Class Action Lawsuits Attack Yogurt Products for Nonconformance with Standards of Identity
Over the past eight months, numerous class action lawsuits have been filed by consumers against yogurt manufacturers regarding the use of milk protein concentrate (“MPC”) as an ingredient in yogurt products. Generally, the lawsuits allege that the yogurt and Greek yogurt products are not actually yogurt because they do not comply with the required standard of identity for yogurt due to the use of MPC as an ingredient. Such lawsuits have been filed against General Mills Yoplait Greek yogurt, Cabot Greek-style yogurt, Dannon Activia yogurt, and Lucerne Greek yogurt.
The plaintiffs in these various suits allege that the products do not meet the FDA-approved standards of identity because the products contain MPC, which is not permitted in yogurt. MPC is often used as a filler to create a thicker product and increase the amount of protein. Plaintiffs also allege that because the products do not conform to the standard of identity for yogurt, the products are misbranded in violation of state law and the Federal Food, Drug and Cosmetics Act (“FDCA”).
Standards of identity define certain food products and govern the ingredients that must be used, or may be used, in the manufacture of those food products. The standard of identity for yogurt describes the permissible ingredients for yogurt, and components and processes that can be used to manufacture yogurt. The standard of identity for yogurt, nonfat yogurt and low fat yogurt are defined in 21 C.F.R. 131.200, 21 C.F.R. 131.203 and 21 C.F.R. 131.206, respectively. As noted in the complaints, MPC is not expressly listed or described as a permitted ingredient in the applicable standards of identity for yogurt.
Pursuant to Section 403(g)( 1) of the FDCA, a food product is misbranded if: (i) it does not conform with the applicable standard of identity; or (ii) its label does not bear the name of the food specified in the definition and standard. 21 U.S.C. § 343(g). Moreover, courts have held that foods which purport to be standardized products, but contain ingredients not recognized in the standard of identity, are misbranded even if the label accurately describes the product’s ingredients. Libby, McNeill & Libby v. United States, 148 F.2d 71 (2d Cir. 1945) (affirming United States v. 306 Cases Containing Sandford Tomato Catsup With Preservative, 55 F. Supp. 725 (E.D.N.Y. 1944)).
According to the complaints, the use of MPC as an ingredient in these products renders the products misbranded pursuant to the FDCA, 21 U.S.C. § 343, because the products are represented as yogurt for which the standard of identity had been prescribed by regulation and the use of MPC in these products does not conform to the standards.
Significantly, manufacturers whose products are deemed by the FDA to be misbranded are subject to enforcement action. Enforcement actions can include the issuance of Warning Letters, injunctions or criminal penalties. 21 U.S.C §§ 332, 333. Previously, the FDA has warned dairy food product manufacturers that when MPC is not listed as an optional dairy ingredient in products governed by a standard of identity, the use of MPC is not permitted and would render the product misbranded. The FDAs Warning Letter can be found here. FDA Warning Letters notify recipients and the public that the FDA believes that a particular firm has violated federal law. Thus, given the bad publicity that these letters generate, it is advantageous for firms to correct possible violations as quickly as possible. The recipients of Warning Letters typically have 15 days to address the issues presented by the Warning Letter and to develop specific corrective actions. Failure to do so may put the recipient in jeopardy of facing product seizures or formal legal action by the FDA. Please see our previous reports here and here, discussing whether, and if so how, the recipients of Warning Letters may respond or challenge the Warning Letters in court in light of the United States Supreme Courts recent ruling in Sackett v. EPA.
Notably, on December 10, 2012, Judge Susan Richard Nelson of the U.S. District Court in Minnesota dismissed the General Mills Yoplait Greek yogurt lawsuit. In the ruling, Judge Nelson invoked the doctrine of primary jurisdiction, concluding that the FDA was best suited to handle the dispute. Under the doctrine of primary jurisdiction, a court has discretion to retain jurisdiction or stay litigation and refer issues that fall within the special competence of an administrative agency to that agency for its decision. See Access Telecomms. v. Sw. Bell Tel. Co., 137 F.3d 605, 608 (8th Cir. 1998). Courts generally apply the doctrine to promote uniformity and consistency within the particular field of regulation. Here, the Court determined that the underlying issue is whether MPC is a proper, permitted ingredient in yogurt as governed by the standard of identity for yogurt, and the resolution of this question falls squarely within the competence and expertise of the FDA, pursuant to the authority granted to the Agency by Congress. See 21 U.S.C. §§ 301, et seq.
It remains to be seen how quickly the FDA will act to address the ambiguities regarding the standard of identity for yogurt. Fuerst Ittleman David & Joseph will continue to monitor the FDAs regulation of food products. The attorneys in the Food, Drug, and Life Sciences practice group are well-versed in the complex FDA regulatory framework. For more information, please email us at email@example.com or call us at (305) 350-5690.