The Food and Drug Administration (FDA) has announced two additional public meetings to discuss proposed rules to establish standards for the growing, harvesting, packing, and holding of produce for human consumption (the produce safety proposed rule), and for current good manufacturing practice and hazard analysis and risk-based preventive controls for human food (the preventive controls proposed rule). The meetings are scheduled for March 11-12 in Chicago and March 27-28 in Portland, Oregon. FDA anticipates that the proposed produce safety rule would “reduce foodborne illnesses associated with the consumption of produce.” The proposed preventative controls rule would evidently apply to human food and require domestic and foreign facilities that must register under the Federal Food, Drug, and Cosmetic Act to have written plans that identify hazards, specify the steps that will be put in place to minimize or prevent those hazards, monitor results and act to correct problems that arise. See…
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The Food and Drug Administration (FDA) has extended until April 26, 2013, the comment period for two draft environmental assessments of the proposed conditions of use submitted by AquaBounty Technologies, Inc., in support of a new animal drug application concerning a genetically engineered (GE) Atlantic salmon and a preliminary finding of no significant impact for those specific conditions of use. FDA has pushed back the deadline in response to “a request for an extension to allow interested persons additional time to submit comments.” Additional details about the proposed rule appear in Issue 466 of this Update. See Federal Register, February 14, 2013.
The Food and Drug Administration (FDA) recently entered a consent decree with Puerto Rico-based Jonlly Fruits, Inc. requiring the company to hire independent experts in labeling, sanitation and Hazard Analysis Critical Control Point (HACCP) before it can begin again to make and sell its fruit and juice products. United States v. Jonlly Fruits, Inc., No. 13-1043 (D.P.R., approved January 17, 2013). The labeling expert is required to “review Defendants’ labeling and ensure that all such labels are in compliance with the applicable FDA regulations.” The other experts are required to develop written protocols and employee training programs and to conduct comprehensive facility inspections. In the meantime, the company has agreed to destroy “all in-process and finished articles of food” currently in its custody, control or possession. According to FDA, the company and its president, Bartolo Pérez Romàn, “have a long history” of failing to comply with current good manufacturing practice…
Evidently in response to public comments, the Federal Trade Commission (FTC) has modified its agreement with Phusion Projects, LLC to require an alcohol facts panel on certain-sized cans of its Four Loko fruit-flavored malt beverage. In re Phusion Projects, LLC, No. C-4382 (FTC, order entered February 6, 2013). The agreement resolves charges that the company and its principals falsely claimed that a 23.5-ounce can contained “the alcohol equivalent of one or two regular 12-ounce beers, and that a consumer could drink one entire can safely on a single occasion.” To the contrary, according to FTC’s administrative complaint, the products contain the alcohol equivalent of four to five 12-ounce cans of beer. Without admitting liability, the company has agreed to label any container of Four Loko or other flavored malt beverage with more than two servings of alcohol with an alcohol facts panel. The panel will set forth the “the container…
A recent article published in Biological Psychiatry reviews the research examining the neurological basis for food addiction and its relation to obesity. Nora Volkow, et al., “The Addictive Dimensionality of Obesity,” Biological Psychiatry, February 2013. Co-authored by National Institute on Drug Abuse Director Nora Volkow, the article proposes that drug and food addiction “share neurobiological processes that, when disrupted, can result in compulsive consumption, while also involving unique neurobiological processes.” In particular, the authors argue not that obesity is the result of food addiction, “but rather that food reward plays a critical role in overeating and obesity, referring to it as the dimensional component of obesity.” To this end, the article describes how drug and food addiction allegedly share genetic, molecular, neurobiological, and behavioral mechanisms that, when coupled with environmental triggers, have “the potential to facilitate or exacerbate the establishment of uncontrolled behaviors.” The authors also speculate that exposure to obesogenic…
A recent study examining the public stigma around food addiction has concluded that the “food addict” label “was perceived similarly to obesity, but more favorably than other addictions.” Jenny DePierre, et al., “A New Stigmatized Identity? Comparisons of a ‘Food Addict’ Label with Other Stigmatized Health Conditions,” Basic and Applied Social Psychology, February 2013. To gauge public perceptions of food addiction, researchers at Yale University’s Rudd Center for Food Policy & Obesity first asked 659 adults about their responses to individuals “with various health conditions and addictions, including obesity, food addiction, physical disability, mental illness, cocaine addiction, and smoking.” A second survey of 570 adults asked them to view only one of three addictions—smoking, alcohol or food—“to specifically compare public perceptions of individuals described as being addicted to food to those with smoking and alcohol addictions.” While the results of the first online survey allegedly showed that “a food addict…
According to a news source, the Council of Better Business Bureau’s National Advertising Division (NAD) has determined that Anheuser Busch promotions for Michelob ULTRA Light Cider® comply with Food and Drug Administration definitions and guidelines. The company apparently claims that the product has one-third fewer calories than its competitors, and the ad industry’s self-regulatory investigative unit “determined that the advertiser had provided a reasonable basis for the claim.” NAD considered the product’s calorie content, the calorie content of other leading hard ciders and their market share, as well as whether the brewer’s claim provided “meaningful and accurate information to consumers.” The company was reportedly “pleased with NAD’s decision.” See Law360, February 5, 2013.
A Yale University event for women graduates will feature an address by U.S. Supreme Court Associate Justice Sonia Sotomayor, and some alumnae have reportedly questioned whether she should be participating in a PepsiCo-sponsored event. An architecture graduate apparently called the association “shocking,” despite assurances from the Supreme Court’s public information officer that “[h]er appearance does not suggest any form of endorsement by PepsiCo.” Public health activist and author Michele Simon, who graduated from Yale with a master’s degree in public health, reportedly said, “PepsiCo has its tentacles deep into Yale. It’s disgusting. What is this nation’s leading educational institution doing participating with this threat to public health?” Details about her report on the relationship between the Academy of Nutrition and Dietetics and the food and beverage industry appear in Issue 468 of this Update. A legal ethics expert opined that Sotomayor’s participation did not implicate any judicial ethics concerns, and…
Advocacy organization As You Sow has issued a report titled “Slipping Through the Cracks: An Issue Brief on Nanomaterials in Food” to “inform companies, investors, and consumers about the emerging use of engineered nanomaterials in food and food related products, and to highlight the potential unknown risks of this technology.” The organization describes how it sought information from major food and food packaging companies about nanomaterials in their products, and of those few responding, most either do not know whether nanomaterials are in their supply chain or were not apparently concerned about the issue. Comprehensive survey results are included in the report. As You Sow also tested a few products and purportedly found nano-sized titanium dioxide in the powered sugar used on a Dunkin’ Donut product. The organization is soliciting contributions to allow it to test other products, such as Trident gum and Pop-Tarts. The report suggests that while initial…
Answering a question certified by the Ninth Circuit Court of Appeals, a divided Washington Supreme Court has determined that a deputy sheriff who was served, but did not consume, a Burger King hamburger contaminated with an employee’s spit, may recover under state product liability law for emotional distress, “but only if the emotional distress is a reasonable reaction and manifest by objective symptomatology.” In re Bylsma v. Burger King Corp., No. 86912-0 (Wash., decided January 31, 2013). The deputy had alleged ongoing emotional distress, including vomiting, nausea, food aversion, and sleeplessness, symptoms that purportedly led him to seek treatment from a mental health professional. So ruling on a matter of first impression, the court majority agreed with the deputy sheriff that the Washington Product Liability Act allows recovery for emotional distress damages absent physical injury. The federal district court which had considered the deputy’s claim, dismissed it on the ground…
