The FDA made its views known in a letter to the lawyers representing Marine Bio USA who had submitted a health claim petition in October 2003.
The company outlined evidence to show that calcium may reduce the risk of hypertension, pregnancy-induced hypertension, and preeclampsia.
FDA said in its letter dated October 12, 2005 that it will consider exercising enforcement discretion for the following qualified health claims:
1. Some scientific evidence suggests that calcium supplements may reduce the risk of hypertension. However, FDA has determined that the evidence is inconsistent and not conclusive.
2. Four studies, including a large clinical trial, do not show that calcium supplements reduce the risk of pregnancy-induced hypertension during pregnancy. However, three other studies suggest that calcium supplements may reduce the risk. Based on these studies, FDA concludes that it is highly unlikely that calcium supplements reduce the risk of pregnancy-induced hypertension.
3. Three studies, including a large clinical trial, do not show that calcium supplements reduce the risk of preeclampsia during pregnancy. However, two other studies suggest that calcium supplements may reduce the risk. Based on these studies, FDA concludes that it is highly unlikely that calcium supplements reduce the risk of preeclampsia.