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Generally Recognized as Safe

I seem to remember that food at one time didn't have to have all of the ingredients listed. I remember there being a big uproar in the food industry when changes were made requiring them to list all of their ingredients. Secret recipes were talked about. It would violate the right of companies to have to make their ingredients public. From what I read, drugs were subject to similar laws. I don't remember and big uproar in the pharmaceutical companies about putting things on the label. In the book "History of the Peanut Allergy" by Heather Fraser, she mentions that peanut oil was GRAS. It doesn't appear on the label. It was probably used before 1938. So I will have to get her book and read about why it doesn't have to appear on the package insert. I know it is in there because there wouldn't be so many patents for vaccine adjuvants that nobody uses or aren't similar to what is currently being used.

FDA should improve GRAS oversight, says GAO By Caroline Scott-Thomas, 08-Mar-2010

Related topics: Food safety, Legislation, Food safety and labeling

The FDA needs to improve its oversight of GRAS (generally recognized as safe) food ingredients, claims a new report from the Government Accountability Office (GAO). The Food and Drug Administration (FDA) no longer ‘approves’ food ingredients as GRAS, but does review their safety if a company submits a research dossier including the findings of an independent scientific panel. Following review, the FDA can issue a letter of no objection, leading to what is commonly referred to as FDA GRAS. However, the company remains responsible for ensuring the ingredient is safe and that it complies with all regulatory requirements. Alternatively, a company can self-affirm GRAS after conducting all necessary research and forming an independent panel to determine its safety. To self-affirm, the company needs to be confident that it could defend the safety of its ingredient based on this process.

No ‘systematic’ checks since 1980s

But the GAO said the FDA should be made more aware of self-affirmed GRAS products, and should systematically review the safety of current GRAS ingredients as new scientific data comes to light. “FDA is not systematically ensuring the continued safety of current GRAS substances,” the report said. “While, according to FDA regulations, the GRAS status of a substance must be reconsidered as new scientific information emerges, the agency has not systematically reconsidered GRAS substances since the 1980s.” FDA officials countered they are continuously reviewing the scientific literature and take action on particular substances if information is brought to their attention that causes them to doubt an ingredient’s safety.

7. How are excipients "approved" for use in pharmaceutical products?

Under U.S. law, an excipient, unlike an active drug substance, has no regulatory status and may not be sold for use in food or approved drugs unless it can be qualified through one or more of the three U.S. Food and Drug Administration (FDA) approval mechanisms that are available for components used in food and/or finished new drug dosage forms.

These mechanisms are:

1. determination by FDA that the substance is "generally recognized as safe" (GRAS) pursuant to Title 21, U.S. Code of Federal Regulations, Parts 182, 184 or 186 (21 CFR 182, 184 & 186);

2. approval of a food additive petition as set forth in 21 CFR 171; or

3. the excipient is referenced in, and part of, an approved new drug application (NDA) for a particular function in that specific drug product. Excipients contained in over-the-counter (OTC) drug products subject to FDA monographs referenced in 21 CFR Parts 331-358 must comply with the requirements in 21 CFR 330.1(e) which reads as follows: "The product contains only suitable inactive ingredients which are safe in the amounts administered and do not interfere with the effectiveness of the preparation or with suitable tests or assays to determine if the product meets its professed standards of identity, strength, quality, and purity. Color additives may be used only in accordance with section 721 of the Act and subchapter A of this chapter."

12. If it is so difficult to qualify a new excipient for pharmaceutical use, doesn't that have a chilling effect on the ability of finished drug manufacturers to develop better delivery systems for new, improved drug therapy for heart disease, cancer, and other serious conditions?

Yes. This is why far-sighted makers and users of excipients used in finished drug dosage forms joined together in 1991 to form the International Pharmaceutical Excipients Council (IPEC). We have made progress, as you will see on other pages of our website, but there still is a long way to go. Will you join us?

Good manufacturing practices for pharmaceuticals by Joseph D. Nally Page 332 (google books)

"Under the 1938 grandfather clause [see 21 U.S.C 321 (p)(1)], a drug product that was on the market prior to passage of the 1938 Act and that contained in its labeling the same representations concerning the conditions of use as it did prior to passage of that Act was not considered a new drug and therefore was exempt from the requirement of having an approved new drug applications.

"Under the 1962 grandfather clause, the Act exempts a drug from the effectiveness requirements if its composition and labeling has not changed since 1962 and if, on the day before the 1962 Amendments became effective, it was (a) used or sold commercially in the United States, (b) not a new drug as defined by the Act at the time, and (c) not covered by an effective application. See Pub. L. 87-781 section 107 (reprinted following 21 U.S.C.A 321); see also USV Pharmaceutical Corp, v. Weinberger, 412 U.S. 655, 622-66 (1973).

I couldn't find an answer to how peanut oil has managed as a GRAS ingredient that it doesn't appear on the package insert so I posted my question on and Heather Fraser answered it.


Largely unknown to the public, government and doctors have expressed concern regarding the allergenicity of refined peanut oil in processed foods and pharmaceuticals including vaccines. And they debated whether or not it should be labeled.

IN FOODS: Refined peanut oil has been shown to sensitize and cause reactions. The most highly refined peanut oils contain trace levels of intact proteins, up to 0.2-2.2 ug/ml. Lower refined peanut oil could contain 3-6 ug/ml of protein. Thus in 2004, the European Food Safety Authority (EFSA) investigated and concluded that refined peanut oil in foodstuffs could cause reactions and that according to their guidelines it must appear on food labels. With the same information, the WHO in 2000 concluded the opposite -- that the oil in foodstuffs did not need to be labeled. The US FDA followed suit, acknowledging the presence of the proteins but because it had GRAS (generally recognized as safe) it did not need to be labeled.

IN INJECTED DRUGS: where the oil appears in parenteral drugs such as vaccines used in Europe, labeling arachis oil on package leaflets as of 2001 was an expectation of EMEA, Euro Medicines Agency. It was expected although not a law that manufacturers should warn users of peanut oil used in any pharmaceutical product. In the US, labeling the oil in vaccines and drugs remained voluntary as well. The FDA has indicated that inactive ingredients that present an increased risk of toxic effects should be noted in the Contraindications, Warnings or Precautions sections of drug/vaccine labels/inserts.

This labeling option in the US, Canada is supported by law. The exact composition of vaccines cannot and will not be disclosed under an exemption that protects business information with the Access to Information Act in Canada and the Freedom of Information Act in the US. Similarly, trade secrets are also exempt under the British Freedom of Information Act.

Thus the guidelines to label refined peanut oil/moral obligation to label peanut oil are in conflict with laws protecting trade secrets. Full disclosure of excipients was not and continues not to be general practice in the US or Canada.

Labeling has become a matter of least legal exposure within carefully worded vaccine product monographs.

The way I understand it... The FDA no longer "approves" things as GRAS. They let the manufacturer submit some studies from an "independent research council". What I found weird was the sentence

"Alternatively, a company can self-affirm GRAS after conducting all necessary research and forming an independent panel to determine its safety. To self-affirm, the company needs to be confident that it could defend the safety of its ingredient based on this process."

WHAT the "H" does that mean? It sounds like the vaccine manufacturers can decide that all highly refined oils are GRAS on their own. And if that is the case, then that is why I found the following patent for a "A stabilized pharmaceutical oil-in-water emulsion" to be used in all kinds of drugs and vaccines:

"wherein the oil phase further comprises almond oil; babassu oil; borage oil; black currant seed oil; canola oil; castor oil; coconut oil; corn oil; cottonseed oil; emu oil; evening primrose oil; flax seed oil; grapeseed oil; groundnut oil; mustard seed oil; olive oil; palm oil; palm kernel oil; peanut oil; rapeseed oil; safflower oil; sesame oil; shark liver oil; soybean oil; sunflower oil; hydrogenated castor oil; hydrogenated coconut oil; hydrogenated palm oil; hydrogenated soybean oil; hydrogenated vegetable oil; a mixture of hydrogenated cottonseed oil and hydrogenated castor oil; partially hydrogenated soybean oil; a mixture of partially hydrogenated soybean oil and partially hydrogenated cottonseed oil; glyceryl trioleate; glyceryl trilinoleate; glyceryl trilinolenate; a ?3 polyunsaturated fatty acid triglyceride containing oil; or a mixture thereof."

I found these patents for all kinds of vaccine adjuvants and culture mediums that use all different kinds of food. Why would people take out patents and so many of them, without intending on using any of them? I wrote the Food and Drug Administration's (FDA) Center for Biologics Evaluation and Research (CBER):

"Aluminum in the form of alum, aluminum hydroxide or phosphate is the only adjuvants used in U.S. licensed vaccines and there is no oil in those adjuvants. The adjuvant, as well as, certain inactive ingredients must appear on the package label. General requirements for the package labeling can be found in 21 CFR 610.61."

Food and Drug Administration's (FDA) Center for Biologics Evaluation and Research (CBER)

So basically they are saying that the oil is not in the adjuvant so that is not a lie. It is interesting that the "certain inactive ingredients must appear..." but not all inactive ingredients. Kinda splitting hairs. As long as they add the oil separate from the adjuvant.... it's ok.... and it is GRAS if the oil is refined as much as the approved soy and peanut oils because it can be self approved as GRAS by the vaccine manufacturer? But if the oil is GRAS and the manufacture can self-approve the oil as GRAS, and it is a protected trade secret.... do they even have to reveal the oil if it is in the adjuvant to the FDA at all?


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