He also said the study "included data based on the use of different product formulations, dose levels and application practices of prototype products from more than one company that were never approved for commercial use."
"Farmers depend on the health and well-being of their herds and will not choose to use products that are not beneficial," Burchett said. "A large number of dairy producers have used Posilac with great success since the product was introduced."
An FDA spokeswoman said the agency would have no immediate response to Monsanto's most recent complaint, which was submitted April 3.
But in a statement, the agency said: "This drug was only approved after [the] FDA established that it is effective and safe. Effectiveness means that Posilac does what the company claims [increases milk production]. Safety covers three main areas: safety of the food products to humans, safety to the target animal [the cow] and safety to the environment."
Monsanto's complaint includes examples of labels and advertisement from 13 dairies.
For instance, milk from HP Hood, a dairy operator based in Chelsea, Mass., carried a label that had "No Artificial Growth Hormones" on the package, along with a note that read "To Satisfy Our Customers."
Dutch-Way Dairy in Pennsylvania sells milk with labels saying, "No Added BST/The way it's meant to be!"
That marketing logic, Monsanto complains, distorts the research on Posilac and the FDA's conclusions.
The Kleinpeter Dairy of Louisiana "claim that milk from non-supplemented cow is healthier for children is patently false," Monsanto writes. "There is no evidence to suggest that milk from rBST-supplemented cows has any adverse developmental effect on children."
Stephen J. Hedges writes for the Chicago Tribune.
BOVINE HORMONE FACTS AND CONCERNS
Monsanto?s Posilac is a protein hormone, as distinct from a steroid hormone.
It supplements the bST (bovine somatotropin), produced by a dairy cow?s pituitary gland, which is among the hormones controlling milk production.
The FDA has found no difference between milk from supplemented and non-supplemented cows, and it says significant amounts of the hormone are not absorbed by humans who drink milk from cows that have received Posilac.
Some consumer activists are concerned because, according to the watchdog group Food & Water Watch, Posilac increases another hormone that in humans has been linked to cancer; other activists have suggested it leads to premature development in children.
