Trace amounts of food protein in vaccines
Tuesday, April 20, 2010 9:59 AM
To: ocod@fda.hhs.gov
Please verify for me that the FDA allows trace amounts of food protein in vaccines. The sources are from the culture medium and the GRAS “pharmaceutical grade” food oils.
Regarding the oils… the way I understand it, the FDA approved highly refined peanut oil to be GRAS and made it voluntary for pharmaceutical companies to list it as an ingredient. The FDA also gave the pharmaceutical companies the power to decide that other ingredients are GRAS without having to submit anything to the FDA.
Culture mediums as the source:
[Code of Federal Regulations]
[Title 21, Volume 7]
[Revised as of April 1, 2008]
[CITE: 21CFR610.15]
TITLE 21–FOOD AND DRUGS
CHAPTER I–FOOD AND DRUG ADMINISTRATION DEPARTMENT OF HEALTH AND HUMAN SERVICES
SUBCHAPTER F–BIOLOGICS
PART 610 — GENERAL BIOLOGICAL PRODUCTS STANDARDS
Subpart B–General Provisions
Sec. 610.15 Constituent materials.
(b)Extraneous protein; cell culture produced vaccines. Extraneous protein known to be capable of producing allergenic effects in human subjects shall not be added to a final virus medium of cell culture produced vaccines intended for injection. If serum is used at any stage, its calculated concentration in the final medium shall not exceed 1:1,000,000.
Note that is says “FINAL virus medium of cell culture.” Up until the FINAL medium, food waste can be used:
..In contrast, complex media will use extracts of a variety of things, including left-over animal parts (cow brains and hearts), yeast (from brewing) or digests of plants or animal slurries (peptones are one example of this category). The exact composition of these extracts is often unknown. The sources of these extracts often take advantage of waste products from other industries to save money….
http://www.bionewsonline.com/3/what_is_growth_medium.htm
US Patent 6953574 – Method for producing a fermented hydrolyzed medium containing microorganisms
Vegetables preferably used are of leaf and root types e.g. various cabbages, beets, rutabaga, carrot, pumpkin, spinach, beet, watermelon, melon, peanut, artichoke, eggplant, pepper sweet, asparagus, and tomato. Fruits to be preferably used are apples, pears, kiwi, plums, citrus, apricots, grapes/raisins, mango, guava, bananas, biwa, cornel, fig, cherry plum, quince, peach, pomegranate, avocado, pineapple, date, papaya. Berries preferably include raspberry, bilberry, guelder rose, dog rose, ash berry (red and black), currant (red, black, and white), sea-buckthorn berries, gooseberry, schizandra, blackberry, cowberry, bird cherry, cranberry, sweet cherry, cherry, and strawberry. Preferred herbs and their roots are ginseng, celery, parsley, dill, dandelion, nettle, ginseng, and spinach. Preferred high protein products are offals including spleen, kidney, heart, liver, brains, maw, and stomach as well as mushrooms, sea products (fish, mussel, plankton for example), eggs or nuts. Preferred products of beekeeping are propolis, honey, royal jelly, and pollen of flower.
http://www.patentstorm.us/patents/6953574/description.html
There is no testing done to check for food protein remaining in the vaccine from the pre-final culture medium.
The other source of food protein in vaccines and pharmaceuticals is from GRAS (generally recognized as safe) ingredients that do not have to appear on the package insert or be listed as ingredients anywhere:
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.
Email from CBER OCOD Consumer Account, Monday, June 15, 2009 1:51 PM
Note that it says only CERTAIN inactive ingredients
VLP. Drug delivery vehicles, adjuvants, and excipients shall not be deemed to be “active ingredients”, except in the case where such delivery vehicle, adjuvant, or excipient is recognized as an active ingredient in accordance with 21 C.F.R. 210.3(b)(7).
http://www.techagreements.com/agreement-preview.aspx?num=616974&title=Avant%2...
FDA should improve GRAS oversight, says GAO By Caroline Scott-Thomas, 08-Mar-2010
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.
http://www.foodnavigator-usa.com/Product-Categories/Food-safety-and-labeling/...
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);
http://www.ipecamericas.org/public/faqs.html#question7
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