Company Destroys hGH Product Labeled With Faulty Claims

COLLEGE PARK, Md.--Nature's Youth LLC of Centerville, Mass., voluntarily destroyed approximately 5,700 boxes of Nature's Youth hGH that was misbranded. In all, $515,000 worth of product was affected. The Food and Drug Administration (FDA) determined the product was misbranded after evaluating unsubstantiated structure/function claims that appeared on product labels and the company Web site. Claims included the product would "enhance the body's natural production of Human Growth Factors and Insulin-like Growth Factor-1" and "improve physical performance, speed recovery from training, increase cardiac output and increase immune functions."

The company had supported its claims by citing a New England Journal of Medicine (NEJM) study (323:1, 1-6, 1990). In the study, 21 healthy men age 61 to 81 with low growth hormone levels were followed for six months. Researchers, led by Daniel Rudman, M.D., from the Medical College of Wisconsin, Milwaukee, concluded, "Diminished secretion of growth hormone is responsible in part for the decrease of lean body mass, the expansion of adipose-tissue mass and the thinning of the skin that occur in old age."

However, as FDA pointed out in its release, NEJM recently ran an editorial saying that using a claim based on these findings was misleading. "If people are induced to buy a `human growth hormone releaser' on the basis of research published in the journal, they are being misled," wrote Jeffrey M. Drazen, M.D., editor in chief. "Although the findings of the study were biologically interesting, the duration of treatment was so short that side effects were unlikely to have emerged, and it was clear that the results were not sufficient to serve as a basis for treatment recommendations."

An FDA spokesperson told INSIDER that the agency had originally gone to Nature's Youth's facility to follow up on a warning letter sent regarding the company's Noni Juice; although that product was found to be in compliance, that is when FDA discovered problems with Nature's Youth hGH. The company decided then to destroy the product rather go through the procedures to make it FDA-compliant.