Posted by Ame Sans Vie on June 22, 2003, at 2:17:49
In reply to Re: » Questionmark, posted by Ame Sans Vie on June 22, 2003, at 2:07:27
While I know Erowid.com isn't the best source of drug information out there, this just may explain it:
http://www.erowid.org/smarts/tryptophan/tryptophan_law.shtml
"There is some confusion added by a statement by the FDA from February, 2001 which states:
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.
This may mean that the FDA has softened its prohibition on the sale of L-Tryptophan containing supplements and these may now be considered 'legal' in the US. Importation of L-Tryptophan is still blocked under this rule."
poster:Ame Sans Vie
thread:235351
URL: http://www.dr-bob.org/babble/20030619/msgs/235983.html