Four dairies got their proverbial hands slapped by the U.S. Food and Drug Administration for marketing what it charges is “misbranded” milk. The regulatory agency recently issued warning letters to the companies–which sell whole milk, reduced-fat milk, and ice cream–saying that their product labels contain false statements about the food’s hormone status.


FDA’s Sept. 24 letter to a Sauk Centre, Minn., dairy, for instance, informed the chief manager that the dairy’s products are misbranded because its labels “contain the statement ‘No Hormones,’ which is false.” The agency’s contention is that naturally occurring hormones are present in all milk and milk products. Indeed, the warning letter charged, “milk cannot be produced in a way that renders it free of hormones.” Even a mother’s milk is laced with natural hormones.

However, natural hormones aren’t what the commercial milk producers have been referring to in their advertising. The dairies’ intent was to highlight that their products came from cows never treated with genetically engineered bovine somatotropin, or rBST. U.S. dairy farmers commonly administer this drug, which is virtually identical to a natural bovine hormone, to boost milk production.

FDA’s warning letters demanded prompt relabeling of the dairies’ products. Failure to do so, it said, could result in product seizures or an injunction prohibiting the sale of the misbranded goods. In fact, all four dairies responded. One withdrew the offending product. The others all relabeled their milk and related goods.

Monsanto in St. Louis is the sole maker of rBST in the United States. Just weeks before the FDA’s action on dairy product labels, the company brought suit against Oakhurst Dairy in Portland, Maine, for labeling its products with the words “our Farmer’s Pledge not to use artificial growth hormones.” That statement appears on every milk product sold by the 82-year-old family-owned dairy. Monsanto’s suit asks the U.S. District Court in Boston to make Oakhurst remove the statement from its labeling.

“We are actively fighting Monsanto’s efforts, and our argument is a simple one–families have the right to know what is and isn’t used in producing the milk they drink,” says Stanley T. Bennett in a statement for the dairy. “While we make no claims regarding the science of artificial growth hormones,” Bennett says, “we feel strongly that keeping our customers fully informed is the right thing to do.”

An account of the lawsuit in the July 8 Portland Press Herald quotes Jennifer Garrett, director of technical services for Monsanto’s dairy business, as saying: “We believe Oakhurst labels deceive consumers; they’re marketing a perception that one milk product is safer or of higher quality than other milk.”

In fact, FDA maintains that food producers “have no basis for claiming that milk from cows not treated with rBST is safer than milk from rBST-treated cows.” However, the agency has also stated that manufacturers who use milk from cows not treated with rBST “may voluntarily inform consumers of this fact on their product labels or labeling, provided that the statements are truthful and not misleading.”

Does such an FDA statement protect Oakhurst Dairy in the litigation? Monsanto says no. In a prepared statement, the company argues that Oakhurst’s labels “fail to fully disclose years of scientific evidence that milk from cows supplemented with rBST is the same as all other milk . . . . Without this information, independent market research shows that many consumers are misled to believe that the milk with labels such as the Oakhurst Dairy label is healthier or safer than other milk.” The company cited surveys conducted by North Hampton, Mass.–based MSR Research Group showing that “more than two-thirds of consumers were misled to believe that the milk with the Oakhurst Dairy label was healthier to drink than milk labeled without such a statement, and that more than 60 percent of consumers were also misled to believe that the milk with the Oakhurst Dairy label was safer to drink than milk labeled without such a statement.”

The Monsanto-versus-Oakhurst Dairy case has a projected trial date of Jan. 6, 2004.

What is rBST?

Two decades ago, scientists at Cornell University pioneered studies of treating dairy cattle with injections of natural bovine somatotropin (BST). Work by researchers there and elsewhere showed that the hormone alters how cows use nutrients–causing them to divert more of their energy intake into milk generation rather than growth (SN: 5/5/84, p. 284). Indeed, early studies in New Zealand had shown that cows that naturally produce more milk than others in their herd do tend to secrete more of the natural form of this pituitary hormone. Cows now getting a genetically engineered version of the hormone typically produce at least 10 percent more milk than other cows do.

Over the years, some scientists have worried that the hormone treatments seed milk with rBST residues. According to the International Dairy Foods Association (IDFA), all milk “contains naturally occurring BST. Milk from rBST-supplemented cows contains no more BST than milk from cows not supplemented with rBST.”

Critics of the therapy have also argued that milk from rBST-treated cows may develop elevated concentrations of insulinlike growth factor-1 (IGF-1). This protein is important to milk production, bone growth, and cell division in all animals, including humans.

Thirteen years ago, both the FDA and a National Institutes of Health expert panel reviewed data on the milk from rBST-treated animals and pronounced it safe (SN: 12/15/90, p. 372). FDA went on to approve sale of the milk a decade ago.

Today, an estimated third of U.S. dairy producers administer rBST to their cows, IDFA maintains. In a position statement on the hormone, it reports that “Canada and the European Union, which have not approved rBST for use in their dairy herds, concede that there is no public health risk associated with milk from supplemented cows.”

Argues IDFA: “FDA and the World Health Organization concluded in 1992 that any reported increase in IGF-1 levels in milk from rBST-supplemented cows is still insignificant, a finding that has been repeatedly reinforced by other scientific bodies.” Moreover, FDA says, IGF-1 in breast milk “is at about the same concentration as that found in bovine milk” from both rBST-treated and untreated cows (SN: 1/27/96, p. 52).

None of these statements, however, has stemmed debate on use of the hormone. Natural food advocates and some environmentalists have argued that rBST injections are unnecessary and risk unduly stressing cows. FDA and livestock scientists have discounted the latter. What’s more, some alternative strategies for increasing milk production, such as milking cows more often, in themselves stress the animals (SN: 5/5/84, p. 282).

Critics of rBST ask why so many U.S. dairies choose to inject their livestock with the engineered hormone when the nation is already experiencing a milk glut. The answer, agricultural economists say, is that dairying doesn’t offer farmers much profit. So any treatment that allows dairies to get hundreds to thousands more gallons from a herd each year looks mighty attractive.

Janet Raloff

Janet Raloff is the Editor, Digital of Science News Explores, a daily online magazine for middle school students. She started at Science News in 1977 as the environment and policy writer, specializing in toxicology. To her never-ending surprise, her daughter became a toxicologist.

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