Summary for Very Busy People
Introduction: Problem with Current Regulations:
Medsafe notified us of violations of the Medicines Act (1981) due to our dietary products with therapeutic properties.
Consequences of Non-Compliance:
Severe penalties include hefty fines and imprisonment.
Compliance is necessary to avoid legal and financial ruin.
Endomet Laboratories' Withdrawal:
Unable to reformulate or re-label products for NZ market.
Withdrawal leads to significant loss for consumers.
Legislative Changes and Financial Implications:
Repeal of the Therapeutic Products Act (TPA) aims to avoid stricter penalties and higher costs.
Replicating FDA functions is financially unfeasible for NZ.
Proposed Solutions:
Separate oversight for supplements and pharmaceuticals.
Accept supplements approved by reputable international agencies.
Allow health professionals to dispense higher-potency supplements if necessary.
Conclusion:
Moral support is appreciated.
Future legislative proposals will be necessary.
Contact us for alternative product recommendations.
Introduction
Medsafe has cautioned us that our actions of importing and selling dietary products with therapeutic properties that classify them as medicines are in violation of the Medicines Act (1981). In this article, I explain the problem, the penalties and outline the solutions.
Bar set too low
Unfortunately, the bar for potency has been arbitrarily set so low in NZ that many dietary supplements are rendered ineffective in times of need, such as when a person is fighting an infection or recovering from surgery. Take zinc, for example:
Some of the products that were on our shelves contain zinc at total recommended daily doses equal to, or higher than 25mg. They are, therefore, according to the Medicines Act, prescription medicines. Please take a moment to go here for a summary of the critical roles and functions of zinc in the body, and you'll appreciate why in some cases, more than 25mg is required:
There'd be hardly a single person in New Zealand who isn't in need of more zinc, and giving them just 25mg per day will do nothing other than prevent things getting worse!
Iodine is a further illustration of how the bar has been set so low as to render dietary supplements as good as useless. Again, most New Zealanders have low iodine due to it not being adequate in the modern diet and the ubiquitous presence of toxic iodine blockers such as fluorine, chlorine, and bromine. So, it'd seem sensible to recommend taking a little seaweed daily. Seaweed, such as kelp, is an excellent source of iodine and many other beneficial nutrients.
Unfortunately, a single capsule of our Endomet Kelp contains 0.6 mg of iodine. Products containing iodine at total recommended daily doses of 300mcg or more are, therefore classified as being pharmacy-only medicines in New Zealand. Again, as with zinc, we're caught, and it's no longer permitted to be sold.
Highlighting the significant difference in iodine limits, the average daily iodine intake of the Japanese, known for their longevity and low disease rates, is around 12mg or 12,000 micrograms (mcg), vastly exceeding the levels seen in Western countries.
Endomet Laboratories, the supplier of the products we've been mandated to remove from the market, stated:
Analytical Research Laboratories (ARL) adheres to all US regulatory authorities and has been licensed under Clinical Laboratory Improvement Amendments (CLIA) act since its inception over 40 years ago. The Clinical Laboratory Improvement Amendments of 1988 (CLIA) regulations include federal standards applicable to all US facilities or sites that test human specimens. Endo-met Laboratories is under the US Department of Health & Human Services and adheres to all US regulatory authorities. Our products are manufactured in facilities using Good Manufacturing Practises (GMP). Our regulatory agencies such as the FDA are highly regarded and its' practises are generally accepted worldwide, and it is quite possible New Zealand may be spending excessive amounts of money in an attempt to replicate the functions and responsibilities of the FDA. Due to the relatively small market in New Zealand, Endo-met Laboratories would be unable to reformulate our products and modify its labelling to meet the countrie's domestic regulations. Instead, we will need to discontinue our operations in New Zealand.
Terrifying consequences of non-compliance
Despite their approval by the FDA of the USA for sale and distribution as dietary supplements, and as explained above, some of our products are classified as "medicines" under the Medicines Act (1981).
Penalties for infringements of the Medicines Act (1981) include a $100,000 fine for the company. $20,000 for each of the Directors (that's Alofa and me) and up to six months in jail. This doesn't include risking being tied up in legal procedures for the best part of 4–5 years, plus a few hundred thousand dollars in legal fees, and the massive loss of trade over that time. So it'd mean enormous stress, and professional and financial ruin for us if we chose to play chicken with the authorities by disputing their rulings. The law is the law, even if it is outdated and considered unfair by us. So, we must comply to avoid being legally tied up for several years, facing hefty fines, financial ruin, and potential imprisonment. So, argue we won't, and comply, we will.
Endomet wrote:
Due to the relatively small market in New Zealand, Endo-met Laboratories would be unable to reformulate our products and modify its labelling to meet the country's domestic regulations. Instead, we will need to discontinue our operations in New Zealand.
Endomet products are no longer accessible in New Zealand, and their testing services may also cease due to discrepancies between their lab's dietary supplement recommendations and the products available in NZ. This is a loss for everyone!
Legislative Changes are Underway
The Coalition Agreement between ACT, National, and NZ First includes the repeal of the Therapeutic Products Act (TPA). We can thank NZ First for this. The TPA was meant to replace the outdated Medicines Act. The new Act, which was passed into law last year and was set to go into effect by 2026, included much harsher penalties for violators.
I've written dozens of articles about the TPA, some of which you can find here, including information on the new penalties. These are indeed terrifying penalties, not only for importers and retailers but also for health professionals who incorporate natural therapies into their practises
Mimicking the FDA at Enormous Cost
Endomet wrote:
Our regulatory agencies such as the FDA are highly regarded and its practises are generally accepted worldwide, and it is quite possible New Zealand may be spending excessive amounts of money in an attempt to replicate the functions and responsibilities of the FDA
Who in New Zealand would disagree with the observation that we are wasting a whole lot of money trying to replicate the FDA?
With a population of only five million, New Zealand finds itself in a deepening financial crisis due to governmental mismanagement. Approximately $90 billion was borrowed and squandered during the ineffective COVID response, resulting in a substantial debt burden that'll hinder the economy for generations. Given our limited resources, replicating the massive regulatory and surveillance capabilities of the US FDA, including trying to detect "unapproved" dietary supplements entering the country is simply not feasible.
Proposed Solutions for New Legislation
The Therapeutic Products Act (TPA), which is being repealed, would have necessitated the hiring of hundreds of public servants to oversee and enforce it. The financial burden of operating this extensive new bureaucracy was to be borne by New Zealand's domestic natural health industry. This would have resulted in skyrocketing costs for everyone, including consumers, without any tangible benefits. Many people feared that the TPA would have a devastating impact on the domestic natural health industry. Fortunately, implementation of the TPA has been suspended while the legislation undergoes repeal and revision.
The solutions proposed here for inclusion in fresh legislation are remarkably elegant and simple. They'll save the country millions of dollars by eliminating the need for massive layers of stifling bureaucratic oversight:
Separate legislation and oversight for dietary supplements and pharmaceutical products. The new legislation recognises the outstanding safety profile of dietary supplements.
If a dietary supplement has been approved for sale and distribution by reputable regulatory agencies such as the United States Food and Drug Administration (FDA), Australia's Therapeutic Goods Administration (TGA), or the European Commission, then it is also approved for importation and sale in New Zealand. It is important to mention that these regulations currently govern the export of NZ-produced dietary supplements to the USA, Australia, and the European Union.
To provide an extra layer of protection, it could be considered to require that imported dietary supplements, which exceed certain potencies, be dispensed only under the supervision of a health professional with a tertiary qualification. Mind you, if an agency such as the FDA authorised for sale of the dietary supplements, it would render this step (3) unnecessary due to their outstanding track record of safety. Besides, the existing regulations in the Consumer Guarantees Act, which handle misleading statements and safety of goods, will guarantee the ongoing high standards of safety and efficacy for dietary supplements available in New Zealand.
Conclusion and Call to Action
For now, I'm not asking anything of you other than your moral support. However, the time will come soon when I'll ask you to make thoughtful proposals to Members of Parliament regarding the writing of the new legislation to replace the Therapeutic Products Act.
By the way, in case you're our customer and your HTMA report has suggested using Endomet products, or you are in need of a refill, there's no need to be concerned. Simply email me and I'll suggest suitable alternatives for you.
In the meantime, sit tight.
Thank you for your understanding.