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.
Category Archives Legislation, Regulations and Standards
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…
Danish Food and Agriculture Minister Mette Gjerskov has reportedly urged the European Union (EU) and its member states to support improved animal welfare standards. In January 2012, the European Commission released a new animal welfare strategy, details of which were covered in Issue 425 of this Update. Speaking to an international conference in Brussels, Belgium, Gjerskov asserted that the “increasing” transportation of animals for slaughter across Europe was “worrying,” as evidenced by a petition signed by 1 million EU citizens who have challenged current regulations allowing such journeys to exceed 24 hours by calling for an eight-hour maximum. “The fact that so many people signed a petition is a signal to politicians that there is great concern about how we care for animals,” Gjerskov said. “We need to raise standards beyond legal requirements.” See theparliament.com, February 29, 2012.
A recent data brief issued by the Centers for Disease Control and Prevention (CDC) has suggested that children and adolescents consume more added sugar calories from food as opposed to beverages. According to the National Center for Health Statistics (NCHS), which relied on data from the National Health and Examination Survey, “Boys consumed more calories per day from added sugars than girls,” with caloric intake from added sugars increasing linearly with age for both boys and girls. In particular, NCHS reported that (i) pre-school aged boys and girls (2-5 years) consumed 13.5 percent and 13.1 percent of their calories from added sugars, respectively; (ii) school-age boys and girls (6-11 years) consumed 16.6 percent and 15.7 percent of their calories from added sugars, respectively; and (iii) adolescent boys and girls (12-19 years) consumed 17.5 percent and 16.6 percent of their calories from added sugars, respectively. NCHS also noted some differences in…
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.
California EPA’s Office of Environmental Health Hazard Assessment (OEHHA) has extended the comment period for several chemicals, including benzophenone, a chemical used in plastic packaging as a UV blocker, that the agency is considering adding to the list of chemicals known to the state to cause cancer (Prop. 65) under the Labor Code mechanism. Public comments are now requested by March 22, 2012. According to OEHHA, “[b]ecause these are ministerial listings, comments should be limited to whether the International Agency for Research on Cancer has identified the specific chemical or substance as a known or potential human or animal carcinogen.”
A meeting of World Health Organization (WHO) health experts has reportedly reached a consensus on whether to proceed with controversial avian influenza research despite potential security risks. WHO apparently convened the consultation after officials expressed concern about H5N1 strains modified in U.S. and Dutch laboratories to spread more easily among mammals. In particular, panelists discussed recommendations to redact two studies on the new viruses and implement “a mechanism for providing the restricted information to legitimate recipients.” “Given the high death rate associated with this virus—60 percent of all humans who have been infected have died—all participants at the meeting emphasized the high level of concern with this flu virus in the scientific community and the need to understand it better with additional research,” said WHO Assistant Director-General of Health Security and Environment Keiji Fukuda in a February 17, 2012, press release. “The results of this new research have made it…
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…
