I smell a rat

[Anonymous]

AIBIOTECH WORKING WITH FDA TO ENSURE NEW GENETIC TEST REMAINS AVAILABLE TO CONSUMERS
Sports X Factor Test Panel Identifies Athletic Strengths & Undiagnosed Risk Factors

RICHMOND, VA (May 25, 2011)American International Biotechnology Services (AIBioTech) today announced it is working with the U.S. Food and Drug Administration to keep its Sports X Factor genetic test available to consumers. The test panel screens athletes and young sports competitors for undiagnosed risk factors and athletic strengths to make awareness of potential health conditions more precise and workouts more effective.

During a meeting with the FDA on May 20, 2011, representatives from AIBioTech committed to working diligently over the next 30 days to submit a plan for performing studies to support Sports X Factor testing,



This sounds like the FDA is challenging AIBiotech's label claims about more effective workouts. Betcha the FDA told the lab PROVE it or LOSE it!

 

[Anonymous]

(h) The term "device" means an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including any component, part, or accessory, which is--

(1) recognized in the official National Formulary, or the United States Pharmacopeia, or any supplement to them,

(2) intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals, or

(3) intended to affect the structure or any function of the body of man or other animals, and which does not achieve its primary intended purposes through chemical action within or on the body of man or other animals and which is not dependent upon being metabolized for the achievement of its primary intended purposes


Sounds to me like the FDA is asking why the sports drink shouldn't be controlled as prescription.