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General Health

Many multi-vitamins do not have what they claim on the label...

That was the essence of an article that a good customer passed on to me and which he read on msnbc. You can access the article by clicking here. I am sure other blog readers have seen this article as well, so I felt I could not let it pass without some comment.

That was the essence of an article that a good customer passed on to me and which he read on msnbc. You can access the article by clicking here.

I am sure other blog readers have seen this article as well, so I felt I could not let it pass without some comment. Before I start I should mention that there are indeed many manufacturers within the US and elsewhere who are still a long way from being compliant with the new FDA GMP regulations and as such their products may indeed not be true to label.

But, on the other hand some of the firms that are referred to in the article may indeed be compliant innocent.I have written about ConsumerLabs on a number of occasions over the years. Many people think that they are a consumer organisation but they are not.

It is a private money making operation. They sell subscriptions for their newsletters to consumers and they give ‘approvals’ to supplement companies who pay them money.

For example, if a manufacturer pays them money and they do a test and if they find it lacking they won’t publish the results…Consequently CL has been a source of controversy for some years amongst the industry. They are not a laboratory just a ‘marketing’ operation.

However, putting aside what may or may not be ethical in their operating procedures, they do tend to sensationalise some of their results even when the results may not have been obtained using correct scientific protocols. The current set of results for those multi vitamins may be a good example.

I’ll try to explain why.

When you have multiple nutrients in a supplement there can be ‘masking’ of some ingredients and misreading of others. This is because of interactions with some ingredients. It is not possible to take a product such as a multi vitamin/mineral tablet and give it to a lab and test it for ingredients and get an accurate result using a single generic methodology.

To help put this in perspective. As part of our US FDA GMP process we are required to validate the efficacy of our blending protocols to ensure that the content of the supplement is true to label.

This is difficult when you have many ingredients such as in our Total Balance because some of them can simply not be tested when blended with other ingredients.

So, several ingredients that remain relatively stable in the mix have to be selected as ‘marker’ compounds and a methodology worked out with the lab for identification and quantification. This is quite an involved and lengthy process to get it right and accurate.

It is also expensive. For example, we paid a lab $30,000 per lot of four ingredients to establish protocols for testing those ingredients in our finished products. This does not include the actual testing. That is extra.

Unless ConsumerLab works with the manufacturers and the laboratory on establishing a unique protocol for each product they test, it is unlikely that they would get accurate results. Generic testing protocols are just not good enough.

Because of this those products which appear to have higher amounts of an ingredient may not really have higher amounts at all. This is because other ingredients can combine together and generate a false reading. This is what is sorted out when establishing a protocol for testing the marker compounds in each product.

Likewise those with lesser amounts could be due to the reaction with other ingredients which were not factored into the testing protocol and were masked by other ingredients.

So, you can see that is not simply a matter of taking a product off the shelf and sending it to a lab for testing. It can be done of course but it takes time to firm up on a protocol. If this was not the case we would not be spending all the money that we do to ensure that we can get accurate results.

Another factor which is a problem for some manufacturers who have not validated their blending methods is stratification of ingredients due to different particle weights. This is a real problem for those manufacturers who are still using ribbon blenders (and many of them do).

They may put the correct amount of ingredients into the mix but they are not evenly spread throughout the batch and this results in some tablets having too little or too much of certain ingredients.

This is why we use a high tech 3D blender which overcomes this problem. I will give you some more info about that tomorrow.

The article also suggests that there needs to be more regulation of the supplement industry. These comments generally come from either people who are either anti supplements or do not understand the current US FDA GMP regulations. The fact is that the new regulations do cover all these issues.

Under these regulations the entire manufacturing process has to be documented and signed off by multiple people to ensure all procedures are properly followed and can be audited. The procedures are very similar to pharmaceutical GMPs.

The blending protocols have to be validated to ensure that the ingredients are properly mixed and there is not an excess of some ingredients in some tablets and a shortage in others. As a further test, in addition to all the steps that have to be taken there is also testing for marker ingredients in the finished product.

So, unless ConsumerLab worked with the manufacturers and the labs to prepare protocols for each product their results may not be accurate. If you are buying products from any of the companies whose products fail I would suggest that you contact them direct and ask for their comments as they may have evidence which refutes the published findings.

As I mentioned earlier a large number of US manufacturers are still not GMP compliant and as such not following the rules. This is a serious problem and the sooner they get their ‘act’ together and comply the better it will be for the industry.

So, the rules are there but there is still some ‘fall down’ on the enforcing of them although the US FDA is becoming a lot more active in this area.

4 Comments

  • “Where can I find the truest and most accurate reviews of daily multi vitamins?  There have been critiques of the Total balance Premium stating that one gets only a small portion of most of the  ingredients included in the pills when much more of these is needed to make a difference in one’s health. Thank you”

    Tony Petronis June 27 2011

  • “Hi Tony, I would be grateful if you could refer me to these critiques. Some people who believe in mega-doses of vitamins feel that we don’t have enough of some vitamins but, the science would bear out our position on this. It would be very easy to increase the level of vitamins because they are the cheapest component of the product, and the least effective. Unfortunately, most people don’t really understand how Total Balance works and how the various ingredient complement each other. For example, various actives in some herbals are designed to complement other herbals. Also the form of the ingredients used is also critical and can make an enormous difference. With some of the ingredients we pay as much as 10 times more than some manufacturers. This is because there can be massive differences in efficacy with ingredients of the same name, which are not exposed in the supplement facts on the label. The reason why we do this is so we can get maximum results from each ingredient that we use and mega doses of individual ingredients are not needed. The amount of each ingredient used is based on what is needed to get the benefits and is also influenced by other complementary actives. In a daily dose of Total Balance Premium we have around 6,000mgs of actives in the 7 tablets. This is much more than most other products on the market. Also being enteric coated none of the ingredients are damaged by stomach acid. If we looked at it from purely the ‘bottom line’ we could reduce the number of ingredients used and improve our margins because more ingredients is more cost due to both the manufacturing process and the identity tests and assays we carry out on each individual ingredient. However, it would not be as effective. I have only seen a few critiques of Total Balance and they have generally come from people who either have their facts wrong or believe that ‘more is better’ and don’t understand synergy.”

    Warren Matthews June 30 2011

  • “Hi R.B, So sorry I overlooked your comment. Chelated minerals are to some extent industry marketing strategy although in some cases they are better. It all depends on the formulation and the type of mineral. We use both chelated and non chelated minerals depending upon the formula. The chelated form is no more expensive so there is no incentive not to use them.”

    Warren Matthews August 18 2011

  • “Thanks for the information, they help alot in understanding some of the facts. Could you please give us some information on chelated mineral and if TB has chelated mineral in it? is chelated mineral good/bad/just industry marketing strategy?”

    R.B July 03 2011

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