U.S. Senator Kirsten Gillibrand (D-N.Y.) has introduced legislation (S.B. 3114) that would require food distributors, retailers and health agencies to notify consumers and local officials in the event of a Class I food recall. Under the Consumer Recall Notification Act, the Food and Drug Administration (FDA) could ask grocery stores and other retailers to provide “on-site notification” where recalled foods are sold. In addition, purveyors that track data through customer card systems would need to alert, by phone and mail, the purchasers of recalled items or risk civil penalties of $100 per customer. Suppliers would also need to notify “applicable retail establishments and restaurants” within 24 hours of a Class I recall to avoid a $1,000 penalty per day, per notification of each level of distribution. “In America, in 2010, it is unconscionable that we don’t have an effective way to communicate food-borne illness outbreaks to consumers and health departments,”…
Category Archives U.S. Government and Regulatory Agencies
The U.S. Government Accountability Office (GAO) recently released a report criticizing the Food and Drug Administration’s (FDA’s) oversight of food ingredients determined to be generally recognized as safe (GRAS). Noting that companies are not required to submit their GRAS determinations to regulators, GAO examined whether FDA can vouch for these substances, which increasingly include nanomaterials. The report apparently concludes that not only does FDA’s oversight process fail to ensure the safety of both new and preexisting GRAS determinations, but it allows engineered nanomaterials to enter the food supply without the agency’s knowledge. According to the report, FDA “has not systematically reconsidered GRAS substances since the 1980s,” nor has it responded to “concerns about GRAS substances, such as salt and the trans fat in partially hydrogenated vegetable oils, that individuals and consumer groups have raised through 11 citizen petitions submitted to the agency between 2004 and 2008.” The findings also fault…
The U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) has announced a March 23, 2010, public meeting to discuss draft U.S. positions for the 26th Session of the Codex Committee on General Principles (CCGP) slated for April 12-16, 2010, in Paris, France. Issues to be discussed include (i) “Draft Revised Code of Ethics for International Trade in Foods”; (ii) “Review of the Risk Analysis Policies of Codex Committees”; (iii) “Definition of the Term ‘Competent Authority’”; and (iv) “Discussion Paper on the Development of Joint Codex and World Organization for Animal Health Standards.” FSIS has also announced a March 29, 2010, public meeting to discuss draft U.S. positions for the 4th Session of the Codex Committee on Contaminants in Food (CCCF) slated for April 26-30, 2010, in Izmir, Turkey. Agenda items include proposed draft maximum levels for melamine in food and feed and a priority list of contaminants and…
The U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) held a March 10, 2010, public meeting to discuss agency procedures “for identifying suppliers of source material used to produce raw beef product that FSIS has found positive for Escherichia coli (E. coli) O157:H7.” FSIS announced the meeting as part of its ongoing efforts to evaluate “the effectiveness of its policies and procedures in responding to findings that raw beef is positive for E. coli O157:H7.” In particular, FSIS intends to issue “new instructions to Enforcement, Investigations, and Analysis Officers (EIAOs) to conduct additional verification activities at suppliers in response to positive E. coli O157:H7 results.” The agency will accept public input on these issues until May 7, 2010. See FSIS Press Release, March 3, 2010; Federal Register, March 8, 2010.
Food and Drug Administration (FDA) inspectors issued a report March 4, 2010, stating that Basic Food Flavors, Inc., the Las Vegas-based company at the center of a massive and growing food recall, “continued to distribute HVP [hydrolyzed vegetable protein] paste and powder products” for nearly a month after receiving the first lab results “indicating the presence of Salmonella in your facility.” While no illness has apparently yet been attributed to the HVP, it is used in dozens of products. As of March 11, FDA had identified some 150 products containing HVP, including bouillon, dressing and dressing mixes, frozen foods, ready-to-eat meals, sauces and marinades, snacks and snack mixes, soups, soup mixes and dip mix products, and stuffings. According to some quality management specialists, this outbreak could be particularly challenging because HVP is considered a generic commodity; it can be purchased from many different suppliers, stored without an effective tracking system for…
The Pew Charitable Trusts’ Produce Safety Project (PSP) recently published a cost analysis claiming that health-related expenditures for foodborne illness far exceed the U.S. Department of Agriculture’s estimate of $6.9 billion annually. Authored by former Food and Drug Administration (FDA) economist Robert Scharff, the report concludes that the United States spends $152 billion per year on foodborne illnesses from all sources. The study also notes that these numbers cover health-related costs only and thus represent “a lower bound estimate of the total societal costs,” including costs to industry and government. “Even when pain and suffering losses from acute illnesses are not included, the cost to society is $103 billion,” maintains the report, which used FDA methods to determine the costs of physician services, pharmaceuticals, and hospital visits related to foodborne illnesses, as well as quality of life losses such as lost life expectancy, pain and suffering, and functional disability. Intended…
FDA Commissioner Margaret Hamburg offered her views on how the agency will move forward on food safety and labeling issues during a “Food Summit” sponsored by The Atlantic magazine at the Newseum in Washington, D.C., March 4, 2010. Hamburg stated that she plans to focus on two critical aspects of food policy: safety and how to make it easier for consumers to make more nutritious choices and reduce the risk of disease. She pointed to three converging factors that affect food safety. First, she stated that both consumers and the industry support reform measures and want a system focused on prevention, where everyone in the supply chain is held accountable and imports are required to meet U.S. standards. Second, she noted that current U.S. food safety legislation (H.R. 2749—passed by the House in July 2009 and expected to be taken up by the Senate this spring) would mandate a shift from reaction…
With the recent uptick in consumer fraud class actions targeting food and beverage labels, and opinions like the Ninth Circuit’s in Williams v. Gerber, 552 F.3d 934 (2009) (reinstating a proposed class action and finding that consumers should not be “expected to look beyond misleading representations on the front of the box to discover the truth from the ingredient list in small print on the side of the box”), the findings of a recent Food and Drug Administration health and diet survey are good news to manufacturers of food and beverage products. On March 2, 2010, FDA released the results of a nationwide survey conducted in 2008 on consumer behaviors, knowledge, attitudes, and beliefs about health and diet. Specifically included were questions about consumer use of packaging labels. Fifty-four percent of consumers “often” read the food label the first time they buy a product. Of these, two-thirds do so to…
Taking aim at companies that make (i) nutrient content claims on foods and beverages intended for children younger than age 2, (ii) 0 gram trans fat claims on products high in saturated fats, and (iii) health-related claims, such as the treatment or mitigation of disease, the Food and Drug Administration (FDA) has issued warning letters to 17 companies and an open letter to industry indicating that it will crack down on false or misleading labeling and marketing claims. Among the targeted companies are Dreyer’s Ice Cream, Inc. (ice cream—no trans fat), Beech-Nut Nutrition Corp. (baby food—nutrient claims for children younger than age 2), Nestle (Juicy Juice products—implied 100 percent juice for juice blends with added flavors), Pompeian, Inc. (olive oil—treat, prevent and cure diseases), Redco Foods (green tea—antioxidants effective in the prevention of cardiovascular disease), and Diamond Food, Inc. (shelled walnuts—omega-3 claims about treating, preventing or curing diseases). Some of the…
Senator Charles Schumer (D-N.Y.), who introduced legislation that would prohibit the use of bisphenol A (BPA) in children’s products, has written to the U.S. Environmental Protection Agency’s (EPA’s) administrator seeking an explanation for the agency’s decision to omit BPA from its December 2009 chemical action plan. In the March 2, 2010, letter, Schumer refers to scientific research purportedly identifying BPA risks “particularly to infants and children,” and the Food and Drug Administration’s recent decision to reverse its conclusion that the chemical is safe for all uses. Schumer also refers to a Milwaukee Journal-Sentinel article reporting that “the agency does not plan to formulate any new plan for regulating BPA for two years. If this is true, it is alarming. At a time when we should be speeding up steps to limit Americans’ exposure to this potentially hazardous chemical, such a decision would apply the brakes.” That article apparently took note of…