Dairy Co. Sues FDA Over ‘Imitation’ Skim Milk Labeling Rule  (subscription to Law360 required)

  • South Mountain Creamery, a family-owned dairy in Maryland, sued the Food and Drug Administration (FDA) in federal court on Thursday (April 5, 2018) claiming its free-speech rights under the First Amendment of the U.S. Constitution are violated by FDA’s regulations requiring the company’s product be labeled as “imitation skim milk” when no Vitamins A and D are added.   The company claims that the name of its product is truthful and not misleading and that Pennsylvania law would permit its product to be labeled as skim milk if not for the prohibition under FDA’s labeling and standard of identity regulations.  The case is South Mountain Creamery LLC v. U.S. Food and Drug Administration et al., case number 1:18-cv-00738, in the U.S. District Court for the Middle District of Pennsylvania.
  • FDA has defined milk and prescribed a standard of identity at 21 C.F.R. § 131.110 (“Milk”).  FDA’s regulation on nutrient content claims for the fat content of foods at Section 101.62(b)(1) permits milk with less than 0.5 grams of fat per serving to be called “nonfat” or “skim” milk.  Under 21 C.F.R. § 130.10 (“Requirements for foods named by use of a nutrient content claim and a standardized term”), however, nutrients shall be added to the food to restore nutrient levels so that the product is not nutritionally inferior to the standardized food (i.e., milk).  Thus, where Vitamins A and D are  removed by skimming the cream from milk to make skim milk, Section 130.10 requires the addition of Vitamins A and D to restore these nutrients to the levels found in milk.  Otherwise, the milk product with Vitamins A and D at levels lower than found in milk is deemed to be misbranded under 21 C.F.R. § 101.3 (“Identity labeling of food in packaged form”) unless it is called “imitation skim milk.”
  • Florida lost a similar lawsuit where the 11th Circuit found Ocheesee Creamery has a First Amendment right to call its milk product without added Vitamin A “skim milk” despite state laws (mimicking FDA’s regulations) that would require it be called “imitation skim milk.”  FDA was not sued in this related case.