Category Archives D.C. Circuit

The Physicians Committee for Responsible Medicine (PCRM) has filed a lawsuit seeking a response to its petition calling for the withdrawal of the federal government’s “current MyPyramid food diagram and dietary guidelines” and the adoption of PCRM’s “Power Plate food diagram and dietary guidelines.” PCRM v. Vilsack, No. 11-00038 (D.D.C., filed January 5, 2011). Brought against the secretaries of the U.S. Department of Agriculture (USDA) and Department of Health and Human Services (HHS), the complaint for injunctive relief calls the agencies’ food diagram “ineffective and confusing” and alleges that it “fails to promote overall health and well-being.” PCRM contends that USDA and HHS have violated the Administrative Procedure Act by failing to respond to its petition in a “reasonable time.” PCRM’s “Power Plate” would eliminate all animal-derived products from the diet. A Florida resident has filed a putative class action against Phusion Projects, LLC, claiming that the company’s Four Loko® caffeinated alcoholic…

According to a news source, a district court in the District of Columbia has denied a request seeking an order that the Justice Department submit a proposal for settling claims of loan program discrimination filed by female farmers against the U.S. Department of Agriculture. Instead, the court apparently urged the lawyers representing the litigants to work together to reach an agreement and to report back during a January 14, 2011, status hearing. Unlike recent cases addressing charges that USDA discriminated against African-American (Pigford I and Pigford II) and Native American (Keepseagle v. Vilsack) farmers, Love v. Vilsack reportedly involves putative class claims that have not been certified. Counsel for the women farmers and those representing Hispanic farmers with similar claims (Garcia v. Vilsack) contend that the government’s settlement proposals thus far pale in comparison to the sums agreed to in Pigford ($2.25 billion) and Keepseagle ($680 million). See National Journal Daily, December…

The Federal Trade Commission (FTC) has filed a motion to dismiss a complaint charging the agency with exceeding its authority in requiring Food and Drug Administration (FDA) pre-approval for health-related claims on food products, violating advertisers’ constitutional rights by requiring compliance with these standards and failing to comply with notice-and-comment rulemaking procedures in establishing the standards. POM Wonderful LLC v. FTC, No. 10-1539 (D.D.C., motion filed November 16, 2010). Additional information about POM Wonderful’s complaint appears in Issue 364 of this Update. FTC contends that the court lacks jurisdiction to consider the matter because the complaint is moot, the company lacks standing, the company is attempting to preclude an enforcement action, and the complaint does not challenge final agency action. Specifically, FTC claims (i) the agency merely created a possible remedy of FDA pre-approval in consent agreements with food producers making health-related claims and not an enforceable rule; (ii) it…

A coalition of major farm, food and fuel industry trade groups has reportedly filed a lawsuit in the D.C. Circuit Court of Appeals to challenge the Environmental Protection Agency’s (EPA’s) decision to allow gasoline with up to 15 percent ethanol (E15) to be sold for vehicles made in the 2007 model year or later. The coalition, which includes the American Petroleum Institute, apparently contends that tests to determine whether the blend will damage these cars, light-duty trucks and SUVs have not been completed. Under the Clean Air Act, EPA may not approve a new fuel additive unless it “will not cause or contribute to a failure of any emission control device or system.” The industry interests also claim that EPA lacks the authority to grant a “partial waiver” to allow the fuel to be used in only some vehicles, saying the agency should not approve the fuel unless it is…

Public Employees for Environmental Responsibility (PEER) has filed a complaint in federal court under the Freedom of Information Act (FOIA), seeking documents from the White House Office of Science and Technology Policy (OSTP) related to the development of policies to protect scientific integrity in federal agencies, such as the U.S. Department of Agriculture and the Food and Drug Administration. PEER v. OSTP, No. __ (D.D.C., filed October 19, 2010). According to the complaint, President Barack Obama (D) issued an executive order in March 2009, requiring the development of such rules by July. They have not yet been promulgated. OSTP Director John Holdren reportedly wrote online in June 2010 that the “process has been more laborious and time-consuming than expected,” and that an interagency panel has developed draft recommendations for OSTP and Office of Management and Budget review. Representatives from the latter two offices “have been honing a final set of recommendations”…

The U.S. Department of Health and Human Services (HHS) and the National Institute of Environmental Health Sciences (NIEHS) have been sued in federal court under the Freedom of Information Act (FOIA) for their alleged failure to produce data and research relating to the herbicide atrazine. Beveridge & Diamond, P.C. v. HHS, No. 10-1713 (D.D.C., filed October 7, 2010). According to the complaint, the Environmental Protection Agency (EPA) is conducting a comprehensive atrazine review that includes the research of a NIEHS research scientist who worked for EPA in the past. The plaintiff allegedly sought the researcher’s data from EPA, but was told she had taken all of her material to NIEHS. NIEHS has allegedly failed to respond to the plaintiff’s request for data, information and reports related to Dr. Suzanne Fenton’s research on atrazine. The plaintiff alleges, “It is critical that NIEHS promptly provide the requested information to allow for meaningful…

POM Wonderful LLC has filed a complaint for declaratory relief in a D.C. federal court against the Federal Trade Commission (FTC), alleging that it (i) exceeded its authority in requiring Food and Drug Administration (FDA) preapproval of health-related claims on food products, that is, those claims stating that a product treats, mitigates or prevents disease, and substantiation of non-disease-related claims with two “well-controlled” clinical studies; (ii) violated advertisers’ First and Fifth Amendment rights by requiring compliance with these new standards; and (iii) failed to comply with notice and comment rulemaking procedures in establishing the standards. POM Wonderful LLC v. FTC, No. 10-1539 (D.D.C., filed September 13, 2010). According to the complaint, FTC has advised POM Wonderful that it must comply with standards recently announced in consent orders against other  companies and now apparently applicable to the food and dietary supplement industry as a whole. Additional information about one of those orders…

With one judge dissenting, the D.C. Circuit Court of Appeals has determined that federal law does not bar domestic almond producers from challenging a rule that requires them to pasteurize or chemically treat their product to prevent Salmonella outbreaks. Koretoff v. Vilsack, No. 09-5286 (D.C. Cir., decided August 3, 2010). While the court allowed those who grow almonds to continue pursuing their challenge to the 2007 rule, it dismissed the claims of companies that package and sell the almonds to consumers, finding that, as “handlers,” they must first exhaust their administrative remedies before turning to the courts to resolve their dispute. The U.S. Department of Agriculture secretary promulgated the challenged rule under the authority of the Agricultural Marketing Agreement Act of 1937 (AMAA). California almond producers and retailers claim that the rule is arbitrary and capricious because it devastated the domestic raw almond market while leaving foreign producers, who are…

The D.C. Circuit Court of Appeals has upheld, in part, the Environmental Protection Agency’s (EPA’s) denial of objections filed to its final rule revoking all residues of the pesticide carbofuran permitted on or in raw and processed foods. Nat’l Corn Growers Ass’n v. EPA, No. 09-1284 (D.C. Cir., decided July 23, 2010). EPA revoked the carbofuran “tolerances” after notice-and-comment rulemaking because it determined that aggregate dietary exposure to residues of carbofuran is “not safe” and because exposure to the chemical in drinking water exceeded “the level of concern with respect to both children and adults.” This action effectively banned its use on both domestic and imported food for human consumption. The U.S. company that makes the pesticide and several trade organizations filed objections to the revocation and a hearing request, which EPA denied. While the objectors had participated in the rulemaking proceeding, they attempted to either introduce new evidence during the…

As part of its ongoing campaign to persuade government authorities to prohibit the use of bisphenol A (BPA), the Natural Resources Defense Council (NRDC) recently filed a lawsuit in the D.C. Circuit Court of Appeals seeking to force the Food and Drug Administration (FDA) to take action on a petition the organization filed in October 2008 requesting that the agency prohibit the chemical’s use in food packaging. In re: NRDC, Inc., No. 10-1142 (D.C. Cir., filed June 29, 2010). One year ago, NRDC also submitted a petition to California EPA’s Office of Environmental Health Hazard Assessment, requesting that BPA be added to list of chemicals “known to the state to cause reproductive toxicity” under the Safe Drinking Water and Toxic Enforcement Act of 1986 (also known as Prop. 65). In its lawsuit, NRDC notes that more than 600 days have passed since its FDA petition was filed, and the NRDC reiterates…

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