Fw: NZ: committee not qualified to reg. herbs

[Guest guest]

-

Dr. J. Rozencwajg, MD, PhD. Saturday, March 09, 2002 1:03 AM

[paracelsus] How about that!!!!!!!

 

 

 

Now read this and you will know where the real Land of the Free is!!!

 

Please disseminate as widely as possible and feel free to use as a

political document, with the compliments of the Kiwis, in nuke-free New

Zealand.

 

VERY IMPORTANT BREAKTHROUGH

 

 

 

The New Zealand Natural Healthcare and Therapeutic Product industry is

stunned and yet thrilled at the Ministry of Health's public admission

that its

Medicine Classifications Committee is not qualified to regulate herbals

products.

 

In overturning the advice of the Minister of Health's own Statutory

Expert Advisory Committee, the

Minister of Health's Delegated Authority, Dr Bob Boyd, has accepted his

own

Ministry of Health's advice to reject the expert committee. Confused?

Read on!

 

The MCC's recommendations would not only have effectively banned safe

herbs such

as comfrey and borage, they would also have introduced an arbitrary

regulatory framework for regulating herbs that could " potentially "

contain

alkaloids deemed to be toxic without robust evidence-base risk analysis.

This would have banned a number of other hitherto safe

products, and prevented some safe ones from being reclassified for OTS

use.

 

What is even more significant is that the advice to reject the

recommendations of the Medicines Classification Committee came from

Medsafe, a Ministry of Health business unit that regulates drugs and

medical devices. Medsafe's senior medical advisor is the chair of the

MCC.

 

The reasons given by the Delegated Authority for accepting Medsafe's

recommendation to reject the proposals are;

 

Medsafe does not recommend that the proposal to adopt the MCC proposed

framework for the classification of herbal medicines be adopted at this

time

for the following reasons:

 

* MCC expertise is in the practice of medicine and the practice of

pharmacy:

members are not skilled in the field of herbal medicines

 

* The consultation process was limited in its effectiveness and

therefore

there is no assurance that all relevant information was considered

 

* Accepting the recommendations would result in unavailability of

products

for which there is no evidence of consumer harm in New Zealand.

 

See http://www.medsafe.govt.nz/Profs/class/mccMin11Dec01.htm

 

Perhaps for the first time in the World, a government department has

acknowledged that its own expert medicines classifications committee is

incompetent regarding the regulating of herbal products. This echoes the

Canadian Parliament's Standing Committee on Health's findings that both

its

Therapeutic Products Branch and its Food Branch lacked expertise and

experience in regulating Natural Healthcare Products.

 

The New Zealand government's decision totally supports the submissions

made

by the National Nutritional Foods Association whose risk assessment

revealed

that there was no evidence of a public health problem, no evidence of

market

failure, that banning comfrey and borage, for example was not a sound

risk

management option (as it would give the two cult status and encourage

home-grown product with no quality assurance systems limiting

pyrrolizidinealkaloid levels,) and that education and GMP controlled PA

standards were the most effective risk management options.

 

This decision also means that the Ministry of Health admits that it too

is

incompetent regarding the regulation of Natural Healthcare & Therapeutic

Products as it has no one with expertise in the practice of natural

medicine

on its staff.

 

The public of New Zealand should be reassured, however, as there have

been

zero deaths from legal herbs, vitamins, minerals and the like in New

Zealand, ever.

 

This stunning victory follows not only industry's insistance on risk

analysis based regulations, and good regulatory practice but also

follows on

the heel of earlier decisions to resist the Australian TGA's attempts to

get

these and other products banned or restricted in New Zealand. These

include

attempts to ban boron, and reduce iron supplements to 5 mg.

 

In 1999, the National Nutritional Foods Association was able to prove to

the Parliamentary Regulations Review Select Committee that the Ministry

of

Health had abused its regulatory powers and failed to follow risk

analysis

methodology when it imposed unjust warninglabels on bee products. A

subsequent 5-person ministerial scientific review found against the

Ministry

of Health on all five terms of reference. For only the second time in

New

Zealand's history the chair of the Regulations Review Select Committee

moved

in the House of Parliament that regulations be revoked.

 

The National Nutritional Foods Association Executive Director, Ron Law,

now

awaits the Ministry's decision to allow Kava Kava to stay on the market

as,

having been given robust analysis of the very tenuous evidence from

Europe

and the USA, there is no scientific basis for banning it -- especially

as

there is no evidence of consumer harm in New Zealand.

 

Other associations and the International Alliance of Dietary/Food

Supplement

Associations (IADSA) should take heart from this occassion -- Gin &

Tonic or

Cappuccino diplomacy will not prevent the Natural Healthcare &

Therapeutic

Products industry from being dessimated by a thousand cuts; robust risk

analysis and rationale thinking and debate will -- even with restrictive

budgets.

 

The pending decision on the EU Food and Herbal Directives is a case in

point --- where is the evidence of market failure in less stringently

regulated economies? There simply isn't any. Therefore, setting up

systems

that are regulated by bureaucrats and 'expert' committees, under the

guise

of safety, to protect vested interests rather than using robust evidence

based risk analysis and considering consumer freedom to choose hitherto

safe and

effective product is a total nonsense. Neither is it commensurate

with the EU's Best Regulatory Practice nor that of the OECD.

 

eg, See

 

http://europa.eu.int/comm/enterprise/standards_policy/international/sec2

001_1296_en.pdf

http://europa.eu.int/comm/enterprise/enterprise_policy/gov_relations/tra

nsparencyint.htm

http://www.easa-alliance.org/news_views/en/press_releases/pr_2002_02_16.

html

http://www.easa-alliance.org/news_views/en/press_releases/pr_2001_02_08.

html

http://europa.eu.int/comm/consumers/policy/developments/enfo/enfo02_en.h

tml

 

 

Given the above decision, effectively by the New Zealand Minister of

Health, the New Zealand government must now revisit the planned

Trans-Tasman Joint Therapeutic Goods Agency which was unanimously

rejected by a pan-industry natural healthcare and therapeutic products

meeting in Auckland on Friday 8 March.

 

Be encouraged folks. Sometimes G & T and Cappuccino diplomacy doesn't work

-- it might be 'nice' but it costs heaps and doesn't seem to be

delivering much.

 

The NNFA is committed to defending its incredibly safe natural

healthcare and therapeutic products using robust evidence based risk

analysis and rational, and if need be, vigorous, debate -- we do this on

a budget of $US20,000 and we look forward to further stunning

announcements from the New Zealand government as we continue to develop

a regulatory system that protects the public, enables free and fair

trade, and doesn't decimate small business through exorbitant regulatory

compliance costs as has happened in Australia.

 

 

Given that the New Zealand and Canadian governments have both deemed

their regulators and so-called expert advisors to be incompetent

regarding the regulating of natural healthcare and therapeutic products,

and given that our New Zealand research using official source documents

has revealed that in New Zealand, highly preventable medical injury is

the third leading cause of death, (after vascular disease and cancer)

and given that highly preventable fatalities due to pharmaceutical

medicines are at least 42,000 times more common than deaths due to legal

natural healthcare and therapeutic products, (There have in fact been

zero deaths identified due to legal natural healthcare and therapeutic

products in both New Zealand and Canada) European politicians should be

asking the hard questions regarding the imminent passage of the Food

Directive -- where is the evidence to support the notion of market

failure? Quite simply, its not there. Sporatic illegal activities

pervade all aspects of society and are not unique to natural healthcare

and therapeutic products -- to regulate our industry differently to

others is way beyond the realms of good regulatory practice, and natural

justice.

 

If the European Food Directive proceeds with retension of the RDA as a

risk management option, then simply, safety and public health are not

the drivers -- the proponents of such a system simply can not justify it

based on the evidence.

 

This also highlights the nonesense of IADSA quiesence and silence

regarding the absurd regulatory response to kava -- simply put, if IADSA

genuinely believes it is acting in the interests of the global dietary

supplement industry, it must forth-with release a press statement

applauding the New Zealand decision, and condemning non-evidence-based

non-risk analysis based regulatory action. It might result in the

cancellation of a few Cappuccino appointments, but our small businesses

and customers will be eternally greatful.

 

Regards

 

Ron Law

Executive Director

NNFA New Zealand

 

PS - feel free to distribute to whoever.

 

 

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