Food and Drug Administration (FDA) representatives are slated to present findings of the agency’s analysis of more than 200 foods containing Class III and Class IV caramels for 4-methylimidazole (4-MEI), a chemical byproduct of manufacturing processes, during the American Chemical Society National Meeting & Exposition, August 10-14, 2014, in San Francisco, California. According to the session abstract, FDA’s analysis estimated dietary exposure to 4-MEI for six U.S. populations: infants younger than age 1; 1-year-olds; children ages 2 and older; children ages 2 to 5; children ages 6 to 12; and teenage boys ages 12 to 18. Consumer Reports has urged the agency to set standards for 4-MEI in foods and called on manufacturers to disclose the types of caramel color in their products so that consumers can avoid 4-MEI. The compound was added to California’s Proposition 65 list of substances known to the state to cause cancer in 2011 based…
Category Archives U.S. Government and Regulatory Agencies
The U.S. Department of Agriculture’s Office of Food Safety and the Agricultural Marketing Service have announced an August 12, 2014, public meeting in Washington, D.C., to provide information and discuss draft U.S. positions to be discussed at the 27th Session of the Codex Committee on Processed Fruits and Vegetables slated for September 8-12 in Philadelphia. Agenda items include draft standards and proposed draft annexes for certain canned fruits and quick frozen vegetables as well as a proposed draft standard for ginseng products. See Federal Register, July 8, 2014. Issue 529
The U.S. Food and Drug Administration (FDA) has released its final guidance on the use of nanotechnology in food as well as draft guidance on use of the technology in animal food. Rather than categorically judging nanotech as either safe or harmful, the agency indicated that it will consider specific characteristics of products with nanotech as they are produced. Among FDA’s nonbinding recommendations are encouragement for food manufacturers’ considerations of composition, safety and regulatory status as well as assurance that the guidance does not change the status of products already generally recognized as safe. The agency also recommends that manufacturers assess whether their implementation of nanotech will change their safety and regulatory status by determining what the physiochemical changes of the food product may be and invites consultations with the FDA about those determinations. “Our goal remains to ensure transparent and predictable regulatory pathways, grounded in the best available science,…
A federal court in the District of Columbia has denied the request of the Black Farmers & Agriculturalists Association, Inc. to intervene in lawsuits brought by female and Hispanic farmers against the U.S. Department of Agriculture (USDA) alleging gender and race bias in the administration of farm loan and disaster benefit programs. Love v. Vilsack, No. 00-2502 (D.D.C., decided June 13, 2014). Additional information about the gender discrimination claims appears in Issue 374 of this Update. The association was not a member of the settlement class established to resolve the claims of African-American farmers who failed to file claims for administrative adjudication before the deadline expired in Pigford v. Glickman (Pigford I). Those missing the deadline saw their claims revived under the 2008 Farm Bill and consolidated in litigation collectively known as Pigford II. Details about that litigation appear in Issue 395 of this Update. The association sought (i) a declaration…
The U.S. Department of Agriculture (USDA) has issued an order requiring pork producers, veterinarians and diagnostic laboratories to report new incidents of porcine epidemic diarrhea virus (PEDv) and porcine deltacoronavirus to state health officials or USDA’s Animal and Plant Health Inspection Service. The order formalizes measures announced in April to combat the spread of PEDv, which has killed some seven million piglets since it was identified in early 2013. USDA also announced $26.2 million to fund a variety of activities to combat the diseases and support affected producers, including vaccine development, state management and diagnostic testing. More information on the April announcement appears in Issue 521 of this Update. Issue 526
The U.S. Food and Drug Administration (FDA) and the Environmental Protection Agency (EPA) have joined to issue draft guidance on mercury levels and fish consumption, directed at pregnant women and guardians of young children. Recommendations include eating 8 to 12 ounces (two to three servings) of low-mercury fish like tilapia, catfish, cod, salmon, and shrimp as well as avoiding four fish high in mercury (shark, swordfish, king mackerel, and tilefish from the Gulf of Mexico) and limiting albacore tuna intake to less than 6 ounces per week. The conclusion of the comment period has not yet been announced. More information on FDA’s updated guidance appears in Issue 525 of this Update. Issue 526
The U.S. Food and Drug Administration (FDA) has issued a clarification of its position on artisanal cheesemakers’ use of wood shelving, which can aid in aging cheese by controlling moisture to form rinds and hosting microbes that add character and flavor. FDA’s Constituent Update called reports that the agency established a new rule banning wood shelving “not accurate,” instead noting that its regulations merely require that “utensils and other surfaces that contact food must be ‘adequately cleanable’ and ‘properly maintained.’” The confusion comes from a letter sent by FDA’s Center for Food Safety and Applied Nutrition to the New York State Department of Agriculture and Markets indicating that wooden surfaces could not be adequately cleaned, thus violating the standards of the Food Safety Modernization Act. The Constituent Update noted that the letter was intended as a background of wood shelving use for aging cheeses and an analysis of relevant scientific…
The U.S. Food and Drug Administration (FDA) has announced a final rule setting standards for manufacturers of infant formula. With a compliance date of September 8, 2014, the final rule includes (i) “current good manufacturing practices specifically designed for infant formula, including required testing for the harmful pathogens (disease-causing bacteria) Salmonella and Cronobacter”; (ii) “a requirement that manufacturers demonstrate that the infant formulas they produce support normal physical growth”; and (iii) “a requirement that infant formulas be tested for nutrient content in the final product stage, before entering the market, and at the end of the products’ shelf life.” Although many companies have already adopted these standards on a voluntary basis, the final rule creates federally enforceable requirements for powdered, liquid concentrate and ready-to-feed formulas. “FDA does not approve infant formulas before they can be marketed,” notes the agency in a June 9, 2014, press release. “However, all formulas marketed…
The Center for Science in the Public Interest (CSPI) has filed a complaint against the U.S. Department of Agriculture and Food Safety and Inspection Service, seeking a declaration that the agencies have unreasonably delayed taking action on its May 2011 petition requesting that certain strains of antibiotic-resistant (ABR) Salmonella in ground meat and poultry be declared adulterants. CSPI v. Vilsack, No. 14-895 (D.D.C., filed May 28, 2014). Details about CSPI’s petition appear in Issue 396 of this Update. According to the nutrition and health advocacy organization, if these pathogens are declared adulterants, affected meat and poultry products would be barred from entering commerce, and the action “would also confirm the agency’s authority to request without evidence of illness that a company recall products containing ABR Salmonella, or—in the absence of a company’s voluntary compliance—to detain and seize those products.” The complaint refers to a number of Salmonella outbreaks, some involving…
In a putative class action alleging that a food company misled its customers by using the term “evaporated cane juice” (ECJ) instead of “sugar” on its labels, a California federal court has followed the lead of several other courts in recent decisions by dismissing the case without prejudice under the primary jurisdiction doctrine—this time, reversing its previous decision to allow the case to move forward. Swearingen v. Yucatan Foods LP, No. 13-3544 (N.D. Cal., order entered May 20, 2014). Guacamole producer Yucatan Foods had argued that the U.S. Food and Drug Administration (FDA) had primary jurisdiction over the matter, but Judge Richard Seeborg initially disagreed, finding that FDA had taken no action on ECJ since 2009 and thus that the agency considered the matter settled. On March 5, 2014, one month after the Yucatan decision was filed, FDA announced that it would reevaluate its previous draft ECJ guidance. Following the…
