After Food and Drug Administration (FDA) investigators found rodent infestation, “insanitary” conditions, poor employee hygiene, and violations of hazard analysis critical control point regulations at a food plant in Louisiana, it dispatched U.S. Marshals to seize tuna salad sandwiches and other food products, totaling more than $72,000 in value. While no illnesses have apparently been linked to consumption of the sandwiches produced by the Bearden Sandwich Company, Inc., the FDA has reportedly pledged to act “swiftly and aggressively” against processors and manufacturers that do not comply with food safety rules. According to an agency spokesperson, “When FDA investigators find violations inside a company’s facility, we will do what is necessary to keep insanitary and potentially harmful products out of consumers’ hands.” See FDA News Release, August 7, 2009.
Category Archives U.S. Government and Regulatory Agencies
The Food and Drug Administration (FDA) has announced a new warning-letter system to notify food companies of safety regulation violations. Scheduled to begin on September 15, 2009, the system stems from an effort to speed up the process from the time a company receives an “FDA 483” inspection report to the issuance of a warning letter. It allows companies 15 working days to respond to the 483 form, and if they do not respond during that time, FDA will send a warning letter. If FDA does receive a response in that time, it will “conduct a detailed review of the response before determining whether to send a warning letter.” According to a Federal Register notice, many companies respond in writing once they get the 483 report by describing completed or ongoing corrective actions or promise of future corrections. “In fact, some inspected establishments submit multiple responses to FDA, sometimes over…
The U.S. Department of Agriculture (USDA) has issued a proposed rule that would create a voluntary labeling program for ‘biobased” products under section 9002 of the Farm Security and Rural Investment Act of 2002, as amended by the Food, Conservation and Energy Act of 2008. According to USDA, “Biobased products are products that are composed wholly or significantly of biological ingredients – renewable plant, animal, marine or forestry materials.” Looking to encourage the increased use of these products in all market sectors, USDA has already identified 15,000 commercially available biobased products across approximately 200 categories, from cleaning products to construction materials. Manufacturers seeking a BioPreferred label must ensure that their items meet or exceed USDA-established minimum biobased content requirements. USDA is accepting comments on the proposed rule until September 29, 2009. See the Federal Register and USDA Press Release, July 31, 2009; Meatingplace.com, August 3, 2009.
The Food and Drug Administration (FDA) has published three draft guidance documents, with industry input, that provide recommended practices to prevent foodborne hazards associated with fresh produce. The documents pertain specifically to tomatoes, leafy greens and melons and “provide a guide for growers and processors to follow so they may better protect their produce from becoming contaminated,” according to Health and Human Services Secretary Kathleen Sebelius. With specific suggestions ranging from clean water supplies to human hygiene, key elements include (i) an acceptable baseline standard of industry practices that help domestic and foreign firms minimize microbial contamination risks throughout the entire supply chain; (ii) specific recommendations relating to growing, harvesting, packing, processing, transporting, and distributing the product; and (iii) recordkeeping recommendations to help FDA quickly trace back to the source when an outbreak occurs. The agency is asking that comments on the drafts be submitted within 90 days from publication…
The U.S. Senate has reportedly approved a fiscal year 2010 budget for the Food and Drug Administration (FDA) and U.S. Department of Agriculture (USDA) that would increase the combined funding for both agencies by 11 percent. Similar to a House of Representatives measure (H.R.2997) passed on July 9, 2009, the $125 billion appropriations bill (S. 1406) includes financial support for farm subsidies, food safety, land conservation, and the federal food stamp program. However, the House version continues a prohibition on cooked chicken imports from China and strips out funding for a voluntary national animal identification systems (NAIS), while the Senate has outlined steps to overturn the Chinese chicken ban and would preserve one-half of the $14.6 million requested by President Barack Obama (D) for NAIS. A House-Senate negotiating panel will meet to reconcile these differences before the bill heads to both chambers for a final vote. “These projects help to…
A federal court in the District of Columbia has dismissed claims that the National Animal Identification System (NAIS) violates a number of federal and state laws, including a religious freedom statute and constitutional protections. Farm-to-Consumer Legal Defense Fund v. Vilsack, No. 08-1546 (D.D.C., decided July 23, 2009). Dubbed in the press as the “mark of the beast” lawsuit, the complaint, brought by farmers “who raise livestock in a sustainable manner,” contends that the U.S. Department of Agriculture (USDA) coerced Michigan’s Department of Agriculture to adopt uniform NAIS requirements that threaten their way of life by gathering information into a national database against their wills and in violation of their religious beliefs. Among the complainants are Amish farmers who apparently believe (i) they have been given dominion and control over animals, and that control has now been given to state and federal agencies; (ii) they are not permitted to take the NAIS…
The Food and Drug Administration’s (FDA’s) Science Board has scheduled an August 17, 2009, public meeting to review the agency’s continuing assessment of the packaging chemical bisphenol A (BPA) in FDA-regulated products and discuss plans to increase research reviews at the Center for Food Safety and Applied Nutrition (CSFAN). See Federal Register, July 28, 2009.
Acting on behalf of an apparently energized Food and Drug Administration (FDA), the Department of Justice (DOJ) has filed a complaint for injunction against a New Jersey company and its owner seeking to halt the manufacture and sale of their dietary supplement products, in part, for failure to comply with good manufacturing practice requirements. U.S. v. Quality Formulation Labs., Inc., No. 09-03211 (D.N.J., filed July 1, 2009). The complaint alleges that the defendants have caused their protein powders and other dietary supplements to be adulterated “in that they have been prepared, packed, or held under insanitary conditions whereby they may have become contaminated with filth (as a result of rodent activity) or may have been rendered injurious to health (as a result of cross-contamination with a major food allergen).” The allergen at issue is milk. The complaint also alleges that one of the defendants’ articles of food is adulterated “in…
USDA’s Economic Research Service has issued a report to Congress that assesses the effects of “food deserts,” low-income rural or urban neighborhoods that frequently lack access to affordable, healthy food venues like supermarkets but instead offer convenience and small neighborhood stores that offer few, if any, healthy foods. Public health literature links such access issues to obesity and diet-related diseases. Titled “Access to Affordable and Nutritious Food: Measuring and Understanding Food Deserts and Their Consequences,” the report asserts that “a small percentage of consumers are constrained in their ability to access affordable, nutritious food because they live far from a supermarket or large grocery store and do not have easy access to transportation.” USDA notes that the causes of limited food access varied between urban core areas, which were “characterized by higher levels of racial segregation and greater income inequality,” and small-town and rural areas, where “lack of transportation infrastructure…
The Department of Justice (DOJ) is seeking to enjoin the operation of a cheese-processing facility in New York due to the Listeria monocytogene (L. mono) contamination of its Queso Hebra, Queso Fresco and Queso Cotija Molido cheeses. U.S. v. Peregrina Cheese, Inc., No. 09-2888 (E.D.N.Y., filed July 7, 2009). According to DOJ, state and federal inspections of the facility since at least 2004 have revealed serious sanitation problems. Because product samples and equipment surfaces tested positive for the same L. mono strain, Food and Drug Administration (FDA) analysts concluded that “the strain has formed a niche at Peregrina Cheese’s facility.” The owners have apparently refused to shut down the plant to properly sanitize it, claiming that the state food safety agency approved the “use of an antimicrobial agent as an additive in Peregrina Cheese’s Queso Fresco product.” The owners did not, however, provide “any information as to the level of use”…
