In an unpublished opinion, the Fifth Circuit Court of Appeals has upheld the dismissal of a biscuit maker’s claim that the Food and Drug Administration’s (FDA’s) negligent testing of its product for Listeria monocytogenes resulted in a false positive report that caused it to lose its contract with a company that supplied 7-Eleven convenience stores with biscuit sandwiches. Lone Star Bakery, Inc. v. U.S., No. 09-50374 (5th Cir., decided November 17, 2009). The litigation arose under the Federal Tort Claims Act following a 2002 Listeria contamination incident for which the biscuit maker was initially blamed, but later cleared of any responsibility. The company sought $2.9 million in damages from the FDA. According to the court, which affirmed a grant of the FDA’s summary judgment motion, while the company submitted evidence showing “several instances where the FDA inspectors failed to follow agency collection and testing protocol,” its evidence was “devoid of…
Category Archives Food and Drug Administration
In collaboration with Health Canada and the U.S. Food and Drug Administration, the United Nations’ World Health Organization (WHO) and Food and Agriculture Organization (FAO) have announced an October 2010 expert meeting in Ottawa, Ontario, to discuss the safety of bisphenol A (BPA), calling for data from the scientific community on any “adverse human health effects at low doses of BPA, especially on reproduction, the nervous system and on behavioral development.” Meeting participants will apparently consider the current literature on BPA toxicology and exposure, weigh available risk assessments and address any knowledge gaps in an effort to develop international guidance. The agencies are specifically requesting both published and unpublished technical information on (i) “current levels of BPA in relevant food groups”; (ii) the analytical methodologies used to detect BPA “in food and other matrices”; (iii) “BPA migration from food contact materials into food”; (iv) “dietary exposure assessments of BPA from foods and other sources”;…
The National Consumers League has sent a letter to the Food and Drug Administration (FDA) urging the agency to issue industry guidance in a renewed effort “to prevent consumers from being misled by the deceptive labeling of tomato products remanufactured from concentrate.” According to the league, it initiated efforts in 1990 that led the government to define the term “fresh” and require manufacturers to differentiate products prepared directly from fresh ingredients and those made from concentrate. The organization contends that “the marketplace once again is littered with false and misleading labels for tomato products claiming to be packed or made directly from fresh tomatoes.” The letter claims that food companies are misleading consumers by using phrases such as “packed full of premium vine-ripened tomatoes,” “packed from 100 percent California tomatoes” and “picks the freshest tomatoes,” to describe products “made from industrial tomato concentrate.” Citing FDA regulations requiring “from concentrate” or…
The Food and Drug Administration (FDA) has published a notice seeking public comment on a proposed experimental study that would examine consumer reaction to possible modifications in the nutrition facts labeling format. The study results will reportedly help the agency understand whether label modifications “could help consumers to make informed food choices.” FDA intends to randomly select 3,600 people to review nutrition facts labels from a selection of different formats, foods and nutrition information, and then judge their reactions as to the foods’ “nutritional attributes and overall healthfulness” and whether the labels help “calculate calories and estimate serving sizes to meet objectives.” FDA invites comments on (i) whether the information collected “will have practical utility”; (ii) the “validity of the methodology and assumptions used”; (iii) “ways to enhance the quality, utility and clarity of the information to be collected”; and (iv) “ways to minimize the burden of the collection of information.”…
The Food and Drug Administration (FDA) has issued a proposed rule that would amend the agency’s animal-food regulations by requiring manufacturers to list the common or usual names of FDA-certified color additives on animal food labels, including animal feeds and pet foods. The amendment would make the regulations consistent with those that apply to human food and suggests how color additives not certified by FDA should be declared on the ingredient list of animal foods. According to FDA, the proposal responds to the Nutrition Labeling and Education Act of 1990, which modified the Federal Food, Drug, and Cosmetic Act by requiring food labels to list the common or usual names of all FDA-certified color additives. The 1990 amendments apply both to human and animal foods, but apparently regulations pertaining to animal foods have yet to be issued. Written comments will be accepted until February 22, 2010. See Federal Register, November…
The Food and Drug Administration (FDA) has extended the period for comments and scientific data and information on acrylamide in food as it considers industry guidance on this issue. In response to a request for a 60-day extension, FDA will accept written comments and scientific data until January 25, 2010. In its original request for comments and data published in the August 26, 2009, Federal Register, FDA described acrylamide as “a chemical that can form in some foods during certain types of high-temperature cooking,” and sought information from manufacturers on how to measure and reduce acrylamide levels in food. The agency asked responders to provide detailed feedback about: (i) techniques for acrylamide mitigation; (ii) best monitoring practices; (iii) standard practices for the delivery, storage, temperature control, reconditioning, and screening of potatoes; (iv) changes to food packaging instructions and other measures that can reduce acrylamide levels during a product’s final preparation by…
The Food and Drug Administration’s (FDA) Center for Food Safety and Applied Nutrition (CFSAN) has released a report that recommends guidelines for establishing a comprehensive food-tracing system along the entire supply chain to reduce foodborne illness. CSFAN commissioned the Institute of Food Technologists (IFT) report in 2008, and will apparently consider its findings when determining how government and industry can more quickly identify products associated with disease and remove risky products from the market. IFT, a nonprofit scientific society focused on the science of food, reportedly examined the tracing methods of 58 diverse food companies to prepare the study, which recommends (i) creating a standard list of key data to be collected at each stage of the food chain, from farm to retailer or restaurant; (ii) developing more thorough, standardized recordkeeping methods; (iii) keeping records in electronic format; (iv) requiring a third-party audit of a company’s tracking system; and (iv)…
The Food and Drug Administration (FDA) has announced its intention to delay a 2011 ban on raw oysters harvested from the Gulf of Mexico during warm weather months. FDA heard from “Gulf Coast oyster harvesters, state officials, and elected representatives from across the region about the feasibility of implementing post-harvest processing or other equivalent controls” designed to reduce illnesses from bacteria like Vibrio vulnificus. “It is clear to FDA from our discussions to date that there is a need to further examine both the process and timing for large and small oyster harvesters to gain access to processing facilities or equivalent controls in order to address this important public health goal,” stated the agency, which will conduct an independent study to assess how bacteria controls can be “feasibly implemented in the fastest, safest and most economical way.” FDA specifically noted that it will (i) continue to collaborate with the Interstate…
Responding to a request from a coalition of state attorneys general, the Food and Drug Administration (FDA) has called on the makers of alcoholic energy drinks to provide information and data showing their use of caffeine in alcoholic beverages is permissible under the law. The letter, sent to nearly 30 companies, explains what the law requires in terms of food additives: the additives must meet generally recognized as safe (GRAS) standards or be given pre-market approval by the agency. According to FDA, caffeine is GRAS only when used in cola-type beverages. The letters were issued on November 13, 2009, and the companies were given 30 days to provide the requested information. In late September, the co-chairs of the National Association of Attorneys General Youth Access to Alcohol Committee called for the agency to pull the products from the market, contending that “the combination of caffeine and alcohol in AEDs [alcoholic…
U.S. Senators Bill Nelson (D-Fla.) and Mary Landrieu (D-La.) have introduced legislation seeking to block a Food and Drug Administration (FDA) proposal that would prohibit the distribution of raw oysters from the Gulf of Mexico during warm-weather months. “Specifically, the legislation, which was co-sponsored by Senator David Vitter (R-La.), would prevent [FDA] from using funds to implement a ban on sales of oysters that don’t undergo a sterilization process,” according to a November, 5, 2009, press release issued by Landrieu. Slated to take effect in 2011, the FDA plan would apparently require processing for Gulf oysters harvested between April and October. The agency has pointed to the risk that raw oysters can cause fatal Vibrio vulnificus infections in people with compromised immune systems, resulting in approximately 15 deaths per year. California has already enacted similar measures that bar the sale of untreated raw Gulf oysters in the state, which has…
