Misbranded Dietary Supplements Destroyed
Park MD, 5 May 2003
Food and Drug Administration (FDA) announced today that Nature's
Youth, LLC, of Centerville MA has completed its voluntary 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.
is committed to help consumers make health and dietary choices based
on accurate information," said FDA Commissioner Mark McClellan,
MD,PhD. "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."
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."
this case, the company claimed that an article in the New England
Journal of Medicine (Volume 323:1-6, Number 1, 5 July 1990)
provided substantiation for their claim. However, the New England
Journal of Medicine (Volume 348:777-778, Number 9, 27 February
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."
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.
Food and Drug Administration (FDA).