The Food and Drug Administration (FDA) has submitted a proposed collection of information involving antimicrobial animal drugs to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act. According to the Federal Register notice, a 2008 amendment to the Federal Food, Drug, and Cosmetic Act requires that “the sponsor of each new animal drug that contains an antimicrobial agent submit an annual report to FDA on the amount of each antimicrobial active ingredient in the drug that is sold or distributed for use in food-producing animals.” The first report under the law will be due March 31, 2010, and must specify (i) “The amount of each antimicrobial active ingredient by container size, strength, and dosage form”; (ii) “quantities distributed domestically and quantities exported”; and (iii) “a listing of the target animals, indications, and production classes that are specified on the approved label of the…
Category Archives Issue
The U.S. Department of Agriculture (USDA) and the Food and Drug Administration (FDA) have issued a joint statement to announce a collaborative effort to improve the safety and quality of fresh produce. As part of the announcement, the agencies report that USDA’s Agricultural Marketing Service “is in the midst of evaluating a proposed marketing agreement for the leafy green industry,” while the FDA “is currently developing a proposed produce safety regulation.” The notice calls for feedback and comments from stakeholders, noting that FDA would establish “a docket to receive information about current practices and conditions for the production and packing of fresh produce and practical approaches to improving produce safety.” See FDA News & Events, February 18, 2010.
The U.S. Department of Agriculture’s (USDA’s) Agricultural Marketing Service has issued a final rule that amends National Organic Program (NOP) regulations to establish “a pasture practice standard for ruminant animals.” Seeking “to satisfy consumer expectations that ruminant livestock animals graze on pastures during the grazing season,” the final rule requires producers to (i) “provide year-round access for all animals to the outdoors”; (ii) “recognize pasture as a crop”; (iii) “establish a functioning management plan for pasture”; (iv) “incorporate the pasture management plan into their organic system plan (OSP)”; (v) “provide ruminants with pasture throughout the grazing season for their geographical location”; and (vi) “ensure ruminants derive not less than an average of 30 percent of their dry matter intake (DMI) requirement from pasture grazed over the course of the grazing season.” This rule takes effect June 17, 2010, for operations seeking organic certification by this date. Operations already certified as of…
The Federal Trade Commission (FTC) has announced that it sent letters to 11 unnamed companies in late January 2010, warning that their promotions and product packaging for omega-3 fatty acid supplements may violate the law “by making baseless claims about how the supplements benefit children’s brain and vision function and development.” FTC apparently gave the companies until February 8 to respond and explain what they have done or will do to ensure they are complying with the law, that is, that their health-related claims “are substantiated.” FTC provides as an example of substantiation “well-conducted, clinical cause-and-effect studies demonstrating that the use of the combination of Omega-3 fatty acids provided in Product X, in the same dosage as provided by one serving of the product, improves or promotes brain function, cognitive function, attention span, intelligence, memory, learning ability, and visual acuity in normal children ages 2 years and older.” The agency…
A recent study has reportedly “confirmed that beer is a very rich source of silicon,” a dietary nutrient that increases bone mineral density. Troy Casey and Charles Bamforth, “Silicon in Beer and Brewing,” Journal of the Science of Food and Agriculture, February 2010. According to researchers with the University of California’s Department of Food Science and Technology, pale ales made from barley grist contained more silicon than non-alcoholic beers, light lagers and wheat beers, “likely because of the high levels of silica in the retained husk of barley.” Of the commercial beers sampled, silicon content apparently ranged from 6.4 to 56.5 milligrams per liter. “During brewing the vast majority of the silicon remains with the spent grains; however, aggressive treatment during wort production in the brewhouse leads to increased extraction of silicon into wort and much of this survives into the beer,” the study concludes. See Reuters, February 9, 2010.
A recent study has allegedly linked soft drink consumption to an increased risk of developing pancreatic cancer. Mark Pereira, et al., “Soft Drink and Juice Consumption and Risk of Pancreatic Cancer: The Singapore Chinese Health Study,” Cancer Epidemiology, Biomarkers & Prevention, February 2010. Using data from 60,524 participants enrolled in the Singapore Chinese Health Study, researchers determined that individuals who consumed more than two carbonated, sugar-sweetened beverages per week “experienced a statistically significant increased risk of pancreatic cancer… compared with individuals who did not consume soft drinks after adjustment for potential confounders.” In addition, the study did not find a similar association for juice consumption. “The high levels of sugar in soft drinks may be increasing the level of insulin in the body, which we think contributes to pancreatic cancer cell growth,” one author was quoted as saying. Other scientists, however, have noted some limitations of the study, which was the…
This article discusses the Food and Drug Administration’s (FDA’s) renewed interest in revising its approach to food serving sizes as front-of-package labeling gains traction in the marketplace. According to Times writer William Neuman, “The push to re-evaluate serving size comes as the F.D.A. is considering ways to better convey nutrition facts to hurried consumers, in particular by posting key information on the front of packages. Officials say such labeling will be voluntary, but the agency must set rules to prevent companies from highlighting the good things about their products, like a lack of trans fats, while ignoring the bad, like a surfeit of unhealthy saturated fats.” Created in the 1990s to help shoppers “compare the nutritional values of different products,” serving sizes are based on eating habit surveys taken during the 1970s and 1980s. Neuman claims, however, that while many people “might eat two or three times” the serving size…
According to this article, pressure from the beverage industry has made policymakers think twice about imposing a tax on sugary beverages, which some have viewed as a way to address both revenue deficits and obesity. The reporters discuss how Congress has handled the issue since the Obama administration indicated an interest in the tax in 2009 and public health advocates testified before a Senate committee urging support for the proposal. They note how a coalition of business interests “operating under the name Americans Against Food Taxes,” quickly mobilized an array of organizations, including the National Hispanic Medical Association, to lobby against the tax. Kelly Brownell, director of Yale University’s Rudd Center on Food Policy and Obesity, apparently responded to the involvement of health groups in the industry initiative by saying, “It’s all about payback. Public health advocates ran into the same phenomena when seeking to increase taxes on tobacco.” The…
According to a news source, U.S. Department of Agriculture (USDA) inspectors, who test the meat and trimmings used in ground beef, deal with about 60 positive E. coli tests annually by taking steps to ensure that the tested meat does not reach consumers, but they apparently fail to conduct a full inspection to try to pinpoint the source of contamination or locate additional meat that may be contaminated. Food safety and consumer advocates, such as Food & Water Watch, have reportedly called on the USDA to adopt a policy change that would require deeper investigations when positive results turn up in routine investigations. They contend that this could indicate a breakdown in the food safety system and consumers are at risk because other tainted meat could remain in the food chain. A spokesperson for the USDA’s Food Safety and Inspection Service (FSIS) was quoted as saying, “The risk profile of these…
A putative class action has been filed in a federal court in Louisiana against CVS Caremark Corp., alleging that the company “has a long history of selling out-of-date medications, baby formula, and food.” Cooper v. CVS Caremark Corp., No. 10-331 (E.D. La., filed February 5, 2010). The named plaintiff, who claims she purchased an expired over-the-counter (OTC) medication from a CVS store, seeks to certify a nationwide class of persons who likewise purchased expired products and asks the court for injunctive relief and compensatory damages. The complaint alleges that the expired OTC medications are “adulterated” under Food and Drug Administration guidelines and that their sale violates the Food, Drug, and Cosmetic Act. The plaintiff also claims that expired OTC drugs, food and baby formula “are unmerchantable and unfit for ordinary use.”
