Question: from Gene

Do you test each batch of Total Balance Premium to confirm that each tablet contains what it says on the label? For example, 100mg chysin. A certificate of analysis, would either confirm or deny that there is 100mg of chysin in 7 tablets.

Answer: from Warren

This 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 unless it is a very simple product. 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 that you have to liquefy some of the ingredients to do the assay. In the process of doing the assay, the chemical composition changes which makes it incredibly complex. We are aware of the changes that take place as the interaction of all ingredients in the formula are studied at molecular level and these changes are supposed to take place. 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. A bit like mixing up colors in paint.

So, from an assay point of view 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 third 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. This 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.

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.