The major amendment will permit products that bear a calcium and osteoporosis claim to also make reference to vitamin D content and its ability to benefit bone health.
Calcium and vitamin D dietary supplements are often sold in combination and studies have demonstrated both nutrients have bone health benefits.
The publishing of the final rule follows amendments made at the beginning of 2007, when vitamin D was first added to an amended claim and a two-month consultation period was opened.
In that time 27 mostly supportive comments were received from trade associations, health-related organizations, academia and consumers.
Other amendments in the published final rule include:
- Remove requirement to list sex, race and age as specific risk factors for the development of osteoporosis;
- Remove requirement that label must state osteoporosis affects different sectors of the US population differently;
- Remove requirement that claim must identify populations at particular risk of developing osteoporosis;
- Remove requirement that claim identifies the mechanism by which calcium reduces the risk of osteoporosis;
- Remove requirement that claim state total dietary intake greater than 200 percent of the recommended daily intake (2000mg) of calcium has no further benefit to bone health when the food contains 400mg or more of calcium per reference amount customarily consumed or per total daily recommended supplement intake;
- Make reference to physical exercise optional rather than compulsory.
Osteoporosis affects more than 10 million US citizens and causes approximately 1.5m fractures annually. Every year, these lead to more than 2.6m physician office visits, over 800,000 emergency room visits, and more than 500,000 hospitalizations, and the placement of nearly 180,000 people into nursing homes.
The public health cost of osteoporotic fractures was measured at $12-18bn dollars in 2002.
The final rule is, in part, in response to a health claim petition submitted by The Beverage Institute for Health and Wellness.
FDA estimated the cost to re-label a product according to the revised health claim language between $6,100 to $16,600 per product.
The proposal is likely to be welcomed by the vitamin industry – at both supply and finished product levels – since it communicates the importance of vitamin D.