Inset: GMPs are hailed by some as a definitive stamp of "quality." But how far can chemistry, manufacturing and controls extend when the goods are ingested by biological organisms e.g. Homo sapiens?
Setting: First Saturday of the month sale, NutriVerse flagship nutrition retail store, Multiverse coordinate 9.d7.404; 4 September 2010.
Undercover Agent affiliation: Food and Dietary Supplement Agency (FADSA)
Agent Bentson: "Test. 1, 2. Test."
Airborne stealth comm center: "Perfect sound levels, Agent Bentson. We're green."
Bentson (whispering): "I'm on it and my dummy knee brace is adjusted. I'm entering the dietary supplement section. I've stopped at the joint and eye care section. I'm scrutinizing a number of labels. OK. A clerk is coming over to me. Switch to hypersonic microphone."
NutriVerse clerk: "Good afternoon Ma'am. May I help you find anything? We have some fantastic First Saturday specials!"
Bentson: "Good afternoon. I was wondering what you have for arthritis. My right knee has arthritis and I'm concerned about using anti-inflammatory drugs for an extended period of time."
Clerk: "We have an excellent selection of quality joint health products. These two over here are best sellers in this store, and the one in the light green box is on sale. My grandmother has arthritis in both knees and has been using it for two years. As you may know all of the supplements we sell are from Good Manufacturing Practices-or GMP-approved companies."
Bentson (holding light green box and examining): "I haven't heard of this ArthroGesic product. What is 'Pico-particle technology for faster action and greater absorption?' And has this product been evaluated in studies in humans-with osteoarthritis of the knee?"
Clerk (confident tone): Several years past companies were using nanoparticle technology-to make particles that were a million times smaller than a millimeter. This new technology uses particles that are a BILLION times smaller than a millimeter. Because they're so tiny they're much easier to absorb. ArthroGesic is made by a GMP certified manufacturer, meaning that it is required by FADSA to be proven safe and effective in humans. That's part of what GMPs are all about."
Bentson (pulling a Multinet communications device from her purse and assuming a self-effacing tone): "I didn't know that dietary supplements were so advanced. And you seem to be very well informed. But would you help me with this information (pointing to a screen on her device, with an FADSA seal at top). I was reading this from the FADSA Multinet site and now I'm confused. In this section here (now highlighted and enlarged text) it states:
'Dietary supplements earning the distinction of GMP certified are a positive step forward in regulation and consumer health. GMPs assure content uniformity and alignment with label/packaging composition claims, and the absence of infectious, undeclared or toxic substances. However, the current GMP regulations do not require that any such certified products also be subjected to human research studies to demonstrate safety and effectiveness. Such studies remain the option of each dietary supplement manufacturer or marketer.'"
Clerk (visibly unsettled): "I'll have to discuss this with my manager. Last month we had an in-store training by a sales rep from the manufacturer of ArthroGesic and she said that all of their products were FADSA-certified GMP, and that this meant they were proven safe and effective."