Bitter orange (Citrus aurantium) fruit contains several adrenergic agonists, primarily p-synephrine, but also octopamine and tyramine, as well as numerous flavonoids. Bitter orange has no specific lactation-related uses, but high dosages are often used in weight-loss agents. No data exist on the excretion of any components of bitter orange into breastmilk or on the safety and efficacy of bitter orange in nursing mothers or infants. Bitter orange is "generally recognized as safe" (GRAS) as a food and flavoring by the U.S. Food and Drug Administration. High dosages of bitter orange are often combined with caffeine and other stimulants in weight loss products, and the combinations may cause cardiac stimulation. Because of the lack of information on high dosages used in supplements and because animal data indicate that the adrenergic agents in bitter orange might decrease milk production, it should probably be avoided by nursing mothers, especially while nursing a newborn or preterm infant.
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.