U.S. Food and Drug Administration
FDA Consumer magazine
January-February 2001
Table of Contents
By Carol Lewis
Stealing drug-manufacturing chemicals from their employer had been easy. The company didn't keep an inventory of two of its ingredients. No one would notice a gradual disappearance, so it seemed like the perfect crime.
But when the thieves tried to deliver the last 1,200 pounds of stolen chemicals on New Year's Eve 1994 to their partners at an underground lab making methamphetamine--usually called speed on the street--their truck crashed on an icy road outside Colorado Springs, Colo.
Labels on containers in the wrecked truck told police that the chemicals came from the Chemins Company, Inc., a dietary supplement manufacturer in Colorado Springs. When authorities informed James R. Cameron about the truck accident involving his company, he didn't react to the apparent theft. Instead, the owner continued the conspiracy in which he had been lying to the Food and Drug Administration for years about production of an "all-natural" dietary supplement.
Among the products Cameron's company produced was "Nature's Nutrition Formula One," a dietary supplement that was supposed to be made from plant ingredients. But Cameron made his with two pharmaceutical-grade chemicals, ephedrine hydrochloride and caffeine anhydrous.
The coincidental truck crash in 1994 launched a three-year investigation by FDA's Office of Criminal Investigations that landed Cameron in jail for 21 months and cost him and his company more than $4.7 million in fines and other fees.
But the story really began in 1992. While FDA was investigating Chemins for violations of an unrelated product, company employees were busy in the back spiking Formula One and other products with the two chemical ingredients. And Cameron told them specifically to hide their actions from FDA.
Formula One's label stated it was an "all-natural nutritional supplement" containing ma huang and kola nut, two naturally occurring sources of ephedrine and caffeine. But Chemins' target potency of 12 milligrams of ephedrine and 40 milligrams of caffeine per capsule could not be obtained using only the natural ingredients, because the capsule would have been too large to swallow. To achieve higher levels of ephedrine and caffeine that would provide added stimulation, keep customers coming back for more, and save on raw material costs, Cameron directed his production manager to substitute pharmaceutical-grade ephedrine and caffeine for the ma huang and kola nut extracts.
Under the Federal Food, Drug, and Cosmetic Act, before the requirements for dietary supplements changed in 1994, a dietary supplement was adulterated and misbranded if it failed to bear the common and usual name of each ingredient on its label. But including chemically prepared ephedrine and caffeine in the product would subject the manufacturer to more stringent regulatory requirements. So Cameron chose not to list the ingredients on the product's label, rather than stop using them. According to OCI special agent Laura Stewart, who handled the case, the investigation also revealed that "the synthetic ephedrine was sometimes substituted at more than double the usual quantity."
To keep FDA from becoming suspicious about the ephedrine and caffeine additions, Cameron created false records for Formula One that omitted the offending chemicals. He knew that FDA inspectors normally collected manufacturing and inventory records during inspections. Cameron also directed company officials to not record incoming shipments of the drug chemicals in the warehouse logs, nor in the company's computerized inventory, and to not assign lot numbers to those materials.
In 1993, when FDA reinspected Chemins for the earlier, unrelated violation, the company's sales manager told the investigator he could not find a key to the storage shed where raw materials were housed. The criminal investigation later disclosed that at 2 a.m. that same night, three company employees moved ephedrine hydrochloride and caffeine anhydrous from the shed to an employee's residence. The next day the FDA inspector was shown an empty shed. Employees periodically returned to the company with only the quantities of ephedrine and caffeine needed for manufacturing.
Even the death of a Texas woman in May 1994, which authorities believe was linked to Formula One, did not dampen Cameron's wrongdoing. FDA inspected Chemins in June 1994 to determine whether Formula One was, in fact, connected to the death. Inspectors requested Formula One's manufacturing records and warehouse receiving logs and received false records. FDA also took product samples for laboratory analysis. And Cameron went so far as to sign an affidavit prepared by FDA stating that Chemins used only naturally occurring raw materials and that at no time did the company ever add chemically prepared ingredients to its herbal products.
But analysis of the Formula One samples detected synthetic crystals in the product that could not be accounted for in the manufacturing documents. According to Stewart, FDA's forensic chemistry center later confirmed that the crystals were in fact pharmaceutical-grade ephedrine and caffeine.
FDA immediately recommended seizure of Formula One, based on adulteration and misbranding violations. But impending passage of the Dietary Supplement Health and Education Act (DSHEA) held up the process. DSHEA would require ten-day notification prior to taking legal actions against firms or their products. And all the while, Chemins continued to deny adding chemically prepared ingredients.
But by November 1994, FDA had received enough complaints of serious injuries and deaths associated with Formula One to indicate that the product presented a significant risk of illness or injury. On November 21, the agency issued a warning letter advising the firm that Formula One contained ephedrine and other alkaloids, and that the product was found to be adulterated and unsafe.
"It's interesting that this was a food case and not a drug case," says compliance officer Shelly Maifarth of FDA's Denver district office. "There was not one drug charge stemming from this entire investigation," she says, because the product was labeled a dietary supplement.
But in a meeting between FDA and Chemins officials to discuss the warning letter, Chemins' attorneys, acting on information given them by Cameron, again denied that the company ever added synthetic chemicals to Formula One or that the formula had in any way been changed.
The New Year's Eve truck crash was instrumental in opening the door for FDA's criminal investigation. Despite extensive documentation, witness interviews, and laboratory analyses, Cameron never admitted to the years-long conspiracy. Of the 14-count indictment on October 21, 1999, charging Cameron and Chemins with conspiracy, violating federal food and drug laws, making false statements, and obstructing an FDA investigation, Cameron pleaded guilty in July 2000 to one count of defrauding the United States government.
Cameron, whose company continues to make dietary supplements, began serving his sentence in September 2000.
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