Last month it was reported that about one-third of FDA’s 90 dietary supplement Good Manufacturing Practices (GMP) inspections in fiscal 2010 revealed severe compliance problems.  The most common GMP problem was reportedly “inadequate identity testing.”  Undoubtedly, relying on certificates of analysis from the raw materials supplier without further testing, or failing to conduct identity testing of a finished product, can result in the creation of a product that contains something it shouldn’t – such as synthetic chemicals or even pharmaceutical drugs.  However, a recent article in The Tan Sheet (10/11/10, page 4) refers to all of these products as “spiked” – even in situations where the presence of the undeclared ingredient is inadvertent.  The indiscriminate use of the term “spiked” by The Tan Sheet only serves to confuse the situation.  The most common use of the term refers to intentionally putting alcohol or drugs into someone else’s drink.  “Spiking” a product connotes intentionally slipping a powerful but undeclared ingredient into it to cause a desired or enhanced effect.  And that’s simply not always the case; particularly when you consider that some of the undeclared substances that have been reportedly discovered in some dietary supplement products are either contrary to, or would not enhance, the desired effect of the product and have been found in an amount that is unlikely to have any physiological effect.

 Certainly, there have been situations in the supplement industry wherein a domestic manufacturer, or even a raw materials supplier, has intentionally added an undeclared drug or chemical to the product to enhance its effect.  This is true “spiking” and it is our recommendation that the term be applied only to this scenario.  This is clearly a criminal act.  Manufacturers who “spike” products do so in violation of the FD&C, and if the undeclared ingredient is a controlled substance, the DEA also has jurisdiction. 

 However, there is a separate category of supplement products containing undeclared ingredients which are better described as “tainted” than “spiked” (and, indeed, this is the term used by Deputy Commissioner Josh Sharfstein).  These “tainted” products may result from several scenarios; most typically, they will result from accidental cross-contamination at the raw materials level as a result of inadequate quality control.  These cross-contamination cases were extensively documented and publicized among bodybuilding supplement products prior to the enactment of the Anabolic Steroid Control Act of 2004, but we have seen more recent instances as well.  Undeclared ingredients may also unintentionally result as chemical by-products during the manufacturer’s synthesis process, or possibly even from degradation of the product’s ingredients due to exposure (e.g., to heat) over time. 

 A final category of problematic products involves ingredients which do not comply with the legal requirements for a dietary ingredient, typically because they are synthetic compounds many of which have been chemically altered to be very close analogues of prescription or illegal drugs.  While these products are referred to as both “spiked” and “tainted” in The Tan Sheet, they are actually neither.  The problematic ingredient isn’t something intentionally or even accidentally added to the intended ingredient, it is the intended ingredient.  In some cases, the ingredient is explicitly listed on the product label; in others, the ingredient’s nature is obscured through creative nomenclature.  Either way, these are quite simply “misbranded drugs.”  Selling them as dietary supplements is a criminal act.    

 By clarifying the categories of problematic supplement products, we can better understand the causes of the problems and better create targeted solutions.  Which brings us to the issue of identity testing.  While identity testing is not a comprehensive solution for all of these problems, identity testing of raw materials and finished products will likely reduce the overall volume of problematic products on the market.