On Thursday, April 14, 2011, dozens of agents from the FDA, the Internal Revenue Service (IRS), and the US Federal Bureau of Investigation (FBI) conducted an unprovoked, full-scale raid on Hood River, Ore.-based Maxam Nutraceutics, a company that produces and sells nutritional supplements primarily for autism spectrum disorders (ASD) and Alzheimer's disease.

Back in October 12, 2010, the FDA sent a warning letter to Jim Cole, Founder and CEO of Maxam, notifying him that several of his company's products were not labeled in accordance with the US Food, Drug and Cosmetic Act. The letter also stated that Maxam had fifteen days from the receipt of the letter to notify the FDA compliance officer of the specific steps it planned to take in order to correct the violations.

You can view a copy of the FDA warning letter here, complete with the name of the FDA compliance officer to whom Jim and his company were instructed to respond, and the FDA district director who sent the letter:

http://www.fda.gov/ICECI/Enforcemen...

Oddly enough, the vast majority of the "unapproved labels" in question were not actually labels at all. They were merely customer testimonials about the products that had been accumulated over the years from satisfied customers, and posted online alongside product descriptions on Maxam's website. Nevertheless, the FDA considered the testimonials to be marketing violations that automatically rendered the products as drugs.

According to Jim, his company immediately responded to the FDA letter by calling the compliance officer and telling her "it was [the company's] intention to come into full compliance as quickly as possible." This included removing all the offending testimonials from the company website after being told by the FDA compliance officer that they were not permitted.

"I contacted a patent and copyright attorney, and he had written [the compliance officer] a letter that it was our intention to come into full compliance," said Jim, noting that his company responded within two days of receiving the FDA warning letter, long before the 15-day deadline period. "So we took down the testimonials, and we thought that was good. And I hired an FDA copyright person [who] went over all the offending verbiage through the website."

Jim cooperated with every demand that the FDA made of him, and was convinced that all was well. But apparently the FDA had different ideas when out of nowhere, the agency, along with the IRS and the FBI, sent as many as 80 armed, SWAT-style agents to both Maxam headquarters, the company's "Big Gym" training center, and even Jim's daughter's house, to confiscate all the products, company documents, and even personal files and computers.

"They took all our products, all our paperwork, all our files -- we've been doing this since 1992 and they pulled everything," said Jim. "They brought in three big moving vans, they had their guns on, their bullet-proof vests -- they came prepared for war."

The armed agents also stole 27 TurboSonic machines, which is a sound-actuated vibration plate device that Jim invented to stimulate growth plates in the body, improve circulation, energize the lymphatic system, and improve muscle strength. The TurboSonic machines were not even mentioned in the FDA warning letter.

"We also have a big Olympic training center up here called the 'Big Gym' -- they went into the gym, they took all the paperwork, all the computer, hard drives, downloaded all of our servers, and trashed a couple of our servers going out," added Jim. "They took products that were not on the list. I had an old bodybuilding line that went back to 1992, they took all of that. They pretty much just had a free-for-all."

According to Jim, the agents stole "hundreds of thousands of dollars in products" as part of the raid, as well as personal files, insurance policies, non-printed checks, and even unopened packages of manila filing folders from an office supply store. Clearly, the FDA's intent was to terrorize and intimidate this small company that, from all available accounts, did absolutely nothing wrong.