DHEA legal to purchase in U.S.A?

David Blanco delano at dax.win.net
Sat Dec 30 02:18:11 EST 1995


Steven,

Thank you. I could not have come to my own defense better.


Happy New Year,
David Blanco
LifeLink

>>If this is so, then what is LifeLink selling as DHEA?
>
>LifeLink is selling DHEA (high-nineties purity). Real DHEA has been
>sold by AIDS Buyers Clubs for about ten years, sometimes with a
>prescription requirement but most times without one. It has been
>available from compounding pharmacies for longer, but always with a
>prescription requirement. Due to the passage of the Dietary
>Supplement Health & Education Act last year, some companies now
>consider DHEA to be a food and therefore exempt from prior
>prescription requirements. This has not yet been tested in court. 
>
>Under the new DSH&EA provisions, dietary supplements are foods and
>not subject to FDA drug-approval regulations, unless therapeutic
>claims are made for them. The definition of dietary supplement is:
>vitamins, minerals, amino acids, nutrients and herbs, and their
>concentrates, extracts and metabolites. One can argue that DHEA
>is itself a nutrient, and that DHEA is a metabolite of cholesterol
>(another nutrient), so DHEA is a dietary supplement and food.
>
>The DSH&EA did not revoke drug status of nutrients that had already
>been declared to be drugs, i.e., L-dopa. But DHEA was never approved
>by the FDA for anything. As far as I can see, the FDA cannot claim
>that DHEA was already a drug by their approval procedures.
>
>Given the FDA-reform proposals circulating in Congress at the
>present time, and the strong anti-FDA rhetoric of some Republican
>members of Congress, I doubt that the FDA will do anything about
>over-the-counter DHEA, no matter how desperately they might want to
>remove it. If they cannot argue an imminent hazard to public health,
>they are required by the new law to hold an open-record rulemaking
>procedure regarding removal of DHEA, something they have never done
>before. Public scrutiny of their position and motives would probably
>be a public relations disaster.
>
>--------------------------------------------------------------
>Steven Wm. Fowkes (fowkes at ceri.win.net)    voice: 415-321-CERI
>Cognitive Enhancement Research Institute     fax: 415-323-3864
>PO Box 4029, Menlo Park, CA 94026 USA        alt: 415-321-6670
>---------------------http://www.ceri.com----------------------
>





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