FDA Warns Oversized, Unmarked Droppers Could Lead To Vitamin D Overdose
This article was originally published in The Tan Sheet
Executive Summary
FDA recommends firms limit the size of droppers accompanying liquid vitamin D supplements for infants to the maximum recommended daily amount to reduce the risk of overdose
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FDA recommends firms limit the size of droppers accompanying liquid vitamin D supplements for infants to the maximum recommended daily amount to reduce the risk of overdose. Alternatively, the agency recommends firms clearly mark the maximum dose of 400 international units on all droppers for liquid vitamin D supplements, including those for adults and older children, according to a June 15 letter FDA sent to industry. FDA explains in the letter that some droppers used to administer liquid vitamin D supplements "can hold considerably greater amount of liquid vitamin D than an infant should receive," which "could lead to a parent inadvertently or mistakenly giving an unsafe amount of vitamin D to an infant." The letter is in response to an April 2010 article in the American Academy of Pediatrics newsletter that warns infants supplemented with liquid vitamin D are at risk of overdose, and should not consume more than 400 IUs of vitamin D a day, said FDA spokeswoman Siobhan DeLancey. AAP increased the recommended daily dose of vitamin D from 200 IUs to 400 IUs in 2008 (1 (Also see "Pediatricians Double Recommended Vitamin D Intake, Suggest Earlier Use" - Pink Sheet, 20 Oct, 2008.)). DeLancey said the warning is not in response to adverse event reports. The Council for Responsible Nutrition, which shares the agency's concern and cautious approach, identified only 32 published case reports of legitimate vitamin D intoxication, 13 of which were in children or infants, said Andrew Shao, the council's senior VP of scientific and regulatory affairs. Likewise, the agency's recommendation is not part of an enforcement action, DeLancey said. However, she added, "If we became aware of adverse events due to manufacturers not responding to this, then of course there is the potential for that." The current communique is "more an advisory to the industry to make sure their packaging is appropriate and that their droppers are appropriate." Shao agreed "it would be prudent for manufacturers to go back and look at their droppers, certainly those aimed at children and infants ... to make sure the directions are clear and droppers are labeled." However, he added, "there is no required change being instituted here." Several manufacturers of liquid vitamin D products already comply with FDA's recommendation. The dropper Mead Johnson Nutrition includes with its Enfamil D-Vi-Sol liquid vitamin D product holds only 400 IU of vitamin D and is clearly marked at the proper dosage with a line, "because we understand how important it is that infants receive safe amounts of vitamin D," said spokesman Chris Perille. The product also includes "easy-to-understand" written and pictorial illustrations on the product carton and insert, and the dose is on the bottle, he added. Carlson Laboratories, which makes and distributes Ddrops vitamin D liquid supplements, reduced the risk of overdose by using a Euro-dropper, which uses a "gravity set device" that accurately measures the drop when a consumer turns the bottle upside down, said sales and marketing executive Carilyn Anderson. The device spares consumers from "eye-balling" the correct dose, she added. Changing oversized, unmarked or inappropriately marked droppers could be "fairly expensive" for firms that do not currently comply with the recommendation, said Greg Clark, president of Sunlight Vitamins/UnitDrugCo. Nonetheless, "I am hopeful people will adhere" to the recommendation because overdose "could be a problem for children and something we shouldn't risk," he said, noting Sunlight Vitamin sells the Just D liquid supplement with droppers marked at 400 IUs. FDA also warned consumers about the overdose risk and advised them to use only the dosing device packaged with a product - a message FDA emphasized last fall when it published its Safe Use Initiative (2 (Also see "FDA Launches Safe Use Initiative; Details TBA Following Stakeholder Input" - Pink Sheet, 9 Nov, 2009.)). The same day the agency unveiled the initiative, it released draft guidance warning OTC drug firms that dosing devices that do not match labeled dosing directions will cause the product to be misbranded (3 (Also see "FDA Gets Strict On Liquid OTC Dosing Devices In Draft Guidance" - Pink Sheet, 9 Nov, 2009.)). - Elizabeth Crawford ( 4 [email protected] ) |