The Complete Patient

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.