The Government Accountability Office (GAO) has just released a report that discusses how the Food and Drug Administration’s (FDA’s) new overseas food safety offices are functioning and offers recommendations for enhancing strategic planning and developing a workforce plan “to help recruit and retain overseas staff.” Titled “Overseas Offices Have Taken Steps to Help Ensure Import Safety, but More Long-Term Planning Is Needed,” the report was prepared for the House Committee on Oversight and Government Reform. According to the report, an FDA presence in foreign countries has improved the agency’s ability to build relationships with stakeholders abroad, to inspect foreign facilities and provide limited food safety training to overseas counterparts. Still, with only 42 total staff covering China, Europe, India, Latin America, and the Middle East, resources are apparently stretched and FDA has had some challenges with staffing. Foreign language capabilities and the domestic reintegration of staff serving abroad have apparently posed…
Category Archives Food and Drug Administration
The U.S. Food and Drug Administration (FDA) has released a 10-year tracking report that calls for increased focus on food safety practices in retail food establishments. A companion 2009 retail food report highlights the need for certified food protection managers to help achieve higher food-safety compliance levels. The 1998-2008 tracking report, which studied more than 800 retail food establishments in 1998, 2003 and 2008, focused on five key risk factors: (i) food from unsafe sources, (ii) poor personal hygiene, (iii) inadequate cooking, (iv) improper holding of food (time and temperature), and (v) contaminated food surfaces and equipment. According to an FDA press release, “continued improvements are needed across the board” regarding personal hygiene, holding of food and food surfaces and equipment. The 2009 report found that the presence of a certified food protection manager in full-service restaurants, delicatessens, seafood markets, and produce markets was correlated with “statistically significant higher compliance…
A federal court in New Jersey has granted the defendant’s unopposed motion to extinguish the stay in a lawsuit contending that Snapple beverage products are falsely advertised as “natural” because they contain high-fructose corn syrup, a purportedly non-natural ingredient. Holk v. Snapple Beverage Corp., No. 07-3018 (D.N.J., decided October 15, 2010) (unpublished). The court had stayed the litigation pending the Food and Drug Administration (FDA) reaching a decision about the definition of “natural.” According to the court’s order, “The FDA in response has declined to address that issue.” Noting that another district court in New Jersey has lifted a stay imposed for the same reason in similar litigation (Coyle v. Hornell Brewing Co.), the court agreed to reopen the case, but refused to reinstate the motions that were pending when the case was “administratively terminated.” The court ordered the parties “to move again, upon new notices of motion and in accordance with…
The Institute of Medicine (IOM) has released the first phase of its report on front-of-package (FOP) rating systems and symbols for food products and recommends that the nutrients of greatest concern to consumers—calories, saturated fats, trans fat, and sodium—as well as serving size, should be highlighted, with calorie-count and serving-size information displayed prominently. According to IOM, “The inclusion of total calories is one way to emphasize the importance of calories in the diet and may help consumers identify lower calorie foods and track the number of calories consumed, . . . [while] serving size information may help consumers better visualize realistic serving sizes and put that portion into context with the other foods and beverages they are consuming.” Sponsored by the Centers for Disease Control and Prevention and the Food and Drug Administration (FDA), the report, titled “Examination of Front-of-Package Nutrition Rating Systems and Symbols: Phase 1 Report,” examines and compares…
The Food and Drug Administration (FDA) has issued a warning letter to Chiquita Brands International, Inc. indicating that the company is violating the Federal Food, Drug, and Cosmetic Act by misbranding several of its pineapple products. According to FDA, because Pineapple Bites with Coconut® is made with a coconut-flavored spray, the product’s statement of identity and ingredient statement are false and misleading and should instead be identified as containing “coconut flavor.” The labeling also apparently states that the product contains antioxidants but does not include the names of the nutrients that are the subject of the claim. FDA further contends that the products include the claim “Plus Phytonutrients.” Because no recommended daily intake or daily recommended value has been established for phytonutrients, such nutrient content claims are not authorized, according to the agency. The products also apparently include the statement “Only 40 calories,” which FDA says implies that the products…
U.S. Representative Rosa DeLauro (D-Conn.) has introduced a bill (H.R. 6325) that would require labeling for food that contains genetically engineered (GE) animal products. The Consumer Right to Know Food Labeling Act of 2010 would amend the Food, Drug, and Cosmetic Act and Meat Inspection Act to compel the disclosure of product ingredients derived from cloned animals or their progeny. It would also mandate labeling for food products that contain GE salmon. In addition to providing for civil penalties and citizen suits in the event of misbranded food, the bill would direct the U.S. Department of Agriculture and Food and Drug Administration (FDA) to develop and implement a recordkeeping audit trail applicable to “any person that prepares, stores, handles, or distributes a cloned product for retail sale.” “A recent Food & Water Watch survey revealed that 78 percent of Americans do not want genetically-engineered salmon to be approved and made available…
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…
The European Food Safety Authority’s (EFSA’s) panel on food contact materials, enzymes, flavorings, and processing aids has released its latest risk assessment for bisphenol A, concluding that there was not any “new evidence which would lead them to revise the current Tolerable Daily Intake [TDI] for BPA of 0.05 mg/kg body weight set . . . in its 2006 opinion and re-confirmed in its 2008 opinion.” The CEF panel undertook the reassessment at the request of the European Commission, which directed scientists to (i) decide on the basis of recent literature whether to update the TDI; (ii) “assess a new study on possible neurodevelopmental effects”; and (iii) advise on a risk assessment made by the National Food Institute at the Technical University of Denmark. Although one minority opinion evidently raised questions about “adverse health effects below the level used to determine the current TDI,” panel members agreed on shortcomings in…
The Food and Drug Administration (FDA) has announced a meeting of the Transmissible Spongiform Encephalopathies Advisory Committee, which reviews and evaluates available scientific data concerning the safety of products that might transmit spongiform encephalopathies such as Creutzfeldt-Jakob disease and the bovine variant commonly known as mad cow disease. Agenda items for the October 28-29, 2010, meeting in Gaithersburg, Maryland, include (i) “FDA’s risk assessment for potential exposure to the variant Creutzfeldt-Jakob disease (vCJD) agent in U.S.-licensed plasma-derived Factor VIII” and (ii) “labeling of blood and blood components and plasma-derived products, including plasma-derived albumin and products containing plasma-derived albumin, to address the possible risk of transmission of vCJD.” The committee will also discuss ways to reduce transmission risks and hear updates on the “development of devices to remove transmissible spongiform encephalopathy agents from blood components and chronic wasting disease.” FDA requests written comments by October 21, 2010. See Federal Register, September…
