U.S. Senators Dick Durbin (D-Ill.), Judd Gregg (R-N.H.), Ted Kennedy (D-Mass.), and Richard Burr (R-N.C.) have introduced the FDA Food Safety Modernization Act (S. 510), which would expand and strengthen the Food and Drug Administration’s (FDA’s) authority to address the safety of the nation’s food supply. The proposal, which has reportedly attracted the support of industry and consumer groups alike, would increase the frequency of food plant inspections, expand FDA’s access to records, give the agency the authority to recall tainted food products, and require the creation of a national strategy to protect the food supply from terrorist threats and intentional contamination. Originally introduced in July 2008 with many of the same sponsors, the bill would require all food facilities to have HACCP plans in effect and allow the FDA to suspend the registration of any food facility that “has a reasonable probability of causing serious adverse health consequences or…
Category Archives Food and Drug Administration
With critics and supporters lined up to do battle over President Barack Obama’s proposed $3.55 trillion fiscal year (FY) 2010 budget, the ultimate outcome for proposals relating to food safety and agricultural subsidies is a question mark. Still, the administration has proposed more than $1 billion for the Food and Drug Administration (FDA) to increase inspections of food facilities and protect the nation’s food supply, an additional $1 billion for the U.S. Department of Agriculture’s (USDA’s) child nutrition programs, as well as a $20 billion increase in food stamps. Additional funds would be provided for enforcement of the National Organic Program. To pay for such spending increases, the proposed budget would reportedly phase out direct payments to farmers making more than $500,000 in annual sales, reduce spending on crop insurance premiums, eliminate the promotion of branded agricultural products, and impose user fees at the Grain, Inspection, Packers and Stockyards Administration;…
The FDA Science Board has announced a public meeting on February 24, 2009, to discuss “the continued assessment of bisphenol A (BPA) in FDA-regulated products.” The board will also receive updates from two working groups on “economically motivated adulteration of FDA-regulated products and rapid detection of Salmonella in foods.” In addition, FDA intends to publish information on its BPA assessment later this month to facilitate public feedback. The board will accept written comments on these issues until February 17, 2009. See FoodNavigator-USA.com, February 10, 2009.
The Pew Environment Group has released documents obtained through a Freedom of Information Act request showing that the U.S. Food and Drug Administration (FDA) faulted three Chilean salmon farming companies, “including the two largest producers of farmed salmon,” for using a number of drugs not approved by the U.S. government. FDA inspections apparently uncovered use of the antibiotics flumequine and oxolinic acid and the pesticide emamectin benzoate, as well as trace residues in products intended for the U.S. consumers. The agency then informed the Chilean companies that, “if the drug is not listed in the approved drug list . . . they are not allowed to use the drug to treat salmon destined for distribution in the U.S., not even if they meet withdrawal periods and no tissue residue can be detected.” The Pew Environment Group applauded the FDA stance, but urged the agency to enforce its standards abroad. “Standards and…
A subcommittee of the House Energy and Commerce Committee conducted a hearing February 11, 2009, to hear from victims, regulators and the individuals who own and operate the Georgia peanut processing facility responsible for the latest Salmonella outbreak. Titled, “The Salmonella Outbreak: The Continued Failure to Protect the Food Supply,” the hearing gave congressmen the opportunity to question Stewart Parnell who owns the Peanut Corp. of America (PCA) about the company’s practice of shipping contaminated product to food processors even after it had tested positive for Salmonella. Parnell and the man who managed the plant invoked their Fifth Amendment privilege and refused to answer questions, including whether they would eat the recalled products, which now number in excess of 1,800 items. The outbreak has reportedly sickened more than 600 in the United States and Canada, led to a suspected nine deaths and launched at least four personal injury lawsuits to date.…
FDA is seeking nominations for several public advisory committees, including the Transmissible Spongiform Encephalopathies Advisory Committee. This committee evaluates “available scientific data concerning the safety of products which may be at risk for transmission of spongiform encephalopathies having an impact on the public health,” according to FDA. Nominees should have experience in clinical and administrative medicine, hematology, virology, neurovirology, infectious diseases, immunology, transfusion medicine, surgery, internal medicine, biochemistry, biostatistics, epidemiology, biological and physical sciences, sociology/ethics, or other related professions. FDA will accept nominations until it fills all current and upcoming vacancies on the committee. See Federal Register, January 29, 2009.
FDA has published a notice requesting comments, scientific data and information “that would assist the agency in its plans to conduct a risk assessment of the public health impact of foodborne Listeria monocytogenes in some ready-to-eat foods, sliced, prepared, and/or packaged in retail facilities.” According to the notice, “[l]ittle is known about how Listeria contamination occurs in retail facilities . . . There is thus a need to identify potential sources and practices that may increase L. monocytogenes contamination in retail settings and practices or interventions that could reduce or eliminate L. monocytogenes contamination of food products (sold to consumers at the retail level) and resulting human illness.” Comments and materials relevant to FDA’s risk assessment must be submitted by April 21, 2009. The agency specifically requests data and information about (i) ready-to-eat food markets in the United States; (ii) deli department characteristics; (iii) product contamination data; (iv) factors influencing the growth of the…
The FDA has issued its final guidance on regulating genetically engineered (GE) animals under the new animal drug provisions of the Food, Drug and Cosmetic Act. The guidance clarifies FDA’s regulatory authority “and provides recommendations to producers of GE animals to help them meet their obligations and responsibilities under the law.” It is intended to apply to GE animals with heritable rDNA constructs. According to the guidance, GE animals are being developed for a number of purposes, including the enhancement of production or food quality traits, improvements to animal health, the production of products for human therapeutic uses, and enhancement of animals’ interactions with humans (e.g., hypoallergenic pets). The FDA explains when GE animal producers must comply with labeling and record-keeping requirements or submit information for agency approval.
The U.S. Centers for Disease Control and Prevention (CDC) and Food and Drug Administration (FDA) are reportedly investigating a Salmonella typhimurium outbreak implicating King Nut and Parnell’s Pride brand peanut butters manufactured by the Peanut Corporation of America (Peanut Corp.) and sold to non-retail food establishments. Health departments have purportedly linked the outbreak to more than 400 illnesses and possibly five fatalities, prompting Peanut Corp. to issue a voluntary recall for 21 lots of peanut butter produced since July 1, 2008, at its Blakely, Georgia, facility. In addition, Kellogg Co. has since issued recalls for its Austin and Keebler brand peanut butter crackers as a precautionary measure. See King Nut Press Release, January 12, 2009; Law 360 and Health Day Reporter, January 13, 2009; Kellogg Co. Press Release, January 14, 2009; The Associated Press and The Wall Street Journal, January 15, 2009. Meanwhile, plaintiffs’ lawyers have apparently cited the incident in urging stricter…
The Food and Drug Administration (FDA) has apparently prevailed in proceedings seeking injunctive relief against two New Mexico dairies that “were not keeping adequate medication records to prevent unsafe drug residues in cattle offered for slaughter” and “were using medications for unapproved indications not specified on the drug label” without a valid veterinarian-client-patient relationship. The companies, Do-Rene and Clover Knolls Dairies, were warned about these violations in 2005 and 2008 following inspections and tissue sampling. Apparently, some of the dairies’ cows tested positive for illegal levels of a number of drugs, including one “expressly forbidden for use in lactating cows.” According to FDA, “These residues may cause allergic reactions in extremely sensitive individuals, and they may contribute to forming antibiotic-resistance in bacteria.” Future violations may result in civil or criminal penalties. See FDA Press Release, January 2, 2009.
