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.