The No. 1 "wink wink, nod nod" of the US dietary supplements industry may well be the words inside that tiny rectangular box on the back of every bottle, which read: "These statements have not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure or prevent any disease."
Box duly printed, manufacturers routinely go ahead and use marketing language that all too often implies if not outright states that the pills inside can indeed treat, cure and/or prevent such-and-such health condition.
As the latest GAO report and associated grilling in Congress in June detailed, retailers are not above flouting these regulations in an attempt to help consumers. For highlights of the Congressional testimony, see "Hatchet job on the Hill." To read the full report, with the recorded "gotcha" audio files of retailers telling lies out of school to undercover government gumshoes, go to the Functional Ingredients website where we've archived all of it. (Contrarians, conspiracy theorists and health-freedom fighters will note that the mainstream media and Big Pharma-funded journals also could legitimately be caught in this legitimacy trap if the bar is truly set at publicizing full, fair and truthful health information and proper interpretation of study results — but I digress.)
Fact is, we want to be regulated appropriately. We want to use the occasion of the Hatch-Harkin bill now before Congress to strengthen DSHEA. We welcome GMPs for what they'll do for consumer confidence. At the same time, we surely need to do a better job as an industry to get this news out to mainstream consumers.
Which brings us back to that little box. Most people in the industry likely look at that box as a perfunctory item to be ignored. Many of us sigh heavily when the media keeps hitting that "unregulated supplements industry" drum. I myself have written many a letter to the editor explaining that supplements are not drugs, that the industry has a regulatory structure that works, that if supplements are really so dangerous then why can no victims be found?
For those of us who wonder why that "unregulated" drumbeat continues, maybe all along it has been that Faustian bargain to get DSHEA passed — that little box — which has served all too well to inform the greater public all these years that the FDA has not "evaluated" — read: regulated — the pills within.