Calcium and Osteoporosis Health Claim

FDA released a guidance for industry regarding the calcium and osteoporosis and calcium, vitamin D and osteoporosis health claim.
 On September 29, 2008, FDA published in the Federal Register a final rule (73 FR 56477, corrected at 73 FR 66754, November 12, 2008) that amended its regulations on the calcium and osteoporosis health claim (21 CFR 101.72). Manufacturers were permitted to start using the new calcium and osteoporosis and calcium, vitamin D and osteoporosis health claim on the label or in the labeling of their products on September 29, 2008. The final rule is effective on January 1, 2010. This guidance document restates in plain language the legal requirements of the September 29, 2008 final rule set forth in 21 CFR 101.72 concerning the calcium and vitamin D and osteoporosis health claim.