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…

The British Medical Journal has published a study that sought to “assess the impact of fast food restaurants adding calorie labeling to menu items on the energy content of individual purchases.” According to the researchers, including an independent consultant and a city official, the more than 8,400 adults interviewed in 2009 did not overall purchase foods lower in calories after New York City implemented regulations requiring calorie posting, but among the one in six lunchtime customers who used the calorie information provided, lower calorie choices were made. Significant variations were apparently found in the data collected from different chains, a matter attributed to customer purchasing patterns and changes in menu options and promotions. More than 7,300 lunchtime customers at 275 fast-food locations, representing 13 chains, were interviewed in 2007 and provided their register receipts so researchers could verify their self-reported purchases. The same method was used to compare and assess…

“The big question is this: How do we get the safest and most ethical food system possible while adequately feeding ourselves?,” asks New York Times columnist Mark Bittman in this latest opinion piece supporting “a massive overhaul of the food system.” Discussing recent E. coli outbreaks in Europe, Bittman concedes that the controversial process known as irradiation “could be a useful tool” in controlling bacteria and other foodborne illnesses, but warns that it should not be viewed as a panacea or replacement for other measures. “The answer will come in steps,” he writes. “[B]etter regulation and inspection of food production; stricter labor laws; more rigorous testing for pathogens, to name just a few— and eventually those steps may lead to a point where irradiation is unnecessary.” Bittman urges lawmakers to adequately fund the Food and Drug Administration’s Food Safety Modernization Act, even while citing “the ironies” inherent in a system…

The Institute of Medicine (IOM) recently released the summary of a November 2-3, 2010, public workshop titled “Leveraging Food Technology for Obesity Prevention and Reduction Effort,” which addressed how the food industry “can continue to leverage modern and innovative food processing technologies to influence energy intake.” According to IOM, “Eating is impacted not only by the biological responses that occur when the presence of food or even the smell of food triggers physiological chain reactions but also by societal norms and values around portion size and other eating behaviors.” Workshop organizers invited behavioral scientists, food scientists and other experts from multiple sectors to discuss “evidence-based associations between various eating behaviors and weight gain and considered the opportunities and challenges of altering the food supply—both at home and outside the home (e.g., in restaurants)—to alleviate overeating and help consumers with long-term weight maintenance.” In particular, the workshop attendees explored four general…

The National Advertising Division (NAD) of the Council of Better Business Bureaus and the Children’s Advertising Review Unit (CARU) have announced the agendas for their joint 2011 annual conferences slated for October 3-5, 2011, in New York. The two-day NAD conference, “What’s New in Advertising Law, Claim Support and Self-Regulation,” will include keynote remarks by David Vladeck, director of the Federal Trade Commission’s (FTC’s) Bureau of Consumer Protection, as well as sessions on online behavioral advertising, claim substantiation, mobile marketing, litigation and FTC enforcement priorities, and the future of advertising self-regulation. Immediately following the NAD session, CARU will host a one-day conference focused on privacy and digital issues in youth marketing, with expert panels dedicated to new FTC regulations, multimedia and social media advertising to children, and responsible food marketing to children.

A 33-year-old man has filed a personal injury lawsuit in a Texas federal court against companies that made and sold the Four Loko® that allegedly caused the stroke he had in October 2010 immediately after consuming two cans of the caffeinated alcohol beverage. Villa v. Phusion Projects, LLC, No. __ (S.D. Texas, filed mid-July 2010). According to the complaint, the plaintiff continues to experience health problems, including slurred speech and lack of balance. Alleging negligence and products liability, the plaintiff seeks damages in excess of $75,000, punitive damages, attorney’s fees, and costs.

A California woman has filed a putative nationwide class action against the company that makes Muscle Milk® beverages and protein bars, alleging that promotions touting the products as “high performance” and “nutritious snacks” are false and misleading because they contain as much fat and calories as Krispy Kreme® doughnuts. Delacruz v. Cytosport, Inc., No. 11-3532 (N.D. Cal., filed July 18, 2011). The company apparently markets the products as “a ‘meal replacement’ to provide ‘healthy sustained energy’” and allegedly “suggests that these fat-filled Products will help people lose weight, telling consumers, among other things, that the Products will help people ‘Go from cover it up to take it off.’” According to the complaint, the named plaintiff purchased the products for six months and consumed them “before workouts, after workouts, in between meals as a snack, and sometimes as a meal replacement.” She contends that she did so in reliance on the…

California EPA’s Office of Environmental Health Hazard Assessment (OEHHA) has announced that its Carcinogen Identification Committee will discuss whether 39 chemicals should be prioritized “for possible preparation of hazard identification materials” during the committee’s October 12-13, 2011, meeting. While no decision will be made at this meeting about adding the chemicals to California’s Proposition 65 (Prop. 65) list of substances known to the state to cause cancer, the process OEHHA is following could ultimately lead to their inclusion. Public comments on the 39 listed chemicals are requested by September 20, 2011. Among those chemicals under consideration is bisphenol A (BPA). According to OEHHA’s supporting materials, which include references to numerous carcinogenicity and genotoxicity studies, billions of pounds of BPA are produced each year in the United States, and most human exposure occurs “through the diet.” Other chemicals under consideration are those used in agriculture, such as the fungicides chloropicrin, dicloran,…

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