The article in the current edition of Sports Illustrated is titled “What you Don’t Know Might Kill You.” It is one of the most clear, direct and searing indictments of the Dietary Supplement industry (or at least a slice of it) that has yet to come out. The real issue is that this publication is very much Mainstream. Likely as not it will also find reference into venues such as ESPN and other popular fare. This piling on of criticism should send shockwaves through the industry. Chances are it won’t though. What will come out from the industry is the litany of descriptions of inaccuracies in the article and mis-representations and other stuff. Since that hasn’t worked with newspapers I doubt it will work here. However, that is what we, as an industry, will do. What we should do is noted at the end of this little publication. First, let us begin the liturgical part of the service:
The authors of the piece (David Epstein and George Dohrmann) start by describing an individual who has started a now successful business in the Dietary Supplement industry. The details of this point to the exceptionally low barriers to entry into the industry and emphasize the lack of credentials of the individual now successfully selling a sports supplement via the Internet. Yes, there are as the article points out “kitchen chemists” who can make big money in the industry. The challenge is why is this possible and this question remains unanswered in the article.
The blame for this apparently falls squarely at the feet of DSHEA (according to the authors). This law apparently allowed the principal of the story to make a phone call and have a manufacturer provide him with a supplement for sale.
FIRST CHORUS OF LITANY: The manufacturer of the supplement provided our entrepreneur with a product that contains at a minimum a non-notified New Dietary Ingredient (please see 21 CFR Section 190.6). Such a submission would likely have resulted in a rejection of the New Dietary Ingredient notification since as the authors point out the primary ingredient is an anabolic steroid. This then renders the product adulterated. The fact that the substance was not notified and the fact that the FDA has not made efforts to enforce the regulation are overlooked.
The article next discusses another entrepreneur who has met with significant success in the industry. He is characterized as the “Willy Wonka” of the industry and his marketing tactics are questioned.
SECOND CHORUS OF LITANY: There are, regrettably a “handful of bad actors” in the industry that gives us a bad name. If the FDA and FTC found the advertising objectionable, they should take action. It is this lack of enforcement that causes "Willy" and his ilk to thrive.
The article goes on to discuss whether companies test the materials that they receive and that Certificates of Analysis (apparently especially those from China) are just pieces of paper that can say anything.
THIRD CHORUS OF LITANY: The FDA has now in place a set of regulations that they are supposed to enforce called Good Manufacturing Practices (GMPs). These regulations mandate testing of materials and products throughout the manufacturing operation. If these regulations were enforced there would be none of the issues cited in the article.
The materials used in many of these supplements (again according to the authors) are not effective for what they are claimed to do. Moreover, there is no pre-market approval by FDA before these products are thrust upon the unwitting public.
FOURTH CHORUS OF LITANY: Please refer to the matter of lack of enforcement of 21CFR Section 190.6 again. The safety of the materials has to be demonstrated for New Dietary Ingredients. Additionally, FDA has published guidance in support of another regulations that defines what substantiation requirements exist for the claims made on the label. FTC has provided spotty enforcement for advertising these products but it is inconsistent in application.
The marketing techniques of some companies by providing financial incentives to retailers of supplements also seem to be a big topic for the authors. The challenges of providing such incentives are that the clerk in the store will push something that does not work strictly because they are going to receive greater financial reward. This squeezes out the more legitimate supplements because “nonsense sells well.”
FIFTH CHORUS OF LITANY: The lack of enforcement of the existing regulations concerning the labeling and advertising of Dietary Supplements is to blame for much of the nonsense being put forth. The matters of economic incentive to sales people are far from restricted to the Dietary Supplement industry. Think only as far as your local automobile dealership to find examples.
This litany is one that we will soon see in responses from our august industry leaders in one form or another. The problem is not so much with the veracity of the litany but with the inaction that it mandates. “It’s not our fault!” we exclaim. In reality what we are saying is that “I can’t help myself – I must falsely promote in order to survive.” Gordon Gecko is running the Dietary Supplement industry and “GREED IS GOOD” is posted above the doors of a great many of the “entrepreneurs” involved in the industry. Shame on us.
What to do? How about conforming to the regulations that do exist rather than continually pointing out that they exist and that FDA is understaffed or unwilling to enforce? How about getting the gumption to address the challenges that this so-called “handful of bad actors” poses us? There are ideas out there that have been proposed for at least 8 years that I know of and none of these has seen the light of day. Why not get our trade associations active in trying to clean this up before the mainstream becomes a flood that washes us all up before Congress as they gut DSHEA? This is too common a plea I’m afraid – but this latest example will not be chanted out by rote repetition of the liturgical service we as an industry have sung for a decade now. If we do not take action, the regulators and the elected officials will. Then you will find a much smaller industry and much less beneficial one. Throw out the bath water please, but keep the baby in place. We are our own worst enemy and yet we have the ability and capacity to change this. Look in the mirror Pogo and recognize this fact.