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Thirteen Years for a Dietary Supplement

If Jay Kimball could be accused of anything, it’s that he was too honest. He told the FDA several times what he was doing and tried to follow their procedures, but he ended up only giving them the ammunition to destroy him.

James Kimball, known as “Jay,” of Zephyrhills, Florida, developed a product in the late 1980s called Liquid Deprenyl Citrate (LDC), which showed success not only with cancer but with Parkinson’s and Alzheimer’s. It stimulates production of a brain chemical that becomes depleted with age and is necessary for proper immune functioning. 

Kimball first contacted the FDA in 1990. A version of the product he wanted to create was being imported from Hungary and sold by a small company, Somerset Pharmaceuticals, owned by two larger pharmaceutical companies.

Kimball pointed out that Somerset’s version had contaminants “detrimental to the actions of the product” and also wanted to know why the FDA restricted information indicating that the product worked for Alzheimer’s. Kimball said, on a (now-defunct) web site about his case, “The FDA threatened me with serious repercussions if Discovery [his company] made public any statement regarding any use of deprenyl not authorized by the FDA.”

Kimball applied to the FDA several times for approval for his product, and his applications were “lost,” ignored, or denied. He finally set up a company in Mexico to make LDC, which was then imported. He also set up a company in Florida, Discovery Experimental and Development, Inc. (DEDI), to make other dietary supplement products.

His motive, according to a “Declaration” on his web site, was not financial. He was already fairly well off when he started DEDI, and he took no remuneration. He also says, “The majority of people, companies and universities that assisted DEDI and GHI/MRI did so to help develop products to help humanity and without payment for their services.” 

The government raided DEDI not once but three times (1990, 1993, and 1999). After the first raid, it took nine grand juries for the government to indict Kimball. His wife, Josephine, says that at the last one, “the only reason they indicted him, they never saw actual testimony. The prosecutor and the federal agents and state agents were actually playacting in front of the grand jury, where the jurors couldn’t ask any questions of the witness — because they [the witnesses] weren’t there.” The transcripts, she says, had statements such as, “Well, you read this part as if you were agent W. Smith, and I’ll read this part.”

The 1993 raid involved “the FDA, IRS, California Drug Enforcement, FDLE [Florida Department of Law Enforcement], U.S. Postal Service, U.S. Customs, the Florida HRS Pharmacy Services and others under a federal warrant issued to U.S. Customs in Tampa, Florida.” In addition to business and personal items, they confiscated files containing Kimball’s proprietary information — trade secrets on the synthesis of deprenyl and other products, the identities of customers, FDA application filings, as well as personal records and books, and documents from unrelated companies — to which his competitor, Somerset Pharmaceutical, was later given access. Agents even raided his daughter’s apartment in California, breaking down the door.

Somerset’s interest in eliminating DEDI as competition becomes clear from the economics of the drug. Their product sold for $120–150 for thirty 5-milligram tablets. Kimball estimates their manufacturing cost to have been less than a dollar. His own product sold for $75 for twice as much, 300 milligrams.

Kimball represented himself at his criminal trial in 2000, because he couldn’t afford a lawyer, and the judge refused to appoint one. The judge contended that Jo Kimball should sell their house, which Jay wouldn’t let her do. Kimball also thought, based on what the prosecutor had told the judge, that the maximum sentence would be three years. He got thirteen years, of which he’s done four.

The judge added ten years to the expected three, Jo says, because he “was so furious with Jay because he didn’t have an attorney and things didn’t go the way they should have during the trial.” The additional time was nominally for a “charge of fraud against the FDA — because they couldn’t find anybody he committed fraud against, couldn’t find anybody he stole money from, couldn’t find anybody to complain, so they said he defrauded the FDA.” For various reasons not limited to this case, the Kimballs believe payoffs were involved. As Jo points out, thirteen years for mislabeling a dietary supplement (the purported offense) is unheard of.

The web site has extensive documentation of Kimball’s decade-long battle, including betrayal by various government and industry people and appalling allegations of prosecutorial and judical misconduct. A hit counter on a previous version of the site indicated that it had been accessed more than 1.8 million times. According to the site, Jo receives “continuous calls from LDC users crying on the telephone, either dying or degenerating” because they can’t obtain the product.

Even after his conviction, Kimball’s problems didn’t end. The judge had requested that he be kept close to home, and at first he was at Coleman Low in Florida, a minimum-security institution. The attorney for Kimball’s businesses says in a letter, “There is also no question in my mind that Jay is being retaliated against by the officials at Coleman,” and he details several instances of that retaliation.

After the 9/11 attacks, Jo learned that prison guards had been abusive toward Middle Eastern inmates. She learned this because the inmates’ wives told her, in the visiting room. She sent emails to some U.S. senators, and the subsequent inquiry resulted in the warden’s transfer — upstairs. He became an assistant to the regional director in Atlanta. Kimball was subsequently transferred, on a pretext, to Yazoo City, Mississippi, seven hundred miles from home.

Kimball points out on his web site that Yazoo City is unofficially considered a “punishment prison” (although retaliation is contrary to Board of Prisons regulations): “The BOP classifies Yazoo Prison as a Disciplinary/Punishment Low Security Prison; although not publicly.”

Kimball has repeatedly requested a transfer from Yazoo City to a minimum-security prison camp in Florida, nearer his home. The request has been approved at the local level but is repeatedly denied at the regional level, apparently by R. E. Holt, the regional director.

Holt was a friend of the former warden at Coleman and gave him a job in Atlanta, working under Holt, after the warden’s removal from Coleman. Kimball’s transfer to Yazoo City occurred subsequent to this incident and was apparently a result of it. The warden is now deceased, but Holt’s vindictiveness lingers on to prevent Kimball from transferring back to Florida.

Update (2011): In June 2005, Jay Kimball was transferred to a minimum-security camp. In December of that year, he escaped. In April 2009, federal marshals found him living with his wife and son in a trailer park in Florida and recaptured him. His legal expenses had resulted in the loss of the Kimballs' home and a building that housed their businesses. At the end of 2010, Kimball's wife, Josephine, died after a long illness exacerbated by despair at his lengthy imprisonment.