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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Vitamin B6

The headline in the Wall Street Journal read, “New Study Gives B Vitamin a Boost” and the first sentence in the article was, “Bring out the niacin.” It turned out that a vitamin — even only a prescription formula — produced better results than Merck‘s new cholesterol-lowering medicine, Zetia.

That was according to a 208-patient trial whose results were announced this month at the annual scientific meeting of the American Heart Association. Score one for the people who have say that vitamins support good health. The smart folks will not claim that niacin lowers cholesterol, but they can leave a copy of the article laying about.

Wait, there is something better. What product and in what dosage? Has it been patented? Uh, no. It’s called a placebo and its effect is often greater than any drug or nutritional supplement, scientists tell the Associated Press. Example: In tests of a new drug to relieve lupus symptoms, about a third of patients felt better when they got dummy pills instead of the drug. What’s more, Michael Perlis, a psychologist and neuroscientist at the University of Pennsylvania, says that he does not know of any herbal remedies for insomnia.

Darn. And it gets worse. A study published in the Nov. 18 issue of the Journal of the American Medical Association raised concerns that high does of folic acid could increase the risk of developing cancer. That could impact the more than $1 billion that is spent annually on B vitamins. Maybe consumers will think they are as better off popping Pez than a prescription pill or Internet-catalog vitamin. All a person has to do is believe that the little candy will make him or her better, and it will.

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Financiers have discovered what the industry knew all along: Economic hard times have not been bad for makers and sellers of wellness products. People are willing to forgo luxuries, even new cars and homes, but not their health. As a result, the supplement industry has weathered the recession much better than automakers and homebuilders. Witness the recent spurt in money-driven deals in the nutraceutical industry:

Vitacost.com Inc. is going public with an offering 11 million shares at $11 to $13 per share. The company will trade on Nasdaq under the symbol VITC. The online retailer and direct marketer of health and wellness products lined up Jefferies & Co. and Oppenheimer to manage the sale. Investment bankers Needham & Co. and Roth Capital Partners are co-managers. How well is Vitacost.com doing? The company said it had about 957,000 active customers as of June 30, up 37 percent from the same time the year before. They made purchases about two to three times per year. Over the last 12 quarters, the average order value ranged from $72 to $77. Vitacost.com had net sales of $143.6 million and net income of $17,407 in the latest quarter.

Quasi-competitor Vitamin Shoppe Inc. has also filed to go public by selling up to $143.75 million of common stock under the symbol VSI on the NYSE.  Underwriters are the well-known J.P.Morgan, Bank of America Merrill Lynch, and Barclays Capital. The company sells more than 8,000 different products at its 425 stores in 37 states and even more items through the Internet and catalogs. Vitamin Shoppe had net sales of $601.5 million in fiscal 2008 versus $436.5 million in fiscal 2005. Retail sales are up over the same time period.

And Herbalife Ltd. (NYSE: HLF) paid $10 million this month for Micelle Laboratories to expand manufacturing capacity. The dealmakers were not announced. Micelle provided contract manufacturing services to Herbalife for 24 years and recently helped develop two Herbalife products, mango-flavored Herbal Aloe Powder and mango-flavored Herbal Aloe Concentrate. None of the 92 full-and part-time workers at Micelle are expected to lose their jobs. Herbalife, a global network marketing company that sells weight-management, nutritional supplements and personal care products, reported smaller profits in the second quarter ended June 30, which management attributed to slower sales and currency fluctuations. Sales quarter over quarter rose 7.7 percent in the United States, 3.2 percent in Mexico and 57.5 percent in China.

So it would seem that nutraceuticals are good for what ails Wall Street: a lack of financing and merger deals. How much busier will the fourth quarter be?

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What has not changed since our first blog on Aug. 2, 2005, is our mission. So it is worth republishing the first entry by our founder, Joel Rothman. For those of you who were not present for the launch, here is the original post:

Welcome friends to the first legal weblog devoted entirely to the nutritional supplement industry. This first post will give you the what and why of this blog, as in what I am going to write about here and why I am writing it. For more information on who I am, click the “About” link on this page.

Okay, what is this blog about? It’s about all forms of nutritional and dietary supplements, vitamins, neutraceuticals and cosmeceuticals, the laws that regulate them, and court cases concerning those laws. It’s about laws regulating supplement safety, advertising and sales. It’s about lawsuits brought by those claiming to have been injured by supplements, and lawsuits brought by and against companies in the supplement business. It’s about the claims dietary supplement manufacturers make in big bold letters on the front of the box, and the disclaimers in tiny letters on the back of the box. It’s about other things too that strike my fancy. So that’s the what.

The why is pretty simple. From time to time I represent nutritional supplement manufacturers. In the past I have found it difficult to get current, topical and useful information about the laws and cases that matter to my clients. Other lawyers I know have also told me that there is really no place to go on the web that addresses legal matters of concern to this young and growing industry. So, I hope to provide some measure of assistance to those like me looking for a resource like this.

Now, a word about what this blog is not. Since I have already said that I have clients in the business, you might have figured out that this blog is not a place to find a lawyer to sue supplement manufacturers because you think you got sick or hurt from taking dietary supplements or using cosmeceuticals. There are lots of lawyers out there who I am sure will listen to you and they are easy enough to find. This is also not a blog that rails against nutritional supplements and the people who make them. This is not a blog about the pros and cons, this is a blog about the legal environment in which nutritional supplements are made and sold. If you have something to say about what is good or bad about a particular pill, creme or protein shake, we are interested only if there are legal implications to it. This blog is also not legal advice, so don’t use it as such and we disclaim any liability to you and yours should you disregard this warning.

So there you have the what and the why. Again, the who is linked on the sidebar. Now, let’s get busy with some content!

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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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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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Vitamin B6

In a bizarre response to a citizen petition, the FDA has ruled that “pyridoxamine dihydrochloride or any other compound containing pyridoxamine” are not dietary supplements within the meaning as indicated by DSHEA, specifically Federal Food, Drug, and Cosmetic (FFDC) Act § 201(ff)  and “may not be marketed as such.”

This FDA pronouncement implicates DSHEA directly because it appears that the agency has determined that there is no “independent, verifiable evidence” of marketing of pyridoxamine as a food or dietary supplement prior to 1994 when DSHEA went into effect.

The Natural Products Association has put a call out to all members of industry for copies of sales records, shipping orders, labels and/or other relevant documentation that clearly demonstrates that pyridoxamine was in commerce prior to DSHEA.  If you can help NPA, please contact Daniel Fabricant, Ph.D., NPA vice president, scientific and regulatory affairs, via e-mail to dfabricant [at] naturalproductsassoc.org directly.

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