According to the FDA, a drug is a substance (other than nutrients) intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease, or to affect the structure or function of the body. Seems crystal clear. Well not so fast. Then we have Big Pharma and big money dirtying just about anything....
Last May a cluster of liver failure was attributed to a supplement called OxyElite Pro. Of the 29 people identified, 24 had taken this “natural” supplement. A manufacturer spokesperson issued statement claiming that USPLabs stands by the safety of all of its products and that the cluster of liver issues in Hawaii was a complete mystery.
However another more recent report in The New England Journal of Medicine pointed out that the problem was actually worse. By that time, the CDC had found 97 cases of liver damage in people who had used this product. Of this group, 47 people were hospitalized, three needed liver transplants and one died.
Eventually the FDA ordered the product to be taken off the market—after the damage had been done.
But, if something is not a drug the FDA doesn’t even get to review it and cannot approve or reject it. So, the obvious route for some manufacturers is to take a substance, even a drug and call it something else like a supplement.
Supplements aren’t supposed to be drugs, right? After all, they are natural, safe and good for you.
Why would anyone want to swallow something that didn’t cure, mitigate, treat, or prevent disease unless it's as tasty as pizza?. Yet, the industry sells thirty billion dollars worth of these non-drug supplements every year.
A 1994 law, using carefully crafted language, permits some drugs to be declared to be not drugs by considering them to be foods, though they don't taste like pizza. In fact, they may have no taste at all.
And so goes the definition of a supplement: a product (other than tobacco )intended to supplement the diet that bears or contains one or more of the following dietary ingredients: a vitamin, a mineral, an herb or other botanical, an amino acid, a dietary substance for use by man to supplement the diet by increasing the total dietary intake, or a concentrate, metabolite, constituent, extract, or combination of any of the aforementioned ingredients.
Great so now just about anything is considered a food!
The labelling requirements on supplement bottles are pretty odd as well. If the supplement bears a claim to affect the structure or function of the body (structure/function claim), a claim of general well-being, or a claim of a benefit related to a classical nutrient deficiency disease, the label must state “This product is not intended to diagnose, treat, cure, or prevent any disease"
Let's take a look at some common issues with drugs and supplements or just about any pill being marketing today:
1. The amount of ingredient(s) in the pill may vary widely from what is on the label.
2. An otherwise-useless herbal product may be spiked with a prescription drug.
3. By far the worst, what is on the label may not be what is in the bottle. In fact, it rarely is. A study published in BMCMedicine looked at contamination of 44 herbal products that were sold by 12 different companies. The researchers found that 59% of the products they tested contained species of plants that were not listed on the label.
Worse yet, when they looked at 44 herbal products from 12 different companies, only two of the companies were even selling what was actually on the label. The rest sold products with various fillers and contaminants.
What kind of contaminants? Pretty much what you’d expect. Various toxins, a few carcinogens and other icky stuff. For herbal supplement users who are keen on the use of natural products this is riveting news.
Take a look at the graph below showing how dramatic the situation really is notably so with product 'a' and 'e'
The study goes on to conclude that, “Many of the dangers of commercial plant medicine have been brought to light by DNA technology based studies that have identified contamination of herbal products with poisonous plants.”
Yet, selling this trash is perfectly legal.
Supplement regulations are driven by money and sleight-of-hand, not science. If you really want to know what you are taking one solution is to know the manufacturer and opt for the basic raw ingredients in powder or liquid form and make your own supplements. You can purchase inexpensive capsuling machines or suppository molds for home use.
Many people are not prepared to go this route however and if you're one of them, you'd best be prepared to pay more for whatever substance your purchasing if its of any quality. After having determined the quality of course- without relying on the label.
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