"The (Food and Drug Administration) is reaching way beyond its authority to intimidate us and what we do, but we will not be intimidated," said Mark McAfee, owner of the Organic Pastures Dairy Company in Fresno, Calif.
The U.S. Justice Department filed suit against McAfee in a U.S. district court Thursday, Nov. 20, claiming that he endangered public health by violating a federal law against interstate commerce in unpasteurized milk.
The U.S. Health and Human Services Department, which oversees FDA, is also participating in the lawsuit.
"Raw milk and raw milk products contain a wide variety of harmful bacteria including, but not limited to, listeria monocytogenes, E. coli, salmonella, campylobacter and brucella, all of which may cause illness and possibly death," according to the federal government's complaint.
According to the federal government's lawsuit, McAfee circumvented restrictions on the interstate shipment of raw milk by labeling outgoing boxes as "pet food." Unpasteurized milk is allowed to cross state lines as long as it's used for that purpose.
However, the retail products within the boxes did not mention pet food and the labeling language was clearly directed at human consumers, according to the government's complaint.
The lawsuit contends that an employee at Organic Pastures Dairy unwittingly acknowledged the pet food label was a "legal loophole for the firm to be able to ship the product out of state" to an undercover FDA investigator.
McAfee admitted as much in a 2005 Portland Tribune article in which he was quoted as saying, "And there is no regulation that you can't eat pet food, either," according to the complaint.
Organic Pastures Dairy no longer labels its products as pet food unless the customer signs an affidavit saying the milk will only be fed to animals, McAfee said. The company established that policy after the FDA threatened it with a criminal indictment earlier this year, he said.
The only product McAfee now ships out of state is colostrum, which, as dietary supplement, can legally cross state lines, he said. Colostrum, or milk that is secreted shortly after birth, is used for immune system support and other health benefits.
"They fail to understand that what we do is completely legal," McAfee said.
McAfee expects the presiding judge, Oliver Wanger, to rule against the federal government before the case goes to trial.
The federal government wants the judge to issue an injunction prohibiting McAfee from shipping his products out of California, no matter how they are labeled.
The government's lawsuit says that seven people died and more than 460 fell ill from diseases associated with raw milk consumption between 2000 and 2005. Epidemiological studies have established a direct link between raw milk and gastrointestinal disease, according to the complaint.
Proponents of raw milk, such as the Weston A. Price Foundation, say such studies are biased and based on sloppy science.
"Most of them represent a rush to judgment in which the investigators blamed raw milk without sufficient evidence or even in the face of contrary evidence," according to a report from the foundation.
Raw milk contains beneficial proteins, enzymes, vitamins and minerals, according to proponents.
Christine Chessen, director of the California Raw Milk Association, said that raw milk can alleviate symptoms of asthma, eczema, allergies and immune disease.
"I don't see why they're making such a big deal out of it, especially since people have gotten such amazing health benefits from it," she said.
The federal government alleges that the Organic Pastures Dairy website unlawfully claimed "that their raw milk and raw milk products can cure, mitigate, treat, or prevent various diseases including, but not limited to, cataracts, ear infections, sinus infections, arthritis pain, allergy, and asthma."
McAfee said that his website did not make such claims, but contained links to other sites that include health benefit information and substantiated those claims with scientific studies.
"That's legal to do," he said.
At one time, the Organic Pastures Dairy website contained testimonials from customers, but those were removed in 2005 after the company was fined by the California Department of Health Services, McAfee said.