Sunshine in a Pill: Shedding Light on the Regulation of Vitamin D

Outside the window of our farmhouse, the sun shines brilliantly on the snowscape.  Inside, I am rMastermindeading MASTERMIND, a New York Times Bestseller recently published by my former high school classmate and friend, Maria Konnikova.  In the book, Sherlock Holmes serves as a guide to upgrading the mind.

I turn the page and read “The weather does much more than set a pretty scene. It directly impacts what we see, what we focus on, and how we evaluate the world.”   Looking out the window at the sunny winter wonderland, I realize my perception is skewed towards happiness and satisfaction.

I’ve lived all over the country, in places hotter, flatter, and foggier than Vermont, but the Green Mountain state is darker than anywhere else I’ve lived.  So most winter mornings, I take matters into my own hands and down a glass of water with my sunshine pill, a tablet of Vitamin D.  I take my tablet daily because the sun is one of the main sources of this vitamin, and I consider myself sun deprived.sunshine pill

Studies link Vitamin D with bone health, but too much Vitamin D in the blood can be toxic, causing nausea, vomiting, confusion, disorientation, and maybe even damage the kidneys.  Thanks to the Institute of Medicine (IOM), I know when I’ve had too much of a good thing.  In 2010, the IOM set a Recommended Dietary Allowance (RDA) based on the how much Vitamin D is needed for adequate bone health in most healthy persons.  According to the IOM, I should take 600 International Units per day, and never more than 4,000 International Units per day.

The IOM is the health arm of the National Academy of Sciences, and provides advice to decision makers and the public about health.   According to the 2010 Report by the IOM, the media often reports that Vitamin D is associated with a range of health benefits beyond bone health, such as improved immunity and muscular support.  However, the Report states that Vitamin D’s link to bone health is the only reliable claim.

Yet Nature Made advertises thatNature Made their Vitamin D tablets support immune health as well as bone health.  A little cross by this statement on my Vitamin bottle refers me to the following disclaimer: “These statements have not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease.”  I have to overcome my sunny day bias to think more critically about Nature Made’s disclaimer.  Inspired by Sherlock Holmes, I practice awareness and attention, and set out to solve the mystery behind this statement.

I am glad I am reading MASTERMIND because it turns out that the Dietary Supplement Health and Education Act (DSHEA) of 1994 allows manufacturers to make unproven claims about the effect of a supplement on the structure and function of the body so long as the consumer is notified with the disclaimer I found on my vitamin bottle.   I really am taking matters into my own hands when I take my sunshine pill, and I would be a fool to ignore the unproven claims on my vitamin bottle.

The Food and Drug Administration (FDA) regulates my little bottle of sunshine pills as a category of foods, not drugs.  In 2007, the FDA implemented a current good FDAmanufacturing policy (cGMP) to ensure that dietary supplements are produced in a quality manner.  That same year, Congress passed the Dietary Supplement and Nonprescription Drug Consumer Protection Act, which requires manufacturers to submit reports of serious adverse event associated with their products.  Despite these efforts to protect consumers, FDA oversight of supplements is limited and compliance with the cGMP is low.

Take one look at the FDA website for dietary supplements and you will find a call to awareness that mirrors that inspired by Sherlock Holmes in MASTERMIND.  “Tips for the Savvy Supplement User,” makes it clear that in the world of supplements, consumers have more of a duty to be aware, than a right to be protected.  Outside my window, the sun shines on.



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