Hibiscus (Hibiscus sabdariffa) flowers contain anthocyanins, proanthocyanidins, flavonols, as well as various pigments, oils and acids. Other Hibiscus species are also used medicinally. Hibiscus is purportedly used as a galactogogue in some cultures and is included in some proprietary mixtures promoted to increase milk supply;[1,2] however, no scientifically valid clinical trials support this use. Galactogogues should never replace evaluation and counseling on modifiable factors that affect milk production.[3,4] No data exist on the excretion of any components of Hibiscus into breastmilk or on the safety and efficacy of Hibiscus nursing mothers or infants. Hibiscus is "generally recognized as safe" (GRAS) as a food by the U.S. Food and Drug Administration. Hibiscus flowers appear to be generally well tolerated, although allergic reactions are possible, including cross reaction with other members of the Malvaceae family (e.g., ambrette, marshmallow).
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.