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FDA Consumer

Megavitamins = megaproblems

Megavitamins = megaproblems – column

Annabel Hecht

Everyone needs vitamin D. It helps build strong bones and regulates metabolism of calcium and phosphate in the body. A diet deficient in vitamin D can cause rickets in children and osteomalacia (a bone disease) in adults.

But too much vitamin D can be harmful–which is why FDA’s Brooklyn district recently sent a regulatory letter to Bioline Lab Inc., Brooklyn. The firm was marketing vitamin D capsules with a labeled potency of 50,000 International Units. The Recommended Daily Allowance for vitamin D for children over 4 and adults is 400 International Units.

Vitamin D is stored in the liver and fat tissues and it fat-soluble. Since it is not readily excreted it can be highly toxic when taken in large doses. Prolonged hypervitaminosis D (the condition caused by taking excessive amounts of vitamin D) in infants can cause mental retardation, slowed physical growth, kidney failure, and death. In adults early symptoms of hypervitaminosis D are loss of appetite, vomiting, diarrhea and headache. Taking repeated doses can eventually cause heart damage, as well as kidney failure and death.

A district investigator visited Bioline to collect a sample of the product. When laboratory analysis confirmed the labeled potency, the district sent a regulatory letter to the firm saying that, at 50,000 International Units, the product was adulterated and potentially hazardous to health.

Representatives of the firm agreed to stop marketing the product. They also recalled 68 bottles from one consignee and sent letters to pharmacists who had been sent three or more bottles, telling them to change the product to prescription status.

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