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[Code of Federal Regulations]

[Title 21, Volume 7]

[Revised as of April 1, 2008]

[CITE: 21CFR610.15]





Subpart B--General Provisions

Sec. 610.15 Constituent materials.

(a)Ingredients, preservatives, diluents, adjuvants. All ingredients used in a licensed product, and any diluent 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.

The Different Grades of Fish Oil Available Today

Copyright © 1999-2008 Authentic Breathing Resources LLC
Last modified: February 27, 2009

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 oxidative process.

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 oil."

The above information in quotes is reprinted with permission, from material that appeared in website in 2003. The term "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 and Testing

"One of the most frustrating realities of the supplement industry is the lack of any credibility in the products. When I 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 Means 

fish oil capsulesHow 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 pharmaceutical grade.

In other words, anyone can 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 more products.

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 source?

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.

What you 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. by FishOilGuy

Almond Oil

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 other glycerides.

Pharmaceutical Uses: Sweet almond 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 carriers.

Medication Safety Today, Issue 11

The Northern Ireland Medicines Governance Team Newsletter

May 2005

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 small amounts 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."

oil (oil)

1. 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). A number of oils are used as flavoring or perfuming agents in pharmaceutical preparations.

2. a fat that is liquid at room temperature.

corn oil  a refined fixed oil obtained from the embryo of Zea mays; used as a solvent and vehicle for various medicinal agents and as a vehicle for injections. It has also been promoted as a source of polyunsaturated fatty acids in special diets.

cottonseed oil  a fixed oil from seeds of cultivated varieties of the cotton plant (Gossypium) ; used as a solvent and vehicle for drugs.

peanut oil the refined fixed oil from peanuts (Arachis hypogaea); used as a solvent and vehicle for drugs.

Dorland's Medical Dictionary for Health Consumers. © 2007 by Saunders, an imprint of Elsevier, Inc. All rights reserved.

Ag Marketing Resource Center

Sesame Profile

Revised January 2008 by Diane Huntrods, AgMRC, Iowa State University.

A current 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) applications.

The Hidden Danger of Soy Allergens

by Kaayla T. Daniel

Extracted from Nexus Magazine, Volume 11, Number 5

(August-September 2004)
from NexusMagazine Website

recovered trough WayBackMachine Website

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.

Soy-allergic people don't react because refined oil contains only minuscule amounts of protein, the culprit in allergic reactions, Hefle said....

 In 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 Division.

The trouble is... they are taking studies where people EAT the oils and saying that these same oils when injected along with ALUMINUM is 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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