Category Archives Legislation, Regulations and Standards

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…

Representative Dennis Kucinich (D-Ohio) has introduced a bill (H.R. 4310) that would amend the tax code to deny “any deduction for advertising and marketing directed at children to promote the consumption of food at fast food restaurants or of food of poor nutritional quality.” The proposal defines “food of poor nutritional quality” as food “determined by the Secretary (in consultation with the Secretary of Health and Human Services and the Federal Trade Commission) to provide calories primarily through fats or added sugars and to have minimal amounts of vitamins and minerals.” Among those advertising-related expenses that could not be deducted would be travel (including meals and lodging), “goods or services of a type generally considered to constitute entertainment, amusement, or recreation or the use of a facility in connection with providing such goods and services,” gifts, and other promotion expenses. The bill, which has four co-sponsors, was referred to the…

The Federal Trade Commission (FTC) recently hosted a forum titled “Sizing up Food Marketing and Obesity,” which heard proposals from federal agencies, consumer watchdogs and industry representatives for regulating food advertising to children. In addition to addressing new research, First Amendment issues and self-regulatory initiatives, the forum unveiled a set of proposed nutritional standards (SNAC PAC) developed by an interagency working group at the request of Congress. Co-authored by FTC, the Centers for Disease Control and Prevention, the Food and Drug Administration (FDA), and the Department of Agriculture, SNAC PAC sets out three standards designed to limit the marketing of foods to children ages 2 through 17. Standard I describes foods that “are part of a healthful diet and may be marketed to children without meeting Standards II and III,” including (i) “100 percent fruit and fruit juices in all forms”; (ii) “100 percent vegetables and vegetable juices in all…

An administrative law judge recently issued an order suspending a Nebraska-based livestock operation’s organic certification for four years, agreeing with the U.S. Department of Agriculture’s (USDA) 2008 complaint that the company failed to keep and produce adequate records. In Re Promiseland Livestock, LLC, No, 08-0134 (USDA, Nov. 25, 2009). A supplier for Aurora Dairy and other organic farms, Promiseland Livestock, LLC, apparently operates five ranches in Missouri and Nebraska with more than 22,000 head of beef and dairy cattle. The judge concluded that Promiseland “willfully . . . failed to make requested records available” to USDA and denied agency representatives “access to review and copy organic operation records required to determine compliance” with the Organic Foods Production Act of 1990 and National Organic Program regulations. Promiseland first came under scrutiny when The Cornucopia Institute, an organic watchdog, targeted Aurora Dairy for allegedly “illegal” operations, according to a recent press release issued by…

A federal court in Connecticut has ordered the payment of $1.9 million in equitable restitution to consumers who purchased Chinese Diet Tea and Bio-Slim Patch in 2003-2004. FTC v. Bronson Partners, LLC, No. 04-1866 (D. Conn., decided December 4, 2009). The court determined in 2008 that the Federal Trade Commission’s (FTC’s) claims of false advertising against the defendants had merit and issued this ruling to explain the basis for its damages award and why it was not allowing any offsets to the defendants from the gross amounts they received for all of the products sold. Essentially, the court found that the defendants’ poor recordkeeping and legal precedent did not allow offsets for credit card refunds, bounced checks, operating expenses, or revenue generated by reorders, which defendants claimed represented satisfied customers. According to the court, reorders could also have represented customers who “had not yet achieved the results promised in the…

In an unpublished opinion, the Fifth Circuit Court of Appeals has upheld the dismissal of a biscuit maker’s claim that the Food and Drug Administration’s (FDA’s) negligent testing of its product for Listeria monocytogenes resulted in a false positive report that caused it to lose its contract with a company that supplied 7-Eleven convenience stores with biscuit sandwiches. Lone Star Bakery, Inc. v. U.S., No. 09-50374 (5th Cir., decided November 17, 2009). The litigation arose under the Federal Tort Claims Act following a 2002 Listeria contamination incident for which the biscuit maker was initially blamed, but later cleared of any responsibility. The company sought $2.9 million in damages from the FDA. According to the court, which affirmed a grant of the FDA’s summary judgment motion, while the company submitted evidence showing “several instances where the FDA inspectors failed to follow agency collection and testing protocol,” its evidence was “devoid of…

In collaboration with Health Canada and the U.S. Food and Drug Administration, the United Nations’ World Health Organization (WHO) and Food and Agriculture Organization (FAO) have announced an October 2010 expert meeting in Ottawa, Ontario, to discuss the safety of bisphenol A (BPA), calling for data from the scientific community on any “adverse human health effects at low doses of BPA, especially on reproduction, the nervous system and on behavioral development.” Meeting participants will apparently consider the current literature on BPA toxicology and exposure, weigh available risk assessments and address any knowledge gaps in an effort to develop international guidance. The agencies are specifically requesting both published and unpublished technical information on (i) “current levels of BPA in relevant food groups”; (ii) the analytical methodologies used to detect BPA “in food and other matrices”; (iii) “BPA migration from food contact materials into food”; (iv) “dietary exposure assessments of BPA from foods and other sources”;…

The last phase of the European Union’s (EU) food origin legislation takes effect January 1, 2010, requiring slaughterhouse operators and livestock keepers to provide Food Chain Information (FCI) for all cattle, sheep and goats sent to slaughter for human consumption. According to UK’s Food Standards Agency (FSA), FCI includes data about the “health of the animals being sent for slaughter, and other information relevant to the safety of meat derived from them, including medicines the animals have been given.” The rules already apply to other species such as pigs and calves. FSA urged slaughterhouse operators, markets and livestock keepers to prepare for the changes now because once the new rules are enforced, meat from cattle, sheep or goats without FCI information will not be passed for human consumption. “The new rules are an important part of ‘farm-to-fork’ food safety controls and highlight the food safety responsibilities of livestock keepers in…

The European Union has reportedly granted Neapolitan pizza a status of “traditional speciality [sic] guaranteed” (TSG), a premium labeling designation that “does not refer to an origin, but highlights the traditional composition or means of production.” According to media sources, the Italian government has successfully persuaded EU member states to approve their application stipulating that pizza napoletana—also known as pizza margherita—must be hand-kneaded and cooked in a wood-fired oven, use mozzarella from the southern Apennine Mountains, and contain specific kinds of flour, yeast, salt, and tomatoes. In addition, the pie must apparently feature an elevated crust rim of 1-2 centimeters (cm), a base that does not exceed 1/3 cm in thickness and a diameter less than 35 cm. While EU restaurants will still be able to proffer their versions of pizza napoletana, only products meeting these exact requirements can boast the coveted TSG logo. The Italian agriculture ministry has since noted…

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