It is understandable that a business built on the notion that the only way to ensure quality is to test, and then set up test procedures and reporting mechanisms designed to scare consumers into believing that only companies that pay to participate in its programs sell quality products, would find the GMPs threatening.  What is striking about CL’s latest attack on the supplement industry is what it reveals about the company’s ignorance of the industry it purports to police.  Two statements in the CL Press Release are particularly noteworthy.

First, CL President Tod Cooperman is quoted as stating that the GMPS are flawed because GMPs “do not set limits on the amounts of lead or other contaminants that can occur in supplements”.  This statement suggests an ignorance of what GMPs are:  a set of regulations designed to ensure that companies engage in “certain activities in manufacturing, packaging, labeling and holding of dietary supplements to ensure that a dietary supplement contains what it is labeled to contain and is not contaminated with harmful or undesirable substances such as pesticides, heavy metals, or other impurities.”  In other words, GMPs require companies to set up process controls.   They are not intended to set limits on things like lead.  Anyone who has taken the time to read this regulation and the lengthy preamble that accompanied its publication in the Federal Register would understand that FDA has made it perfectly clear that companies are expected to take steps to ensure the quality of their products, and that this includes ensuring that those products are not contaminated by things such as lead.  Either Mr. Cooperman does not understand what GMPs are, or has intentionally misrepresented what this regulation is all about in order to scare consumers for his own purposes.

Second, is Mr. Cooperman’s claim that the GMPS are flawed because they do not specify the methodology by which manufacturers are supposed to conduct identity testing on incoming dietary ingredients.  Anyone who has any understanding of the business of manufacturing dietary supplements would know that it is virtually impossible to designate one method or set of standards by which companies should test such a vast array of ingredients.  That notion that CL dissembles when it makes this type of statement is the failure to suggest what standard FDA should have applied.  As anyone who has seriously considered this regulation understands, if FDA had taken the approach CL advocates and specified test methodologies for every dietary ingredient the regulation would have been hundreds of pages long (thousands if you included a preamble discussing each ingredient) and something surely would have been omitted.  If FDA had specified only one acceptable test method, hundreds of dietary ingredients would have been taken off the market because they could not be tested.

I suspect that what was really motivated CL to issue this press release was the announcement that CL is launching a new program whereby supplement companies would pay to participate in a program that applies CL's “rigorous methods and standards.”  Setting aside any question about the validity of CL’s standards (some might suggest that they are selected in a manner designed to generate headlines about supplement industry failures), the claim rigorous methods is quite puzzling.  Since CL is not a laboratory and conducts no testing itself, what “rigorous methods” could this press release talking about?    Could this press release just be another vehicle for CL to attack the supplement industry, trick consumers and the media into thinking that it is something it is not, and entice companies to join its testing program or risk having their names featured in a very unflattering press release? 

Unlike Mr. Cooperman, I am not disappointed with the way the final GMPs look.  I believe that the HACCP type approach adopted by FDA is sensible, and recognizes that the manufacturers of these products are the ones best situated to develop systems designed to ensure that quality products are produced every single time.  When FDA gets around to revising the food GMPs, I would not be surprised to see the agency adopt a similar approach.  If this regulation is implemented by industry and enforced by FDA many of the issues that have fed the notion that the supplement industry is unregulated and incapable of producing quality products should be a thing of the past.  If my business model was threatened by the possibility of such developments, I might find this regulation disappointing too.