FDA says 'raw milk new drug that hasn't been approved'

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Valley dairy pleads guilty in shipping of raw milk

A Kerman-based dairy on Monday agreed to plead guilty to shipping misbranded food -- in this case, raw milk labeled for pet use that instead was consumed by people -- across state lines.

The federal criminal action against Organic Pastures comes a month after the government sought a civil court injunction to stop the dairy from shipping its raw-milk products across state lines.

In a plea agreement filed Monday in U.S. District Court in Fresno, Organic Pastures agreed to, among other things:

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Organic Pastures Dairy in Kerman is one of only two raw-milk producers in California.

Stop shipping unpasteurized raw milk across state lines.

Put a notice on its Web site within two weeks that it no longer will sell raw-milk products outside of California.

Notify, in writing, any out-of-state customers from the past year that the dairy no longer will offer raw milk or raw-milk products.

Allow the federal Food and Drug Administration to, without prior notice, make inspections of the dairy.

If the dairy follows the agreement for two years, the case will be dismissed.

Mark McAfee, owner of Organic Pastures, said Monday that it was easier to settle the criminal case.

"We've got a story and they've got a story," he said. "They don't match, but we don't want to fight about it in court."

Though the dairy has agreed to plead guilty, nothing will be official until a Jan. 9 court date when the guilty plea will be officially entered. For that reason, Assistant U.S. Attorney Kirk Sheriff declined to comment.

In addition, McAfee said the dairy is in negotiations to settle the federal civil action, which has no bearing on the criminal case.

That could include, he said, an affidavit that out-of-state consumers would sign indicating the raw milk would be for pet use only.

The federal government's actions do not affect Organic Pastures' in-state sales. Though the FDA bans cross-border sales of raw-milk products, more than half the U.S. states -- including California -- allow sales within their borders.

McAfee said the dairy is one of only two raw-milk producers in the state. Out-of-state sales, he said, account for less than 5% of the dairy's business.

In the criminal plea agreement, prosecutors cited two October 2007 incidents when Organic Pastures shipped raw milk across state lines that was labeled as "pet food," but knew it was intended for human consumption.

The first instance was a half-gallon of raw whole milk and a half-gallon of unpasteurized raw colostrum that was sent to Renton, Wash. The second was a half-gallon of raw whole milk and a pint of unpasteurized raw colostrum that was shipped to Reno.

In paperwork seeking the civil injunction last month, federal prosecutors alleged that in addition to illegally selling raw-milk products across state lines, Organic Pastures was trying to circumvent the law by labeling out-of-state raw-milk deliveries as "pet food consumption only" and "cat or dog food only" when it knew people would consume the product.

The company also claimed raw milk has therapeutic value, and as such, the federal government says, the product is a new drug that hasn't been approved.

Raw milk and raw-milk products have many fervent supporters who say it keeps colds at bay, among other therapeutic uses. But the products also have many opponents, and even California regulators say they can cause serious, even deadly, illnesses.

McAfee is counting on his thriving state market and said this latest government action will not affect business.

"It's much ado about nothing in my book," he said.

Monday, Dec. 22, 2008

By Ellis / The Fresno Bee