Yet another story just popped onto the wires wherein an unnamed dietary supplement was responsible for some very serious health consequences.   Researchers at the University of Texas Southwestern Medical Center found that consumers of this unnamed “hormonal dietary supplement” experienced very negative consequences – specifically identified as “progression of prostate cancer.  The facts are that this product was scientifically evaluated and then published in a recognized Journal.  The root problem of this situation and fundamental issue with the product itself is that the product contained at least two un-claimed drug entities.  The issue for us then truly is – what kind of a product is it?

The American Herbal Products Association (AHPA) rightly and righteously railed against the scientists identifying the product as a dietary supplement since the product’s composition included drug entities.  However, here’s where the dilemma comes in.  Whether we consciously recognize it or not – US Food and Drug Law is unique.  The simplest description of the foundation of our regulatory structure is:  You Are What You Claim.  It is this structure that allows the same bottle of distilled water to be legally classified as a food, a drug, a dietary supplement, a cosmetic or a medical device.  It all depends on what you say the water does.  This makes for a very interesting and positive environment in which to grow an industry.  As we have seen particularly over the last fifteen years.  The fact that we do not have to burden ourselves with understanding what a “Positive List” of ingredients will allow us to include in our products and the fact that there is a very short “Negative List” (read this as ephedrine alkaloids and steroid precursors) of materials we can’t use – it all comes down to the words we use to talk about what the product does.  There is no better environment and we have benefited mightily from this.

However, the other edge of that sword is the one at work with the study out of the University of Texas.  Recall that the study did not name the product but did identify it as a dietary supplement.  The product contained unnamed ingredients (meaning ingredients that were not listed on the label) that happened to be drug entities.  How then do you suppose the researchers identified the product as a dietary supplement?  Chances are because that is what was claimed for the product.  The mere use of the words “dietary supplement” on the label provided the classification.  Rightly or wrongly classified – as the sword cuts through these words were enough to classify the product.

While I totally agree with AHPA’s position that the product was an illegal drug entity and further support AHPA’s stern response to the publication, it is a little tough to have it both ways.  On the one hand we want to maintain a regulatory structure that insists that claims create the dividing lines for classification while simultaneously contending that something is not a dietary supplement even though it says it is.  The solution is simple:  Call it as it is.  Our aversion to being inappropriately painted with a painfully broad brush is understandable.  Still, just because we do not wish a situation to be as it is cannot be changed via our consternation alone.  When this sort of issue arises – as it no doubt will again in the future – the simple answer is to acknowledge and clarify.  Acknowledge that by virtue of the words on the front panel of the label – that the offending product (whatever it is) was being sold as a dietary supplement.  The product may or may not have actually been a dietary supplement and the distinction would be if it were, in fact, it illegally contained a drug entity.  This does not change how the product was presented to the consumer (the words classifying it) but does change the nature of the discussion.  This then shifts the burden to the Food and Drug Administration – where it rightfully belongs – to enforce the law and regulations in place.  You may NOT include drug entities in dietary supplements. 

This change in semantics may seem trivial but it affords us the opportunity to point out that the product was marketed and classified illegally.  Part of the illegality is the matter of the composition versus the self-identification.  This further shifts the burden of responsibility back to the regulatory agency – where it belongs.  Saying it is not a dietary supplement is secondary to the fact that it was illegally presented as such.  This small difference creates a better position and shifts the foundational argument from stories such as this one.  Attempting to contend that the product was not a dietary supplement is insufficient.  The other edge of the sword – the one we benefit from – gets dulled that way.  When illegal activities occur we should identify them clearly and without equivocation.  This product was an illegal drug marketed as a dietary supplement.  We should not forget the second part of that last statement.  We need to keep the opportunities open and direct attention to where it rightfully belongs – to those who are charged with seeing that the marketing of illegal drugs under whatever false presentation is enforced.