Pharmaceutical Regulatory Affairs: Open Access

Tocotrienols are found naturally in several plant sources, mainly in grains and oils, such as wheat germ, soybean oil, barley, oats, and olive oil. However, these sources have much lower concentrations of tocotrienols. Higher concentrations of tocotrienols are found in Annatto (Bixa orellana L.) seeds. The monograph Dietary Supplement Compendium (DSC) from the United States Pharmacopeia for Annatto Seed Oil Tocotrienols defines that tocotrienols fraction must contain at least 70% of total tocotrienols, calculated on an anhydrous basis of the total tocotrienol content, it must contain between 84% and 92% of δ-Tocotrienol and between 8% and 16% of γ-tocotrienol. The risk assessment with NaturalMax Annatto Tocotrienol™ Oil 70%, extracted from annatto seeds, provided 100% tocotrienols (gamma and delta-tocotrienol) less than 1% α-tocopherol in base anhydrous. NaturalMax Annatto Tocotrienol™ Oil 70% is an innovative ingredient that demonstrated to be according to regulatory requirements and can be applied in dietary supplements, cosmetics, and pharmaceutical products.