and other stakeholders “can better predict and prevent economically motivated adulteration with a focus on situations that pose the greatest public health risk.” The agency will accept written or electronic comments until August 1, 2009. See Federal Register, April 6, 2009.

The Obama administration has reportedly issued a tough warning that it will substantially change the way government oversees food safety. According to published reports, food-handling practices that formerly would have resulted in mild warnings from FDA may now lead to wide-ranging and expensive recalls.“ The food industry needs to be on notice that FDA is going to be much more proactive and move things faster,” David Acheson, FDA associate commissioner for food protection, was quoted as saying. “We’re going to try to stop people from getting sick in the first place, as opposed to waiting until we have illness and death before we take action.” Meanwhile, the Centers for Disease Control and Prevention (CDC) issued a report April 9 claiming the nation’s food safety system needs a thorough overhaul and that even though cases of Salmonella may be increasing, their incidence is not statistically significant. The system should be overhauled,…

In this publication of the Food and Drug Law Institute, Bruce Silverglade examines his belief that the Food and Drug Administration (FDA) should play a significant role in advancing President Obama’s “prevention” agenda. “The Administration should reinvigorate FDA’s nutrition mission and the agency should be instructed to develop and implement a series of initiatives that would help Americans improve their diets and protect their health,” writes Silverglade, who is director of legal affairs for the Center for Science in the Public Interest in Washington, D.C. He outlines ways the government could facilitate improvements in diet and health, including product reformulation, food labeling, universal symbols to communicate nutritional content, and food marketing to children The government, Silverglade writes, “has an important role in mitigating the toxic food environment created by the food manufacturers and restaurant chains promoting huge servings of soft drinks, snacks and ‘value’ meals that are literally penny-wise and…

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