Naturopathic Product Classed as a Drug

by Leisa on May 19, 2010

Just last week I received a letter from Metagenics, one of the premier naturopathic supplement companies in Australia and the US, notifying me of a natural product which had been taken from being freely available for naturopath’s to prescribe, and had been classed as an S4 medication which is now only available on prescription.

For years we have been warned of the dangers of the Codex initiatives, to take our natural supplements out of the hands of well-trained natural practitioners and class them as drugs.  Foods, herbs and supplements fall into this category, where any substance which causes an effect on the body, can be classed as a drug.

There is no discretion between safe substances and dangerous medicines.  The warnings tell us that high dose, or therapeutic levels of supplements will be banned and all we will have left to work with is very small amounts of vitamins which will do very little therapeutically.  For example it has been bandied around that Vitamin C will only be available in 60mg tablets – which is completely ineffective.  For therapeutic levels, I have often prescribed up to 25,000mg per day in certain circumstances – so how many 60mg tablets would we have to use in this case?

The push for Big Pharma to regulate our natural products as drugs, stems from the fact that consumers are turning their backs on pharmaceutical medicine and turning to alternatives in droves.  A monopoly on the health market assures these companies of covering all bases, so they do not lose market share, wherever the dollars are being spent.

In this worst case scenario, taking natural medicines away and making them only accessible to doctors, (who are not trained in how to use natural medicine) means that essentially, this form of treatment will no longer be available to the public.  Doctors are not likely to prescribe anything natural over a drug, and we would therefore be in danger of losing a whole industry.  I hope it doesn’t come to that.

The product that has been taken away from naturopath’s is one called Red Yeast Rice extract which is (from the Metagenics Practitioners Manual) “the fermented product of rice (Oryza sativa) on which red yeast (Monascus prupureus) has been grown. It has been used in China for hundreds of years. The major active components in red yeast rice extract are a group of compounds known as monacolins. These compounds directly inhibit the enzyme HMG-CoA reductase to decrease cholesterol synthesis in hepatic cells, reducing LDL levels and supporting HDL levels.”

Essentially, we used this product as an alternative to statin medication as a successful adjunct to treatment to lower cholesterol levels in people who had been advised to go on medication to manage this marker.

When a patient is advised to go on statin (cholesterol lowering) medication, it is usually viewed as one that they will need for life to “manage” their cholesterol levels.  The medical profession appear to be confused as to the role of cholesterol in a healthy body, and like to see it as low as possible.  Most naturopath’s are aware, however, that cholesterol which has been stable and rises rapidly is just a marker of some type of underlying problem that may need to be addressed.

Liver congestion, poor bile production and fat breakdown, a change in diet, thyroid dysfunction, hormonal imbalances – there are many reasons why someone can present with a marker called “high cholesterol” and the idea is to treat the whole person and bring them back into balance with natural medicine, at which point their cholesterol levels return to normal.

During this process we may use a product such as Red Yeast Rice extract, to assist in managing the biochemistry until other methods of dietary changes, herbal support, exercise, etc are employed to correct any underlying causes.  Then the person is weaned off this supplement as their health improves.  Short term, as a part of a naturopathically managed program, I have no problem with using this product.

But now the TGA in Australia has deemed this product to be too dangerous for naturopath’s to use.

“At the June 2009 meeting, the Committee agreed to a new Schedule 4 class entry for HMG-CoA reductase inhibitors. The June 2009 minutes included the following:
• It was agreed that a patient generally could not self-diagnose hypercholesteraemia.
• Should a patient incorrectly self-diagnose (and take an HMG CoA reductase inhibitor), the patient would be unnecessarily exposed to the risk of side-effects (including the risk of rhabdomyolysis). Furthermore, given that this class of substances was used to lower blood cholesterol in order to decrease the risk of heart attack or stroke, oversight by a medical practitioner was appropriate to look at the entirety of the matter.”

What they are saying in this report, is that anyone taking natural red yeast rice extract for lowering cholesterol should be monitored by a medical practitioner. So instead of finding a way to integrate both our worlds and provide the best outcome for the patient – they have just taken away our ability to work with these patients effectively.

Any good naturopathwho is working with a patient with high cholesterol will also be working with the patient’s doctor as well.  We also like to see blood test results and gauge how our patient is traveling with the treatment.  So what the TGA have effectively said in their report, is that they don’t look at the option of holistic treatment for the patient, but dismiss it entirely.  They do not even mention that this product was “naturopath only” , the patient can not purchase it “off the shelf”, meaning they would need to be in the care of a well-trained natural medicine specialist.  In the report they use the terms “self-diagnosis” rather than giving credence to a valid profession.

This is where our health care system breaks down.  There is no integration between the worlds of natural and orthodox medicine – even if it is in the best interests of the patient.  This is a sad day for natural medicine, and I genuinely hope that this isn’t the tip of the iceberg.



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6 commentsAdd comment

Amber May 22, 2010 at 1:12 pm

Considering that the complications of aspirin are so many, and include death, theoretically aspirin should be an S4 drug!! Instead it is in supermarkets for people to self medicate. Yet another fantastic example of our government/pharmaceutical companies’ scare tactics to keep their lovely sheeple buying products that will cause them harm. Gosh. I imagine that TGA members are medical practitioners. It is immediately evident that they are making decisions biased on their own preference for conventional medicine. May we, as responsible adults be given the choice to access the health care we feel is right for us as individuals?

Leisa May 25, 2010 at 10:29 pm

Hi Amber,
You are so right – aspirin as well as many, many other over the counter medications should be S4. There is such a massive double standard in the industry and unfortunately the natural medicine industry is bearing the brunt of that. The best we can do is keep raising awareness and campaigning against restrictions on natural medicine. I’m not all for anything that could potentially be harmful to be available “on the shelf” at all times – that is what qualified naturoapath’s are for – they know the side-effects the interactions with medications, the interactions between other herbs etc, and can offer a therapeutic doses of vitamins, minerals and herbs as required – but for most general supplements – they are SO safe and shouldn’t be under classed under the same regulations as drugs. It’s just ridiculous!

Christine June 10, 2010 at 1:09 pm

Hello Leisa,
As an experienced Clinician in Nutritional Medicine, I cant totally agree with your arguments about the rescheduling of Red Rice Yeast to S4. The product contains lovastatin and ‘natural’ or not, it exerts the same effect as any other S4 statin drug in human cells. It is an HMG CoA reductase inhibitor which blocks not only the synthesis of cholesterol but also Coenzyme Q10. So if pharmaceutical statins are classified as S4 medication, why is the statin found in the red rice yeast any different? These are ALL symptomatic therapies which do little if anything to arrest the clinical condition. Nutritional or Naturopathic Medicine is about correcting the fundamental biochemical defects and red rice yeast can never do that. The real significance of the blood cholesterol level of itself is arguable. Appropriate dietary intervention as well as targeted supplements to address biochemical dysfunction at the cellular level has been shown to restore endothelial function, the primary defect which leads to heart disease. The epidemiological evidence for diet and lifestyle is very strong not only for for cardiovascular disease but a awhole range of other conditions. So, don’t mourn the loss of red rice yeast – unless you want to practise mainstream medicine – and I’m quite sure you don’t.

Leisa June 20, 2010 at 6:06 am

Dear Christine,
I appreciate your comments on this article, but I do want to re-iterate a couple of points that you seem to have overlooked in my post, and also to address a couple of your very valid points. Yes the Red Rice Yeast also works on the same pathway as statin medication, and yes, any naturopath prescribing this product would also be prescribing it in conjunction with Q10 as you mentioned – this is standard practice for naturopath’s who understand that both this product and medication block the synthesis of Q10 as it inhibits cholesterol production. However, the Red Rice Yeast does not come with the myriad of side-effects that the statin medications come with – so I see it as a much safer and more tolerated option for short term use.

Which brings me to the next point. In my post I wrote “as an alternative to statin medication as a successful adjunct to treatment to lower cholesterol levels in people who had been advised to go on medication to manage this marker.” I didn’t write that we use it in place of natural therapies, but as an adjunct while we are correcting the underlying biochemical dysfunctions. I agree, cholesterol in itself is not an issue, as I mentioned in the article, it is a only a marker that may indicate other systemic dysfunctions.

I also wrote: During this process we may use a product such as Red Yeast Rice extract, to assist in managing the biochemistry until other methods of dietary changes, herbal support, exercise, etc are employed to correct any underlying causes. Then the person is weaned off this supplement as their health improves. Short term, as a part of a naturopathically managed program, I have no problem with using this product.

I still stand by that statement. In no way during this post was I suggesting that Red Rice Yeast should be regarded as a “cure” for high cholesterol, or even that that proposition has any validity. I was trying to make the point that we did have a product that we can use short term, for those patients whose doctor has told them they need to go on medication. This product was a great way to avoid patients having to take dangerous medication, which often, if left in the hands of the doctor they will be on for life, and give them a quick result which keeps both patient and doctor happy – while we go about our job of healing the REAL causes.

I think Christine, that essentially we are both in agreement on these points, but I may not have explained my position clearly enough in my post. I believe Red Rice Yeast was a very handy tool to have in our tool kit for when the situation required it, but no, it is not an essential part of any long-term healing program.

My point was that I don’t want the government taking away this option from qualified naturopath’s who are able to use it in the way it was intended to be used, as an adjunct in certain situations. If the government deems that we are not knowledgable enough to understand how to use this product, then what else are they going to take away from us? It is not this particular product as such, but more the principle of the TGA ignoring the qualifications and knowledge of a whole industry.

Keep up the great work that you are doing,
Warmest regards,

Michele July 9, 2014 at 11:40 pm

I’ve been on 20mg of Crestor (every day) for about 4 years. Im 46 years old. Obviously I had high cholesterol and my doc put me on it. The side effects ive had are terrible memory loss and I get confused. I thought it was just part of aging and then I started hearing and reading about the side effects ! Im going to stop takinv it as of today and be more active about my health. Is it possible to still buy this red rice powder in Australia? I would really appreciate any info or help. I hope you read this.

Leisa July 10, 2014 at 12:53 am

Hi Michele,
Your story is quite common when it comes to medication for high cholesterol, unfortunately… The red rice powder was available through naturopathic companies, but was taken off the shelf a while ago due to some restrictions within the TGA. The best thing to do would be to see your naturopath – and if you don’t have a good one, we have a naturopathic service available in person in the clinic – or by phone or Skype if you are some distance away – and have a look at what might be leading to the rise in cholesterol as there are several different factors that may be involved. For example a low thyroid function can lead to high cholesterol, as can liver congestion, dietary, or low antioxidant status – so it worth getting to the underlying cause if at all possible. For more information go to

Warm regards,

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