Natural Justice?
NZ Natural Healthcare Product Industry SuffersRon Law from New Zealand comments below on the recent Australian recall of over 1300 dietary supplement products. His article Natural Justice? was published in the Independent, the largest business newspaper in New Zealand. He quite correctly questions the Australian TGA's actions, as well as New Zealand Health Minister Annette King's actions in ordering a mandatory recall on Pan's products in New Zealand, going strictly on a basis of TGA hearsay evidence.
Moreover, he catches King in a series of lies, discussed below, pertaining to her loud contention that New Zealand "must harmonize" its laws to Australia in order to "properly protect the public health." This summer the US FDA intends to violate the law (DSHEA), which requires them to draft FOOD BASED GMPs for dietary supplements, but the FDA is on the verge of coming out with GMPs even STRICTER than pharmaceutical GMPs, which will force attorney Jonathan Emord to file yet another lawsuit in order to reign them in. I predict right now what FDA and Congressional sycophants such as Senator Dick Durbin, and Congressman Henry Waxman will do, (with massive backing from the mainstream media): they will attempt to LIE about this TGA recall (EXACTLY AS New Zealand Health Minister Annette King has been) in an effort to "justify" FDA ignoring our current law, and Durbin and Waxman will attempt to ALSO LIE ABOUT THIS in an effort to get cosponsors on their bill (Waxman is drafting a House companion bill.)
As these events unfold in Australia, New Zealand, and the USA, in Canada, the HPB is busy harmonizing Canada to Australia by seeking to slam dunk the supplement industry via Gazette 2, while Friends of Freedom in Ontario attempts to fight back by reintroducing David Rowland's lawsuit charging the HPB with flagrant violations of Canadian's rights under the terms of the Charter of Rights and Freedoms. In attempting to screw the Canadian people via Gazette 2, the HPB is attempting to blatantly ignore the fervently expressed wishes of the Canadian people who voted with their feet against HPB oppression in 1997, but rather than secure the victory that they thought they had secured, all that really happened was that the large companies trying to knock off their smaller competition succeeded in pulling the wool over people's eyes, "led" by dubious "leadership" in the pharmaceutically dominated Canadian Health Food Association. Health Canada literature handed out to supplement industry role players under the guise of "soliciting public comments" (which HPB always ignores) flat out state that Canada is harmonizing to Australia.
The same exact pattern has been occurring in England, and America: where pharmaceutically dominated vitamin trade associations are leading their rank and file membership to the cliff, while keeping the consuming public in the dark about the onrushing genocide. "Leading the way" in this global scam is so called "International Alliance of Dietary Supplement Trade Associations" (IADSA) which has been exposed at http://iadsa-exposed.tripod.com The smoking gun which exposed IADSA as fraudulent is that they kicked NNFA New Zealand out of their umbrella group, refusing to do anything to help them fend off pressure from much larger Australia to harmonize their very liberal food based dietary supplement regs to Australia's highly onerous pharmaceutically based regs which are the strictest in the world. Here, Ron Law exposes the lie that there is any NEED for New Zealand (or ANY nation) to harmonize to Australia's regs.
The fraudulent TGA recall is timed to attempt to cast extreme doubt on the safety of dietary supplements in order to coincide with the passage of the EU's Food Supplement Directive, which is timed to spur completion of a draconian vitamin standard at Codex within the next couple of years which will be made possible by the EU expanding by 10 more nations next year (all of which will fall in line behind Germany and France, which politically dominate the EU. A carbon copy of the EU Dictatorship called the "Free Trade Area of the Americas" is intended for our hemisphere, whereby the intention is to harmonize the USA's dietary supplement laws to Australia (via Canada) and to the EU. The intention is to isolate us, and take us LAST, using the SAME MECHANISMS being seen right now in Australia and Europe.
The FDA has already set us up to lose in a WTO Trade Dispute via which our dietary supplement laws can be forcibly harmonized to a grossly restrictive international standard by falsely defining dietary supplement safety. This has been done via FDA's illegally introducing an unscientific, pharmaceutically funded paper at Codex in direct violation of current US law, titled "A Risk Assessment Model for Establishing Safe Upper Levels for Nutrients" Congress whitewashed an oversight hearing on March 20, 2001 where they truth regarding this unscientific paper and FDA's illegal action could have been exposed. The hearing was whitewashed due to the political influence of pharmaceutically dominated NNFA's lobbying firm on Capital Hill- Parry, Romani, DeConcini and Symms- which has numerous multinational pharmaceutical clients, including Pfizer, the world's largest drug company. I was not allowed to testify, and neither were any of my witnesses including Richard Malter, PhD, who authored a scholarly rebuttal to the NAS so called "Risk Assessment" paper. Malter's rebuttal was published in the Journal of Orthomolecular Medicine.
FDA continues to mount an attack on DSHEA by commissioning the NAS to generate totally unnecessary so called "safety monographs" against the best selling, most popular dietary supplements- with the intention of setting us up for harmonization to grossly draconian international standards. These monographs are being "developed" for melatonin, DHEA, saw palmetto extract, glucosamine, shark cartilage, chapparel, and chromium picolinate. Just 10 days after Congress whitewashed the Codex oversight hearing where NNFA's International Committee Co Chair Karl Reidel made the highly questionable statement under oath that the USA "is not in jeopardy" of having its dietary supplement laws harmonized to a grossly restrictive international standard, his co chair on the International Committee, Randy Dennin, employee of Pfizer, was Chairing a meeting of IADSA in South Africa titled "Toward a Global Regulatory Model". It is painfully clear through Dennin's kicking NNFA New Zealand out of IADSA and doing nothing to protect New Zealand from massive pressure to harmonize to Australia's excessive TGA "system" that IADSA is doing the diametric opposite of what they PRETEND to be doing ("protecting" the industry.)
When will people EVER learn ???? FDA will be coming out with illegal GMP regs this summer which violate DSHEA which only mandates them to come out with food based GMPs. FDA's new regs are even more stringent than pharmaceutical GMPs, and FDA will attempt to justify ignoring the law based on this TGA recall. Senator Durbin will attempt to use the TGA recall to get cosponsors for S.722, the Dietary Supplement Safety Act of 2003, and when Waxman drafts a companion bill he'll also try variations of New Zealand Health Minister King's lies in an effort to urge Congress to gut DSHEA by passing S.722.
These attacks aren't happening in a vacuum. The world's FDA's and legislators world wide are being coordinated via ICDRA International Conference of Drug Regulating Authorities, a UN umbrella group attempting to bring about global harmonization of the laws on behalf of pharmaceutical interests.
The most effective thing vitamin consumers and manufacturers can do in the face of this global attack on the natural products industry is to make an immediate contribution to the Alliance for Natural Health's lawsuit to overturn the EU Food Supplements Directive. See my article at http://www.iahf.com/anh_lawsuit.html and make a donation via http://www.alliance-natural-health.org Overturning the FSD and continued lobbying in the EU Parliament against the Traditional Herbal Medicines Directive and to amend the Pharmaceuticals Directive is the best way to monkeywrench the Cartel's dictatorial global takeover plan. We must get the rest of the world to harmonize to DSHEA. IADSA sure as hell isn't trying to bring about this outcome, they're pretending to, while Dennin is actually setting us up on behalf of Pfizer, his employer. His email address is randy.dennin@pfizer.com See http://iadsa-exposed.tripod.com for jpeg files of solid evidence of IADSA's agenda in the form of original correspondence to and from IADSA and NNFA New Zealand.
published in The Independent- Largest Business Newspaper in New Zealand
Natural justice?
by Ron Law, New Zealand
Deficiencies in the Australian regulatory system will likely cost the Aussie/NZ natural healthcare product industry $300-$500 million, writes Ron Law
The largest regulatory failure of foods or medicines in the history of the planet happened in the self-proclaimed best-regulated country in the world Australia.
Blessed with watchdog the Therapeutic Goods Agency (TGA), extracting $NZ60 million from the pharmaceutical and natural healthcare product industries, Australians probably thought they had a guarantee against the shoddy practices behind this months extraordinary recalls of products manufactured by Pan Pharmaceuticals.
The New Zealand dietary supplements industry of which some players had been clients of the now-suspended Pan has come under grossly unfair and evidentially unwarranted attacks in the wake of the Aussie debacle.
A recent statement by Health Minister Annette King that the New Zealand industry does not want regulation is patently false.
Papers will today be tabled at Parliaments Health Select Committee inquiry into the proposed trans-Tasman joint TGA proving that not only does industry want appropriate regulation, it is fully united and had agreement with the Health Ministry on a proposed Healthcare and Therapeutic Products Bill in November 1998.
The papers will show the minister was, on taking office, advised of the proposed Bill and gave it her blessing, not realising her officials had already scuttled it via a secret letter by former minister Wyatt Creech to his counterpart in Australia in July 1999.
The case for New Zealand to join Australia in health product regulation is demolished by the TGAs recent extraordinary responses to the apparently errant Pan:
" December 2002-January 2003: Serious adverse reaction reports pour in to the TGA relating to a pharmaceutical product Travacalm Original. (Eventually, nearly 100 serious adverse reactions including 19 admissions to hospital will be reported.)
" 21 January 2003: Based on adverse reaction reports, TGA initiates a voluntary recall of Travacalm Original, a product containing dimenhydrinate 50mg, hyoscine hydrobromide 0.2mg and caffeine 20mg.
Over the next week TGA tests the other two Travacalm products. Travacalm H.O. (which contains hyoscine hydrobromide 0.3mg) is found to contain between 0% and 700% of the active ingredient in tablets within a single packet, indicating that the formula was not mixed properly prior to tabletising.
The third Travacalm product, Travacalm Natural, which contains 500mg of ginger, was assayed and found to be OK and not required to be withdrawn.
" 30 January 2003: TGA initiates voluntary recall of Travacalm HO.
All three Travacalm products were contract-manufactured by Pan Pharmaceuticals.
Then, for mysterious reasons, which we can only speculate about at present, three months later,
" 28 April 2003: shortly before close of business, and without any warning, the TGA holds a media conference to announce Pan Pharmaceutical product would be recalled, including export-only products, and many thousands of products made by Pan for other companies were under suspicion.TGA made the calculated statement that, consumers should stop taking ALL complementary medicines.As it turned out, less than 10% of products on the TGA database were eventually withdrawn, and perhaps less than 5% of New Zealand product was implicated.
Having thus placed all natural healthcare products under suspicion, whether made by Pan or not, the medical head of the TGA, bizarrely, reassured the public that pharmaceutical products were kosher.
However, the two products which had failed the TGAs laboratory analysis were pharmaceutical products. The natural healthcare product had been found to be of high quality.
What about the prescription medicines for export that had their licenses revoked were they faulty? How could it be that pharmaceutical products paid for by the Australian government were high quality, yet the same products being exported were not?
The TGA had discovered serious quality and safety breaches in the manufacture of products by that company [Pan Pharmaceuticals] since May 1, 2002,to quote the Honourable Annette King, New Zealand Minister of Food Safety as she issued the largest recall of food products in the world.
Kings recall came less than 24 hours after she publicly stated she couldn't recall these products because they were unregulated and that is why she needed new regulation.
MPs Lynda Scott and Sue Kedgley pointed out in Parliament question time on 1 May that s40 of the Food Act gave her such powers and the minister backtracked.
The recall in New Zealand was mandatory. The minister had no evidence any of the natural healthcare products recalled were unsound or unfit for human consumption or damaged or deteriorated or perished, or contaminated with any poisonous, deleterious, or injurious substance,the only basis s40 provides for a mandatory recall.
Kings only evidence was Australian TGA hearsay (it wont release evidence in case it decides to prosecute).
Our minister would appear to have acted illegally and this may well be considered by Parliaments Regulations Review Select Committee as an unusual or unexpected use of powers in the Act.
But back to the TGA. Having discovered a major public health problem with pharmaceutical products in January, during February, March and April all it did to protect the public from patently unsafe pharmaceutical products was:
" It cancelled Pan Pharmaceuticals license to manufacture microdose medicines including prescription medicines and products such as over-the-counter pharmaceutical folic acid medicines without telling the public or recalling the relevant medicines. The TGA did not appear to care that many women rely on high-dose pharmaceutical folic acid medicines to protect their babies from severe deformities.
" Having established there were major quality assurance problems with at least two pharmaceutical products, it tested every pharmaceutical product made by Pan.
" According to inside sources, the TGA decided against testing the natural healthcare products because that would cost too much.(So much for the natural healthcare industry's paid-up fees.)
Much media comment had suggested New Zealand needed a system such as Australia's to ensure this sort of disaster didn't happen and that products were easily traced and recalled.
We were told New Zealand needed Good Manufacturing Practice (GMP) and a register of products. Yet nearly all the New Zealand companies involved in this Australian scam already operate under GMP (voluntarily). They all have proper recall procedures in place.
And, even with the most burdensome regulatory system in the world, requiring GMP and consisting of a government-controlled central register of products and regular audits, Australia could not guarantee quality.
The TGA had audited Pan Pharmaceuticals and given it the big tick. Companies had contracted Pan because the regulator gave them the big tick.
Why did it take the TGA a week to come up with a full list of products? New Zealand, with its so-called unregulated industry under the New Zealand Food Safety Authority was only ever half a working day behind Australia in recalling products.
This sorry saga demolishes the argument that New Zealand needs a regulatory system such as Australia's to facilitate recalls. In catastrophic situations such as, this no amount of planning or regulation can work. Not when the regulator ambushes an industry sector with zero warning and sends the media and medico-centric politicians into a feeding frenzy preventing industry responding in a measured way.
The TGA has failed society and industry miserably. The TGA system was not even capable of differentiating pharmaceutical and natural healthcare products and could not differentiate registered (Aust-R high risk) and listed (Aust-L low risk) products.
The TGA had to resort to a manual, paper-based system to identify product. Every supplier had to provide via email or fax a separate document relating details of every product affected.
Many Australian companies which used Pan will be driven out of business. They cannot quickly bring to market a product from another manufacturer: regulatory approval will take a minimum of six weeks for a listed product and six months for a registered one. Each entry will cost in the region of $500 plus an equivalent consultant fee and many companies have 300-500 products.
The natural healthcare product industry pays the TGA $6 million in protection money per year, money supposedly to help guarantee the credibility of the therapeutic goods industry. Why did the TGA protect the interests of the pharmaceutical industry and not afford the natural healthcare product industry the courtesy of a phone call?
There is no evidence to show the TGA has analysed a single natural healthcare product involved in this recall and found it wanting. There was no evidence of adverse reactions to natural products. Recalling things like charcoal tablets and vitamin C tablets and suggesting that they are unsafe is absurd in the extreme.
For a problem that surfaced as a result of serious adverse reactions to pharmaceutical medicines, it is a mystery that the Australian regulators have turned that around to hammer innocent parties.
If the TGA had planned to inflict severe wounds on innocent parties it could not have planned it better.
The negative impact on the natural healthcare product industry in Australia and New Zealand is likely to be $300 million-$500 million a figure orders of magnitude more than the maximum fine a court can impose on a guilty party.
It is staggering the TGA has exercised unbridled power without notice, without affording the right to consult a lawyer, without a formal charge, a trial, right of defense or right of appeal.
Not just the alleged sinner, but an industry that is an innocent bystander is punished because it used a manufacturer approved by the regulator itself.
Even those industry players who could be regarded as friends of the TGA have opposed the notion that it dominate the proposed trans-Tasman joint regulatory agency the government and health officials are seeking. Large companies such as Blackmores, Mayne, Healtheries and Nutralife variously described TGA as restrictive,oppressive,overly prescriptive,inflexible,lacking transparency,burdensome,overly-bureaucratic,costly,excessive,and cumbersome in their submissions to New Zealand's Health Select Committee.
Few within the natural healthcare industry would disagree with the above adjectives. To this list could be added vindictive,uncontrolled,vile,despicable and even corporate terrorist.
The Australian system was supposed to guarantee the quality of product but has failed to do so. It seems that the only thing that the Australian TGA system protects Australian citizens from is the good quality imports that we enjoy in New Zealand.
Now is the time to establish an independent commission of inquiry into the wider issue of regulation of health. This would expose how the natural healthcare industry remains in bondage to regulators with motives not driven by good regulatory practice.
Industry should now pool resources, employ the best team of litigation lawyers it can find, initiate a war on corporate terrorism and run the Australian TGA out of town.
Compared with its style of democracy, totalitarianism is a cakewalk.
Ron Law, a former biochemist, advises natural healthcare product associations on industry issues and lectures in business management. He was appointed by the Director General of Health to the Sentinel Event Project working group that advised the Ministry of Health on the reporting and management of medical injury in the public health system.