Category Archives Issue 404

The U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) has issued a public health alert “due to concerns about illnesses caused by Salmonella Heidelberg that may be associated with the use and consumption of ground turkey.” According to FSIS, an epidemiological investigation led by the Centers for Disease Control and Prevention (CDC) and state health departments has linked an estimated 77 illnesses in 26 states to a Springdale, Arkansas, plant operated by Cargill Meat Solutions Corp., which voluntarily recalled 36 million pounds of ground turkey produced between February 20 and August 2. “The outbreak strain of Salmonella Heidelberg is resistant to several commonly prescribed antibiotics; this antibiotic resistance may increase the risk of hospitalization or possible treatment failure in infected individuals,” stated an August 4, 2011, CDC investigation update. “Consumers should check their homes for recalled ground turkey products and not eat them; restaurant and food service operators…

The Food and Drug Administration (FDA) has issued a notice and request for comments about fiscal year 2012 fees under the Food Safety Modernization Act (FSMA). The fee rates, intended to “capture 100 percent of the costs of each activity,” will be assessed for facility reinspections, recalls and importer reinspections. If no foreign travel is required, the rate will be $224 per hour, and if foreign travel is required, the fee increases to $335 per hour. While a separate schedule has not been established for small businesses, FDA indicates that it will waive the fees “in limited cases . . . based on a severe economic hardship, the nature and extent of the underlying violation, and other relevant factors.” FDA has also established a docket “to obtain information that will be used to formulate a proposed set of guidelines in consideration of the burden of fee amounts on small business, as…

The Food and Drug Administration (FDA) has reopened the comment period for its proposed “gluten-free” food labeling rule. Originally published in January 2007, the proposed rule would have defined the term “for voluntary use in the labeling of foods, to mean that the food does not contain an ingredient that is any species of wheat, rye, barley, or a crossbred hybrid of these grains (collectively referred to as ‘prohibited grains’); an ingredient that is derived from a prohibited grain and that has not been processed to remove gluten (e.g., wheat starch), if the use of that ingredient results in the presence of 20 parts per million (ppm) or more gluten in the food; or 20 ppm or more gluten.” FDA seeks comments on a report titled “Health Hazard Assessment for Effects of Gluten Exposure in Individuals with Celiac Disease: Determination of Tolerable Daily Intake Levels and Levels of Concern for…

The Food and Drug Administration (FDA) has warned the company that makes Lazy Larry® brownies containing melatonin that they are adulterated under federal law. According to FDA, “Your ‘Lazy Larry’ product is represented for use as a conventional food, and accordingly is not a dietary supplement.” The company apparently uses the term “dietary supplement” in the product’s “statement of identity” and a “Supplement Facts” panel for its nutrition labeling. FDA contends that these statements do “not make your product a dietary supplement,” because it is marketed alongside snack foods, its website refers to the product as a conventional food, and the appearance and packaging make the product look like a brownie. Noting that the agency “is not aware of data to establish the safety of melatonin for use as an ingredient in conventional foods” and that “reports in the scientific literature have raised safety concerns about the use of melatonin,” FDA…

Less than two weeks after a consumer fraud class action was filed in California against the company that makes Muscle Milk® beverages and protein bars, the Food and Drug Administration (FDA) sent a letter to its CEO warning that the products are misbranded because their labels either prominently feature the word “milk” without containing any or state that they contain no milk while made of milk-derived ingredients. The letter also warns that health-related claims or “0 trans fat” assertions are unauthorized because the products contain too much fat or too much saturated fat. The June 29, 2011, letter demands a response within 15 days of receipt. Additional information about the lawsuit appears in Issue 403 of this Update. According to a news source, CytoSport has indicated that it is “proactively and openly addressing the FDA’s labeling concerns” and also notes, “Concerns like this have been raised before when the dairy…

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