Category Archives U.S. Government and Regulatory Agencies

The U.S. Centers for Disease Control and Prevention (CDC) and Food and Drug Administration (FDA) are reportedly investigating a Salmonella typhimurium outbreak implicating King Nut and Parnell’s Pride brand peanut butters manufactured by the Peanut Corporation of America (Peanut Corp.) and sold to non-retail food establishments. Health departments have purportedly linked the outbreak to more than 400 illnesses and possibly five fatalities, prompting Peanut Corp. to issue a voluntary recall for 21 lots of peanut butter produced since July 1, 2008, at its Blakely, Georgia, facility. In addition, Kellogg Co. has since issued recalls for its Austin and Keebler brand peanut butter crackers as a precautionary measure. See King Nut Press Release, January 12, 2009; Law 360 and Health Day Reporter, January 13, 2009; Kellogg Co. Press Release, January 14, 2009; The Associated Press and The Wall Street Journal, January 15, 2009. Meanwhile, plaintiffs’ lawyers have apparently cited the incident in urging stricter…

USDA’s Food Safety and Inspection Service (FSIS) has published a notice soliciting nominations for membership on a national advisory committee that addresses meat and poultry inspection issues. Names and curriculum vitae must be postmarked no later than January 23, 2009. FSIS is seeking a diverse membership drawn from industry, academia, state and local government officials, public health organizations, and consumers and consumer organizations. The committee “provides advice and recommendations to the Secretary on meat and poultry inspection programs.” See Federal Register, December 24, 2008.

The Food and Drug Administration (FDA) has apparently prevailed in proceedings seeking injunctive relief against two New Mexico dairies that “were not keeping adequate medication records to prevent unsafe drug residues in cattle offered for slaughter” and “were using medications for unapproved indications not specified on the drug label” without a valid veterinarian-client-patient relationship. The companies, Do-Rene and Clover Knolls Dairies, were warned about these violations in 2005 and 2008 following inspections and tissue sampling. Apparently, some of the dairies’ cows tested positive for illegal levels of a number of drugs, including one “expressly forbidden for use in lactating cows.” According to FDA, “These residues may cause allergic reactions in extremely sensitive individuals, and they may contribute to forming antibiotic-resistance in bacteria.” Future violations may result in civil or criminal penalties. See FDA Press Release, January 2, 2009.

In late December 2008, Mexico banned imports of meat from 30 U.S. processing facilities, telling the USDA that sanitary issues were to blame, although some, including Senator Charles Grassley (R-Iowa), suggested that the move was in retaliation for the new country-of-origin labeling (COOL) rules that took effect September 30. Mexican officials denied any connection and reportedly lifted the embargo for 26 of the plants as of December 30. According to a news source, Mexico is the leading buyer of U.S. meat, and the suspension led to a sharp decline in cattle and hog futures at the Chicago Mercantile Exchange. U.S. and Mexican officials were reportedly scheduled to meet January 5, 2009, to discuss meat import issues. Meanwhile, Mexico has reportedly joined Canada before the World Trade Organization seeking consultations with the United States over the COOL regulations. The two countries are apparently most concerned about the impact on meat and livestock,…

FDA has reportedly detected the industrial chemical melamine and its byproduct cyanuric acid in additional cans of U.S.-manufactured infant formula, but stressed that the levels are below the safety threshold set for young children and infants. Four of the 89 infant formula products tested by FDA contained trace amounts of melamine or cyanuric acid, which are used during the manufacturing process as disinfectants and in some food packaging. FDA and other food safety experts have apparently stated that this trace contamination most likely occurred during processing and not as the result of intentional adulteration. See Food & Water Watch Blog, January 5, 2009; The Associated Press, January 7, 2009. Meanwhile, Chinese courts started criminal trials for six cattle farmers and milk collectors accused of making melamine protein powder and adding it to raw milk sold to Chinese dairies, including the government-owned Shijiazhuang Sanlu Group Co. Sanlu recently declared bankruptcy as a…

FDA this week issued a final rule requiring food and cosmetic manufacturers to declare the presence of cochineal extract and carmine in their products. Derived from dried insect bodies, the two coloring agents were previously labeled under “artificial colors” or “color added” on ingredient lists. “This final rule responds to reports of severe allergic reactions, including anaphylaxis to cochineal extract-containing food and carmine-containing food and cosmetics and will allow consumers who are allergic to these color additives to identify and thus avoid products that contain these color additives,” according to FDA, which requires full compliance with the rule by January 5, 2011. See FoodNavigator-USA.com, January 6, 2009. Meanwhile, the Center for Science in the Public Interest (CSPI) has criticized the final rule for failing to indicate the extracts’ insect origins. The consumer advocacy group first petitioned FDA in 1998 for more stringent labeling of cochineal and carmine, citing their widespread…

HHS Secretary Mike Leavitt and Food and Drug Administration Commissioner Andrew von Eschenbach traveled to Costa Rica this week to open an HHS/FDA office that will serve Latin America in the hope of improving collaboration on food and product safety issues. Plans for the new office were apparently launched in June 2008, when health ministers from Central America and Panama gathered in El Salvador to develop a framework for ensuring the trade of quality goods among the countries. Similar HHS/FDA offices are already operating in Brussels, Beijing, Shanghai, and Guangzhou, and other offices will open in two cities in India and a location in the Middle East. The stated goal of the HHS/FDA “Beyond Our Borders Initiative is to foster collaboration with regulatory authorities around the world, as well as to forge partnerships with industry on the safety of food, animal feed, drugs and medical devices.” See HHS Press Release,…

Del Monte Fresh Produce N.A., Inc. has sued the Food and Drug Administration (FDA), seeking a declaration that the agency has “engaged in a pattern or practice that constitutes agency action unlawfully withheld or unreasonably delayed” in connection with several cantaloupe shipments from Guatemala. Del Monte Fresh Produce N.A., Inc. v. U.S., No. 08-02161 (D.D.C., filed December 11, 1008). According to the complaint, the FDA denied release of the shipments until it completed testing for salmonella. The FDA has purportedly failed to respond to company requests for expedited testing and has yet to release the fruit, which is “overripening” and will cost the company more than $4.5 million in losses. A 10-day hold in 2007 allegedly cost the company almost $1 million. Del Monte claims that independent tests have failed to show that the shipments are infected with salmonella and contends that it “has never had a positive test for salmonella…

Plaintiffs in multidistrict litigation against Aurora Dairy Corp. over claims that its “organic” milk products do not meet federal certification requirements have reportedly filed an unopposed notice of voluntary dismissal requesting that the court dismiss Whole Foods Market Group, Inc. from the case without prejudice. In re: Aurora Dairy Corp. Organic Milk Mktg. & Sales Practices Litig., MDL No. 08-1907 (E.D. Mo., motion filed December 13, 2008). While Whole Foods apparently did not sell Aurora’s organic milk, the company was named as successor-in-interest to Wild Oats, Inc., the chain acquired by Whole Foods in August 2007 and alleged to have sold the products. Whole Foods has reportedly argued that Wild Oats retained its assets and liabilities after the merger and has agreed to provide plaintiffs with discovery on that issue. According to plaintiffs’ counsel, “If, after that discovery, we agree with your analysis, we will move the court to strike Whole…

FDA has reportedly stated that it has no objection to granting GRAS (generally recognized as safe) status to stevia for use as a zero-calorie natural sweetener in foods and beverages. An extract form is currently marketed as a supplement, but FDA said it lacked the necessary scientific data to lift an import restriction on food-grade stevia, which is also known as rebaudioside A (Reb A). Several food companies recently requested approval for stevia-based sweeteners after supplying regulators with data that demonstrated the safety of the food additive at 95 percent purity or above. See BeverageDaily.com, December 18, 2008. The Center for Science in the Public Interest (CSPI), however, has called on the next Congress and President-Elect Barack Obama to reverse this “last minute” decision. The consumer watchdog cites research conducted by University of California, Los Angeles, scientists who purportedly concluded that stevia “is inadequately tested in terms of cancer and…

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