Trace amounts of protein + aluminum = allergy
You can't say something is safe to inject when your studies are based on people eating the foods!
Date: 5/19/2009 9:23:23 AM ( 14 y ) ... viewed 3300 times
[Code of Federal Regulations]
[Title 21, Volume 7]
[Revised as of April 1, 2008]
CHAPTER I--FOOD AND DRUG
DEPARTMENT OF HEALTH AND HUMAN SERVICES
PART 610 -- GENERAL BIOLOGICAL PRODUCTS STANDARDS
Subpart B--General Provisions
Sec. 610.15 Constituent materials.
(a)Ingredients, preservatives, diluents,
adjuvants. All ingredients used in a licensed
provided as an aid in the administration of the
product, shall meet generally accepted standards of
purity and quality.
Diluent.... and what are
the "generally accepted standards of purity and quality?"
Can't find any definition on the Web. So I searched on
"pharmaceutical oil" to see what would come up.
1999-2008 Authentic Breathing Resources LLC
Last modified: February 27, 2009
The Different Grades of Fish Oil Available
It is important not to be misled by
dramatic price differences among the various grades of
fish oil products currently available. There is a vast
range of both potency and purity not only between these
grades, but also often between individual products within
a particular grade.
"There are three grades of
fish oil. The first is cod liver oil. The second is
health-food grade fish oil. And finally there is
ultra-refined fish oil. What distinguishes one from
another is the purity and concentration of the long-chain
omega-3 fatty acids. More importantly, the long-term use
of any fish oil is compromised by its impact on the
gastric system which ultimately determines the amounts
that you can take. Each step in the refining process adds
additional cost to the final product, but the increased
purity justifies the cost and the benefits.
Ultra-Refined Fish Oil
Ultra-refined fish oil
starts with thermally fractionated health-food fish oil
that is then distilled by highly complex refining
technology into fractions rich in long-chain omega-3 fatty
acids that are exceptionally low in the long-chain
monoenes (that cause gastric distress) and pollutants such
as PCB's and oxidized and polymerized lipids. The
individual fractions are then combined to provide the most
appropriate balance of EPA and DHA for the finished oil.
The typical one-gram capsule of ultra-refined fish oil
will have at least 600 mg. of long-chain omega-3 fatty
acids. This may not seem a major concentration improvement
compared to the health-food grade fish oils, however, the
increase in the purity of the oil is why it costs nearly
twice as much. This purity is also reflected in a
dramatically improved taste profile....
Note: Vitamin E is often included in fish oils as a
preservative. At low levels, approximately 5 I.U./gram of
fish oil, it is protective. At higher levels, such as 20
I.U./gram of fish oil, it can actually speed up the
OmegaRx ultra-refined fish oil contains a minimum of 60%
of long-chain omega-3 fatty acids (although it routinely
reaches 75%) with 5 I.U. of Vitamin E per gram of fish
The above information in quotes is
reprinted with permission, from material that appeared in
drsears.com website in 2003.
"ultra-refined fish oil" now replaces the original term
"pharmaceutical-grade fish oil" for
reasons explained below by Dr. Barry Sears.
What's in a Name?--A Statement from Dr.
Barry Sears about the Importance of Quality Control
"One of the most frustrating realities
of the supplement industry is the lack of any
credibility in the products.
termed the phase 'pharmaceutical-grade' for describing
ultra-refined fish oil, it meant adhering to strict
quality control standards never before reached with
fish oils. Of course, virtually every supplement
manufacturer started saying their fish oils were
'pharmaceutical-grade'. Just to raise the
bar higher, I now use the term 'ultra-refined' fish
oil concentrates to describe OmegaRx. But don't take
my word for it, go to the
International Fish Oil Standards website where the
standards and data are for true 'pharmaceutical-grade'
fish oils. If you go to that website, you will notice
that only Zone Labs has every lot number we have ever
made posted for the entire world to see. This testing
is expensive, but it is my commitment to our customers
of setting the highest standards for fish oils.
Frankly, if your particular lot of fish oil is not
posted on that site, then it's 'buyer beware' and you
should ask the manufacturer of that fish oil 'what are
they trying to hide?' It's one thing to print
pharmaceutical-grade on a label, it's quite another to
actually make a truly 'ultra-refined' fish oil."
Understanding What Pharmaceutical Grade
can I say there's no such thing as pharmaceutical
grade fish oil? It's easy.
Let's start at the top.
There is no
organization that monitors, accredits, tests,
validates or certifies products that claim to be
In other words,
claim that anything is pharmaceutical grade. And,
there's no one to stop them.
So you can see that without standardization, the term
"pharmaceutical grade" is absolutely meaningless.
Product marketers will use it to mean whatever they
need it to - which almost always means to sell you
An Example of the Deception
Here's an example. Some people use the
term "pharmaceutical grade" to mean "pure." But,
interestingly enough, companies that use the term
seldom offer a guarantee of purity.
Even companies that use the purification method known
as "molecular distillation" admit that it doesn't
remove ALL the heavy metals and toxins from fish oil.
I don't know about you, but I've often wondered why
these companies start with toxic fish oils in the
first place? Possibly because it's the cheapest
Another "implied" definition is that the United States
Pharmacopeia (USP) has validated products claiming to
be pharmaceutical grade. That's just not true. If the
product's label doesn't say "USP Verified" then it's
NOT. Plain and simple. Anything more is just what
slick marketers want you to think.
want to know about the USP is that it does offer
standards for fish oils. But, compliance with these
standards is completely voluntary.
If you want to have some fun, you could ask some of
these "pharmaceutical grade" companies to confirm, in
writing, that their fish oil is in compliance with the
USP guidelines. You may be waiting a long time for
that letter to come in the mail.
Bitter almond oil is volatile and contains traces of
hydrogen cyanide owing to which consumption of bitter
almond oil is prohibited. Sweet almond oil on the other
hand has several beneficial qualities and hence a wide
variety of applications and uses in day-to-day life as
well as certain healing therapies. Sweet almond oil is
extracted from a combination of sweet as well as a minute
quantity of bitter almonds. Sweet almond oil is a fixed
oil, which is clear, pale yellow liquid, with a bland and
slightly nutty taste. Almond oil chiefly includes olein,
small proportion of the glyceride of linolic Acid and
oil is used as a carrier for injectable drugs in the
pharmaceutical industry. Almond oil is
typically used for drugs that deteriorate in water-based
Medication Safety Today, Issue 11
The Northern Ireland Medicines
Governance Team Newsletter
A number of medicines may contain peanut (arachis) oil.
This is often added to preparations as a “carrier” for
other drugs or to aid absorption of some emollients.
Pharmaceutical grade peanut oil is refined to remove
peanut protein (the cause of allergic reactions) during
the manufacturing process, however
of peanut protein may remain in the refined peanut oil.
Raising Awareness of Sesame Allergy
by Maggie Spirito Perkins
"Although refined sesame oil is the main
grade used in pharmaceuticals, medical products and
cosmetics, hypersensitivity reactions have been reported."
an unctuous, combustible substance that is
liquid, or easily liquefiable, on warming, and is
soluble in ether but not in water. Oils may be
animal, vegetable, or mineral in origin, and
volatile or nonvolatile (fixed).
of oils are used as flavoring or perfuming agents
in pharmaceutical preparations.
a fat that is liquid at room temperature.
a refined fixed oil obtained from the embryo of
Zea mays; used as a solvent and vehicle for
various medicinal agents and
vehicle for injections. It has also
been promoted as a source of polyunsaturated fatty
acids in special diets.
fixed oil from seeds of cultivated varieties
cotton plant (Gossypium) ; used as a
the refined fixed oil from peanuts (Arachis
hypogaea); used as a solvent and
Dorland's Medical Dictionary for Health Consumers.
© 2007 by Saunders, an imprint of Elsevier, Inc.
All rights reserved.
2008 by Diane Huntrods, AgMRC, Iowa State University.
pharmaceutical use for sesame oil in the United States is
as a “medical carrier” for injected drug or intravenous
drip solutions. It also is used as a carrier or
as part of a carrier formulation by the cosmetics
industry. The oil for pharmaceutical use is extracted from
high-quality seed and is more refined than oil intended
for human consumption or other “food-grade” (cosmetic)
Danger of Soy Allergens
by Kaayla T. Daniel
Extracted from Nexus Magazine,
Volume 11, Number 5
The industry newsletter,
The Soy Connection, states that highly refined oils
and lecithin "are safe for the soy-allergic consumer".44
Unfortunately, many allergic persons who have trusted such
reassurances have ended up in the hospital. Highly
susceptible people cannot use either safely. Adverse
reactions to soy oils—taken either by mouth as food or via
tube-feeding—range from the nuisance of sneezing to the
life-threatening danger of anaphylactic shock.45–51
If soy oil and
lecithin were 100 per cent free of soy protein, they would
not provoke allergic symptoms. Variable
conditions and the quality control and processing methods
used when the vegetable oil industry separates soybean
protein from the oil make the presence of at least trace
amounts of soy protein possible, even likely.
44. Soybean oil made safe in
processing. The Soy Connection, Spring 2003, 11,2,1. .
45. Bush RK, Taylor SL et al. Soybean oil is not
allergenic to soybean-sensitive individuals. J Allergy
Clin Immunol, 1985, 76, 2 pt 1, 242-245.
46. Awazuhara H, Kawai H et al. Antigenicity of the
proteins in soy lecithin and soy oil in soybean allergy.
Clin Exp Allergy, 1998, 28, 12, 1559-1564.
47. Gu X, Beardslee T et al. Identification of IgE-binding
proteins in soy lecithin. Int Arch Allergy Immunol, 2001,
126, 3, 218-235.
48. Errahali Y, Morisset M et al. Allergen in soy oils.
Allergy, 2002, 57, 7, 42, 648-649.
49. Moneret-Vuatrin DA, Morisset M et al. Unusual soy oil
allergy. Allergy, 2002, 57, 3, 266-267.
50. Buchman Al, Ament ME. Comparative hypersensitivity to
intravenous lipid emulsions, JPEN J Parenter Enteral Nutr,
1991, 15, 3, 345-346.
51. Weidmann B, Lepique C, et al. Hypersensitivity
reactions to parenteral lipid solution. Support Care
Cancer, 1997, 5, 6, 504-505.
2008-09, Institute of Food Technologists.
Soy oil research shaping allergen labeling
4/28/2005-Recent University of
Nebraska-Lincoln research on soybean oil is helping shape
food allergen labeling laws here and abroad. An
international study by UNL food scientists confirmed that
highly refined soybean oil does not cause reactions in
people who are allergic to soybeans, said food
toxicologist Sue Hefle, who headed this research with food
scientist Steve Taylor.
people don't react because refined oil contains only
minuscule amounts of protein, the culprit in allergic
reactions, Hefle said....
March, highly refined soybean oil was among the soy
components that the European Union temporarily exempted
from food allergen labeling regulations slated to
take effect later this year, he said....
Last year, U.S.
regulators exempted highly refined vegetable oils derived
from known allergens, such as soybeans or peanuts, from
the new federal food allergen labeling law that takes
effect in 2006....
For this study, the Institute
of Agriculture and Natural Resources researchers evaluated
30 highly refined soy oils from around the world. They
blended four oils containing the most protein to create a
representative worldwide sample. Collaborating physicians
at U.S., Canadian, French and South African universities
fed soy-allergic volunteers 1.5 tablespoons of soy or
canola oil hidden in oatmeal. None of the 29 volunteers at
the five test sites worldwide had a reaction. These 29
people represented a statistically significant sample of
geographically and ethnically diverse populations....
"We fed them more oil than
anyone is likely to consume in one sitting in the real
world," Hefle said. "If they didn't react to this
worse-case scenario, they're not going to react."...
The United Soybean Board and
food companies helped fund the soy oil research, which was
conducted in cooperation with IANR's Agricultural Research
is... they are taking studies where people EAT the oils
and saying that these same oils when injected along with
ALUMINUM are safe. It is like comparing a popgun to an
atomic bomb. They aren't the same! That itsy-bitsy trace
amount of protein when injected with aluminum causes the
body to react to that protein!
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