A federal magistrate judge in New York has ordered the Food and Drug Administration (FDA) to begin proceedings to withdraw approval for the subtherapeutic use of certain antibiotics in animal feed, agreeing with the Natural Resources Defense Council (NRDC) and a coalition of advocacy organizations that the agency had a statutory duty to hold withdrawal proceedings after issuing notices in 1977 of its intent to withdraw approval because the use of such drugs had not been shown to be safe. NRDC v. FDA, No. 11-3562 (S.D.N.Y., decided March 22, 2012). According to the court, “if the Secretary finds that an animal drug has not been shown to be safe, he is statutorily required to withdraw approval of that drug, provided that the drug sponsor has notice and an opportunity for a hearing.” Further details about the lawsuit appear in Issue 396 of this Update. Questions about whether the agency has…
Category Archives Legislation, Regulations and Standards
Scottish Health Minister Michael Matheson has reportedly written to U.K. Health Secretary Andrew Lansley, urging him to support a ban on all TV advertising for foods high in fat, sugar and salt (HFSS) before the 9 p.m. watershed. According to media sources, Matheson cited OfCom studies allegedly indicating that, while children’s broadcasting adheres to strict advertising restrictions, young viewers were still seeing ads for HFSS foods during programs intended for older audiences such as talent shows. “Broadcast advertising influences the choices made by children and can shape their attitudes to food as they grow into adulthood,” Matheson was quoted as saying. “Tackling obesity and encouraging people to make healthier life choices is one of the most important things we can do to improve the health of our nation.” Although the initiative has since been lauded by groups like the National Heart Forum and British Medical Association, it has also drawn…
The U.S. Department of Agriculture’s (USDA’s) Animal and Plant Health Inspection Service (APHIS) has issued a 66-page proposed rule that would update import rules for bovine spongiform encephalopathy (BSE). The topic was discussed in Issue 427 of this Update. Current U.S. trade rules prohibit beef imports from countries that have outbreaks or high risks of BSE, commonly known as mad cow disease. Under the proposal, APHIS would adopt criteria used by the World Organization for Animal Health (OIE) that identify a country’s BSE risks as negligible, controlled or undetermined. Basing its import policy for a particular country on that country’s risk classification, APHIS would also conduct its own assessment, such as when a country is not yet classified by the OIE for BSE risk and requests APHIS to conduct a risk evaluation using OIE criteria. Countries would be considered an undetermined BSE risk unless officially recognized as negligible or controlled. Calling…
The National Consumers League has written to Food and Drug Administration (FDA) Commissioner Margaret Hamburg, asking the agency to take enforcement action against several companies that label their products as “100%” lemon juice, while they actually contain 35 percent or less lemon juice. According to the March 21, 2012, letter, “The products tested omit requisite amounts of real lemon juice and substitute water, citric acid, and in some cases sugar. The cheating is concealed by labeling the products as ‘100%’ lemon juice or simply ‘Lemon Juice from concentrate,’ and the producers make it appear that the products are of greater value than they really are.” Included with the letter are labels from four different products and lab reports from the company that apparently tested them. The National Consumers League characterizes the juice as “heavily diluted with water beyond what is necessary and appropriate to reconstitute the product.” Its letter also…
California EPA’s Office of Environmental Health Hazard Assessment (OEHHA) has added methanol to the list of chemicals known to the state to cause reproductive toxicity (Prop. 65). The listing, which is effective as of March 16, 2012, is based on the National Toxicology Program’s identification of the chemical as a reproductive toxicant. Because the chemical forms naturally in fruits and vegetables that contain pectin, OEHHA has determined that “methanol that is the by-product of naturally occurring pectin in the food is not considered an exposure under Section 25501. This applies to consumption of both unprepared and prepared fruits and vegetables.” This exception does not apply, however, where pectin is intentionally added “in the production or processing of food, or to nonfood exposures.” According to OEHHA, methanol is formed when “fruits and vegetables are physically prepared for consumption by methods that include, but are not limited to, slicing, chopping, pureeing and…
Polish officials have reportedly withdrawn from commerce more than 500,000 pounds of food possibly contaminated with industrial salt intended for de-icing roads in winter conditions. According to media sources, Poland’s Central Bureau of Investigation has arrested five individuals accused of selling road salt to food processors for use in dairy, fish, meat, and baked goods. The Chief Sanitary Inspectorate (GIS) has since identified the non-iodized salt, which contains “minimal” levels of dioxin and heavy metals, at 48 different locations, but has reportedly emphasized the overall low risk to human health. “It can be concluded with a very high probability that the amounts of these compounds per 100 g of the food products do not pose a health hazard,” one GIS investigator was quoted as saying. See Polskie Radio, February 27 and March 7, 2012; Warsaw Business Journal, March 5, 2012; EurActiv.com, March 7, 2012. Despite this finding and the precautionary…
The Centers for Disease Control and Prevention (CDC) has released an analysis showing that disease outbreaks linked to imported foods apparently increased in 2009 and 2010. CDC experts reviewed data collected by the Foodborne Disease Outbreak Surveillance System from 2005 to 2010, finding that 39 outbreaks and 2,348 illnesses were tied to imported foods from 15 countries. According to CDC, 17 of the 39 outbreaks occurred in 2009 and 2010. Since 2005, imported fish was the most common source with 17 total outbreaks, followed by spices with six outbreaks, including five from fresh or dried peppers. Nearly 45 percent of the imported foods linked to outbreaks came from Asia. “It’s too early to say if the recent numbers represent a trend, but CDC officials are analyzing information from 2011 and will continue to monitor for these outbreaks in the future,” said CDC epidemiologist and lead author Hannah Gould. See CDC…
The Food and Drug Administration (FDA) has issued a warning letter to Staples, Inc. concerning inspections conducted at its California facility where food products are stored. FDA apparently discovered “serious violations of the Current Good Manufacturing Practice (CGMP) regulation for foods.” Among other matters, rodent excreta pellets were found on or near “at least 11 different food products, including various brands of candies, crackers, creamers, pistachios, ramen noodles, and bottled water.” The inspectors also apparently found dead rodents in traps throughout the facility and rodent gnawed holes on individual food packages. FDA acknowledged that the company voluntarily destroyed food products under the agency’s supervision in October 2011 and that the company repaired six roll-up doors at the facility. Still, because the company did not document its corrections with photographs or include a site map indicating the placement of rodent traps or pest control records with its response, it had not…
The U.S. Government Accountability Office (GAO) has issued a March 2012 report urging the U.S. Department of Agriculture (USDA) to adopt several measures to reduce Shiga toxin-producing Escherichia coli (STEC) in cattle before they are slaughtered. According to GAO, USDA currently recognizes bacteriophages, probiotics, vaccines, and sodium chlorate as preslaughter interventions able to control STEC, but has received few applications for commercial products that use these methods. The report notes that even in the case of STEC vaccines, USDA’s requirements for approval are “unclear” and do not address “some of the unique challenges faced by manufacturers of animal health products.” GAO found that, unlike the Canadian Centre for Veterinary Biologics, USDA fails to specify when it requires laboratory or field demonstrations of vaccine efficacy, resulting in delayed application approval. There is also apparently a lack of available products designed to test for six STEC strains—other than STEC O157:H7—that are now considered…
Fifty-five members of Congress have sent a letter to the Food and Drug Administration (FDA) in support of a legal petition demanding the labeling of genetically engineered (GE) foods. Signed by 10 senators and 45 representatives, the March 12, 2012, letter urges FDA “to protect a consumer’s right to know, the freedom to choose what we feed our families, and the integrity of our free and open markets.” Filed in October 2011 by the nonprofit Center for Food Safety, the petition reportedly has the support of more than 400 health and consumer agencies and has received nearly a million comments in favor of GE labeling, the lawmakers said. They assert that FDA’s 1992 policy statement allowing GE foods to be marketed without labeling is inadequate and outdated because it merely covers foods changed “materially” by taste, smell or other senses. “The use of novel food technologies like genetic engineering on…
