Lecithin is a mixture of choline, choline esters, fatty acids, glycerol, glycolipids, triglycerides, phosphoric acid, and phospholipids, such as phosphatidylcholine that are normal components of human milk. Supplemental lecithin has been recommended as a treatment for plugged milk ducts,[1-3] and as an additive to human milk that is given to preterm infants via pumping through plastic tubing in order to prevent fat loss.[4] No scientifically valid clinical studies exist on the safety and efficacy of high-dose lecithin supplementation in nursing mothers or infants. Most nursing mothers do not have adequate choline intake and mothers of very preterm infants may have reduced levels of choline in milk.[5,6] Supplementation with one component of lecithin, phosphatidylcholine, increases choline, but not phosphatidylcholine concentrations in breastmilk and supplementation with choline increases choline metabolites, but not choline in breastmilk. A meta-analysis found that higher maternal choline intake was likely to be associated with better child neurocognition and neurodevelopment.[7] Lecithin is usually well tolerated and is considered to be "generally recognized as safe" (GRAS) by the U.S. Food and Drug Administration.
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