The U.S. Department of Health and Human Services (HHS) and the National Institute of Environmental Health Sciences (NIEHS) have been sued in federal court under the Freedom of Information Act (FOIA) for their alleged failure to produce data and research relating to the herbicide atrazine. Beveridge & Diamond, P.C. v. HHS, No. 10-1713 (D.D.C., filed October 7, 2010). According to the complaint, the Environmental Protection Agency (EPA) is conducting a comprehensive atrazine review that includes the research of a NIEHS research scientist who worked for EPA in the past. The plaintiff allegedly sought the researcher’s data from EPA, but was told she had taken all of her material to NIEHS. NIEHS has allegedly failed to respond to the plaintiff’s request for data, information and reports related to Dr. Suzanne Fenton’s research on atrazine. The plaintiff alleges, “It is critical that NIEHS promptly provide the requested information to allow for meaningful…
A putative class action has been filed in a federal court in Florida against POM Wonderful, LLC and its holding company, alleging that the defendants deceived consumers in the state by making health-benefit claims for POM’s pomegranate juices, pills, extracts, and concentrated liquids. Cortez v. POM Wonderful, LLC, No. 10-23680 (S.D. Fla., filed October 13, 2010). Alleging damages in excess of $5 million, the named plaintiff cites the Food and Drug Administration’s warning letter to the company and the Federal Trade Commission’s recently filed administrative complaint to support claims that the company’s representation about its products are “false and misleading.” Among the product claims alleged to be false are that it will prevent, mitigate and/or treat atherosclerosis, blood flow/pressure, prostate cancer, erectile dysfunction, cardiovascular disease, LDL cholesterol, and other age-related medical conditions. Seeking to certify a statewide class of consumers who bought the products from September 29, 2006, to the…
A company that makes name- and store-brand food products, including cereals, granola products, pastas, and bakery goods, has sued the supplier of soybean food ingredients allegedly contaminated with Salmonella, seeking in excess of $7 million in damages. Ralcorp Holdings, Inc. v. Thumb Oilseed Producers’ Coop., No. 10-1898 (E.D. Mo., filed October 8, 2010). According to the complaint, the companies contracted for the purchase of the defendant’s soy grits under an agreement that guaranteed they would be suitable for human consumption and that the defendant would indemnify and pay damages to the plaintiff for any warranty breaches. Plaintiff Ralcorp Holdings alleges that it incorporated most of the soy grits into its products, specifically granola bars and trail mixes, for sale to a number of retail companies with which Ralcorp had also contracted. Before delivering the final products, Ralcorp claims that it discovered the soy grit ingredient “was, and had been at…
The New York State Office of Temporary and Disability Assistance has approved and submitted to the U.S. Department of Agriculture (USDA) a New York City proposal “to exclude sugar-sweetened beverages, the largest single contributor to the obesity epidemic, from the list of allowable purchases through the nation’s food stamp program (also known as Supplemental Nutrition Assistance Program, or SNAP),” according to an October 7, 2010, press release. Unveiled by Governor David Paterson (D) and New York City Mayor Michael Bloomberg (I), the initiative would prohibit the city’s food stamp users from buying soft drinks and other sugar-sweetened beverages for up to two years while researchers study the ban’s impact. If accepted by USDA, the plan would define sugar-sweetened beverages “as those containing more than 10 calories per 8 ounces (except fruit juices without added sugar, milk products and milk substitutes).” It would also provide for “a rigorous evaluation . . .…
The Food and Agriculture Organization (FAO) and World Health Organization will hold expert and stakeholder meetings to discuss bisphenol A (BPA) on November 1-5, 2010, in Ottawa, Canada. Supported by the European Food Safety Authority, Health Canada, the National Institute of Environmental Health Sciences, and the U.S. Food and Drug Administration, the November 2-5 expert meeting will address the toxicological and health aspects of BPA, assess its safety, and consider alternatives to the ubiquitous plasticizer. The November 1 stakeholder meeting will provide an opportunity for interested parties to present their views on specific questions, which will also be considered during the expert session. The main topics slated for discussion include (i) “General chemistry of BPA and analytical methods for detection in food”; (ii) “Occurrence of BPA in the diet, including studies on migration of BPA from food contact material”; (iii) “Metabolism and toxicokinetic studies of BPA”; (iv) “Toxicity of BPA…
The National Institute for Occupational Safety and Health (NIOSH) and the National Science Foundation Center for High-rate Nanomanufacturing (CHN) have announced a partnership to help companies identify and address potential health and safety concerns related to nanotechnology. NIOSH and CHN—a collaboration of the University of Massachusetts Lowell, Northeastern University and the University of New Hampshire—will provide onsite evaluations and recommend solutions to small- to medium-sized companies and research laboratories across the country. “There is an intense demand from industry to evaluate nanomaterial exposures and develop appropriate control strategies, practices, guidelines and medical surveillance,” stated CHN’s manager of environmental health and safety in a September 22, 2010, NIOSH press release. “Our team has conducted innovative research on nanomaterial toxicology, exposure and control that will help companies develop strategies to protect workers from the potential health effects of nanomaterials, thus paving the way for the commercialization of nano products.”
The U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) has announced an October 13, 2010, public meeting in College Park, Maryland, to provide information and receive public comments on draft U.S. positions to be discussed at the 32nd Session of the Codex Committee on Nutrition and Foods for Special Dietary Uses (CCNFSDU) on November 1-5 in Santiago, Chile. The meeting will address a discussion paper on the “Inclusion of New Part B for Underweight Children in the Standard for Processed Cereal-Based Foods for Infants and Young Children.” Other agenda items will include (i) proposed revision of “Codex General Principles for the Addition of Essential Nutrients to Foods”, (ii) proposed revision to the “Guidelines on Formulated Supplementary Foods for Older Infants and Young Children”, and (iii) “Proposed Draft Nutrient Reference Values for Nutrients Associated with Risk of Diet-Related Noncommunicable Diseases for General Population.” See Federal Register, October 1, 2010. FSIS…
The U.S. Department of Agriculture’s Animal and Plant Health Inspection Service (APHIS) has published a notice announcing the availability of its biotechnology compliance assistance program audit standard. The document “will be used by participating regulated entities to develop and implement sound management practices, thus enhancing compliance with the regulatory requirements for field trials and movement of genetically engineered [GE] organisms in 7 CFR part 340.” APHIS developed a voluntary quality management assistance program to help regulated entities improve their management of domestic GE organism research and development. The new audit standard “provides criteria for the development, implementation, and objective evaluation of the entity’s [program].” See Federal Register, October 5, 2010.
According to counsel for a company that makes dietary supplements containing selenium, the Food and Drug Administration (FDA) has agreed to allow the company to make qualified health claims for the products that include brief disclaimers. The company will apparently be able to label its products with claims that selenium “may reduce the risk” of prostate, colon, bladder, and thyroid cancers as long as it includes the following: “Scientific evidence concerning this claim is inconclusive. Based on its review, FDA does not agree that selenium may reduce the risk of these cancers.” The negotiations that led to the breakthrough reportedly followed a federal district court ruling in May that FDA violated First Amendment commercial speech standards by censoring specific qualified health claims for the company’s products and requiring the use of a lengthy contradictory qualification. The parties are apparently continuing to discuss disagreements over the effect of selenium on other…
The Food and Drug Administration (FDA) has issued a report titled “Advancing Regulatory Science for Public Health,” that outlines the agency’s plan to develop new scientific and technological tools, standards and approaches to improve its ability to assess the safety, efficacy, quality, and performance of FDA-regulated products, including foods and tobacco. FDA expects to use President Barack Obama’s $25 million increased budget request for fiscal year 2011 to expand the initiative and “build additional partnerships with academia, industry and government around the country.” According to a news source, FDA’s budget has been frozen under a continuing resolution Congress passed before taking its latest recess. A new office dedicated to regulatory science will be created, and the initiative’s goals include protecting the food supply by focusing on “the development of more rapid and practical methods for detecting microbial pathogens in food and equipping FDA’s labs to test multiple food samples for…
