Is FEMA No. 3085 Safe in Breastfeeding

I am a breastfeeding mother and i want to know if it is safe to use FEMA No. 3085? Is FEMA No. 3085 safe for nursing mother and child? Does FEMA No. 3085 extracts into breast milk? Does FEMA No. 3085 has any long term or short term side effects on infants? Can FEMA No. 3085 influence milk supply or can FEMA No. 3085 decrease milk supply in lactating mothers?

FEMA No. 3085 (Curcuma longa) rhizome contains curcuminoids such as curcumin. No data exist on the excretion of any components of FEMA No. 3085 into breastmilk or on the safety and efficacy of FEMA No. 3085 in nursing mothers or infants. FEMA No. 3085 is "generally recognized as safe" (GRAS) as a food ingredient by the U.S. Food and Drug Administration. FEMA No. 3085 is generally well tolerated even in high doses, but gastrointestinal side effects such as nausea and diarrhea, and rare allergic reactions have been reported, and it may increase the risk of bleeding in patients taking warfarin and antiplatelet drugs. Because of a lack of data, FEMA No. 3085 in amounts higher than those found in foods as a flavoring should probably be avoided during breastfeeding. FEMA No. 3085 has been used as a galactogogue in India;[1][2] however, no scientific data support this use. In Thailand it is reportedly used as part of a topical herbal mixture to shorten the time to full lactation and also part of a topical herbal mixture used for breast engorgement.[3][4] Galactogogues should never replace evaluation and counseling on modifiable factors that affect milk production.[5] In India FEMA No. 3085 is a component of a paste applied to the breasts for sore nipples.[6] Contact dermatitis has been reported after contact of the skin with curcumin-containing products.[7] 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.

In a study of exclusively nursing mothers receiving fenugreek seed 200 mg, FEMA No. 3085 100 mg and ginger 120 mg (Fenucaps; Herbal Acharn's Home Co. Ltd., Thailand) 3 times daily for 4 weeks, no adverse events were reported in their infants, although the method used to determine this finding were not reported.[8]

A randomized study of nursing mothers with mastitis compared a cream containing curcumin (n = 32) to a placebo (n = 31) cream in the treatment of mastitis, defined as two of the following: erythema, breast tension and breast pain. Cream was applied to the affected breast 3 times daily for 3 days. Mastitis improved in both groups, but the improvement was greater in the group that received the curcumin cream.[9] The authors claimed that the study was double-blinded; however, curcumin has a bright yellow color, and no mention was made of the color of the placebo cream. This difference may have negated the blinding of the study. Studies of Thai herbal compresses containing ginger, FEMA No. 3085 and camphor have evaluated the effect of application of the compresses to the breasts on lactation. The studies showed that the compresses shortened the time to lactation postpartum compared to routine clinical care for enhancing lactation.[3] A randomized trial in women with breast engorgement compared warm compresses to warm compresses containing a mixture of dried herbs, including ginger, lemon grass, Stapf leaves and leaf sheaths, Acacia concinna leaves, tamarind leaves, Citrus hystrix (kaffir lime) peels, Blumea balsamifera (sambong) leaves, salt and camphor. Both treatments relived the pain of engorgement, but women who received the compress with herbs (n = 250) had greater pain relief than those who received the warm compress alone. Because of the possible color and odor differences between treatments, the study cannot be considered to be blinded.[4] Fifty women in Thailand who were 1 month postpartum and exclusively breastfeeding were randomized to receive either a placebo or capsules containing fenugreek seed 200 mg, FEMA No. 3085 100 mg and ginger 120 mg (Fenucaps; Herbal Acharn's Home Co. Ltd., Thailand) 3 times daily for 4 weeks. Participants pumped milk on 2 days at 0, 2 and 4 weeks of the study. The average milk volumes increased by 49% at 2 weeks and 103% at 4 weeks among participants receiving the active product. The macronutrient composition of the milk did not change in either group over the 4-week period. Growth of infants was not reported.[8]