The Union of Concerned Scientists recently criticized the Food and Drug Administration (FDA) for failing to solicit public and scientific input before it approved “the first commercialization both of a drug from a genetically engineered [GE] animal and of the animal itself.” According to the Union, FDA has allowed a Massachusetts company to raise a herd of GE goats capable of producing milk that contains a human protein used to prevent blood clots. The consumer advocacy group has accused the agency of violating its promise to open a public comment period and to gather feedback from an FDA advisory committee before permitting the company to market the goats. “Under the FDA’s process, there were no discussions of the safety or ethical implications of the approval, nor were regulations developed to keep the goats and their milk from contaminating the food supply,” opined the Union in its March 2009 Food &…
Posts By Shook, Hardy & Bacon L.L.P.
German courts in Bavaria have reportedly been considering issues raised in a lawsuit filed by an amateur beekeeper who was forced to destroy his honey after it was found to be contaminated with pollen from a nearby field trial of genetically modified (GM) corn. Beekeeper and handyman Karl Heinz Bablok, aware that his hives were near GM cornfields, apparently had samples of honey tested and found that 7 percent of the pollen was from the GM crops. An Augsburg court ordered him to stop selling or giving away his honey, so he sued the Bavarian State Research Center for Agriculture to recover his costs and lost sales of about US$12,900. Now before a third court, the case reportedly raises significant GM-related issues: if Bablok wins, the GM corn would be discredited; if the court decides that Bablok’s honey is not subject to licensing regulations under the European Union food law,…
A federal court in the District of Columbia has dismissed a lawsuit filed by California almond growers, handlers and grower-handlers against the U.S. Department of Agriculture (USDA) challenging an agency regulation that requires handlers to treat raw almonds grown and sold in the United States to reduce the risk of Salmonella contamination. Koretoff v. Vilsack, No. 08-1558 (D.D.C., decided March 9, 2009). Without addressing the merits of the complaint, the court granted the USDA’s motion to dismiss, finding that the plaintiffs failed to exhaust their administrative remedies, which would have required petitioning the USDA secretary before bringing their action in court, as mandated by statute. Since September 2007, all domestic almonds intended for sale in the United States must be pasteurized by either proplylene-oxide fumigation or steam heat. Growers and handlers reportedly complain that unpasteurized raw almonds demand higher prices, up to 40 percent more, and that foreign suppliers, who are…
Judge Richard Posner, writing for a Seventh Circuit Court of Appeals panel, has determined that the government failed to prove that the defendant misbranded food by changing the “best when purchased by” date on bottled salad dressing that he then resold. U.S. v. Farinella, Nos. 08-1839, 08-1860 (7th Cir., decided March 12, 2009). A jury convicted the defendant of wire fraud and of introducing into interstate commerce a misbranded food with intent to defraud or mislead, and he was sentenced to five years of probation, including six months of home confinement, and to pay a $75,000 fine and forfeit his gains in excess of $400,000. According to the court, the defendant bought 1.6 million bottles of Henri’s Salad Dressing in May 2003, and they were labeled with “best when purchased by” dates ranging from January to June 2003. The defendant resold the dressing in discount stores, but pasted over the…
The Federal Circuit Court of Appeals has determined that a U.S. Department of Agriculture (USDA) Salmonella rule, which interfered with an egg producer’s sales for about two years, was not a compensable taking under the Fifth Amendment. Rose Acre Farms, Inc. v. U.S., No. 07-5169 (Fed. Cir., decided March 12, 2009). The case involved emergency regulations adopted in 1990 that restricted the sale of eggs from farms identified as infected with a type of Salmonella bacteria. The regulations diverted the eggs from three of Rose Acre’s farms from the table to other uses, such as in cake mixes, for 25 months and thus purportedly reduced the company’s profits. The company brought several lawsuits against the government, and the various issues raised were appealed several times. This appeal involved the “takings” issue only and was before the Federal Circuit for the second time. Under the Fifth Amendment, the government must compensate private…
A Florida resident has filed a putative class action lawsuit against General Mills, Inc., in federal court, alleging that its claims about Yo-Plus® yogurt violate the state’s deceptive and unfair trade practices law and constitute a breach of express warranty. Fitzpatrick v. General Mills, Inc., No. 09-60412 (S.D. Fla., filed March 17, 2009). Seeking to certify a class of Florida Yo-Plus® purchasers, the plaintiff alleges that the company cannot substantiate its claims that the yogurt’s trademarked “unique blend of live probiotic cultures and natural fiber,” referred to in marketing and on product labels as Optibalance™, “helps keep your digestive system right on track.” According to the complaint, the unaware consumer “is led to believe that General Mills’ blend of ‘probiotic’ bacterial strains and small amounts of fiber will, in fact, improve the digestive systems of healthy people. In fact, people’s bodies already maintain the proper balance of intestinal bacteria.” The…
The day after Ronald Kuiper died, a jury reportedly awarded the former popcorn factory worker and his wife $7.55 million in litigation against one of the companies that supplied the flavorings with diacetyl used by his employer. Kuiper v. Givaudan Flavors Corp., No. 06-4009 (N.D. Iowa, verdict rendered March 12, 2009). Kuiper apparently alleged that he contracted broncholitis obliterans from his workplace exposure to the butter-flavoring chemical, and he reportedly died from complications of the disease. According to a news source, the jury deliberated for six days following the month-long trial and declined to award punitive damages. The Kuipers, who previously settled claims against other flavorings manufacturers for undisclosed amounts, alleged design defect, failure to warn and failure to test. Givaudan reportedly argued, among other matters, that Kuiper’s claims were barred by a two-year statute of limitations. See Product Liability Law 360 and Mealey’s Emerging Toxic Torts, March 13, 2009.
The U.S. Department of Health and Human Services, Department of Agriculture, and Food and Drug Administration have announced an April 7, 2009, public meeting to discuss agenda items and draft positions for the Codex Alimentarius Commission’s 37th Session of the Codex Committee on Food Labeling (CCFL) slated for May 4-8, 2009, in Calgary, Canada. The CCFL “drafts provisions on labeling applicable to all foods; considers, amends if necessary, and endorses specific provisions on labeling of draft standards, codes of practice, and guidelines prepared by other Codex committees; studies specific labeling problems assigned to it by the commission; and studies problems associated with the advertisements of food with particular reference to claims and misleading descriptions.” In particular, the U.S. agencies are seeking public input about (i) draft codex standards for food labeling; (ii) the implementation of the World Health Organization’s Global Strategy on Diet, Physical Activity and Health; (iii) guidelines for the…
The Occupational Safety and Health Administration (OSHA) has withdrawn its Advance Notice of Proposed Rulemaking (ANPRM) on Occupational Exposure to Diacetyl and Food Flavorings Containing Diacetyl so that a Small Business Advocacy Review Panel can promptly convene to study the effect such a rule would have on small businesses. According to OSHA’s notice, materials submitted before the ANPRM’s withdrawal as well as any other information submitted directly to OSHA after the withdrawal, will be placed in the public rulemaking docket and receive equal consideration as a part of the rulemaking record. Several other opportunities for stakeholders to provide information and comment during the rulemaking process will also be available. Diacetyl is a chemical used in butter flavoring for popcorn and confectionary products that has been linked to bronchiolitis obliterans, an incurable lung disease purportedly diagnosed in a number of workers at U.S. popcorn-manufacturing plants. Earlier this year, OSHA sought information…
On January 5, 2009, the Food and Drug Administration (FDA) issued a rule ordering food and drink manufacturers that color their products with cochineal extract and carmine to declare the presence of those ingredients on labels. Further details about the rule appear in issue 287 of this Update. Last week, FDA confirmed the effective date for full compliance with the rule as January 5, 2011. FDA revised its requirements for these color additives in response to reports of severe allergic reactions to food containing cochineal extract and food and cosmetics containing carmine. The colorings, derived from the dried bodies of beetles, are used in various products such as ice creams, yogurts, fruit drinks, alcoholic beverages, and candy products. They make the products pink, red or purple. The coloring agents were previously listed under “artificial color” or “artificial color added” on ingredient labels. Beginning in 2011, FDA will require foods containing…
