Calcium, vitamin D health claim draft guidance
This article was originally published in The Tan Sheet
Executive SummaryHealth claims that calcium and vitamin D may reduce the risk of osteoporosis must clarify that adequate intake is essential to reduce osteoporosis risk. However, claims may not imply adequate intake is the only risk factor for developing osteoporosis, FDA says in a May 14 draft small entity compliance 1guidance. Beginning Jan. 1, 2010, food marketers may make health claims that calcium and vitamin D reduce the risk of osteoporosis if they comply with a final rule published in November 2008 (2"The Tan Sheet" Oct. 6, 2008, p. 16)
You may also be interested in...
The amyloid-targeting drug is years behind Biogen/Eisai’s aducanumab, but its subcutaneous administration and the GRADUATE studies’ design could give Roche’s gantenerumab an advantage.
Correvio's atrial fibrillation drug Brinavess will return to a US FDA advisory committee more than a decade after the agency first declined to approve the drug; FDA still has a series of cardiovascular safety concerns related to the drug and is not convinced by data from the European experience.