FDA Files Lawsuit to Seize Healthy Food

On October 19, 2017, the United States Food and Drug Administration (FDA) filed a complaint with a federal district court in Kansas to seize and condemn around $70,000 of raw camel milk, pasteurized camel milk, raw camel milk colostrum, and raw camel milk kefir.[1] The camel milk products are currently being held at a frozen food warehouse, My Magic Kitchen, located in Kansas City. The Kansas Department of has placed all the products under embargo, prohibiting their movement from the warehouse.

All labels on the frozen products FDA wants to seize bear the name Desert Farms; the Santa Monica, California based company is the largest raw milk distributor in the U.S. According to the complaint, Hump-Back Dairys of Miller, Missouri produced nearly all of the product being held at the warehouse; the dairy is, by far, the largest camel milk producer in the country.

There has been a thirty-year ban on raw dairy products (other than aged raw cheese) in interstate commerce; FDA interprets the ban to extend to raw milk camel products. In December 2016 Samuel Hostetler, the owner of Hump-Back Dairys, received a warning letter from FDA.[2] The letter to Hostetler warned that he was violating the interstate ban by shipping both raw camel milk and raw camel milk products in interstate commerce; Hostetler responded to the warning letter by informing the agency that he would be complying with the federal regulation establishing the ban.

Walid Abdul-Wahab, the president of Desert Farms, also received a warning letter from FDA in September 2016 but the letter did not mention the interstate raw dairy ban; instead the letter accused Desert Farms of violating the law by shipping “new drugs” that were not approved by FDA in interstate commerce.[3] The letter noted that Desert Farms was making health claims on its website and facebook page about how camel milk was being successfully used to treat various diseases, especially autism. The letter warned that the camel milk products were drugs because “they are intended for use in the care, mitigation and treatment of disease”. As such they were “new drugs” that needed approval from FDA before they could be marketed. The FDA approval for new drugs processing can cost in the hundreds of millions of dollars.

The FDA suit filed for the seizure and destruction of the camel milk products alleges that Desert Farms’ social media pages (Facebook, Twitter, YouTube and Instagram) linked to the company’s website contain claims that “demonstrate that the camel milk products are intended for use in the diagnosis, cure, mitigation, treatment or prevention of disease, including autism, diabetes, multiple sclerosis, Crohn’s disease, viral infections such as hepatitis, the genetic disorder Machado-Joseph, depression, gastrointestinal disease, heart problems, attention deficit disorder, autoimmune diseases, Hashimoto’s disease and cancer.”[4]

What neither the warning letters nor FDA’s complaint for seizure allege is that the camel milk products are adulterated or a threat to human health. As far as is known there has never been a case of foodborne illness in this country attributed to consumption of camel milk. Destruction of the camel milk products at the warehouse would be an absolute waste of healthy food.

It is estimated there are over 10,000 families with autistic children in the U.S. that purchase raw camel milk; many of these families pay $18 a pint or more for the product. There is a reason for that; parents of autistic children have found that raw camel milk and camel milk products can alleviate the symptoms of the condition known as autism spectrum disorder. The science backs them up [5]; pasteurized camel milk can be effective in alleviating the symptoms of autism as well though not to the same degree.

Earlier this year FDA released an article on its Consumer Updates page titled, “Autism: Beware of Potentially Dangerous Therapies and Products.”[6] In the article FDA warns about taking camel milk as a treatment for autism and autism-related symptoms. When FDA warns about taking a product for a disease, it is often because the product is a threat to the profits of the pharmaceutical industry.

FDA is seeking a court order to destroy over 4,300 8- and 16-ounce bottles of camel milk products; product that can help autistic children cope with their condition. The judge hearing the case has the discretion to release the product to Desert Farms.[7] If Walid Abdul-Wahab shows the court that any health claims are no longer on the Desert Farms website and social media and that he is willing to pasteurize the camel milk (with the interstate ban, he would have no choice if he wants the product released) and label the milk containers accordingly the judge could release the product to Desert Farms. Healthy food like this should not wind up in a landfill.

A court date for a hearing on the seizure petition has not been set yet.

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[1] United States of America v. Camel milk products, et al, Kansas Civil Action No. 17-2609 (2017). Access docket files via Pacer.gov for Case #: 2:17-cv-02609-CM-KGS. Retrieved 11/18/2017 from Justia.com at https://dockets.justia.com/docket/kansas/ksdce/2:2017cv02609/118800

[2] FDA warning letter to Samuel P. Hostetler (DBA) Hump-Back Dairys, dated 12/19/16. Retrieved 11/18/2017 at https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2016/ucm534108.htm

[3] FDA warning letter to Desert Farms, dated 9/15/16. Retrieved 11/19/2017 at https://www.fda.gov/iceci/enforcementactions/warningletters/2016/ucm524663.htm

[4] United States of America v. Camel milk products, et al

[5] “Casualties of the Raw Milk Ban”, January 17, 2017, Farm-to-Consumer Legal Defense Fund website. Retrieved 11/18/2017 at https://www.farmtoconsumer.org/blog/2017/01/17/casualties-raw-milk-ban/

[6] FDA, “Autism: Beware of Potentially Dangerous Therapies and Products”, www.fda.gov updated April 12, 2017; originally published April 25, 2014 (see https://www.actcommunity.ca/resource/3565/). Retrieved 11/18/2017 at https://www.fda.gov/ForConsumers/ConsumerUpdates/ucm394757.htm

[7] United States Code, 21 USC 334(d). Accessible at https://www.law.cornell.edu/uscode/text/21/334

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FDA Boxed in on Interstate Ban

For some time now, enforcement on the interstate ban of raw milk and raw milk products by the United States Food and Drug Administration (FDA) has looked to be an exercise in futility (only raw cheese aged 60 days or more is legal in interstate commerce). Thousands of otherwise law-abiding citizens violate the ban in this country on a regular basis. FDA has stated that it will not enforce the ban against individuals transporting raw milk across state lines for their own consumption; to the FDA, it is dangerous when someone is transporting raw milk for consumption by a group of people but is somehow safe when it is only for an individual.

FDA’s last enforcement action against a raw milk producer, concluded over five years ago, has not deterred demand; more consumers want raw dairy products than ever. FDA has never publicly acknowledged that the ban has been a failure but once again it has the opportunity to do so and respect consumer freedom of choice. There are currently two petitions before FDA on the regulation (21 CFR 1240.61) establishing the interstate ban—one filed by Organic Pastures Dairy Company (OPDC) and the Farm-to-Consumer Legal Defense Fund (FTCLDF) and the other filed by the Real Food Consumer Coalition (RFCC). Repeal of the interstate ban is long overdue; granting of the two petitions would be a significant step toward making that a reality. No matter what FDA decides, it is going to have to answer once again why it has not repealed a law that does not work.

On June 22, 2016, FDA received a petition from OPDC and FTCLDF requesting that FDA lift the interstate ban on raw butter. FDA’s only response to date has been a December 13, 2016 letter stating it needed more time to reach a decision on the petition. Federal law requires that FDA respond to a citizen petition within six months of its filing; unfortunately, the courts regard a statement from the agency that it needs more time as a satisfactory response.

More than anything the raw butter petition is a request to FDA that the agency obey the law; in establishing the raw butter ban, FDA violated and continues to violate the Federal Food, Drug, and Cosmetic Act (FFDCA). The FFDCA contains a statute governing standards of identity for foods. Standards of identity are requirements prescribing what a food product must contain to be marketed under a certain name in interstate commerce. For instance, the standard of identity for milk in final packaged form requires that it be pasteurized or ultra-pasteurized and that it contain not less than 8.25% non-fat milk solids and not less than 3.25% milkfat.1 FDA’s long held position is that the pasteurization requirement can be part of the standard of identity. Standards of identity are intended to promote honesty and fair dealing for the benefit of consumers.

Congress has given FDA power to issue regulations establishing standards of identity for most foods, but there are exceptions and one of those is butter. The FFDCA specifically prohibits FDA from establishing a standard of identity for butter; Congress has passed a law defining butter that serves as a standard of identity for the product. That definition does not require butter to be pasteurized. The petition asks FDA to abide by the statutory standard of identity and to stop breaking the law in the name of the law.2

FDA justifies the ban on the grounds that it has the power to regulate communicable disease, a claim the federal government’s own statistics show has no foundation. If raw butter can be banned under this power, just about any other food could be, as well. The citizen petition notes that since the Centers for Disease Control (CDC) created the Foodborne Outbreak Online Database in 1998, not even one foodborne illness outbreak has been attributed to the consumption of commercially produced raw butter.3 There is one 2007 outbreak in Utah where homemade butter was listed as a possible cause for an outbreak as were raw milk and homemade soft raw cheese; given butter’s food safety history, it is likely that the milk or cheese was the cause.

The irony is that possibly more than any other raw dairy product, consumers purchase raw butter for its health benefits. FDA can do better than violate the law by banning a product that doesn’t make people sick.

The RFCC petition, sent to FDA on April 26, 2017, requests that:

“FDA exercise its enforcement discretion to avoid taking, and to cease taking, enforcement action against those who distribute unpasteurized milk and milk products in interstate commerce when the milk products bear labels that include in conspicuous bold face type prominently displayed on the statement of identity for the product: (1) a warning regarding the health risks of unpasteurized milk and milk products; and, when applicable, (2) instructions for safe handling, including self-pasteurization.”4

There is a precedent for the warning label requirement; another regulation, 21 CFR 101.17(g) requires that there be a warning label with a specific statement for juice that has not been pasteurized. The warning label and safe handling statements are intended to provide information and education to the consumer to address FDA’s concern that the agency needs to protect people from themselves.

The petition notes that the request it is making is in line with presidential executive orders issued earlier this year to reduce the regulatory burden on a Regulatory Reform Task Force that is required “at a minimum” to identify regulations that “eliminate jobs, or inhibit job creation; are outdated, unnecessary, or ineffective; impose costs that exceed benefits; create a serious inconsistency. . .”5 The quote is a good description of the interstate raw milk ban.

The RFCC consists of members of some of the bigger food buyers clubs around the country obtaining raw milk, including many mothers who will do whatever it takes to access the foods they believe best for their children’s health, even if that means violating ill-conceived regulations banning foods they have a legal right to consume.

The two petitions are pushing FDA to reevaluate the ban and do the right thing by repealing it. It is time for the FDA to honor freedom of choice and get rid of a regulation a federal judge once described as being in a state of “desuetude,”6 a word meaning “not being used.” A law not worth enforcing is not worth having on the books.

FTCLDF Code of Regulations states that a goal of the organization is “overturning the federal regulation banning the interstate shipment of raw milk (and raw milk products) for human consumption.” That day is getting closer. Thanks to  your support, FTCLDF and other raw milk advocates are winning this battle. Help us continue our push towards ending the ban by attending our fundraiser or by making a donation.

Footnotes:
1 Farm-to-Consumer Legal Defense Fund. Raw Butter Is a Communicable Disease. June 23, 2016. Posted online at https://www.farmtoconsumer.org/blog/2016/06/23/raw-butter-communicable-disease/
2 Mark McAfee and Farm-to-Consumer Legal Defense Fund. Citizen Petition to Lift Interstate Ban on Raw Butter. p. 5 Posted online at
https://www.farmtoconsumer.org/wp-content/uploads/2016/06/1-CitPetFDA-Butter-062216-1.pdf
3 Centers for Disease Control and Prevention. Foodborne Outbreak Online Database. Posted online at https://wwwn.cdc.gov/foodborneoutbreaks/
4 Emord & Associates. Citizen Petition to Exempt from 21 C.F.R. § 1240.61(a) Certain Unpasteurized Milk and Milk Products if Properly Labeled. Posted online at http://hartkepr.com/wp-content/uploads/2017/05/2017-4-26-RFCC-Petition-GoFundMe.pdf
5 Ibid.
6 Judge Mark Bennett. Memorandum Opinion and Order Regarding Plaintiffs’ Motion to Amend Judgment. May 1, 2012. [PDF]

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Raw Milk Dairy Under Investigation

CDC accuses Millers Organic Farm of causing raw milk illness

CDC accuses Millers Organic Farm of causing raw milk illness

A Pennsylvania Raw Milk Dairy Under Investigation by government agencies?

The raw milk dairy under investigation is Miller’s Organic Farm in Pennsylvania, which we wrote about several weeks ago when the CDC accused them of causing illness in 2 people.

David Gumpert has been uncovering additional facts in the case agains this raw milk dairy and reporting about it on his blog.

In his most recent article, he states

“If owner Amos Miller fails to allow inspection of his facilities by the deadline, the U.S. Justice Department “will be forced to initiate enforcement proceedings,” it said in a recent letter to the Pennsylvania farmer. While the Justice Department didn’t say exactly what it plans, presumably it will seek either an injunction of some kind, or a similar action, which would ostensibly restrict sales of Miller’s food and impose severe fines or raids for violation of a court order.”

“Regardless of which agency takes the legal lead, the government’s intent is to challenge Miller’s on the basis of safety rather than the legitimacy of private food distribution. Government lawyers know that it will be much easier to convince a judge to enforce an injunction or similar legal device based on fear-mongering than on the legal aspects of private membership associations.”

Since Miller’s Organic Farm operates as a private membership association so that others can enjoy the raw milk and other raw dairy products, this is an important case to watch. When the FDA, USDA or state level agencies target one farm for “enforcement,” they are effectively targeting all who want access to nutrient dense and healing foods. Including and most especially fresh raw milk from grassfed cows.

An email address is set up to collect testimonials about products from Miller’s Organic Farm and all letters of support. Send emails to WriteToMillers@gmail.com

For a virtual tour of the farm and the family who operates it, see the recent post on Nourishing Liberty about Miller’s Organic Farm

We will continue to update this situation as it changes.

To learn more about raw milk and other nutrient dense foods, visit westonaprice.org

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Is the FDA Quietly Beginning a Campaign Against Raw Milk Cheese?

Maybe it is because it is considered “artisanal” or maybe because it is camouflaged in grocers’ coolers among other cheeses but, for whatever reason, unpasteurized cheeses have never produced quite the same uproar as has raw milk. That might change in the future – David Gumpert is watching the FDA and, on his blog The Complete Patient, he suggests that the FDA is quietly gathering information to begin a campaign against raw milk cheese.

Gumpert noticed that the FDA recently posted a notice on its website that it is seeking input to help it “minimize the impact of harmful bacteria in cheeses made from unpasteurized milk” and is particularly interested in “learning more about the standards and practices in use by…the growing artisanal cheese manufacturing community.”

While this might seem to be an innocent start of an ongoing dialogue between the FDA and the cheese community, Gumpert points out that the FDA does not currently have any evidence of illnesses caused by raw milk cheeses. Gumpert suspects that the FDA appears to be looking for data that will allow it to ultimately try to ban raw milk cheeses.

Read more here.

Support the Campaign for Real Milk, join the Weston A. Price Foundation, today!

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Is the FDA Falling Behind Other Countries in Raw Milk Run?

In July 2014, the United Kingdom’s Food Standards Agency released a report on raw milk that took into account the opinions of over 100 raw milk consumers. Their findings concluded that both consumers and producers “…hold a strong view…that there should be wider accessibility to raw drinking milk but this should still be managed and controlled.”

In exploring how they could take a more lenient approach to raw milk consumption in the United Kingdom, the FSA said it was open to allowing the sales of raw milk through vending machines – which would increase sales within a controlled environment.

David Gumpert, author of The Complete Patient blog, points out that this new report, in addition to New Zealand’s recent consideration of more lenient raw milk regulations, means that the FDA could quickly be becoming internationally isolated on the issue of raw milk.

The Campaign for Real Milk is a project of the Weston A. Price Foundation, a nutrition education non-profit based in Washington, D.C. To learn more about raw milk and other nutrient dense foods, attend one of the upcoming Wise Traditions conferences.

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Popular Wisconsin Raw Cheese Producer Stops Production

In August, Wisconsin-based Rush Creek Reserve announced it would stop making its popular raw milk cheese, due to uncertainty over pending FDA regulations related to raw cheese.

“Food safety officials have been unpredictable, at best, in their recent treatment of soft, raw-milk cheeses, and until our industry is given clear and consistent guidance, we are forced to stop making these cheeses,” said co-owner Andy Hatch.

He added that he hoped the halt in production would be temporary, but loyal customers have already taken to Twitter to express their outrage: @cheesegeek wrote, “The premature death of Rush Creek Reserve is the canary in the coal mine for all American raw milk cheeses.”

The Campaign for Real Milk is a project of the Weston A. Price Foundation, a nutrition education non-profit based in Washington, D.C. To learn more about raw milk and other nutrient dense foods, attend one of the upcoming Wise Traditions conferences.

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FDA bans French cheeses

The U.S. Food and Drug Administration (FDA) recently moved to prohibit the sale of cheeses people have happily made and consumed for millennia.  The agency claims these cheeses full of healthful bacteria are too risky. They issued a ban on imports of French cheeses that exceed “FDA approved” bacteria counts.

The artisan cheese making process involves inoculating milk with select bacteria and encouraging their proliferation to make a safe and delicious product. The FDA’s move means that even such probiotic bacteria now falls under suspicion.

The rule is not new; it has been in place since 2010 but it is only now being enforced leading to the confiscation and removal of highly coveted fine French cheeses.

David Gumpert gives an excellent update and analysis on the situation on his blog.

The Campaign for Real Milk is a project of the Weston A. Price Foundation, a nutrition education non-profit based in Washington, D.C. To learn more about raw milk and other nutrient dense foods, attend one of the upcoming Wise Traditions conferences.

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Milk Is the Most Reported Undeclared Allergen in the Third Annual Reportable Food Registry Report

In May 2013, the FDA released its third annual Reportable Food Registry Report, for the twelve months ending September 27, 2012. The FDA requires food companies to inform the agency about any foods that have been manufactured and released for sale that have a reasonable probability of being hazardous to human health (“reportable foods”). Once identified, the FDA works with growers and manufacturers to reduce the risk of harm. The Reportable Food Registry is an invaluable tool for maintaining a safe food supply. Continue reading

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Got Diet Milk? Dairy Industry Petition to FDA Sparks Consumer Outrage

Aspartame-FDA-Labeling-PetitionThe International Dairy Foods Association (IDFA) and the National Milk Producers Federation have petitioned the Food and Drug Administration (FDA) to drop its requirement that dairy products containing artificial sweeteners, such as aspartame, are prominently labeled for consumers.

Aspartame is a main ingredient in reduced-calorie foods like diet soda and sugar-free chewing gum. Although manufacturers of aspartame continue to assure the public that the ingredient is safe and aids in weight loss, several independent studies link the ingredient to an alarming number of scary side effects, including weight gain and increased blood sugar, headaches, degeneration of nerve cells and cancer.

The dairy industry wants to add aspartame and other artificial sweeteners to flavored milks and other products without labeling the bottle in an attempt to lure children to selecting those drinks at school. If this petition passes, it would mean that any time you reach for a jug labeled “milk,” that milk could include dangerous artificial sweeteners but you wouldn’t know for sure until you read the ingredient list in depth. This isn’t just an inconvenience for adult shoppers, but an irresponsible and dangerous decision that would directly affect underprivileged children, who depend on school lunches for the bulk of their nutrition.

The FDA has opened the topic up to public discussion, and is accepting comments online until May 21, 2013. Submit your opinion to the FDA here: http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm347194.htm

Listen to an in-depth podcast on this controversial issue here: http://hartkeisonline.com/2013/04/10/got-disgust-aspartame-in-dairy-products-with-no-warning-label/

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