Category Archives Issue 376

The Physicians Committee for Responsible Medicine (PCRM) has filed a lawsuit seeking a response to its petition calling for the withdrawal of the federal government’s “current MyPyramid food diagram and dietary guidelines” and the adoption of PCRM’s “Power Plate food diagram and dietary guidelines.” PCRM v. Vilsack, No. 11-00038 (D.D.C., filed January 5, 2011). Brought against the secretaries of the U.S. Department of Agriculture (USDA) and Department of Health and Human Services (HHS), the complaint for injunctive relief calls the agencies’ food diagram “ineffective and confusing” and alleges that it “fails to promote overall health and well-being.” PCRM contends that USDA and HHS have violated the Administrative Procedure Act by failing to respond to its petition in a “reasonable time.” PCRM’s “Power Plate” would eliminate all animal-derived products from the diet. A Florida resident has filed a putative class action against Phusion Projects, LLC, claiming that the company’s Four Loko® caffeinated alcoholic…

German officials have launched an investigation into an animal feed supplier that allegedly distributed a dioxin-tainted additive to 25 feed manufacturers, who in turn sold products to hundreds of poultry, pork and egg farms in Lower Saxony, North Rhine-Westphalia, Thuringia, Saxony, and Brandenburg. According to media sources, Uetersen-based Harles & Jentzsch GmbH made its additive from mixed fatty acids approved only for industrial use and obtained from a biodiesel company. The Federal Ministry for Food, Agriculture and Consumer Protection (BMELV) has since reported that some additive samples contained 77 times the approved limit for dioxin, an industrial byproduct allegedly linked to cancer, although the agency has not received any health notifications related to consumer products. The revelation has drawn international attention, with South Korea and Slovakia blocking German pork and poultry imports after 136,000 tainted eggs were sold to the Netherlands. As a precaution, BMELV has apparently halted sales at…

The U.K. Department for Business, Innovation and Skills has announced plans to relax regulations governing the sale of beer, wine and unwrapped bread loaves. Science Minister David Willetts apparently confirmed the government’s intention to scrap laws stipulating that unpackaged bread “weighing more than 300g must be made up in quantities of 400g or multiples of it.” He also indicated changes to the beer and wine laws, which currently state that pubs and other premises cannot sell wine “in measures less than 125ml while beer must be sold in thirds, halves or multiples of half-pints.” Under the new rules, these businesses will be able to sell wine in measures under 75ml; beer in “schooners” that are equal to two-thirds of a pint; and fortified wine in smaller sizes of 50ml and 70ml. “This is exactly the sort of unnecessary red tape the government wants to remove. No pub or restaurant should…

The National Institute for Occupational Safety and Health (NIOSH) has announced the availability of a draft document that contains a toxicological assessment of the potential health risks of occupational exposure to carbon nanotubes and nanofibers. The draft document also provides recommendations for the safe handling of these materials, which can be found in many applications, including food packaging. NIOSH will hold a public meeting on February 3, 2011, in Cincinnati, Ohio, to explore (i) “whether the hazard identification, risk estimation, and discussion of health effects for carbon nanotubes and nanofibers are a reasonable reflection of the current understanding of the evidence in the scientific literature”; (ii) “workplaces and occupations where exposure to carbon nanotubes and nanofibers occur”; (iii) “current strategies for controlling occupational exposure to carbon nanotubes and nanofibers (e.g., engineering controls, work practices, personal protective equipment”; (iv) “current exposure measurement methods and challenges in measuring workplace exposures to carbon nanotubes…

The Department of Health and Human Services’ National Toxicology Program (NTP) has announced a January 11-13, 2011, workshop in Raleigh, North Carolina, to address how environmental chemicals may be contributing to the “epidemics of diabetes and obesity.” Workshop participants will (i) “evaluate strengths/weaknesses, consistency, and biological plausibility of findings reported in humans and experimental animals for certain environmental chemicals including arsenic, cadmium, chlorinated organohalogens, other organohalogens, bisphenol A, phthalates, and organotins”; (ii) “identify the most useful and relevant endpoints in experimental animals and in vitro models”; (iii) “identify relevant pathways and biological targets for assays for the Toxicology Testing in the 21st Century (‘Tox21’) high throughput screening initiative”; and (iv) “identify data gaps and areas for future evaluation/research.” See Federal Register, December 10, 2010.

The Institute of Medicine (IOM) has announced a January 28, 2011, forum to discuss the Food and Drug Administration’s (FDA) role in ensuring safe food. IOM’s Committee on Review of FDA will meet in Washington, D.C., with agency representatives to review the recommendations put forth in its June 2010 report, Enhancing Food Safety, which described FDA as “reactive, lacking a systematic focus on prevention.” The findings specifically asked FDA to adopt a “risk-based model” that involves increased coordination “with state and other federal agencies that share responsibility for protecting the nation’s food supply.” It also called on Congress to amend the Food, Drug, and Cosmetic Act “to explicitly provide the authority FDA needs to fulfill its food safety mission.”

The Food and Drug Administration (FDA) has announced an initiative to address “the prevalence of animal drug products marketed in the United States without approval or other legal marketing status.” Unapproved animal drugs on the market include injectable vitamins, shampoos, liniments, and electrolyte and glucose solutions. FDA is concerned that the safety and effectiveness of these drugs has not been demonstrated and is open “to using both the agency’s existing authority and new approaches to make more drugs legally available to veterinarians, animal producers and pet owners,” according to a December 20, 2010, press release. The agency requests comments by February 18, 2011, on ways to increase the availability of legally marketed animal drugs and has launched a web page detailing problems involving the use of unapproved products. See Federal Register, FDA Press Release, December 20, 2010.

The Food and Drug Administration (FDA) has reopened the comment period on revisions proposed in 1997 to its rule regarding substances generally recognized as safe (GRAS). Written or electronic comments are requested by March 28, 2011. The proposed revisions would “replace the voluntary GRAS affirmation petition process . . . with a voluntary notification procedure whereby any person may notify us of a determination that a particular use of a substance in human food . . . or in food for animals . . . is GRAS.” The proposal would also “clarify the criteria . . . whereby the use of a substance is not subject to the premarket approval requirements of the [Food, Drug, and Cosmetic Act] because it is GRAS.” The Federal Register notice refers to several developments since 1997, including the use of nanotechnology in foods, a Government Accountability Office (GAO) report on FDA oversight of GRAS…

The U.S. Department of Agriculture (USDA) has issued a final rule requiring mandatory nutrition labeling on 40 major cuts of single-ingredient, raw meat and poultry products. The Nutrition Labeling and Education Act of 1990 requires nutrition facts labels on most foods regulated by the Food and Drug Administration, but USDA-regulated meat and poultry has been exempt, allowing producers to supply the information on a voluntary basis. Effective January 1, 2012, the rule calls for packages of ground or chopped meat and poultry to feature nutrition fact panels on their labels, and whole, raw cuts of meat and poultry to either include facts panels on their package labels or have them available for consumers at the point-of-purchase. Designed to educate consumers about nutrition and diets, the rule requires the labels to supply the number of calories and the grams of total fat and saturated fat. “Additionally, any product that lists a…

President Barack Obama (D) signed the FDA Food Safety Modernization Act (H.R. 2751) into law on January 4, 2011, ending a complicated legislative journey that began with House approval in 2009. In essence, the law gives the Food and Drug Administration (FDA) the authority to order food product recalls, calls for more frequent facility inspections, enhances FDA’s ability to oversee food imports, requires food facilities to have written safety plans, establishes science-based standards for the safe production and harvesting of produce, and exempts small farms that sell directly to local consumers from a number of provisions. As Commissioner of Food and Drugs Margaret Hamburg has noted, while some of the changes take effect immediately, others depend on budgeting. According to her blog post, “The funding we get each year, which affects our staffing and our vital and far-ranging operations, will also affect how this legislation is implemented . . .…

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