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Maryland dairy farmers Randy and Karen Sowers, owners of South Mountain Creamery in Middletown, MD have filed suit against the U.S. Food and Drug Administration (FDA), FDA Commissioner Scott Gottlieb, and Pennsylvania Secretary of Agriculture Russell C. Redding to fight the law that requires them to label their skim milk as imitation skim milk. Click here to read the full complaint, or here to watch a video in which Randy Sowers describes his operation.
South Mountain Creamery produces its pasteurized skim milk by skimming the cream from the top of the milk. The removal of the cream also serves to remove fat-soluble vitamins A and D from the milk. The FDA requires, however, that milk not be labeled as skim milk unless vitamins A and D are added back into the milk after the skimming process.
Certain foods, such as skim milk, have a definition and standard of identity outlined in federal law. According to Section 403(g) of the Federal Food, Drug, and Cosmetic Act misbranding of food occurs when a food has a legal definition and standard of identify and does not meet that definition or standard. Milk without fat or cream may be labelled as skim milk, provided that it meets the meets the standard of identity and is not nutritionally inferior. If milk is nutritionally inferior, it must be labeled with the word “imitation.” 21 C.F.R. § 101.3(e). According to federal regulations, in this case South Mountain Creamery’s skim milk is nutritionally inferior to the standard of identity for milk and must be labelled as imitation skim milk.
This issue began when South Mountain Creamery wanted to expand the sale of its products, including its skim milk, into Pennsylvania. Interestingly, Pennsylvania has its own legal definition of skim milk which would allow an in-state farmer to label skim milk as skim without the added vitamins. The Pennsylvania Department of Agriculture, however, is required to follow federal labelling regulations in the case of South Mountain Creamery’s milk, because as milk produced in Maryland and sold in Pennsylvania, it is a product sold across state lines. Products sold across state lines are subject to the interstate commerce jurisdiction of the FDA.
In the suit, South Mountain Creamery claims the FDA’s regulation constitutes unconstitutional censorship of the words “skim milk” and requiring the creamery to label its slim milk as “imitation skim milk” is misleading and confusing to consumers. According to the complaint filed in the suit, the creamery’s goal is to “to sell additive-free skim milk with a truthful and non-misleading label.”
Although it may seem impossible to challenge a federal agency and regulation, last year the 11th Circuit Court of Appeals ruled in favor of a dairy farmer and against the Florida Department of Agriculture on the very same issue. The Court found the State’s prohibition on the use of the term “skim milk” violated the First Amendment. The Court held the farmer could label her milk with a label stating “pasteurized skim milk, vitamins A & D removed with cream.”
ALEI will continue to watch this case and will highlight any relevant updates in future posts.