FDA sends US marshals to seize elderberry juice concentrate, deems it 'unapproved drug'

Jonathan Benson
Natural News

Wyldewood Cellars, a Kansas-based producer and distributor of elderberry juice, is the latest raid target of the US Food and Drug Administration (FDA), which recently sent US marshals to the company's winery in Mulvane to confiscate the "unapproved drug." According to the rogue agency, Wyldewood had violated provisions in the US Federal Food, Drug, and Cosmetic Act (FFDCA) that restrict health claims for food items, warranting the sudden invasion.

According to Barry Grissom, US Attorney for Kansas, the FDA sent a warning letter to Wyldewood in 2006 to remove or modify certain health claims that it said were in violation of federal law, but the company did not comply. FDA officials claim that Wyldewood continued to make unapproved claims, and that seizing the product was the next step.

FDA targets supplement manufacturers, falsely accuses them of selling drugs

Ethan A. Huff
Natural News

In the eyes of the US Food and Drug Administration (FDA), there is no difference between a legitimate, scientifically-backed health claim, and a phony, made-up claim, as it concerns food and dietary supplements. Only FDA-approved drugs, you see, provide real health benefits, according to the agency. And in its continued assault against health freedom, the FDA has sent warning letters to five different companies that produce natural treatments and cures for sexually-transmitted diseases (STDs) because those companiesdared to make unauthoried health claims, many of which are backed by peer-reviewed, journal-published scientific studies.

The companies being targeted -- MedaVir, Herpaflor, Viruxo Anti-Viral Support, C-Cure, and Never an Outbreak -- all made the mistake of telling their customers about the health benefits of their products without going through the laborious, multi-million dollar FDA drug approval process. As a result, the FDA has accused them all of selling unapproved drugs, and ordered them to withdraw the statements or face further regulatory action.

What is worse, though, is the fact that the FDA has decreed that any food or dietary supplement that provides any sort of health benefit is automatically a "drug." Ordinary foods like almonds, cherries, or walnuts literally become recategorized as drugs when accompanied by claims that they cure, heal, or prevent disease -- and this is currently the law of the land in the US.

FDA threat to your health: Vitamins, supplements and alternative health therapies as “medicinal”

working hand in hand with the "Federal Death Administration"

Marti Oakley, Contributing Writer
Activist Post

Even as the FDA has for decades routinely given a seal of approval to toxic and deadly medications and vaccines, claiming they are safe, and as hundreds and thousands of people, if not millions,  have died or have been permanently injured as a result of their incompetence and gross dereliction of duty, this agency continues its assault on natural remedies and aids claiming they need to be regulated by FDA.

While one toxic and deadly medication, such as Vioxx can claim 70,000 lives, the manufacturer is never shut down by the FDA.  Merck Pharmaceuticals never pays any fines or penalties.  While they may be sued in court for wrongful death, this is only AFTER they have sold enough of their toxin to exceed any long term risk assessment costs.

In other words:  Merck knows its product is lethal.  It weighs the long term risk. The questions are never those of public safety, possible harm or death from using their product, but rather:

Can we sell enough of Vioxx fast enough and at levels high enough to offset what we estimate will be the costs of lawsuits for the people we killed or permanently injured and still make a hefty profit?

And every pharmaceutical company operates their business under this model which is nothing short of pre-meditated murder in my opinion.

Weakness of U.S. Natural Health Laws Revealed in Europe

Brandon Turbeville

Activist Post 

In the previous article I discussed Codex Alimentarius and, more specifically, the DSHEA (Dietary Supplement Health Education Act) in relation to it. I pointed out that the DSHEA law, while a step in the right direction, has major holes in the “protections” it provides for vitamin and mineral supplements. It is therefore important to look at the situation in which natural health advocates find themselves in Europe in order to see the position in which they will soon find themselves in the United States.

Implementation of the Codex machinery has been even more successful in the European Union, at least in relation to vitamin and mineral supplements. In 2002, the EU produced the European Union Food Supplements Directive which is almost identical to the Codex platform for vitamin and mineral supplements.[1]  While a grace period of around eight years was allowed for individual states to exercise their dying sovereignty, the Food Supplements Directive (FSD) went into full effect on December 31, 2009 across the EU, making it the country closest to achieving complete Codex compliance.[2] This deadline has given rise to claims that Codex Alimentarius would be implemented on December 31, 2009 the world over, and that, all of a sudden, natural supplements would no longer be available and themselves be replaced by toxic chemicals. The claim that such a situation would occur is not unbelievable. Rather, it is actually quite probable as one can see through the discussion made thus far. However, that such a situation would occur in such a sudden manner is somewhat less likely.

Unfortunately, most of the people making these claims did so out of ignorance, and some simply were taken out of context. Regardless of how this rumor was started, it is false and those like it only serve to hinder the fight against Codex and obfuscate its dangers. No doubt many woke up on January 1, 2010 and dismissed Codex Alimentarius as a silly conspiracy theory with little relevance to their health based upon the fact that the sky did not fall the night before, as they had been told it would.[3] 

That said, a major step in the implementation of Codex standards was taken on December 31, 2009 when the EU FSD went into effect. In many aspects, the FSD is almost a carbon copy of the Codex Alimentarius Guidelines for Vitamin and Mineral Food Supplements. Exuding a philosophical and policy similarity, it is mentioned in one of the opening statements of the Directive that “Excessive intake of vitamins and minerals may result in adverse effects and therefore necessitate the setting of maximum safe levels for them in food supplements.”[4] 
From the outset, the FSD expresses the same biased stance towards natural supplements as Codex, even though the adverse effects to taking large amounts of natural supplements are almost completely insignificant, especially when compared to those of pharmaceuticals. Nevertheless, this is the justification used for the ensuing attack on basic god-given rights of European citizens.

Similar to Codex Guidelines, the FSD contains provisions for the establishment of maximum levels of nutrient content for supplements. Paragraph 14 states:

When maximum levels are set, therefore, account should be taken of the upper safe levels of the vitamins and minerals, as established by scientific risk assessment based on generally acceptable scientific data, and of intakes of those nutrients from the normal diet. Due account should also be taken of reference intake amounts when setting maximum levels.[5]

Not only does the FSD provide for maximum levels for nutrients, it also bases its determinations, as does Codex, on the flawed methodology known as risk assessment.

Also, it will take the Global Average Daily Diet into account. This is what is meant when it states that “intakes of those nutrients from the normal diet” will be given due account.[6]  
It should be noted that Article 5 Section 1 completely copies (or vice versa) the Codex Guidelines section 3.2.2. They both state, word for word, “Maximum amounts of vitamins and minerals present in food supplements per daily portion of consumption as recommended by the manufacturer shall be set, taking the following into account: (a) upper safe levels of vitamins and minerals established by scientific risk assessment based on generally accepted scientific data, taking into account, as appropriate, the varying degrees of sensitivity of different consumer groups; (b) intake of vitamins and minerals from other dietary sources.”[7]  
It seems very suspect that a supposedly unrelated “regulatory” agency and a European Union law would contain the exact same language without some kind of common connection between the two. Indeed, as mentioned above, while the rest of the law might not be a literal word-for-word carbon copy of the Guidelines, in principle it is exactly that. It should be a cause for concern or, at the very least, skeptical curiosity, when laws or policies begin to be enacted simultaneously in different countries and/or international governing and administrative bodies.

The FSD also provides for the establishment of minimum levels of nutrients. It states, “To ensure that significant amounts of vitamins and minerals are present in food supplements, minimum amounts per daily portion of consumption as recommended by the manufacturer shall be set, as appropriate.”[8]   Although, unlike the Codex Guidelines, the Directive is not specific in terms of percentages, it clearly provides for the two-pronged attack of simultaneous maximum and minimum levels of nutrients in food supplements.

The most frightening aspect of the FSD, however, is not the maximum and minimum levels but the Positive and Negative Lists that are created. All the vitamins and minerals allowed in food supplements are included in the FSD Positive List, while those not included are completely banned for use in supplementation. [9]  The list itself is quite restrictive, prohibiting the production, sale, and distribution of many different vitamin and mineral substances. As the Directive states: 

Only vitamins and minerals normally found in, and consumed as part of, the diet should be allowed to be present in food supplements although that this does not mean that their presence therein is necessary. Controversy as to the identity of those nutrients that could potentially arise should be avoided. Therefore, it is appropriate to establish a positive list of those vitamins and minerals.[10] 

Restricting the inclusion of vitamins and minerals to only those that are part of the diet is bad enough. However, the language of “only vitamins and minerals normally found in, and consumed as part of, the diet,” adds an even more limiting scope.[11]  This is because such language not only limits the approved substances to those found in food, but to those found in the diet of Europeans specifically. Even then, it is only those substances that are “normally” consumed.

Also, the antipathy towards the discovery of new nutrients is clearly expressed in the desire to avoid controversy “as to the identity of those nutrients that could potentially arise.”[12] 
Not only that, but the Directive quietly gives the Council and the Commission of the EU the authority to remove any substance that it wishes from the Positive List. In Article 4, section 5 of the Directive it states, “Modification to the lists referred to in paragraph 1 [the Positive Lists] shall be adopted in accordance with the procedure referred to in Article 13(2).”[13]  Article 13, Section 2 then reads, “When reference is made to this paragraph, Articles 5 and 7 of Decision 1999/468/EC shall apply, having regard to the provisions of Article 8 thereof.”[14]  When one reads these sections of the cited law, it becomes apparent that the authority to change those substances on the Positive Lists is granted to the Council and the Commission.[15]  

Considering the various mechanisms of the WTO, it is only a matter of time before the EU decides to take the US to international trade court over its more liberal supplement market. If this ever occurs, the protections provided by DSHEA will immediately disappear and we would see an immediate change of policy towards natural supplements. This is precisely why the EU FSD means so much to the US DSHEA.

Notes:

---

[1] Tipps, Scott C. “”Foreword – Codex Alimentarius: Global Food Imperialism – What is Codex?” Ed. Scott C. Tipps. FHR. 2007. P. IV.[2] Starling, Shane. “Food Supplements Directive: Stay positive (or bans may follow).” Nutraingredients.com January 8, 2010. http://www.nutraingredients.com/Regulation/Food-Supplements-Directive-Stay-positive-or-bans-may-follow [3]  Press Release: National Health Federation. “December 31, 2009 – Where Were You When The Earth Ended?” January 4, 2010. http://www.thenhf.com/press_releases/pr_04_jan_2010.html [4]  Directive 2002/46/EC Of The European Parliament And Of The Council of 10 June 2002 on the approximation of the laws of the member states relating to food supplements. “Codex Alimentarius: Global Food Imperialism.” Ed. Scott C. Tips. FHR. 2007. Pp. 237-243[5] Ibid.[6] Ibid. [7] Ibid.

See Also,

“Guidelines for Vitamin and Mineral Food Supplements.”http://www.codexalimentarius.net/search/advanced.do?lang=en
[8] Directive 2002/46/EC Of The European Parliament And Of The Council of 10 June 2002 on the approximation of the laws of the member states relating to food supplements. “Codex Alimentarius: Global Food Imperialism.” Ed. Scott C. Tips. FHR. 2007. Pp. 237-243[9] Ibid. [10] Ibid. p. 237[11] Ibid. [12] Ibid. [13] Ibid. p.239[14] Ibid. p. 240.[15]  “Council Decision of 28 June 1999 laying down the procedures for the exercise of implementing powers conferred on the Commission (*) (1999/468/EC)”http://www.ena.lu/council_decision_1999_468_ec_laying_down_procedures_exercise_implementing_powers_june_1999-02-4941     Accessed April 21, 2010.   

Brandon Turbeville is an author out of Mullins, South Carolina. He has a Bachelor’s Degree from Francis Marion University where he earned the Pee Dee Electric Scholar’s Award as an undergraduate. He has had numerous articles published dealing with a wide variety of subjects including health, economics, and civil liberties. He also the author of Codex Alimentarius - The End of Health Freedom   
  

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Codex Alimentarius: The Global Fallout of Health Tyranny

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Updated Excerpt from  
Codex Alimentarius -- The End of Health Freedom

Brandon Turbeville -- Activist Post

In past articles, I have written extensively on the dangers of using Risk Assessment  when dealing with vitamins and minerals. I have explained how the risk assessment methodology is being used to establish both Upper Safe Levels and Maximum Permitted Levels, as well as demonstrated the connections between Codex Alimentarius and the German Federal Institute for Risk Assessment (BfR).  These connections are important because it is BfR that has been contracted by Codex to provide scientific information and advice on nutritional supplements using just this process. In this and subsequent articles, I will examine in more depth the findings presented by BfR and the ramifications they will have for access to vitamin and mineral supplements the world over. 

In 2005, BfR published “Use of Vitamins in Foods: Toxicological and nutritional-physiological aspects,” its list of recommendations for the maximum levels of nutrients in vitamin and mineral supplements. Of the many tables included in these results, Tables 3 and 4 are of particular interest. Table 3 is an overview of the BfR teams’ classification of vitamins and minerals into supply and risk categories (each of these categories being separate).

Supply categories deal mainly with the status of the supply of tested materials such as their possible contamination or their potential to be contaminated during shipping as well as the intake status. However, the risk categories have to do with the potential for nutrients and vitamins to cause adverse effects.   

The risk category is divided into High risk, Moderate risk, and Low risk, and is based on “how large the margin is between recommended/observed intakes and the defined UL” [Upper Limit]. [1]  Rather, how much further than the Recommended Daily Allowance (RDA) a nutrient must go to reach the level of perceived adverse side effects (the Upper Limit).[2]   Indeed, Table 2, which is a different chart showing the criteria for each risk category, is entitled “Various degrees ofprobability that a nutrient leads to adverse side effects.”[3]   This in itself should trigger questions as to what amount of “proof” this study actually offers. 

The idea that it is the probability, not a clearly defined set of risks or causes of those risks, shows that the study has not actually proven that nutrients pose a threat of adverse side effects, even when using the risk assessment process to begin with. 

Yet BfR and subsequently Codex Alimentarius continue to use this data to create a maximum permitted level for nutrients. Vitamins A and D, Beta-Carotene, Niacin (as Nicotinic acid), Sodium, Potassium, Calcium, Iron, Iodine, Zinc, Copper, and Manganese are all added into the High risk category, while the best that any other nutrient or mineral can hope for is the Low risk category. None fall into a no-risk category, because no such category exists in this type of study. 

Clearly, as one can see from the BfR results, the levels suggested by Codex for the Maximum Permitted Levels are excessively low. For instance, the most liberal dosage allowed is for Vitamin C at the levels of 225 mg. Yet the Upper Safe Levels of Vitamin C are nowhere near this small amount. 

Even according to Medline Plus, administered by the National Institute of Health and the U.S. National Library of Medicine, the Upper Safe Levels for Vitamin C is 2,000 mg for adults above the age of 18.[4]   This is a difference of 1,750 mg set by an agency that is not considered exactly friendly towards nutritional supplements or natural healthcare. Of course, for individuals with some kind of sickness such as cancer, the limits on Vitamin C intake are much higher.[5] 

The limits placed on Vitamin D are perhaps the most egregious. BfR sets the Maximum Permitted Levels of Vitamin D at 5 mcg while even the Medline service lists the Upper Safe Limits at approximately 50 mcg (2000 IU).[6]  A comparison of the Upper Safe Limits set by the Medline Plus system (under the direction of the aforementioned government agencies) can be viewed by going on to the Medline website and the BfR site.

Keep in mind, as mentioned earlier, that the U.S. agencies who established these Upper Safe Limits are not exactly those that can be considered champions of health freedom, natural healthcare, or nutritional supplementation. Using their figures, however, provide an opportunity to see just how dramatic a decrease in the level of nutrition is caused by BfR’s Maximum Permitted Levels. 

While some of these differences are smaller in scale than others, most BfR MPLs are much more than double their Medline counterparts. The standards for copper are quite telling as there is a 10,000 mcg difference between the two.

The problem, however, goes even deeper than the establishment of MPLs and USLs.  The Recommended Daily Allowances (RDAs) are of great concern as well. This is not only because they are often instrumental in the setting and justification of MPLs and USLs, but also because they are referenced for human health and individual intake. 

In the United States, the RDA is often taken in conjunction with the Estimated Average Requirement (EAR) under the umbrella of the Dietary Reference Intake (DRI) which is set by the Institute of Medicine of the National Academy of Sciences.[7]   The RDA is officially defined as “the average dietary intake level that is sufficient to meet the nutrient requirement of nearly all (97 to 98 percent) healthy individuals.”[8]  The EAR is defined as “the daily intake value that is estimated to meet the requirement . . . in half of the healthy individuals in a . . . group.”[9]  It goes on to say, “At this level of intake, the other half of a specified group would not have its nutritional needs met.”[10]  

While this article will not deal in depth with this subject, it should be noted that the Institute of Medicine of the National Academy of Sciences has recommended that the national standard of nutritional intake be shifted from the RDA to the EAR.[11]  This would effectively slash the DRI by close to half due to the fact that the original referenced values of nutritional intake would be affected likewise.

Another main concern related to RDAs is the fact that they are not adequately set to promote optimal human health. Indeed, RDAs are set at the lowest level for prevention of single-nutrient deficiency diseases. This means that the RDA is not the level at which intake of a particular nutrient is sufficient for good health, but the lowest level that must be maintained in order to prevent a particular deficiency disease. 

In the case of Vitamin C, for instance, the diseases would be scurvy or rickets. Put plainly, RDAs are the levels of nutritional intake needed to barely get by, not remain healthy.[12]   As James South points out in his article, “Vitamin Safety, RDAs and the Assault on Vitamin Freedom,” the Recommended Dietary Allowances from 1980 plainly stated as much.  South quotes them as saying:

The requirement for a nutrient is the minimum intake that will maintain normal function and health . . . For certain nutrients, the requirements may be assessed as the amount that will just prevent failure of a specific function or the development of  specific deficiency signs – an amount that may differ greatly from that required to maintain maximum (i.e. optimum) body stores.[13] 

This is a source of confusion for many consumers who believe that RDAs are the levels at which their intake is topped out and adequately achieved. Add to this the fact that RDAs are continually being lowered by the agencies responsible for setting them.

In 1989, the National Academy of Sciences revised the RDAs from their already meager levels set in 1980 to even lower levels, some of them by half. Interestingly enough, the National Academy of Sciences exercised some twilight-zone logic similar to Codex Alimentarius when these decisions were made. The assumption made by the agency was that Americans are generally healthy people and, because they generally fail to consume the 1980 RDA levels of nutrients, then a lower standard is adequate for good human health.[14] 

Clearly, either lowering the RDAs or creating MPLs is a threat to the natural supplement industry from the perspective of the consumer as well as the manufacturer. Even without acknowledging the ideological and financial reasons behind the push to end access to vitamin and mineral supplementation, the setting of MPLs, especially at low levels, would create a vast increase in the cost of supplements wherever they were sold. Consumers would then be forced to purchase many more times the amount of supplements to achieve the same result as their current dosage.

If the MPLs reduce a supplement's levels by half, as many do, then the consumer would need to take two capsules for every one he/she currently takes to achieve an equal amount of nutrition. Translate this into buying two bottles for every one bottle purchased at the current levels. This would not only have a crippling effect on consumers, but the industry itself would face similar repercussions as the option of natural supplementation would become unaffordable. Even the supplements themselves would suffer, as each capsule/pill/dose would therefore have to be produced using more filler materials than actual nutrients.

This is actually a concern with another Codex policy that is much less well-known than that of MPLs – minimum levels of nutrients. While many may see this as contradictory to Codex’s general position toward natural supplements, it is in fact included within the Codex Guidelines. Section 3.2.1 of the Guidelines states, “The minimum level of each vitamin and/or mineral contained in a vitamin and mineral food supplement per daily portion of consumption as suggested by the manufacturer should be 15% of the recommended daily intake as determined by FAO/WHO.”[15]

No doubt some, out of ignorance, will assume that this position is positive. In fact the opposite is true. The setting of minimum levels is merely part of a two-pronged attack on vitamin and mineral supplements, and levels of nutrition in general. The problem with this position is that it prevents manufacturers from adding trace amounts of vitamins and minerals to supplements that may be desired or needed to aid in the processing of the main nutrient. Instead, filler will have to be added. As Scott Tips writes:

Besides the obvious moral problem of prohibiting people from freely and voluntarily contracting with one another as they wish, the practical problem with minimum levels is that they foreclose manufacturers from adding something useful (such as a vitamin or mineral) in a capsule or tablet instead of something worthless, like a filler or excipient. In my view, it would be better for a person to get some additional nutritive value from a capsule or tablet, than nothing at all.[16]

Keep in mind, the MPLs of vitamin and mineral supplements will be set so low, according to the risk assessment studies like those of BfR being conducted, that it will be virtually impossible to include trace amounts of supplements below the required 15% of the already low levels of the RDA. They might as well not be included at all, which is the goal of Codex in the first place. 

Notes:

[1]  “ Use of Vitamins in Foods: Toxicological and nutritional-physiological aspects.” Domke, A., Grosklaus R., Niemann B., Przyrembel H., Richter K., Schimdt E., WeiBenborn B., Worner B., Ziegenhagen R., Federal Institute for Risk Assessment, BfR, 2005. P.18. 

[2]   Ibid. 

[3]  Ibid. 

[4] “Vitamin C.” Medline Plus website. http://www.nlm.nih.gov/medlineplus/druginfo/natural/patient-vitaminc.html   Accessed April 15, 2010.  

[5]  “Vitamin C.” Oregon State University. Linus Pauling Institute.http://lpi.oregonstate.edu/infocenter/vitamins/vitaminC/     Accessed April 15, 2010.   

[6] “Vitamin D.” Medline Plus Website. http://www.nlm.nih.gov/medlineplus/druginfo/natural/patient-vitamind.html    Accessed April 15, 2010.  

[7] South, James. “Vitamin Safety, RDAs and the Assault on Vitamin Freedom.” National Health Federation. March 2004. http://www.thenhf.com/articles_19.htm  

[8] Ibid.  

[9] Ibid. 

[10] Ibid.  

[11] Ibid.  

[12] Ibid.  

[13] Ibid.  

[14] Ibid.  

[15]“Guidelines for Vitamin and Mineral Food Supplements.”http://www.codexalimentarius.net/web/standard_list.do?lang=en

[16] Tips, Scott C. “Codex Gets One Step Closer To Control.” Codex Aliementarius: Global Food Imperialism. Ed. Scott C. Tips. P.49-50. 2007. 

Brandon Turbeville is an author out of Mullins, South Carolina. He has a Bachelor’s Degree from Francis Marion University where he earned the Pee Dee Electric Scholar’s Award as an undergraduate. He has had numerous articles published dealing with a wide variety of subjects including health, economics, and civil liberties. He also the author of Codex Alimentarius - The End of Health Freedom 

Read The Rest of The History of Health Tyranny, Parts 1-6

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Conflicts of Interest and Personal Agendas at The Heart of Codex Alimentarius Health Tyranny

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Brandon Turbeville

Activist Post 

In the last two articles, I have discussed the flawed principles of “risk assessment” techniques when applied to vitamins and minerals, as opposed to the toxic substance the term was intended for. Improper application, nutrient group, as opposed to the nutrient form approach, and lack of acknowledgment of positive effects of nutrients all combine to establish a strong case against “risk assessment” methods. However, there is one more angle to “risk assessment” that must be pointed out in regards to vitamin and mineral supplements -- the establishment of Maximum Permitted Levels.

To further understand the danger of using Risk Assessment to test nutrients, one must understand how the process works. Dr. Rima Laibow gives an excellent synopsis:

First a group of test animals, mice, rats, rabbits, et cetera, are given increasing amounts of the toxin of interest. The dose is increased until half of the animals are dead. The dose at which 50 percent of the test animals die is called the Lethal Dose 50 (LD₅₀). A similar dose is extrapolated for humans.

Next, the other end of the dose spectrum is investigated by giving test animals smaller and smaller doses until no impact can be identified from the dose of the toxin to establish the Maximum Upper Limit (MUL). The MUL is divided by a safety factor, typically 100. The dosage that results is called the Maximum Permissible Upper Limit.[1]

Here of course, the “toxin” being administered is a nutrient -- a vital component of human life. This in itself is a contradiction. Add to that the fact that the Maximum Upper Limit is set at the level where there is no impact, then further reduced by a safety factor division, and you begin to see the purpose of banning nutrients coming to fruition. 

Although the synopsis given above is admittedly a simplistic one, the end result is as described above -- the dosage of the substance being tested is reduced further and further until no impact (positive or negative) is observed, this figure is then divided by another number (depending on the evaluation but usually 100) which results in the Maximum Permissible Upper Limit. Already, at the end of such a procedure, dietary supplements are reduced to a state where they are virtually useless. Yet the insanity does not end there. 


The goal of reducing nutrients to virtually nonexistent levels continues with the creation of Maximum Permitted Levels.  Dr. Rolf Grossklaus, Chairman of the Codex Committee on Foods for Special Dietary Uses (one of the Codex committees that deal with nutrition) and Director of the German Federal Institute for Risk Assessment,[2]brought to the committees’ attention what is labeled as the Global Expectable Average Daily Diet.[3] This is essentially what is estimated to be the average diet of all human beings in the world and their nutritional intake as a result of that diet. However, the Global Expectable Average Daily Diet does not take into consideration populations with lower nutritional intake such as Third World countries. It is simply an average that everyone is lumped into.[4] But because populations with very low levels of nutrient intake are not properly included in the estimate, this leaves only those countries where higher levels of nutrient intake exists, falsely providing results that suggest the Global Average Daily Diet is higher than it is.

Essentially, the levels of acceptable nutrient intake will be ratcheted down based on the populations with the highest amounts of nutritional intake. This process removes countries with low level intake of nutrition from the equation, providing Codex with a higher Global Average Daily Diet which it will then use to reduce the levels of vitamins and minerals even further. [5]

This stance is enumerated in the Codex “Guidelines for Vitamin and Mineral Food Supplements” when it is stated, “Most people who have access to a balanced diet can usually obtain all the nutrients they require from their normal diet.”[6] Such a statement is laughable to anyone who has studied health and nutrition, because anyone who has done so knows very well that even in the most highly developed countries in the world we do not receive nearly enough nutrients from our daily diet. Yet Codex is working on the supposition that everyone eats the same diet (on average) and that they get all the nutrition they need from it.

Nevertheless, the Global Expectable Average Daily Diet is then used to subtract the amount of nutrition we allegedly receive from our diets from the Maximum Permissible Upper Limit set by Codex. The value that results is the new Maximum Permitted Level,[7]  -- a value that lowers the acceptable level of nutrients even further. As Paul Anthony Taylor illustrates:

If the upper safe level for vitamin B6 is calculated to be 10mg, as recommended by the UK’s Expert Group on Vitamins and Minerals, and the average daily intake of vitamin B6 from food is calculated to be 2.9mg, as was stated to be the case for men in the UK’s National Diet & Nutrition Survey in 2003, then the “maximum permitted level” of vitamin B6 in supplements could potentially be set by regulators at a mere 7.1 mg. [8]

The rationale is that since we are already receiving a certain amount of nutrients from our food, we must take that amount of nutrients into consideration when establishing a “Maximum Permitted Level” for nutrients in general. Hence the lowering of the “safe” levels.

It should be noted that, while the differences between the Upper Safe Levels and Maximum Permitted Levels are slight, they are still important. One of the main and most important differences is the method by which Maximum Permitted Levels are reached with the further lowering of nutritional content using the Global Expectable Average Daily Diet mechanism. But even semantic differences play a role in the reduction of nutrients as the designation of “Maximum Permitted Level” carries with it a more authoritative and restrictive tone, an important aspect when dealing with scientific, legal, and regulatory labeling. MPLs deal with Maximum Permitted Levels, abandoning the cover language of safety guidelines and moving its motives more out in the open.

The process of establishing Maximum Permitted Levels began in 2005 with recommendations made by the German Federal Institute for Risk Assessment (BfR), the first organization to carry out this task. It should also be noted that not only will BfR be instrumental in providing “scientific” information to Codex, but that Dr. Rolf Grossklaus is BfR’s Director. This is the same Dr. Grossklaus that is the chairman of the Codex Committee on Nutrition and Foods for Special Dietary Uses and has become somewhat famous in the health freedom community for his tyrannical methods of conducting meetings,[9] as well as for making the claim that nutrition is only for maintaining health, not for the prevention or treatment of diseases.[10]

Indeed, Dr. Grossklaus was one of the leading scientists of the team that conducted the studies used in BfR's standings.[11] This is particularly concerning in light of the context of the CCNFSDU as Dr. Grossklaus is the man responsible for guiding the Commissions’ position on the safety of these substances. In this instance, the Chairman of the Codex committee requesting an assessment on nutrients is also the Director of the company conducting the assessment, as well as one of the leading scientists in the assessment itself. True science would never allow someone with such a blatant conflict of interest to take part in these studies. This, however, is business as usual with Codex.

But the clearly unscientific manner in which risk assessment is conducted apparently knows no bounds. Dr. Rima Laibow comments on this obvious conflict of interest further by saying:

Dr. Grossklaus uses his position to bludgeon through his own personal agenda and that of the European Union (EU) representative to Codex and CCNFSDU, Mr. Basil Mathioudakis. The two of them confer regularly as if there were no other members present and whatever the antinutrient Dr. Grossklaus and Mr. Mathioudakis agree upon is the 'outcome' of the deliberations. [12]

Dr. Laibow’s assessment is a fairly accurate one. The methods by which Codex reaches its “consensus” are dubious to say the least. In fact, the “consensus” as declared by the CCNFSDU bears little resemblance to any other real consensus being reached on any other board. Scott Tips, who has regularly attended Codex meetings as an observer, elaborates further:

The Chairman was a German, Dr. Rolf Grossklaus, who ran the Codex meetings in an innovative (to me at least) way. After much discussion on a topic, and especially after the German government delegate did not seem to have anything more to say, the chairman would somehow psychically determine that a “consensus” had been reached or not reached by the delegates and the group would move on to the next topic of discussion. I never once saw a vote taken or even the slightest hint of a show of hands; the outcome was all calculated in Dr. Grossklaus’ marvelous brain as he scanned the room and remembered how many had spoken for or against each proposal. Of course, the squeaky wheels counted the most; the silent ones not at all. We Americans, who suffer from this obsessive notion that votes must actually be counted before deciding upon an outcome, might learn much from this economical and quick means of “voting.” In fact, stupid me, why even vote when the chairman could just decide for all of us?[13]

Anyone who has attended these meetings with the expectation of observing some form of democratic input by anyone except the chairman or the EU must have been seriously disappointed. Indeed, this has been the impression of virtually every health freedom advocate that has ever attended these meetings.

Notes:

---

[1] Laibow, Rima. “’Nutraceuticide’ and Codex Alimentarius.” Alternative and Complementary Therapies, October 2005. P. 227

[2]Codex Committee On Nutrition and Foods For Special Dietary Uses.  https://www.ccnfsdu.de/index.php?id=493

[3] Ibid.

[4] Ibid.

[5] Laibow, Rima. “’Nutraceuticide’ and Codex Alimentarius.” Alternative and Complementary Therapies, October 2005.

[6] “Guidelines for Vitamin and Mineral Food Supplements.” Codexalimentarius.net www.codexalimentarius.net/download/standards/.../cxg_055e.pdf

[7] Laibow, Rima. “’Nutraceuticide’ and Codex Alimentarius.” Alternative and Complementary Therapies, October 2005.

[8] Taylor, Paul Anthony. “Nutrient Risk Assessment: What You’re Not Being Told.” http://www4.dr-rath-foundation.org/features/risk_assessment.html

[9] Tips, Scott C. “Breathe Easier – Codex Adjourns.” Codex Alimentarius: Global Food Imperialism.” Ed. Scott C. Tips. Foundation for Health Research, 2007.

[10] Walter, Suzan. “Important News from Bonn.” Codex Alimentarius: Global Food Imperialism. Ed. Scott C. Tips. FHR. 2007. P.88.

[11] Taylor, Paul Anthony. “Nutrient Risk Assessment: What You’re Not Being Told.” http://www4.dr-rath-foundation.org/features/risk_assessment.html

[12] Laibow, Rima. “’Nutraceuticide’ and Codex Alimentarius.” Alternative and Complementary Therapies, October 2005.

[13] Tips, Scott C. “Breathe Easier – Codex Adjourns.” Codex Alimentarius: Global Food Imperialism.” Ed. Scott C. Tips. Foundation for Health Research, 2007.

Brandon Turbeville is an author out of Mullins, South Carolina. He has a Bachelor’s Degree from Francis Marion University where he earned the Pee Dee Electric Scholar’s Award as an undergraduate. He has had numerous articles published dealing with a wide variety of subjects including health, economics, and civil liberties. He also the author of Codex Alimentarius - The End of Health Freedom 

Related Articles by Brandon Turbeville:

The History of Health Tyranny

The Health Tyrants
The Structure of Health Tyranny
Globalism, Think Tanks, and "The New World Order"  
The Language of Health Tyranny

The S.510 and Codex Alimentarius Link

The Methods of Health Tyranny

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The Methods of Health Tyranny: Codex Alimentarius "Risk Assessment" of Vitamins And Nutritional Supplements

Excerpt from Codex Alimentarius -- The End of Health Freedom 

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Brandon Turbeville -- Activist Post 

In the previous article I addressed the issue of the language of “risk assessment” techniques used to determine the dangers of consuming vitamin and mineral supplements as well as how this methodology would be used to classify nutrients as toxins. For the most part, I focused on the fact that “risk assessment” is clearly an inappropriate testing method to apply toward vitamins and minerals. This is because “risk assessment” is designed to be applied to substances that are known to be toxic for the purpose of establishing an upper safe levels of toxicity to them.

But there are other problems with the process of risk assessment as well. First, the current methodologies are based upon the assessment of entire groups of nutrients as opposed to the individual nutrients that make up the group. This method is called the nutrient group approach, a method which depends upon the lumping of many different forms of a nutrient into one category rather than testing each individual form separately as is done for toxic chemicals.[1]


An example would be assessing Vitamin B as a whole group. Assessing Vitamin B3, Vitamin B12, and Vitamin B6 as separate and individual nutrients is called the nutrient form approach and would be the more rational method to apply (even though risk assessment should not be used in the first place) because the alleged risks posed by these supplements are themselves dependent upon the form in which it occurs.

For instance, Vitamin C, in the form of ascorbic acid, has been known to cause loose bowels in some people who take it in very high doses. Yet, when taken as calcium ascorbate, this does not occur. Indeed, this is about the most severe side effect from a vitamin supplement that one can document. Yet under the risk assessment process using the method of the nutrient group approach, Vitamin C as a whole would be regulated based upon the “risks” associated with the ascorbic acid form of Vitamin C. Therefore, the ascorbic acid form of vitamin C would be the basis for the setting of the upper safe levels or the Maximum Upper Limits of Vitamin C.  This is because this particular method takes the most “toxic” form of the tested substance and uses it for the basis of its regulation.[2] In this case, the nutrient group is considered only as safe as its most dangerous form. 

Indeed, this is the method advocated by the FAO and WHO. In a joint FAO/WHO report published in 2005 entitled “A Model for Establishing Upper Levels of Intake for Nutrients and Related Substances,” reports of conclusions dealing with Vitamin C, Iron, and Zinc are all listed as the nutrient group and not the various forms in which they occur.[3]

Clearly, there is a double standard within the FAO, WHO, and Codex regarding the safety testing of vitamin/mineral supplements and that of chemicals. As Paul Anthony Taylor points out, in the process used for risk assessment of toxins, pesticides, etc., each individual substance is analyzed as a “separate chemical entity.”[4] This is a recurring theme in the discussion of Codex and its guidelines for various forms of food substances and supplements and can be easily seen in its regulation requirements for GMO’s as well. While GMO products are allowed in the international food chain, nutrients are treated as dangerous substances. In this case, simply giving nutrients the same treatment as toxic chemicals would be an improvement over their current treatment.

A second problem with the risk assessment methodology is the fact that it completely ignores the positive health benefits of nutritional supplements and focuses only on their risks.  This is especially important because when a regulatory agency determines, as Codex and other agencies apparently have, that any risk, no matter how insignificant it is, may constitute an “unreasonable risk of illness or injury” it may therefore be banned. Unfortunately, this is actually provided for under the DSHEA law passed in the United States in 1994. This, however, is essentially what the risk assessment procedure is all about - assessing dangers not benefits.

Not surprisingly, most of the evidence such as observational and clinical data that demonstrates a positive effect is ignored. Instead, all we are left with is “peer-reviewed” studies of isolated nutrient forms that are so varied in terms of experimental design, dosages, and even the nutrient forms themselves that they are virtually non-comparable. Not only that, but the form of the vitamin being tested is often in a synthetic form as opposed to its natural state with very little concern given to the individuals’ nutritional requirements or current state of health. Even follow up times vary significantly.[5]  Paul Anthony Taylor explains this in his article “Nutrient Risk Assessment: What You’re Not Being Told,” when he writes:

In some areas of the world, such as the United States and the United Kingdom, supplemental nutrients have been in use for over half a century now. As a result, some doctors and practitioners have built up extensive databases containing carefully documented case histories of patients who have used high doses of vitamin and mineral supplements, safely and effectively, for many years. Similarly, research scientists have conducted numerous small-scale clinical trials that have produced impressive results providing clear evidence of the safety of high dose supplements in human beings.

Nevertheless, a serious flaw in the current regulatory approach to nutrient risk assessment is that some of the most valuable potential sources of positive scientific evidence regarding the use and safety of supplements, such as the types of observational and clinical data described above, are generally ignored. Instead, the sole source of evidence that is considered are peer-reviewed scientific studies of particular nutrient forms, which are often non-comparable owing to differing experimental designs, nutrient forms delivered, dosages given, and so on.

The net result of this is that the evidence-base for nutrient risk assessment tends to be skewed towards consideration of negative outcome studies that used a single vitamin or mineral - frequently in a synthetic rather than a naturally-occurring form – without full and proper consideration of the participants’ overall state of health or individual nutritional requirements. Moreover such studies are often non-comparable owing to differences in their follow-up periods; the fact that many have been conducted on diseased rather than healthy populations; and that many were started well after disease states had already been initiated. As a result, a process that may appear rational, objective and scientific to the lay person or even the regulator, is, we discover, actually flawed and deeply unscientific. [6]

Yet the problems extend to more than just unscientific expansion upon unreliable models. There is both rhyme and reason to the madness of Codex Alimentarius. It is on the basis of the aforementioned science that Codex works to regulate nutrients as if they are industrial chemicals. This goal is achieved through the use of risk assessment methodology by setting Maximum Upper Limits (also described as Maximum Upper Levels or Upper Safe Levels), and later Maximum Permitted Levels of nutrients. There is a fine line between the two but the difference is a very important one. More on this topic will be discussed in a future article. 

Notes: 

[1] Taylor, Paul Anthony. “Nutrient Risk Assessment: What You’re Not Being Told.” http://www4.dr-rath-foundation.org/features/risk_assessment.html   P.2 

[2] Ibid. 

[3] A Model for Establishing Upper Levels of Intake for Nutrients and Related Substances, WHO/FAO. http://www.who.int/ipcs/highlights/full_report.pdf  Accessed May 24, 2010. 

[4] Taylor, Paul Anthony. “Nutrient Risk Assessment: What You’re Not Being Told.” http://www4.dr-rath-foundation.org/features/risk_assessment.html   P.2Ibid. 

[5] Ibid. 

[6] Ibid. 

Brandon Turbeville is an author out of Mullins, South Carolina. He has a Bachelor’s Degree from Francis Marion University where he earned the Pee Dee Electric Scholar’s Award as an undergraduate. He has had numerous articles published dealing with a wide variety of subjects including health, economics, and civil liberties. He also the author of Codex Alimentarius - The End of Health Freedom 

Related Articles by Brandon Turbeville:

The History of Health Tyranny

The Health Tyrants
The Structure of Health Tyranny
Globalism, Think Tanks, and "The New World Order"  
The Language of Health Tyranny

The S.510 and Codex Alimentarius Link

Buy 1 Get 2 Free at Botanic Choice Buy 1 Bottle and Get 2 FREE (select items), plus Free Shipping on $25+ Expires 12/31/2010

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Live Superfoods It is time to Wake Up! You too, can join the "Global Political Awakening"!

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