Finding The Best
How Was The Standard Test Established?
We established earlier that dietary supplements are not treated as drugs by the FDA in the USA but that they are, rather, deemed to be foodstuffs.
Thus it is that the production of dietary supplements is covered by the HYPERLINK "http://en.wikipedia.org/wiki/Good_Manufacturing_Practice" Good Manufacturing Practice regulations as they are applied to foodstuffs, rather than by the far more stringent and strict GMP rules that are applied to pharmaceutical drugs.
This is an extremely important point to bear in mind.
The rules about what you can and cannot do during the manufacturing process of foods are far less onerous or tightly controlled than those of drugs.
It is therefore completely logical that concerns are expressed from time to time about the quality of the end products that emanate from the dietary supplement companies.
Now, this is not principally a question of safety, as it would be were we talking about toxic drugs, for example.
It is rather more about the quality of the final product because each supplement company tends to produce a product that very much reflects what they believe is a well balanced nutritional balance.
There is, in other words, little independent research in the markets of the products that really do represent the best quality supplementary products.
There is, however, some research in this field that was conducted by a group of eminent nutritionist and scientists, rather than by any official or government supported bodies.
The ratings system that was established by this group is called the Blended Standard, which was created from the published recommendations of 12 noted nutritional authorities, including Dr. Robert Atkins, Dr. Michael Murray, Dr. Richard Passwater, Dr. Julian Whitaker, and Dr. Nicholas Perricone.
The first job that they had was to try to establish a standard by which food supplements could be assessed.
The initial step in this process was that each of the individual parties was asked to put forward seven criteria by which they believed nutritional supplements should be judged.
These criteria covered matters ranging from the manufacturing process itself (with reference to the GMP, for example) to the balance of nutrients that each individual specialist believed to be the most efficacious.
Based on their recommendations, what is now called the ‘Blended Standard’ was created, consisting of the 47 nutrients that they deemed to be most essential.
Thus, the quality of any individual manufactured product was to be assessed based on the presence (or absence) of each of the 47 nutrients, allied to the balances between them that the panel considered to be the most beneficial.
The ‘essential 47’ included 19 vitamins or vitamin-like materials, 13 minerals, 5 phytonutrient (fruit or plant based) compounds, 3 omega fatty acids, and 7 other nutritional factors, every one of which the group of 12 concurred are vital for maintaining and improving health.
In addition, in order to qualify for inclusion in the standard test, a manufactured nutrient product needed to be put forward by at least three of the 12 parties in order to merit initial consideration by the group as a whole.
These 47 nutrients, at the levels that are now recommended in the ‘Blended Standard’, are then used to rate each product using eighteen specific Health Support Criteria, including:
Completeness of product (i.e. how many of the 47 nutrients are represented and in what balance?)
Mineral Forms (i.e. the body needs to be able to absorb minerals – could it do so given the way they were presented in each particular product?)
Toxicity
Liver Health (detoxification)
Metabolic Health (blood sugar control)
Heart Health
Bone Health
Bioavailability of Vitamin E
plus other factors, which, taken together led to an accepted standard testing procedure for matching supplements against one another that was, by and large, agreed.
In order to arrive at the supplements that were even accepted into the final testing procedure, the group originally tested over 1000 nutritional supplement products from a massive range of US and Canadian companies.
From this group, there emerged 508 that were actually accepted as products that merited final assessment.
Now, the important point to note here is that the nutritionists and scientists that got together to create this standard test did so of their own volition.
There was, and still is, little or no official interest or involvement in the dietary supplement industry, which many would still see as a good thing, as suggested earlier.
Indeed, the United States FDA do themselves make it abundantly clear that, whilst they do control supplements under the food regulations, they have HYPERLINK "http://www.cfsan.fda.gov/~dms/ds-oview.html" \l "regulate" few responsibilities in doing so:
“Under DSHEA, a firm is responsible for determining that the dietary supplements it manufactures or distributes are safe and that any representations or claims made about them are substantiated by adequate evidence to show that they are not false or misleading. This means that dietary supplements do not need approval from FDA before they are marketed. Except in the case of a new dietary ingredient, where pre-market review for safety data and other information is required by law, a firm does not have to provide FDA with the evidence it relies on to substantiate safety or effectiveness before or after it markets its products.
Also, manufacturers do not need to register themselves nor their dietary supplement products with FDA before producing or selling them. Currently, there are no FDA regulations that are specific to dietary supplements that establish a minimum standard of practice for manufacturing dietary supplements. However, FDA intends to issue regulations on good manufacturing practices that will focus on practices that ensure the identity, purity, quality, strength and composition of dietary supplements. At present, the manufacturer is responsible for establishing its own manufacturing practice guidelines to ensure that the dietary supplements it produces are safe and contain the ingredients listed on the label.”
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Now, as a general observation, because this means that supplements and vitamin based products are widely and easily accessible, most consumers would still see this as a good thing.
Still, it does mean that it has, so far, been left to independent analysis to establish a standard for supplements.
This may seem to be an ideal situation, and, in a perfect world, no doubt it would be.
An independent amalgamation of the best efforts of 12 leaders in the field all working together in harmony, with no vested interest, would indeed be as close as it is possible to get to a perfect result.
The fact is, however, that some of the experts who came together to establish the ‘Blended Standard’ were sometime ‘consultants’ or ‘specialist advisors’ to some of the supplement manufacturers.
This could have led to suspicions that this may have somewhat influenced that particular individuals judgment, but that is no more than a ‘may’, because there is little or no solid evidence for stating this is any stronger manner.
There were, on the other hand, twelve people who together came up with the Blended Standard, so any bias that there may have been probably had so little influence as to be almost totally negligible.
So, the bottom line is that the ‘Blended Standard’ is the nearest we have to an independently produced ‘league table’ of dietary supplements, effectively the de facto criteria by which all dietary supplements are tested and assessed.
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