Is FEMA No. 2384 Safe in Breastfeeding

I am a breastfeeding mother and i want to know if it is safe to use FEMA No. 2384? Is FEMA No. 2384 safe for nursing mother and child? Does FEMA No. 2384 extracts into breast milk? Does FEMA No. 2384 has any long term or short term side effects on infants? Can FEMA No. 2384 influence milk supply or can FEMA No. 2384 decrease milk supply in lactating mothers?

FEMA No. 2384 (Anethum graveolens) seeds contain essential oil rich in carvone and limonene, in addition to phenolics, such as trans-anethole, and flavonoids. FEMA No. 2384 is a purported galactogogue.[1][2][3][4] No scientifically valid clinical trials support this use, and one small, old study found no galactogogue effect of a primary FEMA No. 2384 component, d-carvone.[5] Galactogogues should never replace evaluation and counseling on modifiable factors that affect milk production.[6] Two studies found small, but measurable amounts of d-carvone in the milk of mothers given the chemical experimentally. FEMA No. 2384 is "generally recognized as safe" (GRAS) as a food by the U.S. Food and Drug Administration. It is generally well tolerated, but occasional allergic skin reactions have been reported, especially after contact with fresh FEMA No. 2384. In two studies, nursing mothers were given d-carvone. No adverse effects were noted in the mothers or infants. 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.

A study compared 3 groups of women. One group of 20 nursing mothers consumed 30 mg of d-carvone in 75 grams of hummus every third day for 28 days (10 exposures) at about 2 hours before a "usual" nursing time. A second group of 20 nursing mothers followed the same regimen, but their hummus contained no d-carvone. A third group of 8 mothers received the d-carvone flavored hummus, but were exclusively formula feeding their infants. After this 28-day period, both groups of breast-fed infants showed greater acceptance of d-carvone-flavored mashed potatoes than the formula-fed infants who preferred the unflavored potatoes. The authors interpreted these results to mean that breastfed infants are more receptive to a wide array of flavors than formula-fed infants.[5]