FDA: Food Labeling: Health Claims; Calcium and Osteoporosis, and Calcium, Vitamin D, and Osteoporosis Small Entity Compliance Guide

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) to include vitamin D so that, in addition to a claim for calcium and reduced risk of osteoporosis, a claim can be made for calcium and vitamin D and reduced risk of osteoporosis. 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. That regulation is binding and has the full force and effect of law.

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