FDA Warning on Infant Vitamin D Drops

WASHINGTONFDA held a teleconference and issued a warning on some liquid vitamin D supplements with droppers that may lead to excessive dosing of the vitamin to infants. While the agency issued a caution to parents and other involved in caring for infants, it asked manufacturers of liquid vitamin D supplements to take care to ensure such products have consistent, clear wording on the label that specifies its recommended use.

On the conference call, Linda M. Katz, M.D., M.P.H., Interim Chief Medical Officer, Center for Food Safety and Applied Nutrition (CFSAN), confirmed the agency considers the American Academy of Pediatrics (AAP) guidelines for 400 IU/d of vitamin D for breast-fed and partially breast-fed infants. In response to questions clarifying this dosage recommendation, Katz explained FDA considers this dosage appropriate for children aged one and under; for children older than one year, she said the upper level recommendation is 2,000 IU.

In its warning to parents and caregivers, FDA advised signs of excessive vitamin D in infants include nausea, vomiting, loss of appetite, excessive thirst, frequent urination, constipation, abdominal pain, muscle weakness, muscle and joint aches, confusion, fatigue and, in more serious cases, kidney damage.

Renowned vitamin D researcher Reinhold Vieth, Ph.D., professor at University of Toronto, voiced concerns FDAs warning would scare all users from vitamin D, which has many researched health benefits, from immune to bone health (which Katz said is consumers primary goal , in the agencys view). Katz responded FDA is most concerned about the delivery system and the consistency and accuracy of instructing consumers on how to use the vitamin D drops, not on what the benefits are or if consumers, including infants, should take vitamin D.

Andrew Shao, vice president of scientific and regulatory affairs for the Council for Responsible Nutrition (CRN), asked FDA if this warning was prompted by specific adverse event reports (AERs) and if the agency had further details, including dosages given and if 15-hydroxy vitamin D levels were tested. Katz replied the agency had no specific AERs in this area, but relied on cases it found in the literature.