The Complete Patient

You’d think that after taking nearly four months to answer a few questions posed by Michigan Sen. Carl Levin about the Family Farms Cooperative (FFC) case, the federal Food and Drug Administration (FDA) would at least provide some clarification.

Instead, it only seems to have added to the regulatory and legal confusion around the matter. Here are some key bones of contention:

--Terminology. The FDA in its two-page response to Sen. Levin refers alternately to the “sale” and “distribution” of raw milk . Early on in its letter, it refers to its “activities in enforcing regulations governing the interstate sale of raw milk,” and then concludes by saying it “prohibits the sale of unpasteurized milk…in interstate commerce.” The reason that terminology is so important to FFC is that the co-op argues its use of cow share agreements for co-op members makes the transport of raw milk from Indiana to Michigan a fulfillment of a lease agreement rather than any kind of “sale.”

--The question not answered. Sen Levin inquired about the status of the FDA’s investigation of Indiana farmer David Hochstetler, who provides the FFC’s raw milk and requested that it “provide information regarding the timeline, procedures, and appeal rights under this process.” The FDA’s response explains that it investigated Hochstetler at the request of the Michigan Department of Agriculture (MDA) and that it issued a warning letter that “requests that Mr. Hochstetler notify FDA in writing, within 15 working days, of the specific steps he has taken to correct the noted violations…” But interestingly, nothing is said about “appeal rights under this process.” Maybe because there are no appeal rights?

--Cow-share agreements. A third source of confusion comes from the FDA’s failure to offer any insights into its attitude about cow-sharing agreements. In answer to a question from Sen Levin of whether “the FDA previously investigated interstate cow-sharing agreements,” the agency cites two cases—Dee Creek Farms in Washington and Double O Farms in Kentucky. But in neither case does FDA offer any insight into its views about how cow-share agreements mesh with prohibitions on raw milk in interstate commerce, except by inference—if we investigated them and wrote warning letters, we feel they’re wrong.

So if you thought that by taking its time, the FDA would offer insights, you were wrong. Just more of the same, including its throwaway about ensuring that “people living in Michigan and Indiana are protected from the dangers of raw milk.”

A huge five-foot-by-ten-foot banner went up last Friday in the Ann Arbor meeting hall where the Family Farms Cooperative (FFC) distributes raw milk and other dairy and meat products to members: “This could be our last delivery. We need your help. Please write letters to the FDA and MDA.”

The sign, apparently posted by a co-op member, was well meaning, but the effect was to create rumors, circulated via listserves and word of mouth, that last Friday’s delivery was the last one. In the emotionally and politically-charged atmosphere that has swirled around FFC since the Michigan government’s sting operation against FFC last October, anything seemed possible. Maybe the government was about to shut down FFC. Maybe the Cass County prosecutor was about to indict the farmers who provide FFC products. Maybe one of the farmers who provides product was about to bow to the government pressure and discontinue supplying product.

In fact, nothing had changed beyond what has already been reported. But for Richard Hebron, a farmer and manager of the co-op, such rumors represent just another victory for the government. The problem is that, for all the bravado exhibited by many FFC members and supporters, a significant number of less vocal members have been intimidated by the Michigan and federal government actions. "People are being scared away," says Hebron.

Hebron reports that after the MDA conducted its raid last October, business declined about 25%. Some of that occurred because retailers representing three distribution points in the Chicago area were scared off by the MDA’s actions. But some occurred because FFC members dropped out or stopped ordering dairy and meat products.

Then, when the federal Food and Drug Administration (FDA) issued its warning letter to David Hochstetler, the Indiana farmer, two weeks ago, ordering him to discontinue sending raw milk to co-op members in Michigan and Illinois, there was a further erosion in orders, on the order of five to ten per cent.

“I’ve talked to several people who say, ‘I know (the raw milk) has improved my health, but we don’t want to get in trouble with the government'…They think they’ll be handcuffed and hauled off to jail”

Yes, the publicity around the case has attracted new co-op members, but this hasn’t been enough to make up for the drop-off. “If it wasn’t for the new members, we’d be down even more,” says Hebron.

For all the wonderful letters that have been written to the Cass County prosecutor and other government officials on behalf of FFC, there are still many people who are afraid.

As Michigan authorities inch toward a decision about how to follow up on their Oct. 13 sting operation against Richard Hebron and the Family Farms Cooperative, one of the things they are hopefully doing is reviewing the 232 testimonials sent by Michigan raw milk drinkers and supporters.

I have seen these sorts of testimonials before, in Ohio raw milk cases, and the Michigan versions are just as compelling and touching. They are compelling in the power of their simple message: Please let us consume the natural foods we choose to consume.

The most touching ones are from parents of children worn down by chronic conditions like asthma, allergies, and frequent strep throats and colds, who have experienced nearly miraculous cures following regular consumption of raw milk. They are too specific and personal to have been taken from any kind of template.

Steve Bemis, an Ann Arbor lawyer, sent me copies of the testimonials, which are public record. Many are also posted on the Family Farms Cooperative web site. Here are excerpts from a few:

My youngest has battled GERD along with recurrent ear infections & urinary tract infections since she was 2 months old. She had started drastically regressing from about 10 months on. She was schedueled for a CAT scan because of a suspicion of a brain tumor. She had low-grade fevers for months that would sometimes spike inexplicably. We started raw dairy at about 12 months of age. Her recovery has been miraculous. She is a bright, healthy, happy four-year-old who doesn't even get a cold.

I have a son who at three was diagnosed with "cold induced asthma". Every few weeks he would get a cold and congestion with heavy mucus. We were told by our doctor (a D.O.) to take him off regular store bought milk (which he loved). Within two days he started sleeping through the night (finally) and the coughing was gone. Several years later when he was about seven we were still dealing with occasional asthma attacks and some allergies…While we were picking up our yearly supply of organic meat from a farmer in MN we were offered "raw milk" from their home supply. We loved the taste and the idea that it was "alive". They gave us a gallon to take home. Within two days my son's cough was gone and never returned. Within a short time we located Family Farms Coop as a source of raw milk. We have been purchasing from them for several years. We have seen less colds and my son is now able to drink all the milk he wants with much less colds or asthma attacks than before. In fact most of time his asthma medicine expires rather than gets used.

A year and a half ago I was truly on the brink of disaster with Crone’s disease causing rapid, undesired weight loss. There were fewer and fewer foods that I could tolerate without having terrible negative reactions. I hardly knew what to eat anymore. Through Dr. Mercola and his website (Mercola.com) I learned about raw dairy and grass fed beef. I was terrified to try either one as I was so allergic to both in their usual form (pasteurized dairy and grain fed beef). Miraculously, it was not only OK, but I began to regain desperately needed energy and weight. I am now so totally reliant upon Family Farms Co-op’s nearly magical dairy that it scares me to think it may be in jeopardy. Also, my son was on the Autistic Spectrum, and within the 1st week of taking in large quantities of raw cream, his brain processing speeded up and sensory disturbances disappeared. He was allergic to pasteurized dairy and relied on rice and soy milk (which either have too much sugar or have negative effects on estrogen levels). He is now considered to be off the Autistic Spectrum. There are many others whose Autistic children have experienced dramatic speech improvements by introducing raw dairy to their diets.

My oldest daughter was the only one of my four daughters who could actually handle store bought milk, although she had repeated ear infections as a baby. The other three always vomited store bought milk since infancy, yogurt was no exception. I was constantly worried that they were not getting enough calcium, and I was eventually told to give them raw milk…It has taken me 5 years to find Family Farms Coop! From the first time I brought raw milk home, in the spring/summer of 2006, my family drank it up. Our monthly 6 gallon delivery is usually gone in 8 days! This past Fall no one in our family got a cold, pneumonia, or flu which has been an annual event in our house. My allergies, and that of my second daughter, were also lessoned this past fall. We are all healthier, happier, stronger individuals. Even my husband, who has not tolerated milk his whole life loves this milk and can easily digest it.

It’s difficult to imagine charging the suppliers of this product with a crime. We will hopefully learn shortly if Cass County prosecutor Victor Fitz has been similarly moved.

I've written several postings about the dilemma facing Indiana farmer David Hochstetler and the Family Foods Cooperative (FFC) over the federal Food and Drug Administration's recent warning letter, ordering Hochstetler to discontinue sending raw milk to Michigan and Illinois. The legalities behind that warning letter are both complex and subtle. The Weston A. Price Foundation in a recent email alert explained those issues as well as I've seen them explained.

Because of the inconsistency in the FDA's approach, and the special circumstances surrounding this case, it could become "a litmus test" of federal regulations, the foundation warns. It also points out that going to court to overturn the current FDA regulation could be very costly and time consuming...and while the foundation doesn't say so, there is no guarantee of success.

If you want to understand the legalities behind the federal government's fear campaign against consumption of raw milk, I suggest you review this:

The United States Food and Drug Administration has recently sent a "Warning Letter" to Indiana farmer, David Hochstetler of Forest Grove Dairy, informing him that the agency has determined David distributed unpasteurized milk and cream for human consumption in interstate commerce, violating the regulation codified in Title 21 Code of Federal Regulations, section 1240.61(a) [21 CFR 1240.61]. The letter notified David that he has 15 working days to issue a written response to FDA outlining the steps he has taken to correct the violations and prevent their recurrence.

21 CFR 1240.61 reads, in part: "(a) No person shall cause to be delivered into interstate commerce or shall sell, otherwise distribute, or hold for sale or other distribution after shipment in interstate commerce any milk or milk product in final package form for direct human consumption unless the product has been pasteurized . . . ."

David has entered into herd lease agreements with consumer cooperatives in Michigan and Illinois under the terms of which he provides raw dairy to the cooperatives' members (Richard Hebron, manager of the Family Farms Cooperative, is currently under investigation by the Prosecutor's office in Cass County Michigan for the business he has conducted with Forest Grove Dairy). David has indicated that he will contest FDA's finding of a violation on the grounds that the lease agreements are private contracts not subject to the agency's jurisdiction.

The FDA issued 21 CFR 1240.61 in 1987 in response to a federal judge's order that the agency ban the sale of raw milk for human consumption in interstate commerce. The agency expanded the scope of the regulation far beyond what the judge ordered. FDA contends that any raw milk product for human consumption (except cheese aged at least 60 days) crossing state lines constitutes a violation, not just when there is an actual sale involved.

During the 20-year existence of the regulation, the agency has never enforced it beyond sending warning letters to suspected violators. With David set to challenge the agency's finding of violations, his case could be a litmus test of the validity of the regulation. Much is at stake.

Many consumers are currently able to obtain raw dairy products from out-of-state sources only. FDA enforcement action against David Hochstetler could make suppliers of raw dairy products more reluctant to ship interstate, effectively denying many the freedom to consume foods of their choice. Conversely, an FDA decision not to enforce the regulation against David would make producers more willing to ship raw dairy products interstate and would increase their chances of being able to opt out of the dairy cooperative system and the poverty-level prices paid its members.

21 CFR 1240.61 is an oppressive regulation making no distinction between milk from confinement cows and milk from cows on pasture. It particularly penalizes farmers like David Hochstetler who have an exemplary track record for producing clean, safe milk. For many years David held a Grade A license from the state of Indiana; during that time, tests for bacteria in the milk he produced consistently showed levels well below the limit required for pasteurized milk under the Pasteurized Milk Ordinance (PMO), the governing document for interstate shipments of milk to be sold at retail.

Overturning the regulation in court would be costly and take years to accomplish. A more realistic goal would be to put enough public pressure on FDA so that they don't enforce the regulation.

The foundation encourages individuals to write the FDA and Sen. Carl Levin of Michigan, to object to the FDA's warning letter.

Here are addresses:

Joann Givens, Detroit District Director

FDA, Detroit District Office

300 River Place, Suite 5900

Detroit, MI 48207

Fax:  313-393-8139

Joann.Givens@fda.hhs.gov

CAPT Robert Hennes, Chief CFSAN/Milk Safety Branch

Food and Drug Administration

5100 Paint Branch Parkway College Park, MD 20740

Fax: (301) 436-2715

Robert.Hennes@fda.hhs.gov

Also copy U.S. Senator Carl Levin of Michigan who, on behalf of Family Farms Coop, has made inquiries into the investigation of David Hochstetler (mail to Levin's Washington office is delayed two weeks for security screening somail to:

Patrick V. McNamara Federal Building

477 Michigan Avenue, Suite 1860

Detroit, MI 48226-2576

Fax:  202-224-1388  (DC office)

Go to http://levin.senate.gov to email

I spent some time over the last couple of days watching a DVD of a hearing put on in early January by commissioners of the Michigan Department of Agriculture (MDA) seeking public comment about the National Animal Identification System (NAIS). Michigan is due to become the first state in the country to make NAIS mandatory, beginning March 1 with cattle.

It’s interesting to observe the dynamics of this kind of meeting, especially in light of all the discussion in recent postings about the arbitrariness of the federal Food and Drug Administration (FDA) via its warning letters.

In retrospect the most meaningful part of the Michigan event was what didn’t happen.

The hearing was divided into two parts. First, MDA officials justified the state’s decision to make NAIS mandatory. One of them said, “The citizens of Michigan demand that we take all action to ensure food safety.” The old “protection” issue.

These officials attempted to reassure the dozens of attendees who filled the meeting room and spilled out into the hallway that the NAIS data will be “stored in state owned servers behind firewalls” and that the radio frequency identificatio (RFID) tags contain “simply a number” and “do not contain a battery.”

Then, the meeting was open to about a dozen farmers and representatives of various agriculture groups to comment on the MDA’s decision. They were allowed up to three minutes each to make their comments, and they could leave a text with details of their positions as well.

One speaker, a registered cattle breeder, pointed out that because Michigan is the only state requiring NAIS, “Michigan’s tags become useless outside of Michigan.” Others argued that justifying the NAIS program as a means to attack bovine tuberculosis makes no sense, since existing anti-bovine-TB programs have been successful in nearly eradicating the disease. Still others complained about the required program on religious grounds and as a violation of privacy. One woman, a 4-H leader, said she was given two premises identification numbers, even though she has no cattle. “I’m now fighting for my rights to raise a few 4-H animals.”

Everyone who testified against NAIS received hearty applause from the crowd.

What didn’t happen during about an hour of such testimony was any questioning by the five MDA commissioners in attendance of those who testified. They posed not a single question. It almost looked as if the MDA was going through the motions of inviting public comment, without really listening to it. There is no indication anything positive resulted from the January session or a subsequent one earlier in February. According to the MDA’s web site, NAIS is on schedule to take effect March 1.

The event got me thinking further about my previous posting comparing the evolving regulatory approach in the U.S. to the old Soviet Union or China. I realize that in this country we are actually much more clever about our regulatory processes than those countries. Our regulatory agencies mostly target small but important business, medical, or agricultural segments. Thus, the FDA goes after a few raw milk producers, or makers of nutritional supplements or other food products. The USDA and MDA go after small farms. And since the vast majority of people aren't aware of or don't see any direct impact on their lives, it all happens quietly, with little notice.

It's when the abuse is so egregious that it stirs the passions of a significant number of customers or neighbors of the abused party that we see protests to the agencies. Because the agencies don't want elected officials to become upset, and start asking questions about budgets and leadership, the regulators may reverse course, or just not enforce their edicts. Apparently the noise hasn't been quite loud enough in the case of NAIS in Michigan.