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Posted May 5, 2003

FDA Reports False Claims by Maker of HGH Supplement

On April 30, 2003, the Food and Drug Administration (FDA) announced that Nature's Youth, LLC, of Centerville, Mass., has completed its voluntarily destruction of approximately 5700 boxes (each containing a 30-day supply) of its misbranded product, "Nature's Youth hGH." This destruction, which occurred at locations in Massachusetts and Florida, was recently completed and involved approximately $515,000 worth of product. The firm also indicated it would change the labeling for future marketing of the product in order to comply with the law.

"FDA is committed to help consumers make health and dietary choices based on accurate information," said FDA Commissioner Mark McClellan, M.D., Ph.D. "FDA will continue to take strong action to protect American consumers from dietary supplements that are not accurately labeled or that make misleading claims unsupported by scientific evidence."

FDA determined the product was misbranded after evaluating unsubstantiated "structure and function" claims made on the company's website, as well as a review of the labeling of the product line. Among the false and misleading claims was that Nature's Youth hGH was a "proprietary blend of amino acids and precursor nutrients which enhance the body's natural production of Human Growth Factors and Insulin-like Growth Factor-1" that would, among other things, "improve physical performance, speed recovery from training, increase cardiac output, and increase immune functions." The product also claimed to be "your body's best defense against aging."

In this case, the company claimed that an article in the New England Journal of Medicine (Volume 323:1-6, Number 1, July 5, 1990) provided substantiation for their claim. However, the New England Journal of Medicine (Volume 348:777-778, Number 9, February 27, 2003) included a clear statement that such a claim was misleading. The editor-in-chief wrote in part, "If people are induced to buy a 'human growth hormone releaser' on the basis of research published in the Journal, they are being misled."

FDA will continue to monitor the marketplace to ensure that products purporting to be dietary supplements are labeled properly and that claims being made for these types of products are not false or misleading.