Calendula (Calendula officinalis) flowers contain triterpene glycosides and aglycones, carotenoids, and essential oils. Topical application of calendula products has been used to treat sore and cracked nipples during nursing, either in homeopathic or pharmacologic preparations,[1-3] although little high-quality evidence supports this use.[4] One uncontrolled case series found that a cream containing Mimosa tenuiflora and Calendula officinalis was useful for healing cracked nipples during breastfeeding;[5] however, the lack of a control group and the presence of another ingredient makes the evaluation of Calendula's efficacy impossible. Calendula has also been used topically in combination with Echinacea angustifolia (Calendit-E) for sore nipples in a study of modest quality in which the combination was found to be more effective than breastmilk.[6,7] Oral Calendula has no specific lactation-related uses and no information is available on the oral use of Calendula during breastfeeding. Calendula is "generally recognized as safe" (GRAS) as a food by the U.S. Food and Drug Administration when used as a seasoning or flavoring. Allergic reactions, including cross-reactions to chrysanthemums, daisies and marigolds, occur rarely.
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 prove 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 not 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.