FDA Entangled in Litigation Over Raw Milk Sales

CALIFORNIA Interstate sales of raw milk are at the heart of a lawsuit that was filed last month against the U.S. Food and Drug Administration (FDA) and government officials.  

Organic Pastures Dairy Company, LLC is seeking to force FDA to take final action on a four-year-old petition, requesting the food safety agency grant an exception to the prohibition on interstate sales of raw milk.

Fresno, Calif.-based Organic Pastures has sought permission to transport and sell raw milk across state lines so long as sales of the product are legal in both states.

FDA Sits on Petition for Years

In its lawsuit filed with the U.S. District Court for the Eastern District of California, Organic Pastures stated it has repeatedly asked FDA about a ruling on its petition. The company claims FDA has been unable to provide an answer on when it will issue a ruling, leaving Organic Pastures no choice but to file suit.

FDA only had 180 days to respond to the initial petition, said Pete Kennedy, founder of the Consumer-to-Farmer Legal Defense Fund, which is litigating the case on behalf of Organic Pastures. Kennedy acknowledged FDA could obtain more time under certain circumstances, but "we don't think they are allowed this much more."

FDA has "no respect whatsoever for raw milk," declared Mark McAfee, the founder and CEO of Organic Pastures, in a phone interview Wednesday. "They do not want to regulate it and they want to keep it off their plate."

Some States Allow Raw Milk, Interstate Sales Banned

McAfee said his business is booming with raw milk sales of $10 million a year and 75,000 customers in California. Sprouts, the chain of specialty grocery stores, would like to purchase raw milk from Organic Pastures for retail sales in Arizona, McAfee said. That is not possible today because the federal government has banned interstate sales of raw milk since 1988, he said.

Kennedy of the Consumer-to-Farmer Legal Defense Fund noted at least 30 states allow raw milk sales or distribution in some form, although the laws are varied. For instance, in Arkansas and Mississippi, only sales of raw milk from a goat are permitted, he said.

Arizona and California are among the states that allow for raw milk sales at retail stores, McAfee said.

Motive for Lawsuit Questioned

Attorney William Marler, who sued Organic Pastures several years ago on behalf of children who reportedly suffered kidney failure after drinking raw milk, believes the lawsuit against FDA is more about making a statement than actually prevailing.

"My strong suspicious is it really has little to do with the fact he [McAfee] thinks they are going to win," said Marler, who is managing partner of Marler Clark, "The Food Safety Law Firm", and has regularly blogged on the topic of raw milk. "It has more to do with him trying to keep showing his followers he is fighting the evil empire of the FDA."

FDA has warned consumers about the potential dangers of raw milk, making it unlikely the agency would grant the petition to allow for interstate sales.

Kennedy maintained Organic Pastures simply wants a response from FDA on its petition.

"Once we get an answer, we'll consider our options at that time," he stated in a phone interview Thursday. If FDA rejects the petition, "we have the option to appeal that to a federal appellate court or maybe work on the legislative front instead or do both."

The lawsuit seeking a so-called "writ of mandamus" is at least the second attempt in recent years to challenge the prohibition on interstate sales of raw milk.

U.S. District Judge Mark Bennett last March dismissed a lawsuit that challenged 21 C.F.R. 1240.61. Ruling in favor of the federal government on procedural grounds, Bennett found the plaintiffs lacked standing because they had not suffered actual injury or only faced a threat that was hypothetical.

The Farm-to-Consumer Legal Defense Fund, which filed the lawsuit two years earlier, asserted the previous case made clear FDA would not take action against consumers who cross state lines to purchase raw milk.

But the Court did not rule on the plaintiffs' substantive allegations, namely that the regulation banning the interstate sales of raw milk exceeds FDA's authority, frustrates the laws of at least 28 states and is arbitrary and capricious.

FDA, CDC Cite Raw Milk Hazards

Raw milk comes from cows, goats and sheep and has not been pasteurized to destroy harmful bacteria, according to FDA. Between 1993 and 2006, more than 1,500 people in the United States fell ill from drinking raw milk or eating cheese made from it; and unpasteurized milk is 150 times more likely to cause foodborne illness than pasteurized dairy products, the government agency declares, citing the Centers for Disease Control and Prevention (CDC).  

"This raw, unpasteurized milk can carry dangerous bacteria such as Salmonella, E. coli, and Listeria, which are responsible for causing numerous foodborne illnesses," FDA states. "These harmful bacteria can seriously affect the health of anyone who drinks raw milk, or eats foods made from raw milk. However, the bacteria in raw milk can be especially dangerous to people with weakened immune systems, older adults, pregnant women, and children."

In 2008, Marler filed two lawsuits against Organic Pastures in a California state court on behalf of a nine-year-old boy and an 11-year-old girl who drank raw milk. The children both developed hemolytic uremic syndrome, a common cause of kidney failure, and were hospitalized for several weeks with medical bills totaling hundreds of thousands of dollars, according to the lawsuits. Marler said the cases were settled for undisclosed amounts. 

A study released about a year ago by the CDC found that 60 percent of dairy-related outbreaks reported to it between 1993 and 2006 were connected to raw milk products.

Restricting the sale of raw milk products is likely to reduce the number of outbreaks and can help keep people healthier," a CDC official declared when the study was released. "The states that allow sale of raw milk will probably continue to see outbreaks in the future."

McAfee Blasts Government Information

McAfee believes CDC has posted misleading information on raw milk. Citing a Cornell study analyzing CDC data, he told the CDC in a scathing letter last summer that the number of illnesses caused by raw milk (1,100) between 1973 and 2009 is miniscule compared to those linked to pasteurized milk (422,000). The letter also cited at least fifty deaths from pasteurized cheese or milk while stating raw milk was linked to no deaths during those years.

"Your CDC website is incomplete and shows massive bias," he declared in the letter.

In the phone interview Wednesday, McAfee said FDA continually blows him off and won't consider evidence showing raw milk is safe for human consumption.

The agency "has taken this position that raw milk is not safe in any form. It must be pasteurized," he said. "They will never receive any information from us that has proven otherwise."

FDA hasn't yet responded to the lawsuit.