The Food and Drug Administration (FDA) has entered a memorandum of understanding (MOU) with Boston’s Northeastern University to “develop collaboration between the two parties in the areas of education, research, and outreach.” Focusing broadly on biotechnology and analytical chemistry, the MOU is intended to “provide opportunities for exchanging of graduate and undergraduate students, faculty, and personnel and for advanced training and outreach; stimulate cooperative research, and information exchange in biological product characterization and regulation with Northeastern University’s Barnett Institute of Chemical and Biological Analysis; and develop training programs for FDA and potentially other Government agencies and Industry.” Northeastern University is home to law professor and anti-tobacco activist Richard Daynard who also formed the Public Health Advocacy Institute to address food and obesity issues through legislation and litigation. The law school received a $2.7 million grant from the National Cancer Institute in 2009 to conduct a five-year research project, headed by Daynard,…
Category Archives U.S. Government and Regulatory Agencies
The Food and Drug Administration (FDA) has issued a warning letter to LSG SkyChefs, an airline catering company, to formally notify the company that its classification has been changed from “Approved” to “Provisional.” According to the December 10, 2009, letter, an FDA inspection revealed “significant deviations” from regulatory requirements, including insect infestations, standing water, debris accumulation, and swab samples that tested positive for Listeria monocytogenes. The company’s food processing facility will be re-inspected in 30 days, and if the conditions have not improved, “then your facility will be classified as ‘Use Prohibited’ or ‘Not Approved.’ ” FDA provided copies of its warning letter to the airlines that purchase food from SkyChefs; they will be unable to obtain food from the company if it fails the second inspection.
In a letter recently posted to its website, the Food and Drug Administration (FDA) has warned Nestlé USA that its Juicy Juice® products are misbranded because their labels include “unauthorized nutrient content claims.” According to FDA, the product labels include the claim “Helps support brain development . . . In children under two years old” and also states “no sugar added.” Under FDA regulations, these statements cannot be made on products for children younger than age 2. FDA also states that other Nestlé products have misleading labels because they imply that they contain 100 percent natural fruit juice when they actually contain “Flavored juice blend from concentrate with other natural flavors & added ingredients.” In a separate letter, FDA warns that the company’s BOOST Kid Essentials Nutritionally Complete Drinks® are also misbranded because they are promoted as a “medical food” to address conditions such as “failure to thrive” and “pre/post…
The Congressional Research Service (CRS) has published a report discussing the failure of federal agencies to comply with the Congressional Review Act, which has, since 1996, required that they submit their final rules to both houses of Congress and the Government Accountability Office (GAO) before they can take effect. According to the report, CRS has identified some 1,000 final rules published in the Federal Register during seven of the past 10 years and not submitted to GAO and/or Congress. Among the “missing” rules were (i) a U.S. Department of Agriculture (USDA) rule on national school lunch procurement requirements, (ii) a USDA rule on the Farm Service Agency’s direct farm loan programs, (iii) a USDA rule on farm program payment limitations and eligibility under the CCC program, (iv) the Environmental Protection Agency’s April 2009 rule on its “Endocrine Disruptor Screening Program,” describing the policies and procedures the agency intended to adopt…
U.S. Department of Agriculture (USDA) Secretary Tom Vilsack recently announced an agreement with dairy producers “to accelerate adoption of innovative manure-to-energy projects,” with the goal of reducing greenhouse gas (GHG) emissions by 25 percent by 2020. USDA has vowed to work with farmers and the Innovation Center for U.S. Dairy to develop and implement anaerobic digester technology, “a proven method of converting waste products, such as manure, into electricity.” According to USDA, only 2 percent of U.S. dairies that are candidates for a profitable digester are currently utilizing the technology, which can generate enough electricity to power 200 homes. The agency’s memorandum of understanding reportedly pledges to “increase the number of anaerobic digesters supported by USDA programs,” as well as develop “new technologies to help dairies reduce greenhouse gas emissions.” “Use of manure to electricity technology is a win for everyone because it provides an untapped source of income for…
The U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) has published a supplemental proposed rule that would “require nutrition labeling of the major cuts of single-ingredient, raw meat and poultry products, unless an exemption applies.” FSIS proposed a similar rule in January 2001, and this notice responds to public comments already submitted and “explains how the Agency intends to proceed with a final rule.” Under the proposal, the nutrition facts label would contain information about serving size, calorie content, fat, saturated fat, cholesterol, sodium, carbohydrates, fiber, protein, and vitamins. Additional public comments are solicited and must be submitted by February 16, 2010.
The U.S. Department of Agriculture’s (USDA’s) National Organic Program has reportedly closed its investigation of Target Corp. for erroneously including in newspaper advertisements organic labeling on Silk® soy milk products. The Cornucopia Institute, which charged the retailer with violating federal organic regulations, apparently made public a letter obtained from the USDA indicating that Target admitted the error and is reviewing its processes to ensure the mistake is not repeated. Further details about the institute’s complaint appear in issue 324 of this Update. The organic industry watchdog has been taking a number of initiatives to bring to the public’s attention that the company making Silk® soy milk switched this year from organic to conventional soy beans. See Star Tribune, December 14, 2009; Cornucopia News, December 2009.
The U.S. Department of Agriculture’s Animal and Plant Health Inspection Service (APHIS), responding to a directive issued by the Ninth Circuit Court of Appeals, has prepared a draft environmental impact statement (EIS) on genetically engineered (GE) alfalfa. The agency has preliminarily determined that granting GE alfalfa nonregulated status will have “no significant impact on the human environment.” The draft, which runs more than 1,400 pages, will be available for a 60-day public comment period once it is published in the Federal Register. The agency will conduct four public meetings on the proposed EIS; they will take place in January and February 2010 in Las Vegas, Nevada; Kearney, Nebraska; Lincoln, Nebraska; and Washington, D.C. The GE crop at issue is referred to as Roundup Ready® alfalfa, engineered to be resistant to the herbicide glyphosate. The Ninth Circuit enjoined Monsanto from selling the GE seed and farmers from planting it until APHIS…
According to the Food and Drug Administration (FDA), a food importer from Virginia, who was sentenced to five years in prison for conspiring to import falsely labeled catfish from Vietnam to avoid paying import tariffs, has been barred from importing food into the United States for the next 20 years. This action apparently marks the first time the agency used its debarment authority under a law allowing the FDA to “debar a person from importing an article of food or offering such an article for import into the United States if that person has been convicted of a felony for conduct relating to the importation into the United States of any food.” The law also allows debarment in instances of the importation of adulterated food posing “a threat of serious adverse health consequences or death to humans or animals.” FDA reported that Peter Xuong Lam, president of Virginia Star Seafood…
The U.S. Department of Health and Human Services’ Office of Inspector General (OIG) has issued a report criticizing the U.S. Food and Drug Administration’s (FDA’s) food facility registry and traceability standards. According to the report, “FDA requires each domestic food facility to provide information for the registry,” including contact information for the facility, the owner or operator, and the parent company, and an emergency contact. After sampling 130 selected domestic food facilities, OIG concluded that (i) “Seven percent . . . either failed to register or failed to cancel their registration with FDA, as required”; (ii) “Almost half . . . failed to provide accurate information for the registry”; (iii) “FDA regulations do not ensure that the registry contains certain information that may be needed to locate a facility in an emergency”; and (iv) “Over half of the managers . . . were unaware of FDA’s registry requirement.” OIG has…
