Another Perspective

When Is a Drug a Drug?

"Dietary supplements" aren't necessarily drug free or safe, let alone "nutritional."

By 3.16.12

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According to the FDA, a drug is a substance (other than nutrients) intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease, or to affect the structure or function of the body. Seems clear enough -- that is, until politics and big money get involved.

With the aid of a 1994 law crafted by Senators Orrin Hatch and Tom Harkin, the mega-billion dollar supplements industry has done a splendid job of obfuscating this definition. By taking advantage of consumer's scientific naïveté and some legislative doublespeak, the supplements industry has successfully perpetuated the myth that what it is selling is drug free and safe. This couldn't be more wrong.

It's a timely topic, given that the U.S. Army is now investigating whether the deaths of two young soldiers last year were related to the "dietary supplements" called Jack3d and OxyElite Pro, which they had taken.

But what the soldiers actually took is an amphetamine-like synthetic chemical called dimethylamylamine, a stimulant with multiple cardiovascular and central nervous system effects. It alters the function of the body -- so it's a drug. It is also a banned doping agent used by athletes, but you can buy it at the Vitamin Shoppe or GNC.

"Health" stores have huge displays of similar products -- drugs that are falsely labeled as supplements. Another example is DHEA, a steroid that's converted in the body to various anabolic and neurohormonal steroids, all having profound physiological effects. Is this a drug? You bet.

Another supplement, the subtly named RockHard Weekend, contains extracts from certain bark and roots, including the always-popular Horny Goat Weed. There must be dozens of chemicals in the bottle -- but does anyone know what all of them are, let alone whether they're safe or effective? No.

The mindset exploited by this industry is so pervasive that many people believe supplements-- especially those derived from plants -- can do no harm. This is utterly false. Plants do not exist to benefit humans--their purpose is to survive and reproduce; accordingly, many plants have evolved ways of making some really good poisons to avoid being eaten.

Hemlock, the poison that killed Socrates, comes from an herb. Strychnine (rat poison) comes from the Nux vomica tree. Ricin, one of the most toxic substances on earth, comes from castor bean roots. And even legitimate plant-derived drugs, such as digitalis and taxol, are sufficiently toxic that their use must be carefully controlled.

So why are companies allowed to sell drugs under the guise of supplements that aren't even subject to minimal FDA oversight? This is where the double-speak comes in.

The Hatch-Harken law provided the supplement industry with a legal but anti-scientific end-run around the FDA by introducing some terms that permitted the marketing of unregulated drugs. As long as they were called "dietary supplements," and made no specific health claims, they could be sold. But these "restrictions" are wholly disingenuous.

Does anyone really believe that anabolic steroids and stimulants should be labeled as supplements? Exactly what are they supplementing? By this logic, just about anything you can swallow could then be called a "dietary supplement."

And to avoid making medical claims, the meaningless term "supports," as in "supports heart health," was concocted. Please. When you see "supports" (wink, wink), just mentally substitute "this will cure." Duplicity at its finest.

The FDA is now attempting to establish some control over supplements, although it is not remotely sufficient. For instance, the regulations would require that all new supplements "can reasonably be expected to be safe." Are they kidding? Pretty low standards, if you ask me.

Pharmaceutical companies spend hundreds of millions of dollars to determine the safety of new drugs, only to have many of them fail anyhow due to unexpected side effects. But manufacturers of supplements are not held to any regulations that even approach this level of scrutiny.

Supplement regulations are driven by money and sleight-of-hand, not science. But drugs are drugs. They should all be treated the same.

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About the Author

Josh Bloom is director of pharmaceutical and chemical science at the American Council on Science and Health.