2 years, 4 months ago
about Serotonin
Is tryptophan, a precursor to the nuerotransmitter serotonin, now available in some states as an over-the-counter dietary supplement?
There is a lot of confusing information on the internet that followed the controversial FDA ban of L-tryptophan in 1989 - because of a contaminated batch. Some sites say it is only available by prescription and some say it is available in some states and that some states have banned it. Can you find on the shelf in your state? I would like to know which states have it banned and the states where it can be found. I hear it is commonly available in Europe.
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M$1 Answer
According to erowid.org, the sale of L-tryptophan appears to be legal to be sold as a "supplement" in the United States. And based on a statements of FDA last February 2001, it looks like the agency has softened its stance in the prohibition on the selling of supplements that has L-Tryptophan but importation is still not allowed under FDA rules.
In Austria, L-Tryptophan is sold over the counter, while in Italy & U.K., it is widely available at health food stores. But in France, the product is controlled as pharmaceutical.
-quote-
"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. "
-end of quote-
In Austria, L-Tryptophan is sold over the counter, while in Italy & U.K., it is widely available at health food stores. But in France, the product is controlled as pharmaceutical.
-quote-
"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. "
-end of quote-
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