Brandon Turbeville
January 13, 2013
The recently shelved New Dietary Ingredient
(NDI) draft guidelines proposed by the FDA has been the subject of much
concern by natural health supplement manufacturers and consumers ever
since the announcement was made by the agency in early 2011.
The guidelines,
which were published in the Federal Register, would have clarified some
definitions of terms, changed requirements for “new” supplement
introduction and manufacture, and a host of other more minor, but
important, tweaks in previous FDA policy.
However,
the most concerning aspect of the proposed changes is that many are
actually the stealthy introduction of Codex Alimentarius-compliant
regulations being imposed upon the United States health supplement
industry. Specifically, these guidelines would not only have made it
harder and more expensive for vitamin and mineral supplement
manufacturers to introduce “new” supplements into the market, but it
would also have resulted in the removal of many supplements from the
market as it currently exists.
Most notably, the proposed FDA guidelines
mandated the use of Risk Assessment methodology to determine and
establish what could be easily described as the Maximum Upper Limit or
Maximum Permitted Level of nutrients allowed in vitamin and mineral
supplements – a hallmark of the Codex Alimentarius position in relation
to these products.
If
one is unfamiliar with Codex Alimentarius and the ramifications that
the standards of this international organization will have on vitamin
and mineral supplements in the United States (and every other nation), I
encourage you to read my book, Codex Alimentarius – The End of Health Freedom, which is a comprehensive study of Codex Alimentarius and the fallout of adherence to the standards it sets.
In
this context, it is extremely important to understand the deleterious
effects of using Risk Assessment methodology in evaluating food
supplements as well as establishing Maximum Upper Limits/Maximum
Permitted Levels of nutrition in these products. Essentially, Codex
Alimentarius derives its standards (which are set extremely low) by
classifying nutrients as toxins even while classifying actual toxins such as fluoride as nutrients.
It
is also important to understand that it is the goal of every nation
that is part of the World Trade Organization (WTO) to become
Codex-compliant for trade dispute purposes. Thus, it is easy to see why
regulatory agencies such as the FDA, USDA, and EPA
(which openly desires to become Codex compliant) introduce Codex
guidelines through stealth and under the appearance of their own
independent regulatory standards and volition. As I wrote in my article,
“The Language of Health Tyranny: Decoding the Codex Alimentarius Guidelines For Vitamins and Supplements,”
Risk assessment, while seemingly benign, is actually crucial to the ability of Codex to justify the ban of vitamin and mineral supplements. This concept works on the assumption that the item being tested is inherently dangerous and toxic. This method is completely the opposite of what should be used when evaluating vitamins and minerals. As Dr. Rima Laibow states in her article "'Nutraceuticide' and Codex Alimentarius:"
This use of risk assessment, of course, represents a major deflection from the real use and value of risk assessment, which is to make sure that people are not exposed to the dangerous industrial chemicals that have serious and sometimes lethal effects on them and their children.[1]
By applying “scientific risk assessment” to nutrients and supplements, they are essentially considering them toxins as they are lumped into the same category as chemicals and poisons. There is no need to explicitly state that “nutrients are toxins.” This is done by default. So, in the end, we have the categorization of vitamins and minerals that are essential to human health and life as something that is actually toxic. In this sense, we are entering the world of doublethink.
Regardless, this is the position of Codex, as well as the position of the U.S. Delegation throughout the discussion [Codex Committee on Nutrition and Foods For Special Dietary Uses].[2] Indeed, even many alleged “health freedom” International Non-Governmental Organizations were either gullible enough to be taken in by the promise of the benefits of risk assessment, or morally bankrupt enough to be bought off by the pharmaceutical industry or others who might benefit from the demise of the natural supplement industry. Yet, some of the support for risk assessment methods early on seems to have been based on the fear of the implementation of maximum limits proposed by European countries like France. These limits would have reduced the potency level of each pill to no more than 15% Recommended Daily Intake (RDI), a figure that is already set much too low.[3] Yet those who favored risk assessment seemed to jump from the frying pan into the fire. As Scott Tips of the Natural Health Federation writes:
The so-called 'science-based risk assessment' for establishing Safe Upper Limits (maximum levels) for vitamin-and-mineral potencies, to which the EU has agreed, and about which the Americans are as happy as flies on cow dung, is nothing but a trap. The Americans think that they will be able to get real science to establish high maximum levels for their vitamins and minerals and then sell them to European consumers by the bushels. But by the time the Europeans get through applying their science, those maximum limits will be so low toddlers would be lucky to get any nutritional value out of Codex-harmonized vitamins and minerals. The European Union’s Scientific Committee on Food has already started using its science-based risk assessment to establish laughably low maximum limits for European vitamins. And, lately, I have begun to see a growing concern, if not outright fear, in the faces of some science-based risk-assessment proponents that perhaps things might not go their way here after all.[4]
With
this in mind, the FDA’s NDI draft guidance document would have required
the supplement manufacturer to include an NDI notification for the “new
ingredient.” Among the requirements of the notification is the
establishment of a “No-Observed-Adverse-Effect Level” (NOAEL) as well as
the Acceptable Daily Intake (ADI) for the ingredient. While the ADIs
present their own controversy (always being set too low), the NOAEL is,
in fact, simply another name for Maximum Upper Limits/Upper Safe Levels –
a level which affects the actual production and consumption of the
supplement as opposed to the instructional element.
These
levels, while seemingly benign or even positive constructions, are far
from helpful when applied to nutritional supplements. To give an idea of
how these Risk Assessment numbers are improperly applied and then
ratcheted down until the supplements are rendered virtually useless,
Rima Laibow describes[5] the Risk Assessment methodology as follows:
First
a group of test animals, mice, rats, rabbits, et cetera, are increasing
amounts of the toxin of interest. The dose in 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.[6]
When
the “toxin” is actually a nutrient, setting the MUL at a point where
there is no impact is defeated the purpose of consuming the nutrient in
the first place, as well as the precursor to significantly raising the
costs and practicality of obtaining proper nutrition.
Thus,
the FDA’s draft NDI guidelines as previously submitted were infested
with Codex Alimentarius-based guidelines of Risk Assessment and Maximum
Upper Limits/Upper Safe Levels designed to reduce access and
availability of nutritional supplements both from the shelves and the
factory.
Of
course, these specific guidelines were not the only way in which the
FDA had attempted to impede the development and production of
nutritional supplements. The NDI guidelines also attempted to make NDI
submission supplement-specific as opposed to ingredient-specific. This
means that the agency would have required a new NDI notification for each
specific supplement, formula, or blend in which the NDI is used,
instead of simply the NDI itself. That is, unless the manufacturer is
able to meet some rather strict criteria which, among other things,
conveniently reduce the amount of the NDI in the supplement.
Certain
types of probiotics would also have been restricted given the FDA’s
attempt to exclude the designation of the bacteria supplement as being a
dietary ingredient – thus potentially removing certain amounts of
probiotics from the market.
Thankfully, for the time being, the FDA’s guidelines have been postponed after significant public outcry
and a meeting with a handful of senators and representatives in the
U.S. Congress. However, the guidelines will be revisited in the future
and one can only guess as to what they may include when the updated
versions are released to the public.
Keeping
history in perspective, it is an unfortunate reality that government
revisions often make the original bill seem better in retrospect. This
is because they can count on the second round of opposition to only be
half the size of the first. Thus, after a bit of rewriting and
rewording, the new version of the bill or policy often includes elements
which were even worse than the first version due to the fractured
resistance it will now encounter.
While
reporting on guidelines that have been shelved may, at first, seem like
a waste of time, it is important to point out just how the FDA, along
with its regulatory kin, are determined to harmonize their own standards
with that of Codex Alimentarius to the detriment of the consumer and
the American people they have been tasked with protecting.
We
must be able to recognize these dangers immediately and identify the
sources of such changes to regulatory policy in order to mount an
effective resistance.
References:
[1] Laibow, Rima. “’Nutraceuticide’ and Codex Alimentarius.” Alternative and Complementary Therapies, October 2005. P. 227.
[2]
Tips, Scott C. “Breathe Easier – Codex Adjourns.” Codex Alimentarius:
Global Food Imperialism. Ed. Scott C. Tips. FHR. 2007. P. 33.
[3] Ibid.
[4] Tips, Scott C. “A Meeting Of Two.” Codex Alimentarius: Global Food Imperialsim. Ed. Scott C. Tips. FHR. 2007. P. 101.
[5] Turbeville, Brandon. Codex Alimentarius – The End of Health Freedom. False Flag Publications. 2010. http://www.thebookpatch.com/
Read other articles by Brandon Turbeville here.
Brandon Turbeville is an author out of Florence, South Carolina. He has a Bachelor's Degree from Francis Marion University and is the author of three books, Codex Alimentarius -- The End of Health Freedom, 7 Real Conspiracies, and Five Sense Solutions and Dispatches From a Dissident. Turbeville has published over 190 articles dealing on a wide variety of subjects including health, economics, government corruption, and civil liberties. Brandon Turbeville's podcast Truth on The Tracks can be found every Monday night 9 pm EST at UCYTV. He is available for radio and TV interviews. Please contact activistpost (at) gmail.com.
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