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May 2

Written by: Jim Lassiter
5/2/2009 2:51 PM 


A few years ago I had the opportunity to visit the facilities of a company named MuscleTech.  The impression left was one of a company who was doing things “right”.  This was especially heartening in the world of weight loss products in our industry.  They had managed to work a notable amount of science into their formulation and had some data to back up the claims they made.  All very impressive.  The formulation team I met was professional and competent and were led by a director who knew his stuff.
It is interesting to note that while a lot of other companies in the weight loss end of the industry were hammered by FTC regarding their claims – MuscleTech managed to keep out of that sweep and limelight.  Perhaps they had the goods on the claims they made? 
Now we have a significant recall out of MuscleTech.  This is far from something I saw coming to be sure.  I had looked into the eyes of the folks there and looked into the science they were using and generating concerning the use of their product for weight loss.  Now, as it turns out, there appears to have been a significant fly in the ointment of the weight loss product and its foundation formulation.  The recall that is ongoing is not insignificant and the reason for the recall most disturbing.
What is perhaps more disturbing is the fact that we honestly don’t know (and by we I mean MuscleTech, FDA or anyone) whether there is a single entity within the formulation that is causing the problem or if it’s some sort of combination reaction.  The point here is that we likely won’t know since the investigation would prove amazingly costly owing to the number of ingredients in the product itself.  This of course is no matter to the consumers who appear to have been injured as a result of consuming the product but the lesson is clear.  We as an industry have sought the next big thing every time there is a tail off of the last big thing.  If we venture into the more exotic chemicals or extracts or what have you we increase the risk significantly of presenting another recall such as this one.
Here are some interesting questions to ask concerning the formulation of the Hydroxycut products:
How many of the ingredients in the products are truly “old dietary ingredients?”  You know the ones that had been sold in the United States in dietary supplements prior to October of 1994.  If the answer is ALL OF THEM – we have a significantly larger problem than just this recall.
How many of the ingredients in the products were New Dietary Ingredients that had been properly notified to FDA in accordance with the regulations?  If the answer is that some were not notified – we have a different set of concerns.  This set of concerns harkens back to the lack of enforcement issues we have discussed before.
Lastly – How many of the potential interactions among the myriad of ingredients in Hydroxycut were even remotely considered, let alone studied?  This one is the thorniest.  I recall hearing lectures concerning the issues of supplement/drug interactions even before DSHEA passed.  We have only incrementally more knowledge today as we did then.  Let alone what we know of supplement-supplement interactions.
The answers to the questions above may prove to be critical to the future of this industry.  We will likely hear about this example ad nauseum from our cohorts at FDA for a very long time.  We should try to find some answers to this challenge before they start using the example as a club.  If you are skeptical, please remember that I am posing this from the perspective of an individual who went through the tryptophan trials in the early 90’s.  If you read the preamble to the interations leading up to Dietary Supplement GMPs you will find heavy reliance on the tryptophan incident.  Likely we will continue to hear more of the tryptophan club and now the Hydroxycut club as regulations and perhaps even legislation changes.  Those changes can be onerous.  I suggest we find out some facts and prepare well in advance for this future.
 

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