Posted by Larry Hoover on January 6, 2005, at 11:22:46
In reply to Link to Vet Tryptophan????????????????????, posted by qbsbrown on January 6, 2005, at 0:01:30
> What was that link again please?
> And im confused. I've heard both many times, that it is and it isn't legal/illegal in the states. Which is true.http://www.buygpdirect.com/gpefeed.htm
It is perfectly legal to buy and sell tryptophan for human consumption in the United States. It has been legal since 1994. The restoration of legal trade in tryptophan just didn't get any publicity, unlike the banning of the substance in 1991 because of a single contaminated batch.
It is also perfectly legal to sell tryptophan for veterinary use.
This is a quotation from the FDA website:
"Although FDA continues to enunciate its concern about the safety of dietary supplements containing L-tryptophan and related compounds such as L-5-hydroxytryptophan, this does not mean that FDA prohibits the marketing of dietary supplements that contain L-tryptophan. Under the Food, Drug and Cosmetic Act (the Act), as amended by the Dietary Supplement Health and Education Act of 1994 (DSHEA), the manufacturer is responsible for ensuring that its products are safe. A firm is not required to obtain premarket review or approval from the FDA of its products before marketing them as dietary supplements. Moreover, a firm is not required to submit scientific evidence to FDA of the safety of its products or ingredients. While we are unaware of conclusive scientific data that would establish that a dietary supplement L-tryptophan would be safe, if a firm has information that it believes establishes that a product containing L-tryptophan is safe within the meaning of the Act, it could market such a product as a dietary supplement. The burden and responsibility for assuring that such a product is not adulterated under the Act is with the firm and not FDA."What that means is that tryptophan labelled for use by humans carries an onus of inherent safety, which falls on the supplier, not the FDA.
There's quite a bit more information on that FDA page, so here's the link:
http://vm.cfsan.fda.gov/~dms/ds-tryp1.htmlWhat I believe is that suppliers are using this "onus" to jack up the price, and make obscene profits on human-use tryptophan products. I have thoroughly scanned the chemical supply literature, and the process that was used by that one Japanese chemical supply house will never be used again. Moreover, each batch of tryptophan is tested *at the manufacturing facility* for those identified contaminants, to ensure its purity. In other words, tryptophan is safer now than it has ever been, and that safety extends to veterinary products, because all tryptophan is tested before it is bulk-shipped.
Lar
poster:Larry Hoover
thread:438368
URL: http://www.dr-bob.org/babble/alter/20050101/msgs/438476.html