肝臓障害と関連するとみられるOxyEliteの成分aegelineは法的にサプリメントに使えない

DMAAによると見られる心臓発作や脳卒中の症例があったため、代替成分としてUSPLabsがOxyElite Proの成分として選択したのがaegelineと呼ばれる化合物。これは、インド原産のBaelの樹の実に含まれていて、この樹の実そのものはインドで食用となっている。

Bael (Aegle marmelos), also known as Bengal quince, golden apple, stone apple, wood apple, bili, is a species of tree native to India. ... The fruit is eaten fresh or dried. If fresh, the juice is strained and sweetened to make a drink similar to lemonade.... Aegeline (N-[2-hydroxy-2(4-methoxyphenyl) ethyl]-3-phenyl-2-propenamide) is a known constituent of the bael leaf and consumed as a dietary supplement for a variety of purposes

[Bael (wikipedia)]

しかし、FDAは米国において、aegelineあるいはBaelの実が1994年10月15日以前に食用となっていた証拠はないとして、法規制なしのサプリメントに許認可なく使用できる成分ではないと判断。2013年10月11日付で、USPLabsに警告書間を送っていた。

This letter concerns your products Oxy Elite Pro and VERSA-1 that are labeled and/or promoted as dietary supplements. The labeling for these products declares aegeline, also referred to as N-[2-hydroxy-2(4-methoxyphenyl) ethyl]-3-phenyl-2-propenamide, as a dietary ingredient.

FDA is not aware of any information demonstrating that aegeline was lawfully marketed as a dietary ingredient in the United States before October 15, 1994, nor is FDA aware of any information demonstrating that this ingredient has been present in the food supply as an article used for food in a form in which the food has not been chemically altered. In the absence of such information, aegeline is subject to the notification requirement in 21 U.S.C. 350b(a)(2) and 21 CFR 190.6. Because the required notification has not been submitted, your products are adulterated under 21 U.S.C. 342(f)(1)(B) and 350b(a).

[Inspections, Compliance, Enforcement, and Criminal Investigations (2013/10/11) on FDA]

どうやら、これがUSPlabsのOxyEliteリコールの理由のようである。