The concern is that the droppers can hold a considerably greater amount of liquid vitamin D than an infant should receive. In its letter to them it stated: “FDA has concerns regarding any liquid vitamin D products that could deliver a significantly excessive amount of vitamin D. The FDA wants manufacturers to only supply droppers that hold 400IU of fluid. “We completely agree with the AAP recommendations and are not concerned with this warning,” he said.

The fact some droppers hold much more than 400IU of liquid means caregivers need to pay attention so that they are using the “right tool for the job” as Wouter Claerhout, the senior marketing manager in human nutrition and health for vitamin D supplier, DSM noted. While the warning is centered around the 400IU level, the droppers themselves – and their variations - are highlighted as being problematic. “As many of these products do not require pre-market approval because they are classified as dietary supplements, we have reached out to the trade groups to help in the effort to make industry aware of this,” DeLancey said.īut no timeframes have been set for compliance.

Letters had also been sent to manufacturers of the products in question. To this end, the FDA yesterday met with trade groups such as the Council for Responsible Nutrition and Natural Products Association, to urge them to urge their members to comply with the advisory.

These found breast-fed and partially breast-fed infants should not consume more than 400IU (international units) of vitamin D per day.ĭeLancey emphasized that the warning was not an enforcement action but the potential for enforcement existed if manufacturers failed to alter their products so that it was clear 400IU was the recommended vitamin D maximum.

The gut-brain axis: Psychobiotic opportunity in 25 countriesįDA spokesperson Siobhan DeLancey told that the warning was not sparked by any particular adverse events, rather it follows American Academy of Pediatrics (AAP) recommendations published in April.

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