FDA gray area poses troubling questions

Anyone who walks down the aisles of any su­permarket’s “healthy living” section has probably seen oodles and oodles of the latest vitamins, herbal supplements and other cure-alls waiting for you in a bottle. Perhaps you’ve seen the info­mercials early each morning, often advertising the miraculous ways you can reduce your arthritis, re­gain energy, lose weight or increase your libido. What’s shocking is not just the claims of these supplements, but the rules that govern their legal sale and consumption.

If you’ve ever looked over the fine print for one of these bottles, you may have seen something akin to a disclaimer. In essence, it will usually say something like, “the statements made by this drug manufacturer have not be evaluated by the Food and Drug Administration (FDA).” This is their catch-all for saying, “we have no idea if this really works.”

As we all know, the FDA is the United States’ authority on safe consumption, whether it’s the eggs you make for breakfast or the latest blood pressure medication your parents are using. There are rigorous policies in place to not only prevent contamination and ensure drug effec­tiveness, but to track production in the event of a catastrophe. The standards the FDA set ensure that the 300 million people who live in the U.S. need not worry about safe foods to eat and drugs to purchase.

Herbal supplements and alternative therapies fall under a literal gray area for the FDA. Some vitamin and supplement providers do indeed have their chemicals tested by the FDA, often to assure the quality and accuracy of the supple­ments, but there are very few tests and rigorous medical standards for such supplements. There are regulations, and the FDA can act against sup­plement providers, but the rules are much more lax and revolve around the transparency of the supplements and their contents, rather than the medical claims they’ll carry. This is where those vague disclaimers come in, as the FDA enforces such statements in order to distance themselves from these supplement providers.

This vagueness has done little however to hurt the herbal supplement industry. According to a report by the consulting firm McKinsey & Com­pany, the vitamins, minerals, and nutritional and herbal supplements industry (VMHS) has grown into an $82 billion business between 2007 and 2012, exploding as people continue searching for new ways to improve their health, often research­ing for such supplements through online blogs and other websites. (McKinsey on Marketing and Sales, 2012) In many ways, people depend on the Internet for self-diagnosis, and often they’ll turn to supplements before admitting the need for a professional’s opinion. These fears of high med­ical costs and an artificial lifestyle full of strange, complicated drug names sit in contrast to herb­al supplements, which often advertise humble roots from far-away gurus, or promote their nat­urally-occurring elements. I’m sure you’ve seen these very same infomercials, where they go out and talk about some vague, distant culture that is known for their health and vitality, all thanks to some local root that they’ve packed into a pill for you to purchase. The story goes on.

Here’s the thing. I can understand the value supplements can provide, whether it’s to freshen up skin, supplement a diet with essential nutri­ents, or do whatever to maximize one’s health. However, I don’t think there’s any excuse for their medical claims without a thorough review from the FDA. In fact, it makes sense we enforce this for two major reasons. First of all, it’s ridiculous that a company can sell its supplements on vague health claims without any sort of study or review that would challenge these claims in a typical, medical procedure. This is an expensive process, and of course it is what restricts the medical in­dustry to a few major biomedical firms, but it’s a necessary process to test not just the claims of such supplements, but also in order to better un­derstand potential side effects that would other­wise go unnoticed. Drug interactions are a very important aspect of everyday medicine, and many herbs—even those we use in cooking—can have medicinal effects and side effects on our body. If we don’t document this, we put ourselves at risk through ignorance.

There’s another big reason to do this: Why would we not want to medically document the true benefits of potential future supplements? Imagine if this were true for willow bark—and that a company claimed to sell ground willow bark as an herbal supplement, but had no interest in pursuing FDA medical review. This certainly sounds like any one of several herbal supplements on the market today, but willow bark in fact con­tains a chemical compound—salicylic acid—that we better know today as aspirin. The herbal sup­plements we knew from the 19th and early 20th century are today’s medication. If we force med­ical reviews for these supplements, we force the discovery of the true benefits for these herbal teas and pills. I’d gladly take any supplement if it were proven to medically improve my health.

I’m also not against any specific herbal supple­ments, but ask me some other time about pyra­mid schemes (or rather multi-level marketing schemes) like Herbalife. There’s nothing wrong with you spending your money on supplements if that’s what you feel is money well spent. The is­sue is instead regarding two issues. First, the FDA needs to press harder on this industry to control and better research the impact of these supple­ments. The fact people are taking these pills with a medical mindset ought to deserve a medical re­view. Anything we put into our bodies, whether a new drug or farm fresh eggs, should follow a spe­cific medical or health standard more elaborate than the existing laws.

Second, there’s no excuse for anyone to replace traditional medicine with a natural or homeopath­ic remedy such as an herbal supplement. As the name suggests, the idea of vitamins and supple­ments is to support your other medication, diet and other lifestyle choices, not replace any partic­ular aspect. For all we know, these supplements could indeed have an impact on our health. All I’m saying is that it’s time we eliminate that gray area once and for all.

—Joshua Sherman ’16 is an English major.

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