11.12.2003
Health Minister Annette King is patently wrong in stating that public safety is at the heart of the decision to establish a transtasman agency to regulate dietary supplements. She reneged on promised and agreed regulatory reforms in 2000, and now provides no basis for the joint agency.
That agency looks like the Australian Therapeutic Goods Administration, sounds like the Australian TGA and is dominated by the Australian TGA. Thus, there is every chance that it is nothing but the Therapeutic Goods Administration, perhaps dressed up in drag.
In her Perspectives column yesterday, the minister made statements that were factually incorrect and offered only rhetoric. This rhetoric was seen through by Parliament's health select committee when it unanimously recommended against the joint agency.
Ms King says New Zealanders are not being adequately protected from dietary supplements that have been found to cause serious illness and death. There is no evidence of this.
Contrary to her assertion, there has not been a single death in New Zealand resulting from dietary supplements. After an extensive inquiry, a coroner found that K4 was not the cause of death of a Hamilton man in his 80s; he had terminal prostate cancer.
The second person referred to by Ms King was also an old man suffering from terminal prostate cancer who died in Australia while visiting family and friends. Again, there is no evidence that he died as a result of taking K4.
Hundreds of millions of bottles of K4 have been sold around the world without problems. That Medsafe says something is dangerous does not mean it is dangerous.
K4 is still on the market globally and in New Zealand under a different name with no ill side-effects. If this was "the most tragic example", as the minister puts it, the public can have a great deal of confidence in the safety of dietary supplements.
What has been missing is a willingness on the part of the regulator to make regulation work, and to keep it up to date. The Ministry of Health has, in fact, been pursuing a joint agency for more than a decade.
To say, as Ms King does, that "even food is more strictly regulated than alternative remedies" is also false. Dietary supplements are regulated under the Food Act, so all food-safety law applies to supplements.
The dietary supplement regulations also apply and there are strict labelling laws, which the select committee notes have been enforced pathetically by the minister's officials.
Ms King has all the powers that she needs in section 8 to set any standard she wants, including a code of good manufacturing practice. In fact, as early as 1988 the industry and the ministry developed a code that the ministry never made mandatory.
What public outrage was there after the Pan Pharmaceuticals recall this year? Mostly it was about the fact that the minister at first denied supplements were regulated; therefore, she had no power to act. Then, with no evidence of any harmful effects, she did a triple-twist and recalled all products sold in Australia.
To this day there is not a shred of evidence of any harm to any person from Pan-made products, yet the industry and small investors have been punished to the tune of $400 million.
The only evidence of harm related to a pharmaceutical product, yet dietary supplements were condemned. Why? For the minister to say a joint agency is required because of the greatest regulatory failure in the world highlights the pathetic argument her officials have put up.
Ms King also claimed that our law was so outdated that solvents such as compact disc cleaners could masquerade as dietary supplements. That is absurd; she clearly hasn't read the definition of a dietary supplement in the dietary supplement regulations.
If protecting the public from unsubstantiated or false claims, or from harmful products that masquerade as dietary supplements, is the Government's priority, how many of the purveyors of such products have been prosecuted by Medsafe?
Existing law forbids supplements that contain prescription medicines and contaminants such as lead, yet I am not aware of a single prosecution in the six years I've been associated with the industry. Why? It must be that Medsafe simply doesn't have any evidence that would stand up in a court.
Finally, Ms King says that "a transtasman agency with greater international recognition and a wider resource base will ensure New Zealanders are given the best possible protection from harmful products".
She forgets that the Pan debacle was a classic example of regulatory failure under the eye of the Australian Therapeutic Goods Administration. It did not happen in New Zealand's so-called unregulated market.
* Ron Law, a former clinical biochemist, advises natural healthcare product associations on industry issues and lectures in business management.
