A federal court in California has determined that the U.S. Food and Drug Administration (FDA) has not met the standard for the court to issue an order amending the deadlines set forth in its June 2013 order for promulgating and finalizing implementing regulations under the Food Safety Modernization Act (FSMA). Ctr. for Food Safety v. Hamburg, No. 12-4529 (N.D. Cal., order entered August 13, 2013). Information about the court’s earlier order appears in Issue 489 of this Update. Because the plaintiff agreed that the proposed sanitary transport rule deadline could be extended, however, the court granted FDA’s motion only to this extent. The proposed rule must be published by January 31, 2014, and the court will allow comment on it until May 31. The final rule must be published as originally specified—no later than June 30, 2015. The court rejected FDA’s request to extend the deadline for promulgation of the…
A federal court in California has dismissed several of the claims in a putative nationwide class action alleging that Bromley Tea Co. makes unlawful and deceptive health-related claims on packaging labels and on its website for the company’s green and black teas. Clancy v. The Bromley Tea Co., No. 12-3003 (N.D. Cal., order entered August 9, 2013). The court rejected the defendant’s challenge to the plaintiff’s standing to assert claims as to products he had not purchased or statements he did not see before buying the products he did purchase. According to the court, “The named plaintiff has standing to assert claims relative to the products he purchased. He does not claim to have standing to assert claims related to other products. What he does claim is that he may be a potential representative of a class of people who have such standing. He may or may not be able…
The Second Circuit Court of Appeals, addressing an issue of first impression among the federal appellate courts under the Lanham Act, has affirmed a district court determination that Federal Treasury Enterprise Sojuzplodoimport (FTE) cannot pursue trademark infringement litigation as a “legal representative” of the Russian Federation because while that government designated FTE as its legal representative, it is not legally unable to bring the suit on its own behalf. Fed. Treasury Enter. Sojuzplodoimport v. SPI Spirits Ltd., No. 11-4109 (2d Cir., decided August 5, 2013). So ruling, the Second Circuit held that the Lanham Act’s use of the term “legal representative” requires in addition to an appointment that the appointing entity be unable to appear in the litigation. Another issue addressed was whether FTE was an “assign” of the Russian Federation under a series of documents created since 2002; the court concluded that the documents did not create an assignment.…
The Food and Drug Administration (FDA) has published draft guidance titled “Frequently Asked Questions About Medical Foods; Second Edition” that provides additional information about the definition, labeling and availability of medical foods—“foods formulated to be consumed or administered orally or enterally under the supervision of a physician.” The first edition of this guidance was issued in May 2007. Comments will be accepted until October 15, 2013. See Federal Register, August 13, 2013.
The Food and Drug Administration (FDA) has issued a final rule providing “for the safe use of spirulina extract made from the dried biomass of the cyanobacteria Arthrospira platensis (A. platensis), as a color additive in candy and chewing gum.” According to FDA, “Spirulina is a blue-green filamentous cyanobacteria that occurs naturally in freshwater and marine habits.” Its extract primarily contains “the water soluble components of spirulina, namely phycocyanins and other proteins, polysaccharides, lipids, and minor amounts of components such as vitamins, minerals, and moisture.” FDA has also determined that “there is no need for a specific upper limit for the color additive or phycocyanin content,” although the extract must abide by limits for lead, arsenic and mercury, in addition to testing negative for the microcystin toxin, “which is produced by some species of cyanobacteria that could be potentially present in the water where A. platensis is grown and harvested.”…
The U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) has extended the comment period for a proposed rule that would require “mechanically tenderized” labeling for raw or partially cooked needle- or blade-tenderized beef products, “including beef products injected with marinade or solution.” According to FSIS, the rule would also require the labels of mechanically tenderized beef products destined for consumers, hotels, restaurants, or similar establishments to include “validated cooking instructions” to ensure safe handling and reduce the risk of foodborne illness. Acting at the request of two trade associations, the agency will now accept comments on the new labeling scheme until October 8, 2013. Additional details about the proposed rule appear in Issue 486 of this Update. See Federal Register, August 9, 2013.
A recent study has reportedly claimed that bisphenol A (BPA) can disrupt the maturation of human oocytes in vitro, raising questions about the effect of the substance on human development and fertility. Ronit Machtinger, et al., “Bisphenol-A and human oocyte maturation in vitro,” Human Reproduction, August 2013. Researchers apparently analyzed the impact of both high (20 µg/ml) and lower concentrations (20 ng/ml and 200 ng/ml) of BPA on clinically-discarded oocytes obtained from patients undergoing fertility treatments at Brigham and Women’s Hospital. According to a July 31, 2013, hospital press release, the results evidently showed that as BPA dose increased, there was (i) “a decrease in the percentage of eggs that matured,” (ii) “an increase in the percentage of eggs that degenerated,” and (iii) “an increase in the percentage of eggs that underwent spontaneous activation, the abnormal process when an egg acts as though it has been fertilized, even though it…
A recent Alternet.org article titled “23 Gallons a Day from One Cow? Industrial Agriculture Engaged in Extreme Breeding,” has questioned the longstanding practice of selectively breeding livestock to produce animals that are highly efficient and productive. While acknowledging that “breeding animals to exaggerate traits humans find useful is hardly new,” author Jill Richardson claims that industrial agriculture has taken the practice to new extremes that compromise the ability of animals to live natural lives. “Some of these changes are a result of growth hormones, lighting, feed, and (for dairy cows) more frequent milkings,” she writes, “but a lot of t is breeding and industrial agriculture has taken it to an extreme … [A] look at the variety of chicken breeds kept by small farms, hobbyists, nd backyard chicken owners shows just how much humans have successfully meddled in chicken genetics. You can find chickens adapted to iving in hot weather…
In an August 3, 2013, Washington Post article, writer Kimberly Kindy suggested that some of the chemicals—notably cetylpyridinium chloride (CPC), a purportedly common finishing rinse—used in U.S. poultry processing plants may be masking the presence of Salmonella and other pathogens that remain on the birds that are sold to consumers. Titled “USDA Reviews Whether Bacteria-Killing Chemicals are Masking Salmonella,” Kindy reports that academic researchers agree that “the chemicals could be overwhelming an antiquated testing process,” and she states that several of the scientists have been enlisted by U.S. Department of Agriculture food safety experts to investigate the matter. At issue, Kindy contends, is whether CPC, or other antimicrobials, might remain on the samples collected for pathogen testing at a high enough concentration to kill the bacteria on the way to the lab. If so, Food Safety and Inspection Service experts could perceive a false negative test result when the chicken may…
An August 7, 2013, Slate article by Genetic Literacy Project Executive Director Jon Entine has criticized a recent magazine story allegedly linking eosinophilic disorder—“a multisystemic condition in which white blood cells overproduce in response to allergens”—to genetically modified (GM) corn, calling out Elle writer Caitlin Shetterly for stoking “conspiratorial fears that the government is covering up evidence that GMO foods can damage the public health.” According to Entine, the article in question “was particularly appalling” insofar as it failed to produce any evidence or tests to confirm the “unusual diagnosis” that GMO foods caused Shetterly’s autoimmune disorder. Instead, Entine argues, Shetterly relied on a “journalistic trick… to frame a settled issue in the scientific community as a mystery or a controversy.” “There has not been one study that links the genetically engineered corn or any approved genetically modified food on the market to allergies,” University of California, Davis, plant geneticist…
