At first glance, the U.S. Food and Drug Administration’s two-year legal assault on Estrella Family Creamery in Washington state appears entirely vindictive.
The FDA seems intent on using its enormous enforcement powers to cruelly stomp on and obliterate a tiny business that serves as the livelihood of the Estrella family, and a source of eating pleasure and important nutrition for a community of hundreds of devoted customers.
As a prime example, the agency’s latest legal action in federal district court in Washington state rejects efforts by the Estrellas to negotiate a compromise that would allow the agency to continue monitoring the company, and seeks instead an ongoing investigation process that would not only be onerous to Kelli and Anthony Estrella, but require the Estrellas to pay many thousands of dollars to support.
As I said, if this was all that was going on, it would be shameful enough. But there is more. The FDA is suggesting in the Estrella case that it has the authority to not only regulate food involved in “interstate commerce,” but to regulate operations engaged entirely in local food production and distribution–in intrastate commerce.
Interestingly, the FDA in its motion for summary judgment against Estrella Family Creamery, provides a link to a short documentary about the Estrellas, contending that Kelli Estrella acknowledges the supposedly absolute power of the FDA when she says she could be imprisoned for eating her own cheese. Yes, Kelli Estrella may bow to the FDA’s authority…but, of course, that isn’t nearly enough. (The eleven-minute-plus documentary is well worth watching, to gain a sense of who the Estrellas are and what they have endured.)
Further evidence of the Estrellas‘ evil nature? That they have expressed a desire to get back into business. “Although Defendants have represented that they are not presently distributing cheese, FDA has not confirmed that fact, and, even if true, Defendants have represented that they intend to resume operations in the future.” The evidence of this dark Estrella desire? A quote from Kelli Estrella: It is our desire to make cheese again, but who will protect us from FDA?
What did the agency want? Complete destruction of the Estrellas’ $120,000 of inventory–a major part of their assets–along with various manufacturing facility improvements it wasn’t clear the FDA would approve, nor how much they would cost. When the FDA didn’t reply in late 2010 to the Estrellas’ requests for guidance on how they might dispose of the fast-spoiling cheese, the Estrellas decided to feed it to their pigs. The FDA was outraged that the Estrellas, in some warped legal sense destroyed evidence, and filed an additional complaint in federal court.
Said Kelli Estrella in an affidavit at the time: ““I am told that in France, if a safety issue ever surfaced in a cheese operation like ours, the government would work to help them stay in business, considering that cheese is a national treasure. In our case, WSDA (Washington State Department of Agriculture) was willing to work with us to make our cheese a better and safer product but the FDA did not appear to be interested in making our cheeses safer. The only thing FDA appeared interested in was putting us out of business because we are an artisanal, raw cheese maker, and FDA appears to have a bias against raw milk cheeses… We are absolutely not careless business people who purposely endangered the public, that would be business suicide and it would also be against what we believe morally.”
The Estrellas have been trying to negotiate with the FDA over the past year, seeking to settle the agency’s complaints against them by committing to becoming completely local–a cheesemaker serving only Washington state customers. In other words, to confine themselves to intrastate commerce, outside the FDA’s jurisdiction.
The Farm-to-Consumer Legal Defense Fund is representing the Estrellas, and has filed a motion against the FDA, seeking mainly to separate out the possible remedies to the FDA’s concerns from the FDA’s efforts to gain a ruling that the Estrellas violated federal food laws. As the FTCLDF explains in its own motion for summary judgment:
“Attached to FDAs motion for summary judgment is a proposed consent decree that is onerous, burdensome, draconian and not based in reality. Specifically, the order proposed by FDA presumes that Defendants will resume cheese making operations in order to engage in interstate commerce. Nothing could be further from the truth. Instead, the Defendants have been abused by FDA to such an extent that Defendants are willing to forego their right to engage in interstate commerce, to never again have to deal with FDA, and to instead engage solely in intrastate commerce free from the draconian methods of FDA.”
The FDA’s response? “Although Defendants counsel has represented to the government that Defendants intend to resume cheesemaking, but engage in exclusively intrastate operations, the government in light of Defendants violative history and the governments obligations to protect the public cannot simply take Defendants at their word. Indeed, because Defendants have previously relied on components obtained through interstate commerce, and they have sold their cheese to customers outside Washington State, the government is skeptical that Defendants will be able to operate a wholly intrastate cheesemaking business. Thus, in order to protect the public against the possibility that Defendants re-engage in interstate cheesemaking operations, the governments proposed order authorizes FDA to confirm that Defendants are not engaging in any interstate activities, and enumerates certain conditions that would apply in the event that Defendants resume interstate activities governed by the FDCA.”
As one example of how the Estrellasoperated on an interstate basis, according to the FDA: they purchased rennet for making cheese from Wisconsin.
The new Estrella operation would be entirely local, according to their request for summary judgment. “Defendants have decided that they will make their own rennet, will make their own cultures, and will use salt only from sources that are located within the State of Washington. This has been communicated to FDA…. By sourcing all of their ingredients from the state of Washington, Defendants have chosen to engage in only intrastate sales of cheese. Significantly, FDA has suggested during settlement discussions that if Defendants use ingredients that come from sources located solely within the State of Washington, then Defendants would not be engaged in nor affecting interstate commerce. Defendants have also decided that they will sell their cheese only within the State ofWashington. Thus, Defendants are committed to engaging in intrastate sales only.”
Even though they would be entirely local, the Estrellas offered to submit to FDA monitoring. According to the Estrella motion, “In an effort to achieve a compromise, Defendants offered to allow FDA to conduct inspections of Defendants facility to ensure compliance with the terms of any Consent Decree yet sought conditions on the limit of those inspections. FDA refused to agree to the conditions and instead insisted on complete and unfettered access to Defendants facility, even though FDA would lack jurisdiction over Defendants conduct. Defendants also offered, via counsel, to provide FDA with documents such as purchase orders, shipping invoices and other documents to demonstrate that they were not engaging in or affecting interstate commerce yet FDA refused to consider this as well.”
As an example of the consideration the Estrellas sought, they wanted the FDA to provide advance notice of when they were conducting an inspection, so the inspection wouldn’t interfere with actual cheese making operations–Kelli Estrella logically felt she couldn’t simultaneously make serious cheese and satisfy the needs of FDA inspectors as they rummaged around the cheese-making operations.
By pushing to insert itself into an intrastate operation, the FDA could be leaving itself open to a judicial reversal. Such a ruling, reinforcing the rights of local food producers to operate independently of federal oversight, could set an important precedent.
The FDA seems not very worried about this prospect. It has pretty much had its way with federal and state judges around the country, simply by playing the fear card, as it does once again in this case: “Defendants have prepared, packed, and held cheese they manufacture under insanitary conditions whereby it may have become contaminated with filth or whereby it may have been rendered injurious to health.”
So the FDA keeps testing the limits on its power, which seem nearly non-existent. The only potential problem for the FDA in this case: no one has ever become the slightest bit ill from Estrella cheese since the business started up nine years ago. A judge who bothers to carefully review the facts of this case may wonder why the FDA needs to apply the boot to the neck to confirm whether the cheese maker is operating locally.
When we look back some years from now on the sordid events of our government’s campaign against food rights, right up there at the top of the list will almost certainly be the U.S. Food and Drug Administration’s shameful vendetta against the Estrella Family Creamery.
The fact remains that FDA can maybe stop the Estrella’s from selling their cheese anywhere but inside the state of Washington, but they cannot control what happens to it after it’s purchased unless they follow each and every customer. What if, for example, people vacationing from Oregon or Utah decide to purchase cheese and take it back home? Or what if the vacationers decide to buy extra to take back home to friends and family? The Estrella’s have no control over what happens once their product is purchased by the public.
Did the FDA just go on tilt recently?
Thugs are oblivious of their true nature.
This blogger, David Gumpert, has always reported the truth on the ground. He is honest and a true professional.
Thank you for your hard work, David.
When OPDC dealt with the FDA in 2008, Gary Cox sent them slithering back under the rock from which they had come. They got nothing. Initially they begged the Federal Court to mandate that every instate buyer of OPDC raw milk be made to sign an affidavit at the cash register that made the customer swear that none of the raw milk would go across a state line. The judge laughed at the FDA and the FDA got nothing. That is a precedent and it should be used in the Estrella case.
Perhaps a change in strategy is in order. At OPDC we make lots of NCIMS & FDA compliant & inspected raw cheese. We have no problems with the FDA ( now ). They never so much as raise an eye brow with us. Why???
We comply immediately with their stupid requests and then they leave… never to return.
When the FDA comes to visit, we take pictures of them and make them Face Book fodder. The FDA hates to be exposed to sunlight and wither under any public screwtiny. Just like the evil shadow dwelling monsters that they are. Years ago, When the FDA set a date for a grand jury indictment ( after their sting ops against OPDC )…we went to the press and told the story of how their investigators had harrassed two young mothers that were employees of OPDC at their homes asking them to wear recording devices in an effort to create a criminal out of Mark McAfee. These young moms were even offered payment to wear the wires….they refused. Instead we went to the press. This is why I am so driven to build market.
The dates for the Grand Jury hearing were dropped along with all the supoenas ( just a couple of days prior to the hearings )….they are all hot wind in a losing battle. Do not back down from them. Seize the initiative and attack.
In other words we eat them for lunch and take no prisonors. We expose their every move and their every mistake and show the people what they are all about. I also do not allow them to take advantage of any weaknesses. We immediately change or modify anything to comply.
The FDA are the very filth in the world of which they should be cleaning up. Their policies, their drugs, their pasteurized milk….these are the killer foods and medical therapies.
Just expose them….they will die off just like pathogens under UV light.
GOD I hate the FDA. Autism, 4000 childrens deaths from Asthma every year, Crohns, the 8 Deaths from Pasteurized Allergic milk since 1998….all lie at their feet.
Much appreciated, kturner. Thank you.
Well stated, Mark. I have come to think of the FDA as a key component of America’s secret police apparatus, focusing itself on undermining small entrepreneurial food producers, so as to increase and tighten control of the food system by Big Ag.
No, milk is a linchpin of the food system. It is a multi-billion dollar industry in its own right, but perhaps more important, it serves to bring customers into the supermarket on a regular basis, since it must be replenished every week or two. While buying milk, people buy other foods. Raw milk drinkers follow the same pattern. While buying their milk, they buy eggs, meat, butter, yogurt, and other items from farmers…and don’t buy those items at the supermarket. Milk creates a huge ripple effect in the marketplace.
Here is yet another study which shows how important our gut flora is. From the journal Nature: “Consideration of the microbiotahealth correlations in the long-stay cohort (Fig. 4), upwards along axis 2, highlights the association with increased frailty, reduced muscle mass, and poorer mental activity moving away from community-type microbiota.
Healthmicrobiota associations were statistically significant, even when regression models were adjusted for location. Although other factors undoubtedly contribute to health decline, and are difficult to completely adjust for in retrospective studies, the most plausible interpretation of our data is that diet shapes the microbiota, which then affects health in older people.”
This is why we must fight and grow thick skin when we are attacked by goverment agencies. They can not be allowed to arbitrarily and capriciously oppress raw milk. That is exactly what happened to the Bechards. I am proud of them and Gary Cox for staying in the fight and addressing those that are ignorant in our government. The price paid in the Bechard family and is high….these are the costs of this WAR for real healing food in America. Food that heals farmers and consumers as well.
I must admit that Mark is a very funny guy even if is unintended, that is just a hilarious spelling. They (regulators) concentrate on screwing the tiny and occasionally the midsized but will never go after the big boys that are the crux of the problem. Cowards.
Its a Milk Moonshiners Movement.