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…
Category Archives Food and Drug Administration
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…
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…
FDA has reportedly sent a draft report to the White House Office of Management and Budget, seeking to reverse the government's recommendation that women of childbearing years, pregnant or nursing mothers, infants, and children limit their fish intake due to possible mercury contamination. The agency has claimed that the positive health effects of omega-3 fatty acids and other beneficial nutrients found in fish outweigh the risks of dietary mercury, which can behave as a neurotoxin during early development. The draft report would update a 2004 joint advisory statement issued by FDA and the Environmental Protection Agency (EPA) warning women and children to avoid four types of fish high in mercury: swordfish, shark, tilefish, and king mackerel. In addition, the federal government advises these consumers to reduce their fish consumption to less than 12 ounces per week, including at most 6 ounces of canned albacore tuna. FDA apparently acted unilaterally in…
According to the director of the FDA’s Office of Food Additive Safety, the agency will conduct additional analysis of the effects of bisphenol A on human health after its panel of independent science advisors called the agency’s position on its safety flawed. Laura Tarantino reportedly said that a lot of work remains; she would not indicate if the reassessment would take months or years. Among the issues the FDA is apparently exploring is the cumulative exposure people face over a lifetime given the chemical’s presence in food and beverage containers, plastic medical devices and coatings on gel tablets. A spokesperson for an environmental organization was quoted as saying, “More years of research by FDA to determine what thousands of scientists worldwide already know about the toxic chemical is a waste of time, taxpayer dollars, and will place millions of babies yet to be born at risk.” See The Washington Post,…
WHO experts have reportedly determined that a tolerable daily intake (TDI) of melamine is 0.2 milligrams per kilogram of body weight (mg/kg bw/d). This threshold is lower than the one recently adopted by the U.S. Food and Drug Administration (FDA), which accepts 0.63 mg/kg bw/d as an appropriate TDI for dietary melamine. The WHO standard is also more stringent than the TDIs used in both Europe (0.5 mg/kg mw/d) and Canada (0.35 mg/kg bw/d). Although the organization felt that the U.S. measure provides an acceptable margin of safety, it nevertheless stressed that melamine is not ever considered “safe” for consumption. “Melamine is a contaminant that should not be in food. However, sometimes it is unavoidable,” said WHO in a statement. “TDI represents the tolerable amount of unavoidable contaminant in food that a person can ingest on a daily basis without appreciable health risks.” See Bloomberg.com, December 6, 2008; Law360, December…
Reversing a position it took in July 2008, the FDA has issued a notice announcing the withdrawal of a final rule that prohibited the extra-label use of cephalosporin antimicrobial drugs in food-producing animals. As we noted in issue 266 of this Update, the FDA issued its prohibition “based on evidence that extralabel use of these drugs in food-producing animals will likely cause an adverse event in humans and, as such, presents a risk to human health.” According to the November 26 notice, “The agency received many substantive comments on the order of prohibition. Therefore, to allow more time to fully consider the comments, FDA has decided to revoke the order so that it does not take effect November 30, 2008.” Should the agency again decide to ban use of the drugs, it will provide a public comment period before implementing it. A number of organizations, including agriculture groups and animal-drug…
China has reportedly estimated that nearly 300,000 infants were sickened and six died after ingesting melamine-tainted formula linked to kidney stones and renal failure. The government has increased the number of illnesses six-fold from its first calculations and doubled the death toll as the Health Ministry investigated fatalities purportedly involving infant formula. “The new figures are more realistic and objective than previous figures,” said one Beijing lawyer who represents several families seeking compensation and is considering the creation of a public fund for victims. “I assume the government is worried about the situation of the dairies and is afraid the companies may fall if they have to pay compensation amid the current financial crisis. The government may be worrying about the interests of the companies first.” See Associated Press, December 2, 2008. In a related development, the U.S. Food and Drug Administration (FDA) recently updated its safety assessment for melamine and…
