Changes in Label Presentation

December 2010, Warren Matthews

Summary

If you have recently purchased Total Balance Men's Premium you may have noticed that the label looks quite different to previous bottles. This is not due to changes to the product. This is just a change in the format in which the ingredients are presented.

If you have recently purchased Total Balance Men's Premium you may have noticed that the label looks quite different to previous bottles. This is not due to changes to the product. This is just a change in the format in which the ingredients are presented.

These format changes are being applied across our entire range of supplements. Most products are now going out with the new format and over the next few weeks as we use up our current stock of products with the old style labels the roll-out of the new labels will be completed.

What is the reason for this?

Up until now we have designed and formatted our labels to comply with New Zealand regulations. However, our manufacturing processes are now governed by the new US FDA cGMP rules. The NZ regulations with regard to labels were not 100% compatible with the US FDA GMP rules and as such would not fully comply. On the other hand the new US labelling rules are acceptable in New Zealand, so, given that around 80% of our business is in the US we decided to ‘switch’ to the US labelling regulations so we are in complete compliance with all the FDA’s dietary supplement rules.

This has been a major undertaking and has been going on for months with our QA department in conjunction with a US based consultant who specialises in FDA regulations. What made it such a major undertaking was that we had to break down every ingredient into its component parts.

For example, we use the much more effective and bio-available form of Vitamin B6 called Pyridoxal-5-phosphate. Most manufacturers use the cheaper Pyridoxine, which is not as good. However, the Pyridoxal-5-phosphate has as the name suggests some phosphorous. So, we have to list the phosphorous as one of the ingredients in Total Balance.

Another example is Vitamin C. Previously we had listed the 200mgs of Potassium Ascorbate by itself. That is now listed within the Vitamin C ingredient, but only part of it (the ascorbate). The other part is Potassium. So instead of having it listed as a single ingredient it is split into two components, part under Vitamin C and the other part under Potassium.

Due to the large number of ingredients in Total Balance we are very limited in what we can put on the label and we were forced to include some groups of ingredients as a proprietary ‘blends’. As long time readers will know I am usually critical of proprietary blends as they can be misleading. So, to ensure that customers know what is in the blend we have set out each component of the blend in detail on the ingredient pages on our website, so there is full disclosure.

We are only listing the active ingredients on the bottle label. For example, often the gross amount of the ingredient is listed on dietary supplements labels. For instance, we use 50mg of Tea Polysaccharides 25%. For this ingredient we have only listed as 12mgs because that is the amount of the key active in that particular ingredient. Sometimes there are other important actives but they are not included in the net amount listed on the label.

I hope that this is not too confusing. If any aspects of these labels are not clear, please raise a question or make a comment here.

You can view the 'new' supplements facts on the website for the first new product label by going to the Ingredient page of Total Balance Women's Premium.

The day that we ship out products with the new labels is the day that we update the new info on the website. So, it is possible with some products that you order we may have the new label on the website when you receive it, but you may have the ‘old’ label as it was updated whilst your product was in transit. This is nothing to be concerned about because it is the same product. The only difference is that we are distributing a different batch…however all our batches are fresh and offer optimum efficacy.

10 Comments

  • “Hi Murray…sorry about the small print on the label. You are right, it sure is hard to read…but you can ‘blow it up’ on the website. We were forced to go that small in order to fit everything on as required by the FDA.”

    Warren Matthews - December 14 2010

  • “I’d noticed the change with the last delivery – but – as usual I don’t have a 1000 power microscope with which to read the label. Photo-reduction and old age don’t go well together.”

    Murray - December 10 2010

  • “I noticed the change of label with Omega 3 Prem. in my recent shipment, now I finally come to understand the reason why.  Though I must say I prefer the old label which is clear.  The new one does look like most commercial supp. products in the retail market, indeed very U.S. like. :( Yet to see the new Women TB Prem. label in my next shipment cos the batch I got in Dec still bearing the old label.”

    E - December 10 2010

  • “Hi Joseph, Can I ask you to be more specific please? None of the vitamins and minerals in the Total Balance are less than the RDI so I am a rather curious as to which ones you consider weak.  In other words what are you comparing them with?  Part of this may be due to the way the figures are presented.  For example, some companies still may say zinc citrate 20mgs which infers a high level of zinc whereas the amount of zinc present may only be 5mgs.  We are only referring to the elemental or the active component of the vitamin or mineral.  That is how they are supposed to be presented under the new regulations. They are at optimal levels. It would be very easy for us to increase them as they are the cheapest component of the entire formula.  But, to increase them any further from what they are would not be in the best interests of our customers. However, please get back to us with more detailed questions about this.  As a point of interest the cost of enteric coating the tablets is greater than the cost of all the mineral and vitamins in the formula. We do it for efficacy.”

    Warren Matthews - January 12 2011

  • “I am wrong, I admit it! I found out that the New Zealand Health Department does indeed set a limit of 300mcgs for folic acid! the question now is why such a stupid rule? Why not allow at least 100% of the rda!”

    Joseph Thorpe - February 11 2011

  • “what about folic acid at 69% of rda? I also wish more minerals were included; not a megadose, but a balanced amount to cover mineral needs. 5% of rda for calcium,17% for magnesium and 10% for copper could be higher, I would think. Is there a compelling reason for this? Would it be a good idea to take a separate mineral supplement? I do realize there may be a simple, logical reason why these amounts are what they are, so let me know!”

    Joseph Thorpe - January 19 2011

  • “I was studying the label on my recent order of Total Balance Men’s Premium and was disappointed at how weak many of the vitamins and minerals are. I realize that Mega doses are not desirable but I can’t help but to think the amounts are pitifully small and that perhaps the enteric coating excuse is partly marketing hype. If a vitamin is nearly non existent so what if the coating maximizes absorption? I would perhaps absorb more by taking a larger dose without the coating. If my suspicions are invalid please educate me here! I certainly don’t want to find your product to be less than the very best.”

    Joseph Thorpe - January 08 2011

  • “Hi Joseph, Thanks for your question. The percentage rdas are a guideline and include what you receive in your diet. For example, if you have a reasonable diet which includes green vegetables then it is very likely that you would be getting your full quota of calcium. By the way, with regard to calcium it is not just the intake of calcium that counts but the loss of it which can occur if there is a shortage of other nutrients. We deliberately do not put larger amounts of calcium (or Magnesium) in our formulas (other than Bone-Protec) as it is a very cheap nutrient and quite unnecessary for most people and if we put extra in our Total Balance and left something else out it would either decrease the efficacy of our formulas, or, require additional tablets if we were to include more. Ingredients work differently in formulation than if you were taking them alone, singly. The rda amounts refer to the single ingredient only. Certain ingredients in our formulation are only needed in smaller amounts as they are what are known as co-factor ingredients. They work with the more speciality ingredients, at very specific mg levels, to enhance their properties for best effect. So large amounts of them aren’t needed. The properties are coming from the effects that result between the speciality ingredients and the general vitamins and minerals. This also applies to the mineral content, so you don’t need to add a further mineral supplement unless you have a specific medical need to do so. With regard to folic acid, that is one vitamin that we would have liked to have included a little more but NZ regulations prevent us from using any more. However, we are allowed an overage of 10% on folic acid as with some of the other vitamins so the actual amounts present with folic acid and some of the B vitamins are actually 10% over what is stated on the label. This is to allow for any degradation during the shelf life of the product, and is permitted by the regulators. Because our product is rarely more than 6 months old when you receive it no degradation would have taken place during that period so your actual dose rates are a little higher. Joanna”

    Xtend-Life Expert - January 25 2011

  • “according to this information Xtend Life should be able to put 500mcgs of folic acid in all Total Balance products: <h5 class= x_prov x_labelled >Maximum daily doses <ul class= x_prov > <div class= x_subprov > <p class= x_subprov ><a href= http://www.legislation.govt.nz/regulation/public/2010/0005/latest/link.aspx?search=ts_regulation_dietary+supplements_resel&id=DLM102135#DLM102135 class= x_extref >Regulation 3(1) is amended by omitting the item relating to folic acid and substituting the following item: <div class= x_flush-left-margin-1 > <blockquote class= x_amend x_amend-default-margin > <div id= x_DLM2682820 class= x_table x_pgwide-1 > <table class= x_frame-none width= 100% > <col id= x_N101F4tab1col1 ><col id= x_N101F4tab1col2 > <tbody align= center > <tr class= x_row > <td headers= N101F4tab1col1 >Folic acid <td headers= N101F4tab1col2 >500 mcg in the case of a dietary supplement that the Director-General of Health has confirmed has been prepared in a way that accords with the New Zealand Code of Good Manufacturing Practice for Manufacture and Distribution of Therapeutic Goods <tr class= x_row > <td headers= N101F4tab1col1 > <td headers= N101F4tab1col2 >300 mcg in the case of a dietary supplement that the Director-General of Health has not confirmed has been prepared in a way that accords with the New Zealand Code of Good Manufacturing Practice for Manufacture and Distribution of Therapeutic Goods <div id= x_DLM2682820 class= x_table x_pgwide-1 >I would assume that Xtend Life prepares their products in a way that accords with the New Zealand Code of Good Manufacturing Practice for Manufacture and Distribution of Therapeutic Goods. ”

    Joseph Thorpe - February 11 2011

  • “I am looking for potassium ascorbate in tablet or capsule form”

    Xtend-Life Expert - July 09 2016

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