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…
Category Archives U.S. Government and Regulatory Agencies
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…
U.S. Representative Louise Slaughter (D-N.Y.) has sent a letter to more than 60 food producers and retailers, “asking them to disclose their policies on antibiotic use in meat and poultry production.” Citing “decades of research,” the February 16, 2012, letter claims that agricultural antibiotic applications have contributed to drug-resistant disease in humans and seeks to clarify “the extent to which the fast food industry sources its meat and poultry from companies that routinely use antibiotics to raise livestock.” Slaughter, the only microbiologist in Congress, is soliciting information from retailers about their meat and poultry purchasing practices, as well as any efforts to educate consumers about the antibiotics used during food production. In particular, the letter directs recipients to provide details about whether their beef, pork and poultry supplies were produced (i) “without any antibiotics”; (ii) “in a manner that includes antibiotics only for disease treatment”; (iii) “in a manner that…
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 ,…
The U.S. Department of Agriculture’s (USDA’s) Foreign Agriculture Service recently issued a Global Agricultural Information Network (GAIN) report concluding that a French proposal to prohibit all food packaging and materials containing bisphenol A (BPA) would “very likely… impact and jeopardize U.S. processed and other food exports to France.” Introduced after a French National Agency for Food Safety and Occupational and Environmental Health report questioned BPA’s safety, the legislation apparently reflects “strong political pressure from environmental and consumers’ groups,” as well as public distrust of the regulatory system following “the mad cow scandal, the Mediator diabetes drug scandal and even the PIP breast implant scandal.” As a result, the French food industry has evidently expressed concern that a BPA ban is unavoidable “in a short to medium term” even if the current bill is challenged at the EU level. The GAIN report warns U.S. companies that the proposed measure would require…
The U.S. Department of Agriculture (USDA) has published its semiannual regulatory agenda outlining measures currently under development for 2012. Among the agenda items are proposed revisions to the rules that govern “certain genetically engineered organisms [GMOs] in order to bring the regulations into alignment with provisions of the Plant Protection Act.” Billed as the first comprehensive review of these regulations since 1987, the undertaking would apparently take into account the agency’s accumulated rulemaking experience as well as “advances in genetic science and technology.” USDA thus anticipates that any rule changes will affect “persons involved with the importation, interstate movement, or release into the environment of genetically engineered plants and certain other [GMOs].” In addition, the agenda includes modifications to the rules governing the importation of livestock and poultry at risk of transmitting bovine spongiform encephalopathy (BSE) or highly pathogenic avian influenza. In particular, USDA has suggested (i) amending BSE regulations…
The Natural Resources Defense Council (NRDC) has filed a complaint in a New York federal court seeking an order that would require the U.S. Department of Agriculture (USDA) to respond to the organization’s request under the Freedom of Information Act (FOIA) for documents on “the agency’s proposed deregulation of herbicide-resistant crops.” NRDC v. USDA, No. 12-0795 (S.D.N.Y., filed February 6, 2012). According to the complaint, USDA “is currently considering petitions to deregulate several herbicide-resistant varieties of corn and soybeans, which, if granted, would significantly increase usage of the herbicides to which those genetically modified [GM] crops are resistant.” NRDC apparently submitted a FOIA request to USDA in October 2011, seeking records concerning the proposed agency action, as well as a “fee waiver on the grounds that disclosure of the requested information is in the public interest.” The deadline for a response, according to NRDC, was November 15, but USDA has…
