A federal court in New York has dismissed putative class claims filed against Dannon Co., alleging that its Activia® yogurt products are not actually yogurt because they contain filler products including milk protein concentrate (MPC), an ingredient that the Food and Drug Administration (FDA) purportedly prohibits from use in yogurt. Conroy v. The Dannon Co., Inc., 12-6901 (U.S. Dist. Ct., S.D.N.Y., decided May 9, 2013). The defendant challenged the claims on the ground that the “plaintiff’s allegations are premised on a misunderstanding of the FDA’s standard of identity for yogurt.”

The court agreed with Dannon that while MPC is not included in the list of permissible ingredients for yogurt, it is a permitted “other optional ingredient” despite FDA’s failure to include MPC in its 1981 definition of the phrase. According to the court, the issue in the case was the proper interpretation of a stay FDA imposed in 1982 on certain provisions of its yogurt standards of identity rule in response to objections. The plaintiff contended that the stay struck the entire “other milk-derived ingredients” list “such that no milk-derived ingredients may be added to yogurt.”

The court disagreed, finding that FDA explained that it issued the stay in “response to objections concerning the replacement of the phrase ‘other milkderived ingredients … with a limited list of names of milk-derived ingredients.’ The objectors had argued [that] the replacement of the broad term with a limited list did not promote honesty and fair dealing because it barred the use of other safe, nutritional, and functional milk-derived ingredients, and did not appear to have any rational factual basis. The FDA concluded that ‘the objectors raise[d] a genuine and substantial issue of fact that must be resolved at a public hearing’ and issued a stay.”

Thus, the court concluded that, in context, FDA’s action “means that paragraph (d)(1) is only stayed insofar as it limits the kinds of safe and suitable milk-derived ingredients that may be used” and not that MPC is prohibited. The court further noted that in 2004, “FDA expressly stated that MPC may be added to yogurt … in an FDA-issued memorandum from the Milk Safety Branch to all Regional Food and Drug Directors.”

The court also rejected the plaintiff’s claims that Activia® was adulterated due to its MPC content, because FDA has never determined that it is generally recognized as safe. In the court’s view, “FDA would not have made the clear and unambiguous statement that MPC may be used in yogurt ‘if that same permissible addition would render the yogurt illegally adulterated.’” Finding that the plaintiff failed to demonstrate that amending her complaint would not be futile, the court denied her informal request to amend her complaint.