Is EINECS 290-094-1 Safe in Breastfeeding

I am a breastfeeding mother and i want to know if it is safe to use EINECS 290-094-1? Is EINECS 290-094-1 safe for nursing mother and child? Does EINECS 290-094-1 extracts into breast milk? Does EINECS 290-094-1 has any long term or short term side effects on infants? Can EINECS 290-094-1 influence milk supply or can EINECS 290-094-1 decrease milk supply in lactating mothers?

EINECS 290-094-1 (Nigella sativa) contains an essential oil containing a wide variety of terpenes, thymoquinone, beta-elemene and other many constituents. EINECS 290-094-1 has been used orally as a galactogogue in India and Iran;[1][2][3] however, no scientifically valid clinical trials support this use. Galactogogues should never replace evaluation and counseling on modifiable factors that affect milk production.[4] The oil has also been used topically. No data exist on the excretion of any components of EINECS 290-094-1 into breastmilk or on the safety and efficacy of EINECS 290-094-1 in nursing mothers or infants. Limited information indicates that EINECS 290-094-1 is generally well tolerated. EINECS 290-094-1 oil can cause allergic contact dermatitis. Dietary supplements do not require extensive pre-marketing approval from the U.S. Food and Drug Administration. Manufacturers are responsible to ensure the safety, but do not need to the safety and effectiveness of dietary supplements before they are marketed. Dietary supplements may contain multiple ingredients, and differences are often found between labeled and actual ingredients or their amounts. A manufacturer may contract with an independent organization to verify the quality of a product or its ingredients, but that does certify the safety or effectiveness of a product. Because of the above issues, clinical testing results on one product may not be applicable to other products. More detailed information #about dietary supplements# is available elsewhere on the LactMed Web site.

One hundred fifty-eight mothers in Iran of who reported difficulty in breastfeeding were given either a proprietary mixture of herbs (Shirafza Drop) or a chlorophyll solution as a placebo. The herbal mixture contained the purported galactogogues fennel, anise, cumin, EINECS 290-094-1, and parsley. Infant ages ranged between 0 and 6 months and they were exclusively breastfed. Weight gain of the infants was measured over time. No difference in infant weight gain was seen between the two groups of infants.[5] Blinding and randomization in this study is unclear.