What follows is a fairy-tale-turned nightmare that, for some reason, has me thinking about leeches. After you’ve read the story, see if you can figure out why. Or maybe you’ll have your own image.
Once upon a time, in the year 2000, Annette and Ken Fischer decided to start a business supplying healthy nutrient dense products like coconut oil, dried berries, and spices over the Internet. They started the business in their home in the remote forests of Minnesota and named it Wilderness Family Naturals.
The couple worked hard, involved their children as helpers, and gradually grew the business so much that they had to move it out of their house to a small town about twenty miles away, so they’d have regular mail and delivery service and the ability to hire employees. After another couple years, they moved to even larger facilities in the neighboring town of Silver Bay, a town of 2,000 people. Soon Wilderness Family Naturals was the town’s second largest employer, with close to thirty people, and it was selling its coconut oil, dried berries, and herbs to people all around the U.S.
It would have been nice to say they lived happily ever after, but alas, in 2005, Cinderella’s coach turned into a pumpkin, as it were, when Annette and Ken received a letter from the U.S. Food and Drug Administration.
The letter told them they were making health claims for their products—for example, providing links to research suggesting that certain foods were rich in antioxidants, and providing guidance on how to use herbs—and that amounted to selling foods as drugs.
The couple tried to change the company’s web site to please the FDA, but further alas, the FDA didn’t think the changes were complete enough. The whole exercise was frustrating because the FDA officials wouldn’t tell them specifically what the remaining problems were. Instead, the FDA filed suit against the company in federal court, alleging violations of the federal Food, Drug and Cosmetics Act.
The couple hired lawyers, who told Annette and Ken to try to settle the suit. They also told the couple to avoid talking to the news media about the entire matter, because that would just make the FDA officials angry, and make a settlement more difficult.
The FDA said it would settle the matter with the company, if it adjusted its web site further. Wanting to please the government officials, Annette and Ken tried negotiating. “We negotiated for about three months,” Annette recalls. At that point, the FDA said the couple had to accept its terms, or the agency would seek a court order to seize all the company’s products, and possibly even put the couple in jail. Fighting in court would probably take two years, and they’d likely lose, which would mean they would lose their business and if they went to jail, lose their children to social services.
So, after spending about $100,000 in legal fees—some of which they had to borrow from a bank—the couple last December signed a consent decree that requires Wilderness Family Naturals to meet a number of requirements over the next three years, in exchange for the government dropping its suit. For example:
— Make sure there’s not a hint of health claims. In the decree’s language,discontinue selling via interstate commerce “chickweed Salve, St. John’s Wort Salve, Chest Rub Salve, Goldenseal-Comfrey Salve, Flux hull lignan, Green Food Feast, any coconut oil product, and any other product that is a new drug within the meaning of the Act…(until) Defendants have removed all claims …that the product is intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease…and removed from the product labels, labeling, promotional materials, and websites or other media owned or controlled by Defendants, that the product is intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease…”
— Retain an outside expert “to review the claims Defendants make for each of their products on their product labels, labeling, promotional material, and any internet websites owned or controlled by Defendants including, but not limited to websites referenced, endorsed, or adopted directly or indirectly by Defendants…” In other words, pay an outside expert (on the order of $100 an hour) to check out your web site and any web sites you may link to, to certify to the FDA that it’s okay.
— And, adding insult to injury, open your doors to the FDA for at least twice-yearly inspections, along with additional entry and search at any time of the day or night (without search warrants required), and “reimburse FDA for the costs of all FDA inspections, investigations, supervision, reviews, examinations, and analyses specified in this Decree or that FDA deems necessary to evaluate Defendants’ compliance with this Decree.” The fee schedule: $81.61 per hour for “inspection work,” $97.81 per hour “for analytical or review work” and, oh yes, 58.5 cents per mile for travel by auto and “the equivalent for travel by air or other means” plus “the published government per diem rate…for subsistence expenses…”
It just so happens the FDA conducted one of its inspections a couple weeks ago, and one immediate outcome was to force Wilderness Family Naturals to end its “affiliate program” whereby other web sites that linked customers to Wilderness received a commission. That meant Wilderness had to sever relations with 300 web sites, and send each of them a copy of the 18-page consent decree. More income lost, and the company hasn’t yet received the FDA’s bill for the inspection services.
One of the recipients misread the part about selling coconut oil and other items via interstate commerce, presuming the company was totally prohibited, leading Don Wittlinger to post a comment about Wilderness possibly being forced out of business following my previous post.
That comment apparently led to a flood of inquiries to the company wondering what was happening. “We are still in business,” says Annette.
The comment also convinced the company that its keep-quiet approach about the decree was counterproductive. I first met Annette last November at the Weston A. Price Foundation’s Wise Traditions national conference in San Francisco. She was manning a display of the company’s foods and herbs, and told me something about her nightmare with the FDA. But because she didn’t want to offend the agency, she asked me to keep quiet about the situation.
But all that has changed. Not only is the FDA bleeding the company by demanding it pay huge fees to monitor its web site and reduce its income from links and ties to other sites, but it is also via the decree creating an impression among its business associates that it is in danger of going out of business. Moreover, the FDA is taking the same sort of actions against dozens of other small sellers of health-care products.
“We have huge amounts of money going out because of the FDA’s overbearing approach to us…But we’re doing everything we can to have new products and grow. As long as people don’t think we’re not in business any longer.”
As they say, you couldn’t make this stuff up. A federal government agency robbing hard-working people selling real products during a time of economic hardship, and imposing censorship in the process. And now there’s a congressional effort to give this agency even more power. It’s beyond comprehension.
Keeping quiet allows organizations like the mafia to thrive….seems it’s the same way with the FDA…………
I’ve been watching these updates on Warning Letters for some time, and indeed within the last several months, the volume and variety of such letters has significantly increased.
We need a class action lawsuit against the FDA. Desparately!!
This is goverment criminal activity that is being conducted as a direct protection of the Pharma industry.
The FDA’s actions against Wilderness Family Naturals are an exact blue print of what the FDA is doing to OPDC.
The words, tone, requirements and nearly ever other detail is exactly the same.
We did not settle with the FDA on their civil complaint. There reqauirements were illegal and criminal….but they thought they could get away with them through power and intimidation. We elected to take it to the judge and jury instead. The exposure of their conduct has already made the judge take notice.
When raw milk becomes a new illegal drug and no one can speak of the healing that raw milk brings to them….it is time for a revolution and we all must stand and fight like hell is coming….because it is….it is arriving on FDA horseback. It is ugly.
A class action lawsuit…is desparately needed. Can anyone say….Gary Cox FTCLDF . He is the man and he would do well standing before the Supreme Court.
The FDA has blood on its hands and no one is powerful enough to stand and fight them independently….together we would crush them. Michele Obama would never stand for this, not with an organic garden growing in the back yard of the White House. Add Manna House and a few Amishmen and this is food and fuel for change….
Mark McAfee
The following is an example of a [fraudulent] claim on your website:
Sambucol Immune System Elderberry Formula supports your natural defenses against the Flu, and Colds, and is especially popular during the winter season.
The letter goes on to say:
The Secretary of Health and Human Services has determined that a public health emergency exists nationwide involving the H1N1 Flu Virus that affects or has the significant potential to affect national security.
and from there:
The marketing and sale of unapproved or uncleared H1N1 Flu Virus related products that are not authorized by and used in accordance with the conditions of a Emergency Use Authorization, is a potentially significant threat to the public health.
The FDA gun, apparently, can be affixed to any number of assault vehicles.
FDA Warns Web Sites against Marketing Fraudulent H1N1 Flu Virus Claims
http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm166801.htm
In May, there was a lot of media coverage following a warning letter FDA sent about Cheerios’ health claims.
"Your Cheerios product is misbranded," the letter said. General Mills defended its heart health claim saying that it has been FDA-approved for 12 years and the message about lowering cholesterol has appeared on Cheerios boxes for more than two years."
http://money.cnn.com/2009/05/13/news/companies/General_Mills_FDA/index.htm?postversion=2009051310
Another recent link:
http://www.usdoj.gov/usao/mow/news2009/pham.ple.htm
http://tinyurl.com/ls4qw6
The interesting and significant aspect of the FDAs pecking at Cheerios was that they expressed no concern whatsoever about the effects of consuming a processed, corn fraction-containing, sweetened grain, but instead took issue with the notion of food as medicine. (This is especially troubling in the context of Cheerios’ immense popularity with mothers of toddlers.)
Mark hit the nail on the head when he suggested that the FDA is protecting big pharma (and, I would add, industrial food).
We must all remain composed as our temperatures reach a boiling point.
If we boil over the pretext of being an enemy of the state and being classified as a bioterrorist or some other mal content puts bullets in their guns literally. They did this at Manna House and others. They love using guns….it trumps logic and other rational thought. Stalin said once true power comes from the end of a gun….I say that is perhaps true….but those that use guns die by them also.
News today says that there is a building domestic terrorism threat. I know why now…it is the FDA and the furor that they are raising with and among common citizens. The only way that the common man can fight back is by using unconventional warfare tactics and become an enemy of the state which protects industry, Monsanto and Vaccine companies etc… Rogers Rangers were classified as terrorists by the British in our own revolution for indepedence.
Lets just remain calm and fight these jerks in the courts. We do not need to become involved in a conflict that would give them any excuses to use violence….they love to do that. The American Media eats that up and makes us look like extremists. The FDA is the extremist….that is a fact. They are the bioterrorist and sterile food engineers.
With good legal work the FDA will looks like extremists and they hate that….we need Gary Cox to represent us as a joined force….the FDA would go done in flames. FTCLDF needs us all to contribute $10 per month. Thats how Obama became president. It was everyone giving a little often.
Together we would kick the sterileness out of them and they would end up in jail not us. There is a PBS special that may be coming out this fall that will speak directly to this issue.
Its just food….thats why it has people fighting mad. It is our food!! Our bodies!!
Mark
Where is no FDA statute on this subject???
There is none.
If raw coconut oil is illegal then raw coconuts are also illegal and so is Kombucha and raw honey.
Some one please explain….
The FDA has gone over board and Wilderness Family Naturals must fight back. The FDA has nothing to stand on….this is all fabricated and hot air….call their bluff!!
Mark
FDA Issues Final Regulation on Dental Amalgam July 28, 2009
" elemental mercury and a powder alloy-used in dental fillings —- the levels released by dental amalgam fillings are not high enough to cause harm in patients" What is their definition of harm?
FDA recomends that product labeling includes A warning against the use of dental amalgam in patients with mercury allergy. Aren’t we all allergic to the poison mercury?
The mercury component of dental amalgam has been reclassified from Class 1 [low risk] to Class 2 [moderate risk]
It would appear that these folks think that mercury in our mouths contains very little risk not so fresh raw milk and now even coconut oil.
Their final conclusions based on what they call "STRONG SCIENCE" gives me no comfort of mind!
http://www.fda.gov/Food/FoodSafety/Product-SpecificInformation/MilkSafety/ucm122062.htm#pasteur
The information they give is misleading and intentionally deceptive.For example: they say that raw milk may contain mycobacterium tuberculosis(johnes disease in cows,crohn’s in people).Then they say:
" How does the pasteurization of raw milk protect consumers?"
"Pasteurization is a process that kills harmful bacteria by heating milk to a specific temperature for a set period of time. Pasteurization kills the bacteria responsible for diseases such as listeriosis, salmonellosis, campylobacteriosis, typhoid fever, tuberculosis, diphtheria, and brucellosis, as well as other bacteria."
They would like you to believe that raw milk might give you crohn’s disease but that pasteurized milk will not,which is false as pasteurization does not kill mycobacterium tuberculosis.The chances that drinking pasteurized milk from a factory farm will expose you to mycobacterium paratuberculosis are very close to 100%.Raw milk from pasture based farms is very unlikely to contain mycobacterium paratuberculosis.Crohn’s disease among children is a very serious problem and the FDA’s deceptive website is contributing to the coverup of this disaster.
This is just one example.The website is full of biased and misleading statements that are not supported by real science. They should remove their website.
David
http://blogs.wsj.com/health/2009/07/29/rice-krispies-complete-with-snap-crackle-and-immunity/
"Did Kellogg have to go through any special process to get the Rice Krispies claim on the box? No, because of a company analysis of what the FDA rules cover and what they dont. Norwitz said that Rice Krispies immunity claim is a structure-function claim, not a health claim, and as such, it doesnt require FDA approval.
If the FDA attempts to regulate intrastate raw milk that would mean that the FDA would be required to have some standards for raw milk. Banning it will not fly in CA or other states that have sacred raw milk laws. But…we could see FDA inspections and some heavy FDA fees for these inspections and perhaps wriitten directives on improvements that the FDA might require.
BUT…….There is a hidden treasure in this.
This is our ammunition that would permit raw milk that met their standards to cross state lines. I know I am making a bit of a quantum leap of legal faith….but thats the math that could be our return fire. The FDA does not get it both ways their way. If they regulate raw milk then it would would qualify as a federally approved raw milk.
The passage of HR 2749 is going to be very interesting. If the FDA uses their new found power….they are also going to have some new fights they have never seen before. A whole new can of worms….not to mention the appeals process that would require the FDA to hold hearings for raw milk producers if there is a problem. This is the opportunity for dialogue….Sheehan would be required to become engaged.
This will press us all to action to protect our farms and unprocessed foods. In the past….when the FDA gets this kind of authority it must go through massive administrative proceedures development in order to impliment the new law. This takes time and public comment. This is not over yet. This engages the FDA and that is a very good thing. No more shooting from behind rocks.
Mark
It will have to be someone else’s can of worms as I cannot afford to fight and my children cannot afford to loose their dad.
This is tyranny plain and simple. They’re trying to give the FDA food quarantine power? Crazy! Millions have been murdered with just such power.
In 2009 do we have enemies at the gate? Maybe the WHO WTO IMF UN ?
Do we have enemies from within? Maybe the USDA FDA NAIS CODEX ALIMENTARIUS HR 2749? And what does the so called Health Care bill have in store for our future?
http://blog.flecksoflife.com/2009/07/19/the-hc-monstrosity/
Are not these all interconnected as if by design just like a spiders web that will ensare its prey WE THE PEOPLE? Where is the outrage among we the people as we all watch the nations HEALTH and WEALTH being PLUNDERED and in broad daylight?
It has been the result of looking at things unconventionally and then applying hard work to serve our consumers. It has been the result of never ever giving up….ever. Never.
I see this as just one more hurdle. I see this as the FDA opening up a gate that has been closed for a long time. I do agree that it sucks….big time. But that is the lemon we have been given.
The question is this….how do we thrive given these new circumstances.
OPDC will thrive because I will not stop producing safe pasture grazed raw milk for our consumers….FDA at the gate or not.
They have been here before. I do not fear them one little bit. They are not nazis ( at least in public )…they must follow the rules and I will make them follow the rules. My camera is ready. My email list is ready to call out all the moms and mother lions. The FDA hates the media and the media will come if they screw with us in anyway. In CA we have separate standards for raw milk and the FDA can do nothing about that. There biggest mistake would be to agree with CA raw milk standards and adopt them. That would and could force a change in CFR 1240.61…that would be a blessed day.
Remember that they must develop implementation regulations. The devil is in the details and the details are yet to be developed. This will take lots of time. Lots of time.
In everything there are some bright spots….you just have to find them.
Mark
Mark It seems that your favorite Organic Garden has a big problem shall we call it bio-sludge instead of sewage laced with lead and other "things"? There is a bit of irony here when viewed in the light of what has been done to the small American farmer over the last 100 years.
You are so right. Michele has a little Clinton era garbage to deal with.
She should annouce a search for the best most vital humus rich organic soil in the USA. Direct the FDA and USDA to lead the search.
Then bring in the "back hoes" and dig that crap up and send it to a processing facility to extract every last drop of contaminant from it. Then hold a ceremony to celebrate the renewal of the soils of the Whitehouse with certified organic dirt….dirt that is free from lead and what ever else was left there by the Clintons.
This would be highly symbolic and would really be in your face to Monsanto and others that polute our soils and our foods.
When the back hoe digs it should dig deep….I mean really deep. Dig until they can not find a trace of lead….try twent feet down or forty feet down….what ever it takes and get it all out. Then bring in truck after truck of organic soils and make a grand event of it all.
Then plant some organic carrots and vegies for next season.
Then announce in a grand ceremony at the White House ( with the farmer whose dirt was transplanted )…that this soil is the very basis of our future generations health….good organic dirt that is not poisoned or contaminated by industry as the food of our future grown in furtile organic soils. Have Mike Pollan speak and let Joel Salatin plant the seeds.
That would beat the hell out of a headline grabbing "beer summit" with a "stupidly acting" abusive cop and a hot headed PhD.
That’s leadership…thats news!!
Mark
Soils are the basis of nutrition and nutrition is the basis of disease prevention and thusly….universal health care….
Mark
The government must follow the rules? That is laughable. If they followed the rules they’d never pass such unconstitutional, immoral legislation as this. No, it is about power and what they can get away with. But most people don’t have your resources and capability for publicity. We’re just struggling to stay alive the way it is already.
Just you wait – next they’ll be banning The Complete Patient….if you become too popular, you’re bound for legal trouble. Thanks and blessings for your courage, David!.
There’s a subscription server that hides the source; it’s untraceable. We could receive news and place orders for good food without the FDA tracking the source. I read about it in a magazine; sorry I don’t have details – and if I did, dare I publish it here?
WFN is a wonderful, reputable, honest family business – place a big order to help them!!!
Who died and left the FDA God?
I don’t know who said it but he was right.
"The best defense is a good offense"
I can’t imagine why the lawyers for Wilderness advised them to give up and pay up. The FDA has no real power, just like the IRS, it’s all bluff and puff.
They go around looking for victims, high profile and easy targets. Make a big stink about and then use that to scare everybody else into submission.
Fear is a powerful tool used by those who don’t really have the power.
How in the hell did we come to have the food police making raids on dairy farmers, and threatening health food stores?
How much harm can come from selling coconut oil?
How much harm is done from the sale of hard liquor in bars and stores?
What kind of hypocrites are running the FDA?
Raw eggs with salmonella can be sold anywhere with no problem, but talk about the potential benefit of vitamins and raw foods and you can go to jail?
And then you must pay off the FDA to inspect you?
PAY OFF THE FDA TO DO THEIR JOB!
Isn’t that called bribery? They get paid off to drop a lawsuit, right?
THAT IS INSANE
Is this the level that American Law has fallen to?
It’s fast becoming a joke worldwide, and getting worse by the hour.
But I’m not laughing, I live here and I’m not going to take it anymore.
We need to stop thinking that every solution comes from the court.
If we had waited for the courts, America would still belong to England.
If Ghandi had waited for the courts, India would still belong to England too.
If we had waited for the courts, Women and Blacks still couldn’t vote.
If we had waited for the courts, we’d still be waiting in segregated cities and towns.
There is a time to wait and a time to take to the streets to protest.
Just because they passed a law doesn’t make that law just or right.
It doesn’t make it fair, doesn’t make it viable, doesn’t make it impossible to change for the better.
Just because THEY made it a law means it’s good for US, good to US or good by Us.
It does make it good for Them. It’s always in the favor of those who oppose us.
Follow the money, who stands to gain the most from these new laws?
Who does it shut down and put out of business?
Who does it keep from doing something as natural as selling good food, real food to help people?
You always find those companies afraid of competition behind any restrictive regulations on other businesses.
It shouldn’t happen in this country, not after all we’ve gone thru.
Whatever became of the free market?
It’s given way to the robber bandits of big corporations determined to put little businesses out of business.
No more playing nice, no more trying to play by the rules.
We didn’t make these rules or have a say in passing them, why should we obey them?
We have to fight dirty, fight hard, make lots of noise and don’t back down.
Make them look bad, make them look stupid.
Put up videos on YouTube.com, Blog and Blog some more, write, speak out, picket and march in front of their offices and in front make our cause known everywhere.
Stop being afraid of going to jail, they don’t have enough jails to hold all the people willing to fight. Look at the Marches on Washington DC in the past.
We don’t have to be polite, certainly not play by their rules.
This is a matter of life and death, of losing the last freedoms we have and any hope living to a ripe old age in good health.
I refuse to be bullied, refuse to bow to tyrants and dictators of any kind or with official titles.
Name a dictator that denies his people basic food?
Only the FDA does.
The next thing will be outlawing backyard gardens as well as family farms. What’s next, you have to eat according to official government menu for the week?
They know what’s best for us cause we are too stupid to choose food for ourselves?
It’s not 1984, it’s 2009 that Big Brother moves in for the kill, to take over lives, totally and completely.
This is an assault on our very way of life, this is the beginning of the Food Wars.
Enough is enough.
Mark, I do not know a lot about this kind of stuff; but I am very interested in your comment about getting GROUPS of people to stand up to these abuses and the idea of a class action suit. I would love to understand more about this. This may be the best way to support this family right now.