IAHF Distribution List:

The document reported on below was leaked by someone inside the S.African
government to PHARMAPACT, the S.African health freedom group that I've been
working closely with.

The document wasn't intended for distribution to the public, only to people
within the S.African Health Dept. The significance is that the S.African
government is trying very hard to force full pharmaceutical Good
Manufacturing Practice Regulations on the dietary supplement industry
there, and the memo states their intention to go into Berlin in September
to recommend that the same thing be done world wide. The danger is that
Prof. Folb of S.Africa is Director of the WHO Collaborating Centre on Drug
Policy, and he has been working directly with Prof. Graham Dukes from
Norway, who is WHO Director of European Drug Policy. An effort is being
made here to force the world to "harmonize" to EEC 65/65, the European
Directive which makes all vitamins "drugs" but PHARMAPACT & IAHF are trying
to monkeywrench their plans.

**Americans: you MUST go to the breaking news section of the IAHF website
to download the latest form letter in order to file comments on FDA's
latest effort to screw us through a comments period on structure function
claims. Today's NY Times had a front page article titled :"Drug Regulators
Make Push to Rein in Herbal Remedies" Please read PHARMAPACT's expose
carefully.
 

PHARMAPACT EXPOSE :

                          SHOCKING LEAKED DOCUMENT !

        (Our abridged, bolded & underlined exerpts)(Our Ed. comments in
brackets)

                          Published by PHARMAPACT, 10 June, 1998.
 
 

FROM: THE MEDICINES CONTROL COUNCIL

TO: THE DEPARTMENT OF HEALTH

[May 6, 1998 (Number 25)]

[Docket No. 98N-0417]

    Proposed Regulations for the Control of Dietary Supplements and
Complimentary
                                                 Medicines

  SUMMARY: The Medicines Control Council is announcing that it wishes to
institute
rule-making to develop Current Good Manufacturing Practice (CGMP)
regulations for
                      Dietary Supplements and Complimentary Medicines.

The industry (HPA) submission was tendered to the Technical Sub-Committee
of the Complimentary Medicines Committee, whose function
was to democratically, and with all role-players, set standards for the
future control and regulation of dietary supplements and Complimentary
Medicines under Act 101 of 1965, and are requesting that the Minister pass
as expediently as possible, regulations to prescribe good manufacturing
practices under the listing system.(This was never
democratically/representatively conducted. Ed.)

Such regulations must be modelled after current good manufacturing practice
regulations for drugs. Such high regulations we would certainly
welcome, considering South Africa is a member of a CODEX commission where
such enforcement world-wide will become standard practice
by 1999, through CODEX mandate.

Other interested parties, such as consumers, pharmapact, segments of the
industry not represented by the HPA who submitted the outline, and the
health care community, should have an opportunity to provide comment before
the Council develops these measures in 1999. The MCC have
continually requested meeting with spoiler groupings, but to no avail.
(Bullshit, Ed.) The single, largest obstacle we face is that the consumers
and other such groupings feel they have a right to these substances without
our proposed regulations. (There you have it from the lion's
mouth. We can stop them with your help. Join us now. Ed.)

All herbs and especially Homeopathic Medicines are not safe. South Africa
may lead the international trend through recommendations
the WHO and CODEX in Berlin later this year.

Good Manufacturing Practices for dietary supplements and dietary
ingredients, include Complimentary Medicines and Traditional Medicines.
Dietary supplements/ingredients may include vitamins; minerals; herbs or
other botanicals; amino acids; other dietary substances used to supplement
the diet; and concentrates, metabolites, constituents, extracts, or
combinations of these. This also applies to traditional health substances
in the
African model of health care support. Supplements in the physical form of
conventional food shall comply with these regulations.

There is no desire or intent to impose on dietary supplements the type of
documentation and validation currently required in the manufacture
of pharmaceutical products as yet, however these will be necessary in due
course as the industry establishes itself in belief of
protection.

We believe that all supplements and Complimentary medicines should be
classified as pharmaceutical substances, and the Good Manufacturing
Practices applicable to them are similar to those generally applicable to
other pharmaceutical substances in an imperative pubic protection plan
directed by the World Health Organisation. (This false public safety
red-herring has been indisputedly intellectually demolished by us elsewhere.
Ed.)

Proposed GMP (includes:)

     Registered pharmaceutical facility.
     Representable samples, analysed at the company's expense at any time.
     Documentation of training shall be retained by the manufacturer and
set out by the MCC.
     Supervision shall be clearly assigned to qualified personnel
registered as Pharmacists in the Republic of South Africa.
     No manufacture will be allowed in a private home, or in any area
adjoining a private home.
     There shall be a quality control unit with adequate laboratory
facilities.
     Laboratory records shall be maintained and shall include complete data
derived from all specified tests.
     Substances must be supported by certificates that the product meets
established specifications at the expiration date.
     Each lot of a raw material (especially herbs shall be subjected to
microbiological tests before use.
     Each lot of raw material shall undergo at least one test by the
manufacturer to verify its identity, including chemical and laboratory
     tests, gross organoleptic analysis, microscopic identification, or
analysis of constituent markers and also shall be tested for
     conformity with all other established specifications.
     Every active ingredient must be listed on the packaging. All
accipients must be added to the list of ingredients. For plant
     substances, the common name, botanical name, and part of the plant
part/s used must be identified.

Economic Issues

The MCC sees a lot of scope for dietary supplements and complimentary
medicines in the pharmaceutical marketplace in South
Africa. Many pharmaceutical companies have indicated that the access to
these substances from competent health care
providers such as pharmacies, and medical personel can unfold into a
fruitful extension of current pharmaceutical markets. How
closely the current practices of firms manufacturing dietary supplements
conform to the industry submissions, has already been achieved by
assessing the companies applications to list their products under such a
standard. (Big Five. Ed.)

The establishment of CGMP could have economic effects on small businesses
in the dietary supplement industry. The MCC requests
that it be responsible for testing and that the companies involved, by
required by law to pay for such services.

The presence of pharmacologically active substances in these products
distinguishes them from foods. Efficacy for these products
must be established through medical trials.

MCC suggest a limited number of licence holders so that the industry can
conform in a limited amount of time.

Dated: May 6, 1998.

Prof. Peter Folb

Chairman - Medicines Control Council

Director : WHO : Collaborating Centre For Drug Policy