The Washington Post recently published an article asserting that vitamin D is shaping up to be the nutrient of the year, if not the decade. The article started factually strong but weakened at the end when it made specific recommendations.

The Post references an article in Consumer Reports titled “Most people get insufficient Vitamin D, but extra supplements may not be needed.” That article correctly notes that vitamin D blood levels in U.S. residents are on average below what is now thought by some experts to be what is needed for optimal health; the magazine perhaps overstates the case by writing that “…77% of Americans have insufficient amounts.”

In an article published last year in the American Journal of Clinical Nutrition, Elizabeth Yetley uses NHANES data to show approximately 6 percent of adults are below the traditional cut-off defining vitamin D deficiency and 77 percent are below what some nutritionists now opine to be the preferred target of 80 nmol/L.

The Consumer Reports article also points out what is putting the U.S. population at risk, primarily increases in obesity (fat sequesters some of the vitamin D synthesized in the skin) and less skin exposure to sunlight’s ultraviolet radiation.

The Institute of Medicine is currently reviewing the Dietary Reference Intake value for vitamin D, which was last updated in 1997. A final report is expected this May.  Currently, people 19 to 50 years of age are advised to consume at least 200  International Units per day,  those 51 to 70 at least 400 units, and those over 70 at least 600 units. Estimates are that adults get 100 to 150 units daily from food.

Consumer Reports goes astray when it writes: that people don’t need a special supplement; that overdosing is unlikely; and who should be advised to have their blood levels tested. Although makers of nutritional supplements are planning reformulations of their multivitamin products pending the institute’s report, most of what is on the shelves now is still at only 400 units.

What defines overdosing is up in the air. Officially, the Tolerable Upper Intake Level is 2,000 International Units per day. While bets are that the Institute will raise the adequate intake to 1,000 units per day, it is less clear whether the upper limit will also be increased. Writing in the American Journal of Clinical Nutrition, John Hathcock and his colleagues make a case for 10,000 units as a safe limit. The Institute has a conservative approach to upper limits.

Finally, people should not wait to get a blood test until they are diagnosed with weak bones or an absorption problem, contrary to what Consumer Reports says. Better advice would be for all adults to start taking 1,000 units per day from supplements. If you are in a higher-risk group for low vitamin D levels (obese, female, older, bypass surgery, Hispanic, African-American), get tested a few months later.

David A. Mark, Ph.D., is president of dmark consulting LLC, a science consulting company serving the dietary supplement and functional food industry. Contact him at david@dmarknutrition.com or 978-897-0890.

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David Ortiz

The confusion surrounding steroid use in professional baseball has taken another strange turn. The Associated Press and New York Times report that eight of the 104 players who tested positive for steroids in 2003 fall into another category. The AP says that the eight did not test positive; the Times says that the eight took 19-norandrostenedione, which was legally sold over the counter at the time. It is now illegal and a player caught with it in his system will be suspended for 50 games.

David Ortiz has said from the time his name was publicly tied to the list that he had been taking vitamins. At a press conference on Aug. 8 before his Boston Red Sox played host New York Yankees, Ortiz said that he had bought supplements in the Dominican Republic and the United States. “I’m not here to make any excuse or anything,” according to a Times article. “I really used a lot of supplements and vitamins.” He added that companies would send him supplements, “but I never used or buy any steroids.”

Former Red Sox teammate Manny Ramirez, Yankee Alex Rodriguez and former Chicago Cub Sammy Sosa were also on the 2003 list. But for what? The details are in the hands of federal investigators, the players’ union cannot tell its members, and a federal judge has told everyone to keep their mouths shut.

Any language confusion in identifying nutritional products may seem unimportant to the public, but to folks in this industry there is a huge difference between a vitamin and a steroid. Or a supplement and a steroid.

When companies do not make the distinction to the satisfaction of the FDA, they hear about it. In October 2004, the agency wrote a warning letter to All American Pharmaceuticals and Natural Food Corporation regarding the labeling of the prohormone as a dietary ingredient. “FDA is not aware of any information demonstrating that androstenedione, 19-norandrostenedione, and 5-androstene-3b 17b-diol were lawfully marketed as dietary ingredients in the United States before October 15, 1994,” the letter said in part.

Apparently, 19-norandrostenedione is pretty strong stuff: “One of the most frequently misused steroid precursors (prohormones) is 19-norandrostenedione (4-estrene-3,17-dione, NOR), which is, after oral administration, readily metabolised to nortestosterone, also known as nandrolone (durabolin),” begins the abstract to a study published in 2008 on the prohormone. Its effect on the careers of All-Star players and Major League Baseball is being felt today.

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Playboy Enterprises likes to put its name and trademark bunny-head logo on products. Get ready for a supplement on which you can nibble the ears. At its second-quarter earnings call on Aug. 4, the president of the licensing division told investors, “Before year-end, we expect to add yet another new product category, nutriceuticals [sic]. We recently signed a deal for a nutriceutical [sic] product which we expect to see in the market before year-end.”

Alex L. Vaickus told analysts on the conference call that Playboy had recently labeled an energy drink via a licensing agreement. That product was being rolled out in the United States and introduced to other countries.  That followed the launch of Codi, a branded fragrance for which a body spray is coming.

What vitamins does Hugh Hefner want to promote? None of the analysts on the phone with Playboy execs asked that question. The analysts were more concerned with a possible takeover, the company’s long-term viability, and video on demand.  No one asked about the energy drinks, either. CirTran Beverage Corp. makes the beverages in regular and sugar-free flavors in 8- and 16-ounce sizes. According to the Playboy drink site, the “proprietary formula contains ginseng root, guarana extract and damiana leaf, ingredients that are believed to stimulate energy levels.”

Details on the Playboy nutraceutical are harder to come by. The licensing division reported that second quarter income fell 22 percent from the same quarter a year before, due largely due to the global recession. The earnings news release did not specify a new product, but said that the company was developing new product categories. Vaickus came to Playboy from ConAgra Refrigerated Foods and before that was with Sara Lee.

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What is good for the patient is good for the nurse and doctor, too. The Council for Responsible Nutrition hired Ipsos Public Affairs to ask doctors and nurses how often they took vitamins and why. The results offer insights into groups that are rarely asked how they maintain personal health. The survey found that 72% of physicians and 89% of nurses had used dietary supplements. The figures for regular use dropped to about half of doctors and 59% of nurses. Why? That is probably a good topic for another survey.

While the leading reason for taking vitamins was good health, the predominantly female nurses’ group also cited bone health and joint health. Doctors, most of whom were men, cited heart health. And — FDA alert! — both groups cited flu or colds as reasons for taking the supplements.

The most common supplement for both doctors and nurses was multivitamins. Of those surveyed, 79% of physicians and 82% of nurses recommended to their patients that they take supplements, too.

A note of caution: Study participants volunteered to be surveyed. That skews the results, as anyone who has researched a supplement ingredient knows. The doctors and nurses were more likely to be interested in supplements, even though as a whole they did not use them on a regular basis more often than the general population, the study found.

Findings often lead to more questions, and here are some we would like answered:

• To what extent does labeling influence the choice of supplement?
• What are the three biggest influences (brand name, referrals, price, etc.) on choice of supplement?
• What is the best measure (more energy, feeling better, etc.) in deciding whether a supplement is effective?

We look forward to those survey results.

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GUEST BLOG by David A. Mark

The Institute of Medicine is currently reviewing the Dietary Reference Intake value for vitamin D that last changed in 1997. While a final report is not expected until May 2010, some dietary supplement companies are boosting their dosages now. The increases have implications not only for consumer health but for regulatory action.

The Tolerable Upper Intake Level for vitamin D for adults today is 2,000 International Units per day. The Daily Value is 400 units. Depending on a person’s age, the Adequate Intake is between 200 and 600 units. Those numbers could go higher once the Institute issues its report.

Most people get 100 to 200 units of vitamin D daily from their food. Most multivitamins provide a daily dosage of 400 units. Some manufacturers have begun to offer products with 1,000, 2,000 and even 5,000 units per day. The last is more than double the current upper limit.

Is there a benefit – or a danger — from getting more vitamin D? A growing scientific consensus says that a combination of food, dietary supplements and the typical exposure to sunlight is not sufficient to reach blood levels for ideal health.

While the cumulative evidence supports an increase in the figure for adult intake of vitamin D to perhaps 1,000 units per day or higher, there is not an equivalent body of new evidence sustaining an argument for a safe, higher upper limit.

The identified risk of chronic, high, vitamin D consumption is elevated serum calcium, resulting in inappropriate tissue calcification. The current Daily Recommended Intake text identifies 3,800 units per day as leading to abnormally high serum calcium. The text also says that 2,400 units per day produces an elevated serum average, but still within the normal range. This was a small, short study without evaluation of clinical consequences. Ongoing, massive, multi-year vitamin D clinical trials may detect subtle negative outcomes. Researchers will keep an eye out for harm to kidneys and arteries.

It is reasonable to assume that the Food and Drug Administration is also watching the situation. It would not surprise me if the agency issued warning letters to companies selling vitamin D products containing 2.5 times the current upper level, telling those businesses that their products are potentially unsafe.

FDA action is not the only risk. Recently, the FDA amended the qualified health claim for selenium. Shortly thereafter, the consumer advocacy group Center for Science in the Public Interest filed a complaint with the FDA against Bayer Healthcare, stating that the existing (now superseded) label claim for One A Day Men’s Health Formula overstated the putative prostate cancer health benefit. The Center also said that recent research suggested that selenium supplementation might increase risks for hypertension and diabetes.

The center and other non-government organizations might take the same action against high-dose vitamin D products, potentially creating negative publicity, especially if new research links them to negative health effects. The supplement industry would be wise to prepare for such developments.

David A. Mark, Ph.D., is president of dmark consulting LLC, a science consulting company serving the dietary supplement and functional food industry. Contact him at david@dmarknutrition.com or 978-897-0890.

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