Under the Food, Drug and Cosmetic Act and accompanying regulations, the Food and Drug Administration (FDA) is charged with promulgating regulations pertaining to food, including the labeling of food. Specifically, FDA must ensure that labels are not false or misleading to consumers. Until earlier this fall, the FDA’s determination that milk from cows treated with artificial growth hormones was the same as milk from untreated cows had never been challenged by a court. In International Dairy Foods Association v Boggs, the 6th circuit found that the two milks are in fact different, disregarding the FDA’s prior determination, and struck down an Ohio regulation prohibiting milk producers from labeling milk as coming from non-treated cows.
FDA approval for rBST and labeling policy
In 1987, Monsanto submitted to the FDA a new animal drug application for Posilac, a synthetic growth hormone that increases milk production in dairy cows (also known as an rBST or rBG). It took Monsanto over 6 years to bring rBST to market, and Monsanto supplemented the application with studies and reports documenting the safety and effectiveness of the drug. After reviewing those materials, the FDA approved Monsanto’s application for the use of Posilac in 1993. In January 1994, a Congressional task force concluded that the FDA’s position was adequately supported.
In addition to approving rBST for public use, the FDA had to determine whether milk from rBST treated cows should be labeled differently than regular milk. Besides enforcing requirements necessary to ensure that the labeling is not false of misleading, the FDA is prohibited from placing some additional requirements on labeling—the agency cannot require labeling based solely on differences in the production processes of identical foods. After an extensive agency investigation outlined above, the FDA found that there was no material difference between milk from rBST-treated cows and milk from non-rBST-treated cows, and accordingly it could not impose additional labeling requirements.
The standard for determining if two foods are the same is a materiality standard. Materiality relates to nutritional, organoleptic, or functional characteristics of the food. In general, the FDA has not found that foods from genetically modified organisms are different than their conventional counterparts. Therefore, the FDA could not require any additional labeling of rBST milk. This decision was specifically upheld in Stauber v. Shalala, when the Wisconsin district court determined that absent evidence of a material difference between milk from rBST-treated cows and non-rBST-treated cows, the FDA could not create any additional labeling requirements. Later, the FDA advised that milk from untreated cows could be labeled as such, but recommended the inclusion as a disclaimer that accompanying the statement “from cows not treated with rbST” with the statement that “No significant difference has been shown between milk derived from rbST-treated and non-rbST-treated cows.”
6th circuit finds rBST milk “materially different”
In International Dairy Foods Association v. Boggs, the 6th Circuit determined that Ohio’s 2008 law prohibiting the labeling of milk from non-rBST treated cows was unconstitutional under the 1st amendment. The court based this decision in part on its finding that the two milks were different, thus overruling the FDA’s prior determination. The court cites three reasons milk produced by rbST-treated cows is different: increased levels of the hormone IGF-1, a period of milk with lower nutritional quality during each lactation, and increased somatic cell counts in the milk. The court further noted that higher somatic cell counts indicate milk is poor quality and will turn sour more quickly.
The 6th circuit’s willingness to overturn the FDA’s determination could have important implications for other genetically modified foods on the market and those looking to enter the market, including genetically modified salmon. Companies spend enormous amounts of resources convincing the agency and the public that their products are safe to eat, have no environmental harms, and are overall the “same” as conventional foods. In fact, producers of genetically modified foods encourage labeling restrictions so that consumers cannot tell from the label which foods are genetically modified and which are not. The argument goes that since the FDA says the two types of food are materially the same, consumers should not be told that they are different in any way. Telling a consumer that a product is made from “cows not treated with rBST” creates an impression that milk from treated cows is worse, and thereby creates confusion.
As demonstrated by the Ohio case, specific regulations in each state can be the target of suits by consumers or producers of conventional foods. Companies will now need to continuously manage public and scientific opinion of their food products. In fact, genetically modified food producers will need to decide if they even want to pursue labeling requirements, when doing so could force them to defend the FDA’s materiality determination in 50 separate suits.