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…
Category Archives Issue 494
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.
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