IUBio

DHEA legal to purchase in U.S.A?

Steven Wm. Fowkes fowkes at ceri.win.net
Fri Dec 29 17:03:48 EST 1995


 
In article <heaton-2812951749420001 at ppp-01-nerdc-ts5.nerdc.ufl.edu>, 
Cherrill P. Heaton (heaton at unf6.cis.unf.edu) writes:
>
>> Beware, such offers are often a yam product that has a compund in it that
>> is claimed to convert to DHEA in the body. DHEA is a presciption drug.
>
>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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