Thursday, November 02, 2006

Statutes; Ethnobotany; Cultural reasons for Ban, not Health (abortion?)

FDA at 21 CFR 189.180

1. The ban on sassifras is found at 21 Code of Federal Regulations 189.180 [21 CFR 189.180] FDA Ban 21 CFR 189.180. Excerpt: "(b) Food containing any added safrole, oil of sassafras, isosafrole, or dihydrosafrole, as such, or food containing any safrole, oil of sassafras, isosafrole, or dihydrosafrole, e.g., sassafras bark, which is intended solely or primarily as a vehicle for imparting such substances to another food, e.g., sassafras tea, is deemed to be adulterated in violation of the act based upon an order published in the Federal Register of December 3, 1960 (25 FR 12412)."
..........................................................................................................................................................
So, boiled water is fine as a "food" in itself, but to add flavoring adulterates the water and makes tea, so teas are an adulterated food subject to FDA rule. (?)
...........................................................................................................................................................
2. The specification of extracts of sassafrole that have removed the safrole are acceptable for use in food is at 21 CFR 172.580. The extract is called a "food additive." Excerpt:

"The food additive safrole-free extract of sassafras may be safely used in accordance with the following prescribed conditions:

"(a) The additive is the aqueous extract obtained from the root bark of the plant Sassafras albidum (Nuttall) Nees (Fam. Lauraceae).

"(b) It is obtained by extracting the bark with dilute alcohol, first concentrating the alcoholic solution by vacuum distillation, then diluting the concentrate with water and discarding the oily fraction.

"(c) The purified aqueous extract is safrole-free.

"(d) It is used as a flavoring in food.

Lists, Comments, Herb Bans and Restrictions lists the ban at Title 121. Not there that I could see.
.......................................................................................................................................................
Goldilocks mystery.

Why the overkill on sassafras, the underkill on cigarettes, and just right on other things.

Why does profit come to mind, and intruding on other people's business because you can, so there. I found a new profession category looking all this up: Ethnobotany.

At Medical Botany, Herbal Use, Multi-Cultural sassafras is listed in the module for "dangerous drugs", and the discussion is there: in summary, most things are dangerous if used wrong.

Lots are worse than sassafras.

Discuss in your Blue Book: An objectively unnecessary prohibition of an ingestible food or drink is a tactic, a victory goal for an advocate of a cultural position, and not necessarily a health measure. There are too many inconsistencies with other matters not banned, and worse in effect.

How to tell? Ask, before accepting any governmental agency ban on anything, who benefits, who gains control of another, whose industry or pocketbook is enriched, whose choices are lessened, whose position is advanced.

Why does the abortion capacity come to mind. A dose can indeed be used as an abortifacient.* FDA prefers back alley operators? What transcripts of deliberations are available? Roe v. Wade did not give legal protection to acts in this area until 1973, and the safrole ban was in the 1960's. Roe v. Wade.

Here is a large cut-and-pasted quote from the site below:

"Medicinal Action and Uses---Aromatic, stimulant, diaphoretic, alterative. It is rarely given alone, but is often combined with guaiacum or sarsaparilla in chronic rheumatism, syphilis, and skin diseases.

"The oil is said to relieve the pain caused by menstrual obstructions, and pain following parturition, in doses of 5 to 10 drops on sugar, the same dose having been found useful in gleet and gonorrhoea.

"Safrol is found to be slowly absorbed from the alimentary canal, escaping through the lungs unaltered, and through the kidneys oxidized into piperonalic acid.

"A teaspoonful of the oil produced vomiting, dilated pupils, stupor and collapse in a young man.

"It is used as a local application for wens and for rheumatic pains, and it has been praised as a dental disinfectant.

"Its use has caused abortion in several cases. [this effect is repeated in numerous sites, including Floridata.* What would a search of the FDA records show as to this element? What were the arguments, information? Roe v. Wade decided in 1973 to protect some rights in this area Roe v. Wade.

"Dr. Shelby of Huntsville stated that it would both prevent and remove the injurious effects of tobacco.

"A lotion of rose-water or distilled water, with Sassafras Pith, filtered after standing for four hours, is recommended for the eyes.

"---Dosage---Of fluid extract, 1/2 to 1 drachm. Of Sassafras bark, 1 to 2 drachms. Of oil of Sassafras, 1 to 5 drops. Mucilage, U.S.P., 4 drachms.

Medicinal pros and cons.
................................................................
* "WARNING
Use of sassafras oil has caused abortion in pregnant women. Research in the 1960's showed that safrole, a principal constituent of oil of sassafras, caused liver cancer in mice, and the US Food and Drug Administration outlawed the sale of flavorings (including oil of sassafras) containing it. Today's rootbeer is made with synthetic flavorings or oil of sassafras from which the safrole has been removed. Apparently filè powder does not contain enough safrole to be dangerous, and it is available commercially."

No comments: