The food ingredient known in Western culture as “black cumin” or “black caraway”, Nigella sativa L., has a three-millennial history of use in Middle- and Far-Eastern cultures as a food ingredient and therapeutic agent. Quantitative analysis of the volatile fraction yields widely variable results which may be due to one or a combination of different crop origins or possible varietal differences, contamination, method of extraction, stage of maturation of seed and other factors. Nonetheless, many publications cite quantifiable outcomes in acute, sub-chronic and chronic testing; as well as cytotoxic, mutagenic, and anti-mutagenic effects. There are a few reports describing allergic reactions in humans when N. sativa extracts are applied to the skin. Inasmuch as there is a paucity of credible evidence characterizing the safety of comparable N. sativa seeds or their extracts, there is likewise no evidence that the intact seed of N. sativa is harmful to the public when it is used in food as currently practiced. Notwithstanding the preceding and to paraphrase the Select Committee on GRAS Substances (SCOGS), it is not possible to determine, without additional data, whether a significant increase in consumption [of the whole seed] would constitute a dietary hazard (FDA, 2018).
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