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,…
Category Archives Legislation, Regulations and Standards
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…
New York Governor David Paterson (D) has reportedly proposed an 18 percent tax on soft drinks and other non-diet sweetened beverages as part of his plan to lessen a $1.5 billion shortfall in the state’s annual budget. The tax would purportedly raise $404 million, but industry leaders have called the maneuver a “money grab” that would hurt union jobs at major bottlers located in the state. “We think that everybody has to keep in mind that we’re in a recession, and in an economy like this, the last thing we should be doing is raising taxes on everyday needs like clothing and groceries. That doesn’t wash with the consumer,” an American Beverage Association spokesperson was quoted as saying. See Times Union, December 14, 2008; Advertising Age, December 15, 2008. Meanwhile, a recent New York Times op-ed column hails the proposal as a “landmark effort that, if other states follow, could help…
The Chinese government has reportedly published its first official list of food additives that are prohibited in the domestic food supply. The list includes 17 acids, chemicals and other substances–such as formaldehyde, boric acid and sodium thiocyanate–used to improve the appearance, texture or longevity of food products. In addition, the country’s regulators have warned of raids on high-risk companies that have thus far failed to address their own safety problems. “These lists . . . cannot cover all problems linked to illegally adding substances in food and abusing additives in the industry,” stated the Chinese health ministry, which this month launched a food safety initiative to increase consumer confidence. See AFP, December 16, 2008.
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,…
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…
