A crackdown on illegally imported human growth hormone has revealed that Chinese manufacturers are a primary source for the U.S. market, and documents obtained by Yahoo! Sports show a link between HGH from China and the ongoing scandal involving professional athletes and performance-enhancing drugs.
A Florida man who in March pleaded not guilty to charges of illegally selling HGH and steroids received $108,900 of Somatropin, a generic form of HGH, imported from China in violation of the U.S. Food and Drug Administration rules, according to documents. Glenn Stephanos, owner of one of the wellness clinics implicated in the case that has centered on Signature Pharmacy in Orlando, Fla., is listed as the recipient of the HGH shipment.
When reached by telephone Wednesday, Stephanos declined comment.
The FDA has never approved the distribution or use of any human growth hormone made in or imported from China, according to an FDA official, and federal authorities have increased enforcement as Chinese HGH used by athletes as a performance-enhancing drug has flooded the U.S. market.
Chinese HGH has gained popularity in the United States because it is readily available online without a prescription and is relatively inexpensive, often less than half the cost of American pharmaceutical-grade HGH. Some athletes apparently obtain Chinese HGH without knowing its origin when they make surreptitious purchases from U.S. clinics.
U.S. government authorities say Chinese-made growth hormone is subjected to less stringent manufacturing guidelines than those enforced by the FDA, therefore increasing potential health risks.
Recently, authorities have begun making arrests and the issue is drawing more scrutiny as the federal government continues to investigate the illegal distribution of performance-enhancing drugs.
Three weeks ago, an owner and a sales representative of a pharmacy in Colorado Springs were indicted for allegedly importing and distributing Chinese HGH. If convicted, they would have to forfeit $4.1 million in assets that federal authorities allege the pharmacy made selling the HGH over an 18-month period and serve time in prison, according to published reports.
In May, narcotics agents surprised Lowen's Compounding Pharmacy in Brooklyn, N.Y. with an inspection and seized a stockpile of Chinese HGH that could have sold for as much as $1.35 million, according to a report in the New York Daily News. Lowen's was not charged, but a source familiar with the inspection said authorities still could prosecute.
That same month, an order for $108,900 of Somatropin was placed for Stephanos, who owned a wellness clinic that sold the substance to New England Patriots safety Rodney Harrison and Dallas Cowboys quarterback coach Wade Wilson, according to published reports. The NFL suspended Harrison for four games and Wilson for five games for violating the league's drug policy, which bans HGH.
The address to which the drugs were shipped corresponds with two Palm Beach Gardens companies owned by Stephanos – Palm Beach Rejuvenation Center and Palm Beach Pharmaceuticals, Inc. In February, federal officials raided another branch of the Palm Beach Rejuvenation Center in Jupiter, Fla., and Signature Pharmacy as part of a far-reaching investigation into the illicit distribution of steroids and HGH.
The Somatropin was imported from China by DNP International, a company in Whittier, Calif., according to documents.
DNP also imported Chinese HGH that it sold for $48,748 to Lowen's, the Brooklyn pharmacy where authorities seized Chinese-made HGH. Documents show Lowen's ordered two shipments from DNP in October 2006. Lynn Chau, manager of information systems for DNP, said she could not discuss specific shipments of Somatropin but said DNP had stopped importing HGH from China while it looked into licensing issues. Attempts to reach company president David Ji were unsuccessful.
According to the company website, DNP International "distributes raw ingredients, helping manufacturers advance products in the food, beverage, nutritional supplements, pharmaceutical, cosmetic and feed industries."
Stephanos received 32 grams of Somatropin – which equates to more than 5,000 vials or about 100,000 doses – imported from China on May 1, about two months after agents raided Palm Beach Rejuvenation Center, which then closed it's Jupiter office. The mailing address on the purchasing documents corresponds with Palm Beach Pharmaceuticals, Inc., and the Palm Beach Rejuvenation Center.
Unlike steroids, which as a scheduled drug fall under the auspices of the Drug Enforcement Agency, HGH is governed by the FDA under the Food, Drug and Cosmetic Act. But the DEA, which has played a critical role in slowing the supply of illegal steroids from Mexico, has the authority to investigate HGH.
In January, the FDA issued an import alert on Chinese HGH. Citing several federal codes, the alert states that Chinese HGH is "subject to the refusal of admission" at U.S. borders.