Vitamin D Added to FDA Osteoporosis Risk-Reduction Health Claim

  • Author: Health Informer
  • Filed under: Health News
  • Date: Sep 30,2008

As a result of a 2004 petition from the Beverage Institute for Health & Wellness (hereafter the Institute) of The Coca-Cola Company, the US Food and Drug Administration (FDA) announced today that it has amended its osteoporosis risk reduction health claim to reflect the importance of vitamin D, in combination with calcium, in promoting long-term bone health. The amended rule also includes a broader definition of the populations that could benefit from consuming calcium and vitamin D to include both men and women of all ages and races.

The amended labeling regulation explains that vitamin D is required for the normal absorption of calcium, and authorizes the health claim: “Adequate calcium and vitamin D throughout life, as part of a well-balanced diet, may reduce the risk of osteoporosis.”

“Osteoporosis is a growing public health crisis, and all Americans, men and women alike, will benefit from knowing that vitamin D along with calcium can help delay or prevent the onset of this disease,” said Robert P. Heaney MD, FACP, John A. Creighton University Professor and Professor of Medicine at Creighton University in Omaha, Nebraska. “Along with weight-bearing exercise, the most valuable intervention for maintaining bone health is an overall healthful diet that supplies adequate amounts of all nutrients such as vitamin D.”

The US National Osteoporosis Foundation predicts that by 2010, about 12 million people over the age of 50 will have osteoporosis and another 40 million will have low bone mass. These numbers are expected to continue climbing. To help address this significant public health issue, the FDA developed this health claim for manufacturers to include on labels of appropriate foods and dietary supplements. The new labeling can help consumers identify products with adequate calcium and Vitamin D that can help to reduce their risk of osteoporosis.

Increasing Awareness and Consumption of Vitamin D

“We initiated this petition because we believe consumers will benefit from efforts to increase awareness of the link between calcium and vitamin D and bone health,” said Dr. Rhona Applebaum, Vice President and Chief Scientific and Regulatory Officer for The Coca-Cola Company. “Revising the osteoporosis risk reduction health claim to include both vitamin D and calcium will help the food industry communicate the importance of these nutrients to consumers.”

According to Carolyn E. Moore, PhD, RD, Principal Scientist with The Coca- Cola Company’s Institute, studies sponsored by the Institute at the Boston University Medical Center and ENVIRON Health Sciences, demonstrated that many consumers are not getting enough Vitamin D from food and dietary supplements. The groups at greatest risk in the US include teenage girls, women, the elderly, and African-American and Mexican-American adults.

It was The Coca-Cola Company who sought approval to add vitamin D to calcium-fortified juices and juice drinks from the FDA, through research the Company sponsored at the Vitamin D and Bone Health Research Laboratory at Boston University Medical School. Results from this research demonstrated that vitamin D is readily absorbed by the body when added to skim milk and orange juice. The FDA approved the addition of vitamin D to calcium-fortified juices in 2003.

The Importance of Vitamin D for Strong Bones

Vitamin D requirements of all age groups can be met under conditions of adequate exposure to sunlight. However, several factors can reduce the production of vitamin D from the skin including the use of sunscreens, increased skin pigmentation, normal aging, and insufficient exposure to sunlight.

The primary function of Vitamin D is to aid in the body’s absorption of calcium, helping to form and maintain strong bones. Without Vitamin D, the body absorbs 10 – 15 percent of calcium consumed in the diet. With Vitamin D, the absorption level increases to 30 – 50 percent.

Emerging Research on Vitamin D

Vitamin D has been the subject of extensive basic and clinical research in the past several years, which has generated valuable insights about this vital nutrient.

  • In a recent study supported in part by the Institute, researchers from Boston University School of Medicine found that vitamin D2 (found naturally in plants) is equally as effective as vitamin D3 (produced as a result of sun exposure and found in some food sources such as cod liver oil and oily fish) in maintaining circulating blood levels of vitamin D.
  • With support from the National Institutes of Health and the Institute, the United States Department of Agriculture’s Nutrient Data Laboratory is in the process of conducting an updated analysis of vitamin D content in a wide range of whole and processed foods, including, for the first time, specific forms of vitamin D, i.e., D2 and D3.

Source: The Coca-Cola Company


Recent reports of medical studies about Vitamin D deficiency may be causing some people to overreact and take harmful large doses of this naturally occurring, healthful byproduct of sunshine, according to Boyd Lyles, M.D., Chief Medical Officer of U.S. Preventive Medicine(R), an organization specializing in disease prevention.

Although there are studies that show that both men and women who have lower blood levels of Vitamin D also have a corresponding higher mortality rate, more Vitamin D is not necessarily better, said Dr. Lyles. He notes that other studies have shown significant toxicity in people who have consumed 2,000 IU (International Units) of Vitamin D daily, in part because Vitamin D is fat soluble and tends to accumulate in the body when taken in excess.

“We should all have a healthy respect for Vitamin D and its potential benefits and likely consequences if it’s overlooked or underutilized,” he said. “When visiting your physician, ask about your personal risk for Vitamin D deficiency and how much sun or supplements you should be getting. Even though guidelines exist for Vitamin D supplementation, the dose should be personalized and the best person to consult is your doctor.”

The actual recommendations for Vitamin D established by the U.S. Institute of Medicine of the National Academy of Sciences are as follows: 200 IU for those under age 50; 400 IU for those ages 50 — 70; and 600 IU for people over age 70.

Increased dosages are recommended as a person ages due to the skin’s declining ability to absorb the sun’s UVB radiation and the body’s declining ability to convert it to Vitamin D in the liver and kidneys. The usual recommendation of five to 15 minutes of daily sun exposure to the face, arms and hands should be weighed against an individual’s risk of developing skin cancer from sun exposure, cautioned Dr. Lyles. Some foods, such as fish, milk and other foods, are often fortified with Vitamin D.

Source: U.S. Preventive Medicine


As the United Nations General Assembly convenes this week, the Alzheimer’s Foundation of America (AFA) is encouraging foreign leaders to collaborate on a global effort to advance a dialogue about minimizing the impact of Alzheimer’s disease on the 26 million people worldwide currently living with the disease and those who will be affected in the future.

Eric J. Hall, AFA’s president and CEO, said the increasing incidence of the disease worldwide — expected to quadruple by 2050 — warrants further awareness-raising on a global level, similar to the national advocacy efforts that AFA has been advancing in the United States.

As part of its outreach, AFA has been corresponding with UN delegates this week and is holding a cocktail reception for them on September 24.

“Together, we can more aggressively tackle this worldwide health crisis and optimize quality of life for those affected by this brain disorder,” Hall said.

Among AFA’s suggestions for collaboration on awareness-raising, it is recommending additional education about the importance of early detection and ongoing disease management, and the value of caregiver support, as well as prevention surrounding this health issue.

In addition, AFA is inviting delegates to participate in its memory screening initiative, aimed at proper detection of memory problems and education about successful aging; and its AFA Quilt to Remember, a powerful arts project that pays tribute to those affected by Alzheimer’s disease. Some countries have already stepped forward on both these fronts.

Concerning memory screenings, AFA has been holding National Memory Screening Day each November since 2003. Qualified healthcare professionals at community sites nationwide provide free confidential memory screenings to those concerned about memory loss or who want to establish a baseline score; the screenings do not represent a diagnosis but individuals with abnormal scores or concerns are encouraged to follow up with their clinicians for evaluation.

This year, AFA will hold National Memory Screening Day on November 18 in the United States, and for the first time the Alzheimer’s Foundation for Caregiving in Canada, a sister organization to AFA, will introduce the initiative in Canada.

The AFA Quilt to Remember marks the first grand-scale dementia-related quilt that pays tribute to individuals with Alzheimer’s disease and related illnesses, their caregivers and healthcare professionals. Unveiled in late 2005, the collection now includes more than 100 heartfelt quilt blocks crafted by individuals and organizations across the United States.

Recently, the Quilt to Remember received its first panels from outside the United States — from Canada and Brazil.

“The AFA Quilt to Remember shares personal stories of loved ones and spreads the message of Alzheimer’s disease in a create and powerful way,” Hall said. “Contributions from around the world will boost the message of the quilt to an even stronger and more global level.”

The Alzheimer’s Foundation of America is a national nonprofit organization headquartered in New York and unites more than 950 member organizations that provide hands-on programs to meet the educational, emotional, practical and social needs of families. For more information, visit www.alzfdn.org or call 866-AFA-8484.

Source: Alzheimer’s Foundation of America


Lilly CEO Lechleiter detailed registry plans at Indianapolis speech

Eli Lilly and Company announced that it is set to become the first pharmaceutical research company to disclose its payments to physicians in the United States.

At a speech before the Economic Club of Indiana today, Lilly’s president and chief executive officer, John Lechleiter, Ph.D., outlined the company’s plans to launch an online registry of physician payments in 2009. Lechleiter announced the physician registry as a part of a broader outline on the company’s transformation efforts.

“With each of our industry firsts, from launching our clinical trials registry to the public reporting of educational grants, Lilly is striving to be a leader in improving transparency across our industry,” said Lechleiter. “As Lilly continues to look for more ways to be open and transparent about our business, we’ve learned that letting people see for themselves what we’re doing is the best way to build trust.”

Earlier this year, Lilly was the first pharmaceutical research company to endorse bipartisan federal legislation – known as the Physician Payments Sunshine Act – that would establish a national registry of payments to physicians by medical device, medical supply and pharmaceutical companies. The legislation, which was introduced by United States Senators Charles Grassley (R-Iowa) and Herbert Kohl (D-Wisconsin) last September, has not been passed yet by Congress.

Lechleiter added, “Though we remain hopeful that the Sunshine Act will be passed by Congress at some point, Lilly is taking action independently. Being more transparent by opening up our business to the public is an important step to building trust and confidence.”

Under the Lilly registry plan, the public will have access to an Internet database listing its payments to physicians. Lilly will launch this registry as early as the second half of 2009. When first launched, its contents will include 2009 payments to physicians who serve the company as speakers and advisors. By 2011, Lilly plans to expand the reporting capabilities of the registry to resemble the Sunshine Act legislation. The registry will be updated annually to reflect the previous year’s payment information.

“Eli Lilly is leading the charge for transparency in the relationship between pharmaceutical companies and doctors by fulfilling the obligations of the Physician Payments Sunshine Act before it has been enacted,” said Senator Kohl. “It takes a lot of courage to be the first. They have made a principled decision that I believe will benefit both their business and the consumers of their products.”

“Lilly is proud of the important and longstanding relationships we have with physicians,” said Lechleiter. “Many physicians perform valuable services for the biopharmaceutical industry by advising us on the development of new medicines and giving lectures to other medical professionals to educate them about new treatment options. For these services, they are compensated at market rates. These services help to advance the science related to medicines and are important to both current and future patients who rely on pharmaceuticals as an integral part of their therapy.”

“Our primary focus is the well-being of our patients and APA has adopted strict disclosure policies to ensure our patients are informed regarding relationships between physicians and industry,” said James H. Scully Jr., M.D., CEO and Medical Director of the American Psychiatric Association. “We applaud efforts by Lilly to ensure there is transparency in their relationships with physicians.”

Lilly’s plan to create a physicians payments registry is consistent with other voluntary actions it has taken recently to enhance transparency in health care, including its support of the Physician Payments Sunshine Act. In 2004, Lilly became the first company to voluntarily make public its clinical trials and its clinical trials data; that information can be found at www.lillytrials.com. Last year Lilly added another first by publicly reporting all of its educational grants and charitable contributions and, each quarter, posting the data online at www.lillygrantoffice.com.

Source: Eli Lilly and Company


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