It discusses the use of PS formulations, such as sitosterol, as therapeutic agents for hypercholesterolaemia and their classification as Generally Recognized as Safe (GRAS) by the FDA.
Molecules · 4 authors, 4 centres
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It discusses the use of PS formulations, such as sitosterol, as therapeutic agents for hypercholesterolaemia and their classification as Generally Recognized as Safe (GRAS) by the FDA.
It discusses the use of PS formulations, such as sitosterol, as therapeutic agents for hypercholesterolaemia and their classification as Generally Recognized as Safe (GRAS) by the FDA. The review details the toxicological assessment of PS, noting that the main long-term safety concerns are interference with carotenoid absorption and the formation of potentially cytotoxic phytosterol oxidation products (POP). It highlights that the EFSA estimated a daily safe level of POP and that maximum recommended PS intake could exceed this level. The review also identifies gaps in research, including the need for long-term randomized clinical trials and more comprehensive safety evaluations that consider mixed diets and specific PS components.