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…
Category Archives U.S. Government and Regulatory Agencies
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,…
President-Elect Barack Obama has reportedly named former Iowa Governor Tom Vilsack (D) to serve at the helm of USDA. Political observers characterize Vilsack as a centrist who balanced his state’s budget, resisted tax increases and agreed to spend tax revenues on education and health. Vilsack briefly sought the Democratic presidential nomination, but dropped out due to difficulties raising campaign funds. He is apparently a renewable energy proponent and is known as a staunch advocate of ethanol. An issue the USDA secretary will face in 2009 may be whether to grant the ethanol industry billions in federal aid as part of an economic stimulus package. The Organic Consumers Association has already begun a campaign to stop Vilsack’s confirmation by the U.S. Senate. According to the association’s executive director, “Vilsack’s nomination sends the message that dangerous, untested, unlabeled genetically engineered crops will be the norm in the Obama administration. Our nation’s future…
This op-ed piece advises President-Elect Barack Obama to select a reformer for the top position in the Department of Agriculture and to recast the agency as the Department of Food, thereby “giving primacy to America’s 300 million eaters.” Appointing a “secretary of food” would signal Obama’s intention to “move away from the bankrupt structure of factory farming that squanders energy, exacerbates climate change and makes American unhealthy – all while costing taxpayers billions of dollars,” according to columnist Nicholas Kristof. He faults both Republicans and Democrats on congressional agriculture committees for “kowtowing” to industrial farming interests, which have allegedly used their influence “to inflict unhealthy food on American children in school-lunch programs, exacerbating our national crisis with diabetes and obesity.” Kristof points readers to an online petition that names six potential reform candidates for the secretary of agriculture post, including the Center for Rural Affairs’ executive director, Chuck Hassebrook. In…
The American Soybean Association (ASA) has asked the U.S. Department of Agriculture’s Office of the Inspector General to investigate the administration of the federally mandated soy checkoff program that is responsible for industry-wide marketing and promotion efforts. “Serious ethical, legal and financial allegations have been raised about how farmer checkoff funds and program activities are being conducted,” stated ASA President John Hoffman in a press release that levied several charges against the United Soybean Board (USB) and the U.S. Soybean Export Council (USECC) for their oversight of checkoff resources. The association’s allegations include “the improper and wasteful expenditure of both checkoff and federal funds; potential evasion of mandated salary and administrative spending caps by USB; conflicts of interest at USB; use of checkoff funds for prohibited purposes by USB; and wasteful and excessive spending by USB.” In addition, ASA cited concerns about “improper USB oversight and tolerance of actions that…
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…
According to a press report, the D.C. Circuit Court of Appeals has refused the request of Whole Foods Market, Inc. that the court reconsider, en banc, a July 2008 decision by a three-judge appellate court panel reviving the Federal Trade Commission’s antitrust challenge to the company’s merger with Wild Oats Markets, Inc. More information about the panel’s divided ruling appears in issue 269 of this Update. The commission will conduct administrative hearings on the merger in February 2009. While the merger was completed in August 2007, the commission could apparently try to stop further integration of the companies’ operations or require Whole Foods to sell some properties. In a statement, Whole Foods reportedly indicated its intent to vigorously defend the administrative proceedings, “even though we believe it is an unfair process and a violation of the company’s due process rights.” See Dow Jones Newswires, November 21, 2008. Meanwhile, a Chicago…
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…
FDA this week released a progress report on the Food Protection Plan launched in November 2007 to address “both food safety and food defense for domestic and imported products.” The report states that federal regulators are "working collaboratively across the agency to implement the three-core elements of protection: prevention, intervention and response.” It particularly notes that FDA has (i) established offices in China and India, with the intention of expanding its presence in Europe, Latin America and the Middle East; (ii) developed melamine and cyanuric acid testing for animal feed; (iii) developed rapid detection methods for E. coli and Salmonella; (iv) enhanced its ability to track foodborne illness outbreaks; (v) signed cooperative agreements with six states to form rapid response teams to handle emergencies; and (vi) approved the use of irradiation for iceberg lettuce and spinach. FDA also inspected 5,930 high-risk domestic food establishments in fiscal year 2008 and plans…
