On April 5, 2018, the Institute for Justice (IJ), on behalf of South Mountain Creamery (South Mountain), filed a complaint against the U.S. Food and Drug Administration (FDA) in the U.S. District Court for the Middle District of Pennsylvania, stating that the Agency is violating First Amendment rights by requiring that South Mountain label its milk, from which fat has been removed, as “imitation skim milk” or “imitation milk.”
South Mountain is a creamery based in Maryland that produces milk and milk products and sells to customers in Washington D.C., Maryland, and Virginia. The business produces natural, additive-free, pasteurized skim milk by skimming the cream from the top of the milk. The skimming process results in the removal of fat-soluble vitamins A and D. South Mountain does not want to replace these vitamins because it wants to produce additive-free skim milk. However, under FDA requirements, the “skim” milk may not be labeled “skim milk” because, without the addition of vitamins A and D, it is nutritionally inferior to the milk as that term is defined by FDA regulation. Under FDA regulation 21 C.F.R. § 131.10, it would need to be labeled as either “imitation milk,” “imitation skim milk,” or “imitation milk product.”
Section 403(g) of the Federal Food, Drug, and Cosmetic Act (FDC Act) states that a food shall be deemed misbranded if “it purports to be or is represented as a food for which a definition and standard of identity has been prescribed” unless “it conforms to such definition and standard” and “bears the name of the food specified in the definition and standard.” The standard of identity for milk allows for vitamins A and D to be added. Milk without fat may be named skim milk, provided that it meets the requirements for the nutrient content claim “skim,” meets the standard of identity in all other respects, and is not nutritionally inferior. If it is nutritionally inferior, it must be labeled with the word “imitation.” 21 C.F.R. § 101.3(e). Among other things, a product is nutritionally inferior if it contains fewer nutrients, such as vitamins A and D, than the standard food. Id. §§ 101.3(e), 130.10(b).
Thus, South Mountain may not market its product as skim milk unless it labels the product as imitation, or adds vitamins A and D. South Mountain alleges that FDA’s regulation is unconstitutional, as it constitutes unconstitutional censorship of the words “skim milk,” stating that labeling pasteurized skim milk as “pasteurized skim milk” is non-misleading speech about a lawful activity. South Mountain further contends that the phrase “imitation skim milk” required by FDA is misleading and confusing to consumers. The company also states that the labeling requirements are unreasonable, unnecessary, fail to advance any legitimate government interest, and are not tailored to any legitimate government interest.
The issue of labeling all-natural skim milk products has been litigated before, in a suit brought by IJ on behalf of Ocheesee Creamery (see our post here) against the Florida Department of Agriculture. In that case, the Eleventh Circuit determined that the State’s prohibition on the truthful use of the term “skim milk” violated the First Amendment. The court reasoned that the creamery could use the term “skim milk” with disclosures that it lacks vitamins A and D for its additive-free milk product. Subsequently, the Florida Department of Agriculture agreed that the milk could be marketed with the label stating “PASTEURIZED SKIM MILK, VITAMINS A & D REMOVED WITH CREAM.” In discussions with FDA, South Mountain has requested that it be allowed to use the same or similar labeling. However, FDA has not been receptive to South Mountain’s requests.