Agribusiness & Food Safety Associates Ann Havelka and Jara Settles have co-authored an article titled “FDA Warning Isn’t Enough Proof for Takings Claim” published on October 17, 2014, by Law360. The authors discuss a recent Court of Federal Claims ruling that rebuffed a takings claim filed by tomato growers who alleged that a 2008 Food and Drug Administration (FDA) warning about a Salmonella outbreak purportedly associated with certain raw red tomatoes caused tomato sales to decline dramatically. The outbreak was eventually linked to Mexican peppers. The article concludes that while the plaintiffs may have focused on the wrong argument to support their claims, the ruling “should prevent a flood of takings claims in the wake of garden-variety governmental warnings,” which, the authors contend, will allow FDA the flexibility it needs to protect public health. Additional information on the ruling appears in Issue 539 of this Update. Issue 542
Category Archives U.S. Government and Regulatory Agencies
The U.S. Department of Agriculture (USDA) has scheduled a November 4-5, 2014, public meeting of the Grain Inspection, Packers and Stockyards Administration (GIPSA) Advisory Committee at the National Grain Center in Kansas City, Missouri. Issues for discussion at the meeting will reportedly include the reauthorization status and standardization of user fees paid by official agencies; commodity inspection fees; and updates on quality assurance, compliance, science, and technology programs. See Federal Register, October 14, 2014. Issue 541
The Natural Resources Defense Council (NRDC) has joined the Center for Science in the Public Interest and other consumer groups in petitioning the U.S. Food and Drug Administration (FDA) to remove several chemicals from food contact materials. The first food additive petition asks FDA to promulgate a new rule “prohibiting the use of perchlorate as a conductivity enhancer in the manufacture of antistatic agents to be used in food contact articles,” and to amend existing regulations to ban the use of potassium perchlorate in food container sealing gaskets. Citing “the well-recognized toxicity of perchlorate,” the petition alleges that dietary exposure can impair fetal and infant development, especially when pregnant or nursing women do not consume enough iodine. A second petition urges the agency to revoke approval for “the use of long-chain perfluorocarboxylate [PFC] oil and grease repellents in paper and paperboard.” Noting that FDA has already asked some domestic manufacturers to…
A California federal court has granted in part and denied in part a motion for summary judgment in a lawsuit alleging that Mott’s violated the U.S. Food and Drug Administration’s (FDA’s) and California’s Sherman Law standards on the use of “no sugar added” on food packaging. Rahman v. Mott’s LLP, No. 13-3482 (N.D. Cal., order entered October 14, 2014). The plaintiff alleged that Mott’s 100% Apple Juice included a “no sugar added” label but failed to follow the additional FDA regulations requiring “a statement that the food is not ‘low calorie’ or ‘calorie reduced’ (unless the food meets the requirement for a ‘low’ or ‘reduced calorie’ food) and that directs consumers’ attention to the nutrition panel for further information on sugar and calorie content.” Mott’s moved for summary judgment on four grounds: the plaintiff (i) did not suffer damages as a result of purchasing the apple juice, (ii) lacked standing…
The U.S. Food and Drug Administration (FDA) has scheduled a meeting of the Science Advisory Board (SAB) to the National Center for Toxicological Research (NCTR) for November 6-7, 2014, at NCTR’s research campus in Jefferson, Arkansas. Public sessions of the two-day meeting will include the NCTR director’s update on scientific initiatives; a report from the National Toxicology Program on opportunities for collaboration; and discussions of specific research needs from representatives of the Center for Veterinary Medicine, Office of Regulatory Affairs and the Center for Food Safety and Applied Nutrition. Individuals interested in making presentations during the meeting should express interest in doing so by October 22 while those wishing to submit data or views in writing should do so by October 30. See Federal Register, October 9, 2014. Issue 540
The U.S. Court of Federal Claims has ruled that the U.S. Food and Drug Administration (FDA) is not required to compensate tomato growers for a regulatory taking after incorrectly warning the public in 2008 that a Salmonella outbreak was linked to tomatoes. Dimare Fresh Inc. v. U.S., No. 13-519 (Fed. Cl., order entered September 18, 2014). The growers argued that FDA had “appropriated a benefit” through the seizure of tomatoes, but “[a] regulatory takings claim is not plausible and cannot proceed when the government action at issue has no legal effect on the plaintiff’s property interest,” the court said. “Advisory pronouncements, even those with significant financial impact on the marketplace, are not enough to effect a taking of property under the Fifth Amendment.” The growers were attributing independent consumer behavior to FDA, the court found, and the argument that consumer advisories alone constituted takings had no support in case law.
The National Advertising Division (NAD) has referred Talking Rain Beverage Co. to the Federal Trade Commission (FTC) after the company failed to comply with a previous NAD determination finding that certain aspects of its advertising could be misleading. After a July 2014 NAD investigation, Talking Rain’s advertising for Sparkling ICE—which it presents as “the adventurous side of water,” “the vibrant side of water” and “the bold side of water”—was found to be misleading if the product was not shown because consumers may believe that the product is water without additional flavoring. NAD found that Talking Rain’s claim “Naturally flavored sparkling mountain spring water” was not misleading when displayed with the product, which is brightly colored and bears a list of ingredients indicating the inclusion of flavoring agents. In July, Talking Rain said it disagreed with the conclusion but would take NAD’s recommendation into consideration, but following several months of inaction…
To ease producer burdens under the Food Safety Modernization Act (FSMA), the U.S. Food and Drug Administration (FDA) has revised four proposed rules related to produce safety; preventive controls for human food and animal food; and the foreign supplier verification program. After receiving feedback from consumers and industry stakeholders, the agency has (i) updated water quality testing provisions; (ii) exempted farms with less than $25,000 in sales from produce-safety rules; (iii) addressed the use of spent grains in animal food by clarifying that brewers and distillers subject to the human-food rules do not need to comply with all animal-food rules; and (iv) granted importers more flexibility under the proposed foreign-supplier verification program “to determine appropriate supplier verification measures based on risk and previous experience with their suppliers.” FDA has requested comments on the proposed changes by December 15, 2014. “Ensuring a safe and high-quality food supply is one of the FDA’s…
The U.S. Department of Agriculture’s National Organic Program (NOP) has issued a final rule amending the National List of Allowed and Prohibited Substances (National List), which governs the use of synthetic and nonsynthetic substances in organic crop production and processing. Effective October 30, 2014, the final rule adds biodegradable biobased mulch film to the National List and defines third-party standards for compostability, biodegradability and biobased content. The agency also removed nonorganic hops (Humulus lupulus) and unmodified rich starch from the National List, as their use exemptions have expired, and rejected recommendations to include Citrus hystrix and curry leaves on the National List. See Federal Register, September 30, 2014. Issue 539
The Center for Science in the Public Interest (CSPI) has filed a citizen petition with the U.S. Department of Agriculture (USDA) seeking a declaration that four antibiotic-resistant (ABR) strains of Salmonella are adulterants under federal law. This is CSPI’s second petition on the matter and attempts to respond to data gaps identified by USDA’s Food Safety and Inspection Service (FSIS) when it denied the consumer advocacy organization’s 2011 petition in July 2014. Details about the denial appear in Issue 532 of this Update. CSPI bolsters the first petition with additional information on ABR Salmonella outbreaks, including numbers of individuals sickened and types of antibiotics to which the infections were resistant. CSPI also emphasizes that FSIS has already been declaring these pathogens adulterants on a case-by-case basis in issuing certain recalls, but its inconsistency in this regard, in CPSI’s view, is “putting consumers at risk.” While CSPI argues that its first petition…
