3 replies to this topic

[doug123]

News source: FDA.gov

FDA News
FOR IMMEDIATE RELEASE
P07- 02
January 5, 2007
Media Inquiries:
Mike Herndon, 301-827-6242
Consumer Inquiries:
888-INFO-FDA

FDA Updates Health Claim for Calcium and Osteoporosis
Proposal Would Give Consumers More Information to Make Healthy Food Choices

The Food and Drug Administration (FDA) is proposing to allow new claims on foods and dietary supplements containing calcium and Vitamin D to show their potential to reduce the risk of osteoporosis. The proposed rule would allow manufacturers to include new information on their food and supplement labeling and to eliminate certain other information, described below.

“This is important information for all citizens,” said Robert E. Brackett, Ph.D., director of FDA’s Center for Food Safety and Nutrition. “All persons lose bone with age, and the loss can influence an individual's risk of developing osteoporosis. Maintenance of an adequate intake of calcium and vitamin D in all stages of life can help lower one’s risk.”

Today’s action is part of FDA’s continued commitment to helping consumers make informed and healthy food choices, and responds to a health claim petition submitted by the Beverage Institute for Health and Wellness, The Coca-Cola Company.

The proposed rule would amend one of the first health claims authorized in 1993 through the Nutrition Labeling and Education Act of 1990 for the relationship between calcium intake and osteoporosis. The proposal would amend this existing health claim by allowing for claims of a reduced risk of osteoporosis with the consumption of both calcium and vitamin D.

The proposed rule also would eliminate certain requirements that were a part of the required claim language in the existing calcium and osteoporosis health claim. However, FDA is not changing its conclusion that there is still significant scientific agreement to support claims for calcium intake and reduced risk of osteoporosis.

“Osteoporosis is a significant public health problem, especially for women,” said Kathleen Uhl, MD, assistant commissioner of FDA’s Office of Women’s Health. “This new labeling should assist consumers to select foods - and women especially since women do the majority of food shopping in the US - that provide adequate calcium and Vitamin D intake and hopefully prevent the occurrence of osteoporosis in themselves and their family members.”

FDA’s decision to amend the existing health claim is based on the agency’s review of the publicly available scientific evidence, which included the 2004 Surgeon General’s report on Bone Health and Osteoporosis and the 2000 NIH Consensus Statement on Osteoporosis, Prevention, Diagnosis and Therapy.

Specifically, FDA is proposing to change the calcium and osteoporosis health claim to:

Add a claim for calcium and vitamin D together and a reduced risk of osteoporosis.
Shorten the claim language by:

Dropping the reference to sex, race, and age since the benefits apply to both sexes at all ages and race categories.
Dropping the need to identify the mechanism by which calcium reduces the risk of osteoporosis.
Dropping the requirement that the claim state that there are limits to benefit of calcium intakes above 200% of the Daily Value.
Comments may be submitted electronically to http://www.accessdat....cfm?AGENCY=FDA (click on the Docket Search link on the left side and put in the docket number 2004P-0464) or in writing to the Division of Dockets Management, 5630 Fishers Lane, room 1061, Rockville, MD 20852. Please reference the docket number when submitting comments.

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[doug123]

The Daily India reported the same news here...with a slightly different persepective.

Three daily servings of dairy dramatically cut osteoporosis risk

Washington, Jan. 6 (ANI): The National Dairy Council (NDC) has acknowledged an amended health claim proposed by the Food and Drug Administration (FDA), which may help communicate to consumers that foods high in calcium and vitamin D, and physical activity reduce the risk of osteoporosis.

"The proposed claim provides a clearer way to communicate the benefits of calcium and vitamin D in bone health," said Ann Marie Krautheim, registered dietitian and senior vice president of nutrition and health promotion at the NDC.

"We hope the simplified language will help consumers better understand the importance of three daily servings of dairy to obtain these nutrients and reduce the risk of osteoporosis." Krautheim added.

The report also recognises the importance of regular physical activity in contributing to bone health, besides recognising the importance of dairy products in cutting the risk of osteoporosis.

"A proposed new health claim demonstrating the connection between calcium and vitamin D and the role it plays in reducing the risk of osteoporosis will draw attention to milk as one of the richest dietary sources of calcium and vitamin D, critical for building strong bones in kids and teens, and providing the best defense against developing osteoporosis later in life," says Dr. Frank Greer, the Chairman of AAP Committee on Nutrition.

"While calcium supplements and non-dairy foods such as calcium-fortified beverages are an alternative, these products do not offer milk's unique nutrient package," he added. (ANI)

Copyright © 2004-2007 DailyIndia.com

[Pablo M]

Everyone seems very gung-ho on calcium. In the health food store I work at, I see these older women w/ recommendations from their doctor to take 1500mg of calcium. In conjunction with the average American diet, that is a ridiculously high dose. So they'll take 2-3 pills of calcium carbonate with dinner, because no one likes to take pills 3 times per day (excepting of course ImmInst members). Now we have a couple to three grams of calcium carbonate that's acting like an antacid and possibly hindering the absorption of other nutrients as well as being useless as a calcium source because the body simply cannot utilize that much calcium at once. The older woman's diet is already high in dairy because of her doctor and the USDA's advice, and she's likely not getting enough magnesium. Now we have tons of extra calcium that can fuel kidney stones and heart disease. If she's lucky her doctor mentioned vitamin D, but there was never a mention of zinc, copper, boron, silicon, magnesium and all the other bone health cofactors.

I personally am somewhat cautious with calcium. I always take my vitamin D, silicon and magnesium, and I supplement with menatetrenone to make sure the calcium doesn't just deposit in my arteries.

[doug123]

This looks promising:

News Source: LAtimes.com



Once-a-year drug targets osteoporosis
The risks of fractures among post-menopausal women were greatly reduced by intravenous therapy, a study finds.
By Thomas H. Maugh II
Times Staff Writer

May 3, 2007

A yearly 15-minute intravenous infusion of a new drug substantially reduces bone fractures in post-menopausal women, offering a new treatment option for women who have trouble taking existing bone-strengthening drugs, researchers reported today.

Although drugs like Fosamax and Actonel are also effective at preventing bone loss and reducing the major health risks associated with fractures, up to half of women stop taking the medications within six months because of the complicated regimen required and the risk of side effects.

The new drug, called zoledronic acid, "requires an encounter with the medical establishment only once a year, so there is no problem with compliance and adherence," said Dr. Robert R. Recker of the Creighton University School of Medicine in Omaha.

The drug also avoids the esophageal problems that are common with the oral drugs, said Recker, who is vice president of the National Osteoporosis Foundation and was not involved in the study.

The three-year study of 7,736 post-menopausal women found a 70% reduction in the risk of spinal fractures and a 40% reduction in the risk of hip fractures.

"But even more remarkable were the strong, significant and consistent effects across all fracture types," said epidemiologist Dennis Black of the UC San Francisco School of Medicine, who led the study.

The results were "impressive," wrote Dr. Juliet Compston of the University of Cambridge School of Clinical Medicine in Britain in an editorial accompanying the report in the New England Journal of Medicine.

The drug is already sold by Novartis in the United States under the brand name Zometa for the treatment of Paget's disease — a genetic disorder in which bone becomes soft and breaks down readily — and the prevention of bone loss in cancer chemotherapy.

The company is applying to the Food and Drug Administration to sell it under the name Reclast for treatment of osteoporosis.

About 10 million people in the United States suffer from osteoporosis, and another 34 million have low bone density, which puts them at risk for the disorder, according to the osteoporosis foundation.

One out of every two women over 50 will suffer a fracture, many of them quite serious.

Among women over 65, for example, one out of every five who suffer a broken hip will die within a year from complications.

Reclast, Fosamax, Actonel and Boniva are all members of a class of drugs called bisphosphonates, which bind to cells in bones and prevent them from breaking down bone tissue.

This breakdown is part of the body's normal process for remodeling bones, but in older people the breakdown tends to outrun the rebuilding, leading to a net loss of bone.

Existing drugs are given orally either weekly, monthly or every three months.

They must be taken on an empty stomach with a full glass of water and the patient must remain upright for at least 30 minutes after taking them.

"The other drugs on the market are good drugs, but we know that the vast majority of people don't stay on them past six months," said Dr. Felicia Cosman of the Helen Hayes Hospital in West Haverstraw, N.Y., another member of the research team.

"The real advantage is that we are going to be able to give [zoledronic acid] once a year and see benefits extend to the real world," she said.

The primary side effects of the infusion were fever and muscle pain, which could be controlled with aspirin or ibuprofen. The side effects disappeared within three days and did not recur on subsequent infusions.

About 1.5% of the women also suffered episodes of atrial fibrillation, a form of abnormal heart rhythms, within the first two months after the infusion.

Researchers are at a loss to explain this, Cosman said, because the fibrillations have not been seen in previous trials and "we don't understand what the potential biological mechanism is."

In a second paper in the journal, however, Black and his colleagues found a similar risk during a reexamination of data from trials for Fosamax.

"I think it is a problem that could have occurred by chance," Recker said. "It doesn't disturb me much."

The trial was sponsored by Novartis and all of the researchers have received grants or other support from pharmaceutical companies.

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thomas.maugh@latimes.com