From: shava@hermes.oit.unc.edu (Shava Nerad Averett)
Newsgroups: alt.magick
Subject: Re: herbal freedom
Date: 24 Aug 92 02:49:33 GMT
Organization: University of North Carolina, Chapel Hill

In article <Gerald_Del_Campo.0089@sorinc.UUCP> Gerald_Del_Campo@sorinc.UUCP (Gerald Del Campo) writes:
>In a message dated Thu 20 Aug 92  5:11, mcgrath@cs.uiuc.edu (Robert
>McGrath) wrote:
>|> 4. That truthful health information about dietary supplements is
>permitted.
>          ^^^^^^^^
>|> 5. Tha the FDA has no prior restraint authority on truthful labeling or
>|> advertising.                                       ^^^^^^^^
>
> RM> No criticism intended, but just exactly what does "truthful" mean? Is
> RM> this a standard legal term I'm not familiar with?  Otherwise, how is
>it
> RM> intended to be interpreted?
>
>In the context it is being used I would assume they mean factual (unlike
>the information being desseminated about these herbs presently).

Shava launches into a short history lesson...  Not guaranteed to be accurate
in specifics, since I don't have my references at hand...

Toward the end of the last century, well into the middle part of this 
century, a lot of people peddled 'patent medicines,' which were odd 
nostrums containing a lot of herbs, but often the most active ingredient
was alcohol.  These compounds were particularly popular during prohibition
(medicinal alcohol was legal) and in dry counties, and among otherwise
teetotaling folk who found the medicine...uh...curiously refreshing.

Some of these medicines really worked, but many of them were, shall we say,
limited by the faith of the consumer.  Lydia Pinkham's medicines are an
example of a patent medicine which proved out as medically sound over time.
As a remedy for 'women's complaints,' it contained several herbs that 
contained compounds that were precursors or which simulated estrogen.
It's still sold in some old-fashioned drug stores, and in an occasional
funky health food store.  

The 'Pure Food and Drug Laws' which were, as I remember, put thru in the
FDR administration somewhere, began restricting the claims of herbal 
medicines, but the revisions to the medical patent laws in the 1940's
clinched it.  The Pure Food & Drug laws made it such that any herbal
compound, to be marketed as a drug, must *prove* truthful it's claims of
efficacy, and also prove a lack of harm.  But the patent law revisions
made it such that an herbal compound -- i.e. anything derived from the
plant, rather than synthesized chemically -- could not be patented.  

The result of these two laws was to shut down funding for zoopharmocognosy
in this country (zoo -- from living sources; pharmo -- drug; cognosy --
knowledge of, more or less..).  While in Germany, for example, Valerian is
used safely and effectively in OTC medicines, here it is distributed without
claims or safety instructions -- because no one can afford to test it, 
without being able to patent a medicine to recoup their research.  So 
instead, in the 50's, one of the major drug companies analyzed valerian
(a non-addictive drug with few side effects) and isolated one of the 30-
odd suspected active compounds in the herb.  They synthesized it, and 
marketed it as Valium -- possibly the worst abused drug of the 60's.

When the govt asks for "truth" in these cases, they are asking by the
criteria of the FDA's truth-in-labelling.  This presumes scientific
proof of the safety and effectiveness for an herb in *FDA* trials.  As
most of us have noticed with AIDS and morning-after pills and such, the
FDA has no interest in off-shore research.  However, the US patent office
still will not allow patenting of any compound including herbal material,
so research to FDA trial standards is not fundable for any herbs.

As a note, next time you are in a drug store, take a peek at some of
your favorite OTC medications.  Many of them list 'inactive ingredients'
that are herbal compounds.

This new law would, in my opinion, be an unenforceable mess for anything
that could be grown in this country (at least for us herb gardeners! ;),
but I believe that it is wrong-minded in its concepts (opinion, in case
you think I'm pontificating).  I believe that people would be better off
with a more liberal reform of the patent laws in this country, which would
allow us to certify the effectiveness of herbal medicines in a cost-effective
manner -- or at least prove no-harm, and label the herbs for their TRADI-
TIONAL theraputic use, so people don't end up poisoning themselves. (My
favorite current example is the sports drinks with aloe vera juice in them.
Aloe, in addition to being a pretty powerful laxative when taken internally,
is a powerful abortifacient -- yet the FDA won't allow a 'unproven claim'
to be published as a warning on the labels of these drinks, warning women
who might be pregnant away from them -- of course, one suspects that the
FDA doesn't want folks to know that there are effective, and cheap 
abortifacients out there...)

I encourage folks to contact their congresscritters.  Remember that 
this law would also restrict trade in traditional medicinals such as
mhyrr, which folks here might like to use for various purposes...  

-- 
Shava Nerad Averett				shava_averett@unc.edu
/*  all materials (c)1992, Shava Nerad Averett, and have nothing significant
    to do with the University of North Carolina, a mostly owned subsidiary 
    of the NC Legislature, a mostly owned subsidiary of the DOT.      */
Newsgroups: alt.magick