Category Archives U.S. Government and Regulatory Agencies

Putative class actions have been filed in New Jersey and California federal courts against Tropicana Products, Inc., alleging that the company misleads consumers by labeling and marketing its orange juice as “100% pure and natural,” when it actually “undergoes extensive processing which includes the addition of aromas and flavors.” Lynch v. Tropicana Prods., Inc., No. 11-07382 (D.N.J., filed December 19, 2011); Lewis v. Tropicana Prods., Inc., No. 12-00049 (E.D. Cal., filed January 6, 2012). Both plaintiffs seek to certify nationwide classes. The New Jersey plaintiff alleges unjust enrichment, breach of express warranty, violation of the New Jersey Consumer Fraud Act, and injunctive and declaratory relief. He requests compensatory, treble and punitive damages; prejudgment interest; restitution; injunctive relief; attorney’s fees; and expenses and costs of suit. The California plaintiff, who also seeks to certify a subclass of California consumers, alleges unjust enrichment; breach of express warranty; violation of the state Consumers…

According to news sources, the Center for Food Safety, which lost its challenge to the U.S. Department of Agriculture’s (USDA’s) decision to deregulate without restriction genetically engineered (GE) alfalfa, plans to appeal the matter to the Ninth Circuit Court of Appeals. A federal court in California determined on January 5, 2012, that the law does not require the agency to “account for the effects of cross-pollination on other commercial crops” in assessing whether a new crop poses risks. U.S. District Judge Samuel Conti also reportedly said that USDA lacks the authority to require a buffer zone between GE crops and conventional or organic crops. Noting that the Environmental Protection Agency (EPA) has approved the use of glyphosate on Roundup Ready® alfalfa, Conti further observed, “If plaintiffs’ allegations are true, then it is disturbing that EPA has yet to assess the effects of glyphosate on most of the species found near…

The U.S. Food and Drug Administration (FDA) has issued a final rule prohibiting the extra-label use of cephalosporin antimicrobial drugs in livestock. Citing “evidence that certain extralabel uses… will likely cause an adverse event in humans,” the agency has specifically barred using cephalosporins (i) “at unapproved dose levels, frequencies, durations, or routes of administration”; (ii) “in cattle, swine, chickens, or turkeys that are not approved for use in that species (e.g., cephalosporin intended for humans or companion animals)”; and (iii) “for disease prevention.” The final rule, however, still permits the use of an older drug, cephapirin, while allowing veterinarians to oversee limited extra-label cephalosporin use “in cattle, swine, chicken, or turkeys as long as they follow the dose, frequency, duration, and route of administration that is on the label.” “We believe this is an imperative step in preserving the effectiveness of this class of important antimicrobials that takes into account…

George Washington University Law Professor John Banzhaf has issued a press release highlighting recent action the Food and Drug Administration took against a food company that purportedly misbrands one of its products by declaring it “All Natural” while making the product with a synthetic chemical preservative ingredient. According to Banzhaf, the agency’s warning letter is “likely to lend support to and encourage an ever-growing number of major class action law suits being filed on these grounds, says the public interest law professor whose earlier movement to use legal action as a weapon against obesity apparently inspired these new legal actions.” He claims that The American Lawyer recognized how he started this litigation movement, noting in an article that he used the courts to address obesity, “just as he had earlier done in leading the use of legal action as a weapon against smoking.” Banzhaf further states, “The movement which Banzhaf started…

A federal court in Georgia has determined that it has personal jurisdiction over a Michigan food-packaging company that was sued as a third party defendant in litigation over a recalled baby food product. IPN USA Corp. v. Nurture, Inc., No. 11-501 (N.D. Ga., decided December 12, 2011). A Food and Drug Administration investigation apparently concluded that the third-party defendant (Liquid) had violated agency regulations on the manufacture of acidified and acid food products. While the baby food manufacturer (Nurture) allegedly sustained millions in damages in the recall, it was the packaging supplier (IPN) that brought the lawsuit against Nurture for breach of contract. According to the court, Liquid had sufficient contacts with Georgia for the court to exercise jurisdiction over the company. For purposes of packaging Nurture’s baby food, Liquid had purchased a machine, packaging supplies and other equipment from IPN’s Georgia-based entity, which referred a “significant number” of prospective customers…

The U.S. Department of Agriculture’s Animal and Plant Health Inspection Service (APHIS) has reopened the comment period until January 17, 2012, on a proposed rule that would amend and republish the Agricultural Bioterrorism Protection Act’s “list of selected agents and toxins that have the potential to pose a severe threat to animal or plant health, or to animal or plant products.” Details of the proposed rule were covered in Issue 412 of this Update. See Federal Register, December 15, 2011.

The Office of Inspector General (IG) of the U.S. Department of Health and Human Services has issued a report that “identified significant weaknesses in FDA’s [the Food and Drug Administration’s] oversight” of its contracts for state inspections of food facilities. In recent years, FDA has increasingly shifted to the states its responsibility for conducting inspections, and has apparently “failed to ensure [in eight states] that the required number of inspections was completed,” “did not ensure that all State inspections were properly classified and that all violations were remedied,” and “failed to complete the required number of audits for one-third of the States and did not always follow up on systemic problems identified.” Based on an analysis of FDA inspection data and interviews with agency officials, the report, titled “Vulnerabilities in FDA’s Oversight of State Food Facility Inspections,” opens by noting that annually “128,000 Americans are hospitalized and 3,000 die after…

Eight U.S. Senators have urged the Food and Drug Administration (FDA) to “publicly and vigorously” defend the safety of Gulf seafood in the wake of last year’s oil spill. Led by Senator David Vitter (R-La.), the lawmakers signed a December 1, 2011, letter to FDA Commissioner Margaret Hamburg asserting that although “rigorous testing” has revealed that Gulf seafood is safe for human consumption, many consumers believe otherwise because of “misinformation and unscientific claims.” Vitter wrote a similar letter to Hamburg in November. The effort was prompted by opposing claims made by the Natural Resources Defense Council (NRDC), whose scientists assert that FDA’s safety thresholds for Gulf seafood “significantly” underestimate cancer risks from seafood contaminants. NRDC published a study in Environmental Health Perspectives concluding that “FDA risk assessment methods should be updated to better reflect current risk assessment practices and to protect vulnerable populations such as pregnant women and children.”

The Center for Science in the Public Interest (CSPI) has petitioned the Food and Drug Administration (FDA) to require the disclosure of food color additives on front-of-package labeling. Citing “the ubiquity of food colorings” in the American diet, the petition claims that consumers are misled when colorings are used to either mask less-nutritious ingredients or make a product “appear to be of higher quality or nutritional value than it actually is.” The group also points to studies suggesting a link between certain food additives and behavioral effects in children. CSPI urges FDA to “amend the labeling requirements set forth at 21 C.F.R. § 101.22” to require foods containing such additives to state “Artificially Colored” “on the product display package next to the product name in bold letters not less than half the height and weight of the name of the food.” According to CSPI, FDA already possesses the statutory authority and…

A federal court has approved an agreement between the Food and Drug Administration (FDA) and the Natural Resources Defense Council (NRDC) resolving NRDC’s complaint that the agency unreasonably delayed issuing a final decision on its petition seeking a regulation that would prohibit the use of bisphenol A (BPA) in food packaging. NRDC v. HHS, No. 11-5801 (S.D.N.Y., consent judgment filed December 7, 2011). Under the agreement, FDA will issue its final decision on or before March 31, 2012. Noting that its petition was filed three years ago, an NRDC spokesperson said, “While we are glad FDA is finally going to make a decision [on] BPA in food packaging and this is a major step forward in the legal process, it is discouraging that FDA has not responded and that we had to ask the court to intervene just to get FDA to do its job. The agency has been dragging…

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