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Supreme Court to Hear Dispute Over Allegedly Deceptive Food Labeling

January 14, 2014


The Supreme Court has agreed to hear a dispute between POM Wonderful and Coca-Cola involving the intersection between FDA food labeling requirements and the Lanham Act’s restrictions against deceptive product labeling and advertising.  At its essence, the Supreme Court is being asked to determine whether a private party can bring a Lanham Act claim against a food manufacturer for a food product whose label otherwise complies with FDA regulations governing the label.

POM Wonderful and Coca-Cola have been entrenched in litigation for years surrounding Coca-Cola’s marketing of pomegranate blueberry juice that contained only small amounts of pomegranate and blueberry juices (about 0.3% and 0.2%, respectively) and larger amounts of apple and grape juices.  POM Wonderful has long argued that Coca-Cola’s use of the term “pomegranate blueberry juice” is misleading to consumers given the actual ingredients in the product.

In 2012, the Ninth Circuit Court of Appeals determined that POM Wonderful could not

FDA Begins Accepting Electronic Submittal of Dietary Supplement Adverse Event Information

January 13, 2014


On January 13, 2014, FDA announced that it would begin accepting adverse event information on dietary supplements electronically.  This policy applies to voluntarily-submitted information as well as information where reporting is mandatory (information submitted via the 3500A and 3500 forms).  As stated by FDA:

Under the Dietary Supplement and Nonprescription Drug Consumer Protection Act (Public Law 109-462), the manufacturer, packer, or distributor of a dietary supplement whose name appears on the label of a dietary supplement marketed in the United States is required to report to the FDA any serious adverse events received regarding their dietary supplement products when used in the United States.

Reporting of dietary supplement adverse events is critically important in protecting consumers’ health and safety. The FDA routinely monitors the marketplace. However, with more than 85,000 dietary supplements on the market and no product specific registration requirement, adverse event reporting is invaluable in

FDA Publishes Draft Rule to Address Intentional Adulteration of Food

FDA published a draft rule today designed to require the largest food businesses in the United States to take steps to address vulnerabilities in their operations to prevent the intentional adulteration of food – “food terrorism,” in other words.  The proposed rule will generally apply to both domestic and foreign facilities that manufacture, process, pack, or hold food and are required to register as a food facility.  Exempted from the rule are small businesses (less than $10 million in annual food sales), farms, food for animals, certain food holding facilities, and certain packing or labeling facilities.  As explained by FDA:

Under the proposed rule, a food facility would be required to have a written food defense plan that addresses significant vulnerabilities in its food production process. Facilities then would have to identify and implement strategies to address these vulnerabilities, establish monitoring procedures and corrective actions, verify that the system is working,

FDA To Further Amend Draft Rules Implementing FSMA

Yesterday, FDA Deputy Commissions for Foods and Veterinary Medicine, Michael Taylor, announced that FDA would further amend the draft rules on produce safety and preventive controls for human food, which were originally published in draft form in January 2013.  Acccording to Mr. Taylor’s statement:

[W]e believe that significant changes will be needed in key provisions of the two proposed rules affecting small and large farmers. These provisions include water quality standards and testing, standards for using raw manure and compost, certain provisions affecting mixed-use facilities, and procedures for withdrawing the qualified exemption for certain farms. We have heard the concern that these provisions, as proposed, would not fully achieve our goal of implementing the law in a way that improves public health protections while minimizing undue burden on farmers and other food producers.

As FDA considers the changes to be significant, it will once again accept comment only on

FSIS Publishes Final Rule on Generic Labeling

December 5, 2013


In November, USDA’s Food Safety and Inspection Service published a final rule relating to generic labeling of meat and poultry products regulated by the USDA.  Unlike labeling for food regulated by FDA, labeling for meat and poultry products regulated by the USDA has historically been reviewed and approved by USDA.  This rule, which will be effective on January 6, 2014, was designed to provide generic approval for certain types of labeling. Once effective, only certain types of labeling will need to be submitted to FSIS for evaluation and approval.  These types of labeling are: (1) temporary approvals; (2) labels for export only that bear labeling deviations; (3) religious exemption labeling; and (4) labels bearing special statements and claims.  Special statements and claims that must be reviewed include third party certifications, animal production claims (e.g., relating to use or non-use of certain foods, hormones or antibiotics), breed claims, certified claims, gluten free claims, health or

FSIS Releases Salmonella Action Plan

USDA’s Food Safety and Inspection Service released today a strategy to reduce Salmonella exposure.  According to FSIS, Salmonella in meat and poultry products is “the most pressing problem it faces,” with an estimated 1.3 million illnesses attributed to Salmonella each year.  The plan seeks to reduce Salmonella illnesses by establishing priorities for future rulemaking, industry guidance and public education relating to Salmonella, including modernizing the poultry slaughter inspection system, enhancing sampling and testing programs, developing guidance for sanitary dressing in hogs, establishing new performance standards, and improving Salmonella-related education and outreach.  A copy of the action plan can be found here.



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