Proving Nutritional Health Supplement Label Claims

Question: From Gene

You are promoting the Total Balance multi nutrient health supplement so I have a question. Why doesn’t the manufacturer, Xtend-Life, release their COA’s for Total Balance to prove that all the ingredients are truly there in the claimed amounts?

 

Response From Brett:

Hi Gene

I contacted the xtend-life company about your question.

They said that they cannot release their Certificates Of Analysis (COA’s) publicly but if you are in New Zealand and visit their company they will show you all the COA’s.

 

Follow Up Comment from Gene

Hi Brett

It sounds like Xtend Life has got something to hide. Other nutritional health supplement manufacturers, Source naturals for one, has a COA in each bottle of supplements!

 

Follow Up Response from Brett

I think that there could be a misunderstanding here. So, I wanted to write to you again and find out exactly what you are asking for . I am still making inquiries for you with the Xtend-life company but they have asked me to clarify whether you are asking for a COA for the finished product or a COA for each individual ingredient?

Xtend-Life can certainly provide a COA for each finished batch of Total Balance. But if you are asking for a COA of each individual ingredient in the formula that would be a different story as some of that info is proprietary.

I am sure no manufacturer would release their COA’s for each individual ingredient- and I’m very sure that the Source Naturals COA you referred to is in fact a COA for their finished batch.  Xtend-Life goes to a lot of trouble and huge expense to get the right fractions and specs of each raw ingredient. This is particularly critical for the herbal ingredients. They are completely open about their formulas but if they were to hand over the COA’s for each ingredient they would in fact be handing over their entire formula to their competitors. No leading company would do that (and for multi ingredient nutritional health supplement formulas that would be a ton of paperwork).

Xtend-Life has Prof. Dr. Munem Daoud PhD; MSc; ND. heading up their R & D and product formulation. He is a world renowned bio scientist and is one of the few individuals working in the supplement industry which has both pharmaceutical and natural substance backgrounds at the highest levels. This allows him to formulate more effective natural supplement formulations that his contemporaries cannot. His credentials, affiliations, awards, patents and experience are highly impressive when you see them all.

Xtend-Life are happy for someone to visit their facilities and we will show them the COA’s for each specific raw ingredient but not give out a copy.

Gene, can you kindly let me know whether you were asking about the COA for the finished product or all the COA’s for each ingredient?

Best of Health Always

 

Follow Up Response from Gene

Hi Brett

Total Balance Men’s Premium version for example. Dosage is 7 tablets per day. After the batch is mixed and pressed into tablets the bottle is labeled with the dosage for each ingredient. Do check this do they take 7 tablets and break them down and test the 7 tablets to find out that the 7 tablets are true to the label claims. In other words take the ingredient Chrysin, listed at 100mg.  A  C.O.A. would either confirm or deny that there is in fact 100mg of Chrysin in 7 tablets. Hope this helps you understand what I’m getting at.

 

Response From Warren Matthews – Chairman, Xtend-Life Company

Hi Gene,

Brett Seagrott has passed on your comments to me as he thought that it may be appropriate to do so.

I understand what you are saying and it is a valid question.

Most companies only do a microbiological test for each batch. We also do that but additionally we do one for heavy metals as well. I do not know of any company who does a full assay on a completed multi-ingredient tablet for each batch. It is just not economically viable. To give you an idea. We have around 85 ingredients in our Total Balance and to do an assay of the batch would cost US$35,000 each time, IF a protocol can be worked out to successfully do this.

This is the price we have had quoted by various laboratories including the NSF who we are working with on our US FDA GMP compliance program. The scientists at NSF have not as yet been able to come up with a protocol to achieve a reliable assay. The problem is Gene is that you have to liquefy some of the ingredients to do the assay. In the process of doing that the chemical composition changes. We are aware of that and this is what is supposed to happen. In other words we know that if you combine two or more ingredients and then liquefy them together the chemical composition of the mixed product will change. Bit, like mixing up colors in a paint.

So, the whole process is fraught with problems and the end result is not particularly reliable. It is easy for a simple multi vitamin or mineral but not for a complex product like Total Balance which has not only vitamins and minerals but also amino acids, herbals, enzymes and other specialty nutrients.

To further reinforce this point, a few years ago we approached Consumerlab.com with the objective of having them test our products. They admitted that they could not test all the ingredients and we would just have to select a number of ingredients that could be tested. There was no point in doing that. If we were dishonest we could just make sure that those ingredients that were to be tested were present and basically put in anything for the rest.

In order to keep our products as fresh as possible we do small regular batches…generally around 1,600 bottles at a time. So, if we were to do an assay on each batch (if it could be done) it would add almost US$22 of cost per bottle which would be unacceptable to most of our customers.

Some companies make a big thing about having their products approved by a 3rd party such as Consumerlab, but it really doesn’t mean much simply because the test only applies to one batch a year and they may do 12 batches per year, and it rarely covers all ingredients unless it is a simple product with only a few ingredients.

The FDA and all regulatory bodies recognize the practical difficulties and indeed the impossibility of doing a complete assay on all ingredients. It is for this reason why GMP programs provide for the proof of ingredient input to be quantified by input. In other words having a manufacturing process in which there can be no mistakes and no deviations and everything is cross referenced. This is what we do and why we welcome anyone visiting our factory to observe the processes after which their minds are fully at rest.

I hope that this helps answer your question.

Cheers,

Warren

PS. I can assure you that the Chrysin and everything else on the label is present.   I rely on the TB Men’s Premium myself for my own continuing good health.

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12 Responses to “Proving Nutritional Health Supplement Label Claims”

  1. Gym Candy Says:

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  2. Louise Canny Says:

    Thanks this has helped me understand C.O.A.’s a little more

  3. Health Supplements Guy Says:

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  6. Duncan Aker Says:

    I have been doing business with Xtend Life for less than a year. I have found their products to do what they claim. The company seems quite ‘straight up’. Chairman Warren from my readings is a ‘straight up’ guy.
    I am just getting into taking several of their products, so honestly need more time, but at this point, I am pleased. I have been searching for years for supplements and a company that works and are honest. I believe I have finally found one: XtendLife. As long as their products work well, they will have my business. If their products begin to go ‘south’, then I will jump ship. I have on two other occasions taken U.S. products that worked very well, only a few years later ‘Big Pharma’ beat them up and they changed their product, I threw in the towel-the products no longer worked.

  7. Taylor Says:

    I find this it to be a complex subject area where its hard to get good information on health related products, especially the vitamins and mineral type products that are not highly regulated.

    Hard to know what will work the best and what to buy

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