PART 610 -- GENERAL BIOLOGICAL PRODUCTS STANDARDS

Subpart B--General Provisions

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=610.15

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.

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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 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 drsears.com 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.

http://www.squidoo.com/pharmaceuticalgradefishoil

by FishOilGuy

http://www.buzzle.com/articles/almond-oil.html

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.

http://www.medicinesgovernanceteam.hscni.net/newsletters/newsletters/MST%2011.pdf

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.

http://www.pharmj.com/pdf/articles/pj_20011124_sesame.pdf

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."

http://www.agmrc.org/commodities__products/grains__oilseeds/sesame_profile.cfm

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.
 

http://www.bibliotecapleyades.net/ciencia/ciencia_geneticfood01.htm

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.
 

http://www.ift.org/cgi-bin/news/archives.cgi?view=4-2005

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 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!