A South Carolina-based family farming operation has filed a complaint seeking damages that it alleges were sustained in 2008 when the Food and Drug Administration (FDA) issued a nationwide recall of round tomatoes due to a purported Salmonella outbreak. Seaside Farm, Inc. v. United States, No. 11-1199 (D.S.C., filed May 18, 2011). The plaintiff claims that independent audits before the recall was announced verified that its produce and practices were safe. Still, according to the complaint, “At the time of the recall, the FDA had not positively identified a single tomato as a current source of the salmonella outbreak in the United States” and “The FDA never identified any contaminated tomatoes and ultimately conceded that tomatoes were not the source of the salmonella contamination.” Claiming that the recall “decimated the market price for fresh tomatoes,” the plaintiff seeks unspecified general and special compensatory damages and interest under the Federal Tort Claims Act.…
Category Archives Food and Drug Administration
The Institute of Medicine’s (IOM’s) Food and Nutrition Board has announced a June 7, 2011, meeting that will focus on the safety of imported foods “with the purposed of engaging science, technology, and policy personnel representing the global food supply chain, government agencies, and academia.” Titled “Food Forum Meeting on Supply Chain and Policy/Regulatory Approaches to Import Safety,” the meeting will include a morning panel featuring actors representing the supply chain “from producer to retailer/food service provider” and an afternoon panel of government officials representing “governance processes from the state to global level.” By focusing on the Food and Drug Administration’s new authority granted under the Food Safety Modernization Act (FSMA), including “importer accountability, third party certification, certification for high risk foods, voluntary qualified importer program, and authority to deny entry,” the meeting aims to “provide perspectives and ideas useful for the development and implementation of the multifaceted import tools available…
The Government Accountability Office (GAO) has issued a report criticizing the Food and Drug Administration’s (FDA’s) oversight of imported seafood safety. Noting that about one-half of imported seafood comes from fish farms that may use antibiotics to prevent bacterial infections, the report claims that “residues of some drugs can cause cancer and antibiotic resistance.” Titled “FDA Needs to Improve Oversight of Imported Seafood and Better Leverage Limited Resources,” the report urges FDA to enhance its import sampling program. “FDA’s oversight program to ensure the safety of imported seafood from residues of unapproved drugs is limited, especially as compared with the European Union,” the report states, adding that FDA inspectors “generally do not visit the farms to evaluate drug use or the capabilities, competence, and quality control of laboratories that analyze the seafood.” The report also recommends that FDA (i) “study the feasibility of adopting practices used by other entities to…
U.S. Senator Dick Durbin (D-Ill.) has asked the Food and Drug Administration (FDA) “to clarify its authority to regulate foods that contain additives, such as baked goods that contain high doses of melatonin,” after media reports drew attention to so-called “relaxation brownies” touted for allegedly alleviating stress and easing sleep deprivation. In a May 18, 2011, letter to FDA Commissioner Margaret Hamburg, Durbin argues that melatonin-laced sweets “with names such as Lazy Cakes, Kush Cakes and Lulla Pies” could raise health concerns for consumers who “may not recognize they are consuming a neurohormone, that they should consult a doctor before eating it, and that it may not be appropriate for children, people with auto-immune diseases, or women who are pregnant or breast-feeding.” He notes that these products contain “roughly 8 milligrams of melatonin—almost double the upper limit of a typical dose” set by the Natural Medicines Comprehensive Database, which advises…
The Food and Drug Administration (FDA) has filed a complaint for permanent injunction against Tennessee-based companies that process food products and ingredients, such as spices, spice blends, herbs, and sauces, claiming they have repeatedly violated the law by selling adulterated foods. United States v. Am. Mercantile Corp., No. 11-02371 (W.D. Tenn., filed May 11, 2011). According to the complaint, the foods are adulterated because “they have been prepared, packed, and held under insanitary conditions whereby they may have become contaminated with filth.” An array of insects and insect and rodent excreta were allegedly observed on a number of occasions at defendants’ facilities, and repeat visits by inspectors showed that the cited violations had not been corrected. Other problems included spilled food, unsatisfactory cleaning, gaps in the building exterior, and expired products. FDA seeks to permanently enjoin the defendants from “introducing or delivering for introduction into interstate commerce any article of food…
FDA has issued the first two new regulations under the Food Safety Modernization Act. Effective July 3, 2011, the interim final rules are designed to strengthen FDA’s ability to help prevent potentially unsafe food from reaching U.S. consumers. The first rule amends FDA regulations concerning the detention of food for human or animal consumption. It allows the agency to detain food it believes has been produced under unsanitary or unsafe conditions or is adulterated or misbranded. Previously, the agency was able to detain food products only when it had “credible evidence that a food product presented was contaminated or mislabeled in a way that presented a threat of serious adverse health consequences or death to humans or animals,” FDA said in a May 4 press release. Now the agency can detain questionable food from the marketplace for up to 30 days while it determines if enforcement action such as seizure…
The Food and Drug Administration (FDA) has announced the availability of updated safety standard guidelines for the seafood industry. The 476-page document “supports and complements FDA’s regulations for the safe and sanitary processing and importing of fish and fishery products using hazard analysis and critical control point (HACCP) methods” required of commercial seafood processors. The revised guidance provides current information on (i) “potential hazards associated with the known commercial species of vertebrate and invertebrate seafood,” (ii) “potential hazards associated with certain processing operations,” (iii) “HACCP strategies that may be used to control the potential hazards,” and (iv) “other information related to food safety.” See Federal Register, April 28, 2011.
The Food and Drug Administration (FDA) has answered criticism of a July 21, 2000, final rule allowing “the safe use of ionizing radiation for the reduction of Salmonella in fresh shell eggs,” and denied requests for a hearing on the ground that the objections “do not raise issues of material fact or otherwise provide a basis for revoking or modifying . . . the regulation.” FDA evidently received 26 submissions contesting the final rule, which permits the irradiation of fresh shell eggs at doses not to exceed 3.0 kiloGray (kGy), but only one letter from Public Citizen raised specific issues within the rule’s scope. The April 13, 2011, Federal Register notice responds to Public Citizen’s claims that FDA misrepresented irradiation’s efficacy and its effect on vitamin A loss and egg yolk carotenoids; that FDA raised the dose allowance to 3.0 kGY without properly updating its analyses; and that FDA failed…
The Food and Drug Administration (FDA) has announced an April 20, 2011, public meeting to discuss a Food Safety Modernization Act (FSMA) mandate to implement “comprehensive, science-based preventive controls across the food supply.” FSMA requires human, pet and animal food and feed facilities registered under section 415 of the Food, Drug, and Cosmetic Act (21 U.S.C. 350d) “to take certain preventive actions, including to evaluate the hazards that could affect food manufactured, processed, packed, or held by the facility, and to identify and implement preventive controls to significantly minimize or prevent the occurrence of such hazards.” The meeting will help FDA establish these controls as well as industry guidance “for conducting a hazard analysis, documenting hazards, implementing preventive controls, and documenting their implementation.” In particular, the agency has requested information on “preventive controls used by facilities to identify and address hazards associated with specific types of food and specific processes.”…
The Food and Drug Administration (FDA) and the Food Safety and Inspection Service (FSIS) have announced that they are seeking comments and scientific data to update a risk assessment on the relationship between foodborne Listeria in selected ready-to-eat (RTE) foods and human health. According to the agencies, the effort is designed to evaluate reduction or prevention strategies of Listeria exposure to RTE foods, such as “the impact of changing refrigerated time and temperature storage prior to consumption.” The agencies specifically request comments or data on areas including (i) Listeria “contamination in different RTE foods sampled at retail or in the processing plant,” (ii) Listeria “survival and growth dynamics in RTE foods,” (iii) “the relationship between the dose of Listeria monocytogenes ingested with food and the frequency of Listeria,” (iv) “current food consumption practices in the United States” relating to RTE foods, and (v) storage times and temperatures that may affect Listeria growth during…
