Contact: Alisa Cahan 305-672-4422, [email protected]
DHEA: Fountain of Youth or Dangerous Steroid?
DHEA, developed to treat lupus, has recently made its way into mainstream health food stores and is being marketed as a naturally occurring "Fountain of Youth." The problem: The natural drug is converted to testosterone and can have unsightly, even dangerous side effects. The latest research shows that using DHEA can lead to facial hair growth, acne and osteoporosis in women or prostate cancer in men. After testing 16 mainstream DHEA products, researchers found that only half actually met manufacturers' label claims. Since the FDA does not yet monitor "dietary supplements," consumers need to be aware of the dangers of natural drugs.
See Abstract below:
Analytical Chromatographic Applications Poster Session
Date and Time: 11/19/98, 9:00:00 AM - 12:00:00 PM
ANALYSIS OF DEHYDROEPIANDROSTERONE (DHEA) DIETARY SUPPLEMENT PRODUCTS.
R. Petesch*1 and J. Parasrampuria2. 1SRI International,
Menlo Park, CA 94025; 2Genelabs Technologies, Inc., Redwood City, CA 94063.
Purpose.
Currently DHEA (dehydroepiandrosterone) products are sold in the United States as dietary supplements, and the U.S. Food and Drug Administration (FDA) have not evaluated their safety and efficacy. Sixteen randomly selected DHEA products were analyzed for the presence and total content of DHEA to assess the accuracy of the manufacturers' label claim. Methods. All products were analyzed by HPLC with ultraviolet photodiode array (UV-PDA) detection to establish the presence and content of DHEA by comparing the peak retention time and UV spectrum profile of DHEA reference material. DHEA presence was confirmed by analyzing extracts of each product by Fourier-Transform infrared (FTIR) spectroscopy.
Results.
On the basis of HPLC retention index, UV-PDA and FTIR spectral analysis, of the 16 products tested, one was found to contain no DHEA. One product was found to contain an average of 150% of label, with an RSD of 32%. Two other products labeled as containing "naturally occurring DHEA" were each found to contain only 0.5 mg/dose on the average. Of the remaining 12 products, only 6 were found to contain an average ranging from 95-105% of label claim.
Conclusions.
Only half of products tested were found to meet the manufacturers' label claim using typical release specification criteria of 90-110% as applied to most pharmaceutical products manufactured as per cGMP. In the worst case, the product did not contain any DHEA. Supported by Genelabs Technologies, Inc.
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