A federal court in South Carolina has dismissed three of four claims in a lawsuit filed by a family farming operation that claims the Food and Drug Administration’s (FDA’s) 2008 tomato recall, which later proved unnecessary as the agency conceded that tomatoes were not the source of the Salmonella contamination, caused the farm substantial economic harm. Seaside Farm, Inc. v. United States, No. 11-1199 (D.S.C., decided March 6, 2012). Further details about the litigation appear in Issue 395 of this Update. The court dismissed the plaintiff’s Takings Clause claim, the claim that FDA violated the South Carolina Unfair Trade Practices Act and the defamation claim. The plaintiff’s negligence claim will, however, proceed. While the court suggested that this may actually be a claim for defamation and thus may also be subject to dismissal under the Federal Tort Claims Act, because the defendant did not seek to dismiss on this ground, the court declined…
Category Archives Food and Drug Administration
The Food and Drug Administration (FDA) has announced the availability of industry guidance concerning drugs for veterinary care. The guidance provides “recommendations on what documentation to submit to support the CMC [Chemistry, Manufacturing, and Controls] information for fermentation-derived intermediates, drug substances, and related drug products for veterinary medicinal use.” Noting that a variety of products are manufactured from fermentation processes, such as “competitive exclusion products” that consist of one or more microorganisms intended to prevent harmful bacteria like Salmonella from colonizing, FDA has requested comments on the guidance at any time. See Federal Register, March 8, 2012.
The Food and Drug Administration (FDA) has released industry guidance addressing the testing procedures for Salmonella species “in human foods and direct-human-contact animal foods.” Applicable to firms that manufacture, process, pack, or hold these products for distribution to consumers, institutions or food processors, the guidance also discusses the interpretation of test results when the presence of Salmonella “in the food may render the food injurious to human health.” The guidance excludes egg producers and others covered under different FDA food safety rules. The agency will accept comments at any time. See Federal Register, March 8, 2012.
The Food and Drug Administration issued a warning letter to BreathableFoods, Inc., which makes AeroShot Energy®, an “inhalable”caffeine product, on March 5, 2012. According to the agency, the AeroShot product is misbranded because it is labeled as intended for inhalation while the company’s Website indicates that the product is intended for ingestion. “Your labeling is false and misleading because your product cannot be intended for both inhalation and ingestion,” states the letter. FDA also notes that the product label fails to include a domestic address or phone number through which reports of serious adverse events associated with the product may be received. The letter further informs the company that FDA has “safety questions about the possible effects of your product.” FDA expresses concerns regarding “contradictory messages” about use of the product “in combination with alcohol. On the one hand, your website includes a posting of a news interview in which…
The Food and Drug Administration (FDA) and the Natural Resources Defense Council (NRDC) have agreed to a timeline for the production of material NRDC requested under the Freedom of Information Act (FOIA) involving bisphenol A (BPA) in food packaging and food contact materials. NRDC v. FDA, No. 11-8662 (S.D.N.Y., stipulation and order filed February 21, 2012). Additional information about the litigation appears in Issue 420 of this Update. The agreement narrows the request, limits the FDA offices required to conduct searches for responsive records and specifies the format in which the records will be produced. It also creates a timeline for FDA to produce internal material, material involving other agencies and a list of withheld documents. Any further proceedings in the litigation NRDC filed to force the agency to respond to its FOIA request are stayed until further order of the court on or after August 22, 2012. NRDC is…
A federal court in South Carolina has reportedly determined that a tomato grower seeking damages from the U.S. Food and Drug Administration (FDA) allegedly caused by a 2008 tomato recall that followed a Salmonella outbreak which was ultimately found not to be linked to contaminated tomatoes, may pursue negligence claims against the agency. Williams Farms Produce Sales, Inc. v. United States, No. 11-01399 (D.S.C., order entered February 23, 2012). Further details about the case appear in Issue 398 of this Update. The court has apparently dismissed claims of defamation, slander of title, product/commercial disparagement, unconstitutional taking, and violation of unfair trade practices law. See Law360, February 23, 2012.
The Food and Drug Administration (FDA) has issued updated industry guidance “pertaining to the establishment and maintenance of records by persons who manufacture, process, pack, transport, distribute, receive, hold, or import food.” Although this fifth edition is effective immediately, FDA welcomes comments at any time. Requiring records that identify “immediate previous sources and the immediate subsequent recipients of food” along the food-distribution chain, FDA has been given expanded authority by the Food Safety and Modernization Act of 2011 to “access records relating to foods that may cause serious adverse health consequences or death to humans or animals.” Although the guidance incorporates these statutory changes, it has not deviated much from the fourth edition released in September 2006, FDA said. Rather, it provides practical information on such topics as records requirements, retention and availability, and “the consequences of failing to establish and maintain required records or failing to make required records…
According to Senator Charles Schumer (D-N.Y.), the Food and Drug Administration (FDA) has agreed to investigate the safety and legality of AeroShot®, which allows consumers to inhale a powder delivering 100 mg of caffeine to the body. Created by a Harvard professor and a company led by Harvard graduate Tom Hadfield, the product was apparently launched in January 2012 in New York and Boston markets. Its sale is not limited by any age restrictions nor has the product been reviewed by any agency. Still, Hadfield has reportedly indicated that the FDA review “will conclude that AeroShot is a safe, effective product that complies with FDA regulations.” Schumer called for the FDA review in a December 2011 letter raising concerns about the use of caffeine by children and adolescents. He also noted that a company marketing video “flashes through a variety of settings, including a dance party, a club scene, and…
The Center for Science in the Public Interest (CSPI) has petitioned the Food and Drug Administration (FDA) to establish performance standards for the shellfish industry to reduce the threat of a “naturally occurring but deadly contaminant” found primarily in raw or undercooked oysters. According to a CSPI letter to FDA Commissioner Margaret Hamburg, Vibrio vulnificus (V-vulnificus) bacteria in contaminated shellfish is responsible for sickening approximately 30 people and killing 15 annually. Claiming that an annual “outbreak” occurs between April and November when Gulf Coast water temperatures create an ideal environment for the contaminant to grow, CSPI has urged FDA to “act now” to enforce regulations in 2011’s Food Safety Modernization Act requiring performance standards for significant contaminants such as V-vulnificus. “If we knew a serial killer were going to kill a dozen people like clockwork each year, the police would spring into action to stop it,” said David Plunkett ,…
Three consumer advocacy organizations have filed a petition with the Office of Food Additive Safety of the Food and Drug Administration’s (FDA’s) Center for Food Safety and Applied Nutrition requesting that ABT Technologies’ application to approve genetically engineered (GE) salmon be reviewed under the food additive provisions of the Food, Drug, and Cosmetic Act. The company’s new animal drug application for the GE salmon is currently pending before the agency’s Center for Veterinary Medicine. According to Food & Water Watch, Consumers Union and the Center for Food Safety, the company’s GE process “significantly alters the salmon’s composition . . . in a way that is reasonably expected to alter its nutritive value or concentration of constituents, and the new substance raises safety concerns. Under the Agency’s regulations and guidelines, such a substance must be treated as a food additive and the Agency must make a closer inquiry into the safety…
