If you use supplements regularly, and look at the label at least a little carefully, you may have noticed that a little disclaimer that says something like
“This statement has not been evaluated by the Food and Drug Administration. This product is notintended to diagnose, treat, cure, or prevent any disease”
The reason most (not all, as we’ll soon discuss) supplements say this on the label is simply to comply with FDA regulations which make it mandatory to disclose this information. Regardless of your opinion on the subject of government regulation in general, this seems like an inherently good rule to have. After all, the last thing we want is a bunch of nutjobs out there running around selling useless herbs and claiming they can cure diseases…Oh wait, that’s what’s going on.
It appears as though, despite the FDA being extremely clear in it’s labeling guidelines that supplements can’t be marketed as cures, treatments, or preventions for any diseases, companies are still doing it.
Last week, a district court in Lousianna charged Guy Lyman, owner of Flor Nutraceuticals, with interstate trafficking of an unapproved drug. In other words, what the court is saying, is that Flor Nutraceuticals was selling what it claimed was a treatment for Herpes. The issue is, this “treatment” was never approved by the FDA. These charges come after at least one warning letter were sent to Mr Lyan and Flor Nutraceuticals for the very same reason in 2011.
So what is Herpaflor anyway? We pulled this label from the product site:
If you take a look at the label above, you might notice the words “Dietary Supplement” are clearly displayed on the front and the ingredients are just herbs and vitamins, each of which can be found in a ton of other dietary supplements out there. For the most part, Herpaflor looks just like any other dietary supplement (except for the distinct lack of FDA disclosures).
So why is it that Herpaflor violates the law but another dietary supplement with exactly the same ingredients could be perfectly legal. It all comes down to one word: intent.
According to the Food Drug & Cosmetic (FD&C) Act:
“A product is considered a drug if it is intended for use in the diagnosis, cure, mitigation, treatment, of prevention of disease.”
Whether or not a product is considered a “drug” has nothing to do with what it’s made of or who makes it. It’s all about the intended use.
A dietary supplement can cross over into “unapproved drug” territory the second it gets marketed as a treatment for a disease. Conversely, a dietary supplement can become an approved drug if it goes through the necessary steps to get FDA approval.
This seems fairly straightforward on paper, but it becomes a bit complicated when you have supplements that ARE actually useful in the treatment of certain conditions.
There are plenty of Joint Support supplements, for example, that may be useful if you have Osteoarthritis, but in order to be sold as a treatment for that disease, a product must be FDA approved. Otherwise, it can only be sold as a “joint support supplement”.
So, what we have is a bunch of dietary supplement out there that are used by people with diseases to treat those diseases, but can’t legally be marketed for those purposes.
This of course poses some difficulties to supplement companies who make useful products for people with certain diseases, but it’s probably for the best. Without regulations like this, the already blurry line between dietary supplements and drugs would be completely non-existent.
There would be even more supplement companies taking advantage of people’s insecurities and circumstances to make profit…and there’s already too much of that going on!