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FDA Amendment to Include Vitamin D in Osteoporosis Claims

Press Release
Source: http://Vitamin Retailer Magazine
October 29, 2008

 

Effective January 1, 2010, the Food and Drug Administration (FDA) amended its label regulation authorizing a health claim on the relationship between calcium and a reduced risk of osteoporosis to include vitamin D.

Additionally, the FDA eliminated the following claims:
• listing sex, race and age as specific risk factors for the development of osteoporosis;
• stating or implying that the risk of osteoporosis is equally applicable to the general US population;
• identifying the mechanism by which calcium reduces the risk of osteoporosis;
• including a statement reflecting the limit of the benefits derived from dietary calcium intake; and
• requiring that the claim include a statement that a total dietary intake greater than 20 percent of the recommended daily intake (2,000mg) has no further effect to bone health when the food contains 400mg or more of calcium.

This final rule is, in part, in response to the health claim petition submitted by the Beverage Institute for Health and Wellness, LLC. Because current regulations do not permit food producers to claim health benefits for products by linking the intake of vitamin D and calcium together with a decreased risk of osteoporosis, this regulation will open doors for manufacturers who look to promote D vitamins’ ability, when combined with calcium, to assist in decreasing osteoporosis risk.

Manufacturers will be able, under these new rules, to recreate product labels to add health claims to their products that qualify or reformulate products (by fortifying with calcium or vitamin D) to qualify for the health claims.

The FDA solicited comments on the calcium and vitamin D proposed rule, with the comment period closing on March 21, 2007. The agency received 27 responses from trade associations, health organizations, academia and consumers. Most of these comments supported the proposed amendments.

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Link to press release here.

 

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