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FDA Attempts to Corral Raw Milk Producer

With government health officials warning that raw milk can make you sick–or even kill you–and raw milk advocates telling consumers that pasteurized milk is a “dead food” whose health-giving nutrients have been destroyed by heat, the battle over this contentious issue continues.

Earlier this month, on Dec. 8, the U.S. government lobbed a legal spear into the camp of California raw milk producer Mark McAfee, owner of Organic Pastures Dairy Company, in the form of a request for a permanent injunction that would forever prevent the dairy from selling its raw milk and raw milk products across state lines, no matter how they’re labeled.  Organic Pastures Dairy is the largest retail-approved raw-organic-dairy-products producer in North America.

Although California state law allows licensed raw milk dairies to sell raw milk and raw milk products to consumers, federal law prohibits the sale of those products for human consumption across state lines.

If the District Court for the Eastern District of California deems that the government has presented enough evidence to warrant imposing a permanent injunction, Organic Pastures will not be allowed to sell any of its raw milk or raw milk products interstate–even if it’s labeled as “pet food.”

In a Dec. 16 interview with Food Safety News.com, McAfee said that “all of this is for naught” since he had already recommended that the court issue a summary judgment that parallels an earlier criminal settlement reached between Organic Pastures, himself, and the federal government.  “I could care less about a permanent injunction,” he said, referring to interstate sales. “We’re selling in 375 stores here in California and can’t keep up with demand.”

On Dec. 22, 2008, Organic Pastures pleaded guilty to two counts of selling its raw milk in other states “misbranded” as pet food.  As part of the legal agreements with the federal government in January 2009, Organic Pastures and McAfee agreed to cease all interstate sales of raw milk and raw milk products and to make changes to the company’s website that make it clear that under federal law, raw milk and raw milk products in final package form intended for human consumption cannot be sold across state lines.

The federal government’s Dec. 8 request for the permanent injunction includes statements from McAfee that describe using the “pet-food” label as a legal loophole.

In a 2005 newspaper article in the Portland Tribune, McAfee was quoted as saying: “The neat thing about the law is that it can be interpreted in many ways. The state of Oregon understood that there was a loophole by putting a pet sticker on the product. And there’s no regulation that you can’t eat pet food, either. I am a revolutionist in this, and I won’t overlook any loophole that will get the milk out there.”

The motions submitted by the federal government on Dec. 8 also point out that as recently as Oct. 15, 2009,  McAfee said he would bring ten half gallons of California raw milk with him and drink it with the demonstrators on the steps of the Wisconsin court house steps.

“They will not take my raw milk from me . . . no matter where I physically stand on American soil,” he vowed.

His comments echo shades of “past revolutions” over raw milk and the passion it evokes. In 1920, for example, a Milwaukee ordinance requiring that all milk sold in the city be pasteurized angered milk dealers who described the ordinance as an invalid exercise of police power because it did not promote public health, according to a rundown on the history of pasteurization in the United States provided by food-safety attorney Bill Marler.

Despite those claims on the part of the milk dealers, the Wisconsin Supreme Court disagreed, saying that “Public health demands that milk and all milk products should be pure and wholesome.” In an interesting twist in this recent raw milk battle, the federal government is also asking the court to stop Organic Pastures from making claims that raw milk can cure a laundry list of immune-related health problems ranging from asthma to Crohn’s disease.

That request is based on federal Food and Drug Administration’s stand that claiming a product can cure or help improve a health problem is tantamount to declaring it a drug. But to do that legally, the health benefits of the product must be substantiated. General Mills discovered that this this spring when the FDA sent a letter to the company warning that its promises on its Cheerios packages that the toasted oats would lower cholesterol and reduce the risk of heart disease and cancer could result in a seizure of the product.

An FDA regulator told Bloomberg.com that the labeling on the Cheerios package “went beyond what the science supports.”  General Mills responded by modifying its health claims on its Cheerios labels.

In line with that focus on health claims, FDA says that raw milk and raw milk products are “unapproved new drugs” and therefore prohibited from being sold interstate.

Organic Pastures has taken heed of this, and in compliance with its “plea agreement” with the federal government now includes this answer to a question about “diseases aided by consuming raw milk and raw dairy products” on its website’s list of questions and answers:

“OPDC may not make a medical claim or post cures for any disease process relative to any OPDC product. That is a crime under current FDA law.”

Along those same lines, Stefano Luccioli, MD, senior medical advisor with FDA’s Center for Food Safety and Applied Nutrition, provided 10 pages of testimony to the motions filed with the court, detailing claims about the benefits of raw milk and the lack of scientific evidence for them.

” . . . I do not believe that raw milk is a safe or effective treatment for asthma, other allergic disorders, cataracts, ear infections, sinus infections, arthritis/arthritis pain, eczema, psoriasis, constipation, Crohn’s disease, or hypertension,” he said. “Moreover, in my opinion, there is no general recognition among physicians qualified to evaluate these conditions that raw milk is safe or effective for the treatment of such conditions.”

In contrast, McAfee, in a YouTube video titled “Raw Milk Ninja,” says he started selling raw milk and raw milk products only because consumers started coming to his farm and asking for it, telling him that it helped clear up an array of immune-related health problems.

“What we are doing works,” he says on the video. In a blog, McAfee said that this controversial issue “lies deep in the political and economic game of selling dead food from industrial farms that do not know any of their customers, personally.”

Even though the feds and McAfee did hammer out an agreement in which McAfee agreed to halt interstate sales of Organic Pastures’ raw milk and raw milk products for human consumption, Barbara Cassens, district director of FDA’s San Francisco District Office, provided written testimony to the court that included a warning.

Saying that based on her familiarity and experience with McAfee and Organic Pastures Dairy and FDA’s efforts to persuade them to comply with the law, she believes that unless the court enjoins them from violating several federal laws, they will resume their unlawful activities as soon as the criminal plea agreement is dissolved — if not before.

The feds say they want to make sure that Organic Pastures and McAfee don’t revert to former marketing strategies once the conditions set forth in the plea and deferred prosecution agreements come to an end on January 2011.

Pointing to what the federal government describes as McAfee’s “long history of continued violations” of several federal laws and “the fact” that he only agreed to stop the unlawful activity in light of a criminal prosecution–and that he has
made numerous public stateme
nts that he will do whatever he can to evade the prohibition on the interstate sale of raw milk — the feds contend that “a permanent injunction is necessary to make sure he doesn’t resume those unlawful activities in the future.”

“The bottom line in this,” McAfee said in the interview with Food Safety News.com “is that the FDA hates raw milk and refuses to acknowledge that California has strict raw milk standards and all raw milk in California sold for retail must meet and exceed pasteurized milk bacteria standards without pasteurizing.”

A hearing on the government’s motions, during which McAfee plans to testify, will be held on Jan. 25.

On the net:  Legal papers submitted to the court on Dec. 8.

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