A Utah-based corporation that distributes a product called BioGevit…

A Utah-based corporation that distributes a product called BioGevity – an oral spray product that used to contain human growth hormone (HGH) – was ordered today to pay a $500,000 criminal fine and to forfeit $1.25 million in profits.

Neways, Inc., which is based in Salem, Utah, was ordered to forfeit the $1.25 million, which represents profits the company made on the sale of BioGevity from March 1999 until April 2000.

Neways, which pleaded guilty in October 2003 to illegally distributing HGH throughout the United States, was sentenced this afternoon by United States District Judge A. Howard Matz. In addition to the monetary sanctions, Judge Matz placed the company on probation for three years and required the company to notify the Court of any claims of harm resulting from the use of BioGevity.

The sale of HGH for human consumption is illegal without a doctor’s prescription. As part of this case, Neways is admitting that it distributed HGH to individuals without a doctor’s order. The sentencing of Neways concludes the first prosecution in the United States of a company that distributed an oral spray containing HGH.

Neways distributed BioGevity through its network of independent distributors. Because of the HGH in BioGevity, the product was touted as having a rejuvenating effect, and Neways’ promotional material touted the effectiveness of the oral spray version of HGH, calling it the equivalent of injectable HGH. Neways sold about 100,000 bottles of BioGevity during the time it was on the market with HGH in the product. After April 2000, Neways changed the formula for BioGevity, taking out the HGH.

HGH is a naturally occurring hormone produced by the pituitary gland. A major function of HGH is to regulate growth from birth until adulthood, with its most apparent effects occurring during adolescence. If children do not produce enough HGH, they may suffer from stunted growth.

When the body produces an excessive amount of HGH, it is usually the result of a hormone-producing tumor of the body. When overproduction occurs in adults, it produces a disease known as acromegaly. When HGH is misused by an adult, the individual is at risk of developing symptoms seen in acromegaly, which may may include enlargement and distortion of facial features, hands and/or feet. There also may be excessive growth of parts of the skull, thickening of the skin, the development of hypertension, muscle weakness, enlargement of internal organs(including the heart, liver and spleen) and other syndromes.

The musculoskeletal and cardiac disease associated with growth hormone excess may be irreversible, and abnormalities of the heart muscle (cardiomyopathy) is the most common cause of death in acromegaly.

The investigation into the sale of HGH is continuing. As part of its guilty plea, Neways had agreed to cooperate with the government in the ongoing investigation being conducted by the FDA’s Office of Criminal Investigations

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