“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….”