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March 05, 2008

Are Nutritional Supplements Really "Unregulated?"

WildwestBy watching television news stories and by reading newspaper articles relating to dietary supplements, it's easy to develop an image of the nutritional supplement industry as some sort of lawless frontier akin to the American Wild West.  More often than not, the theme of such media pieces seems to be that since nutritional supplements aren't regulated in the same fashion, and don't require the same FDA approval process as pharmaceutical drugs, that they are somehow "unregulated," and may therefore contain potentially harmful compounds.

But to assume that nutritional supplements are "unregulated" simply because they're not regulated in the same fashion as pharmaceutical drugs is illogical to say the least.  Such an assumption displays a fundamental misunderstanding of what nutritional supplements truly are and what they do.  But, as wildly unfounded as this assumption may be, still, the public perception of dietary supplements as "unregulated" is frighteningly common.

Much could be said about this issue, including the fact that even the FDA approval process which is in place for pharmaceuticals isn't nearly sufficient to protect the American people from adverse effects of medications (even in a hospital setting):

Study Link - Incidence of Adverse Drug Reactions in Hospitalized Patients

But the most important fact to get across to the American public is that dietary supplements are regulated by the FDA, and, in fact, dietary supplements are regulated very similarly to the foods we buy at the grocery store everyday.  This isn't terribly surprising when you think about it.  Dietary supplements (properly defined) are, after all, components of, or compounds found in foods. 

Dietary Supplements ARE Regulated By The FDA

The FDA has this to say about their regulation of dietary supplements:

Congress defined the term "dietary supplement" in the Dietary Supplement Health and Education Act (DSHEA) of 1994. A dietary supplement is a product taken by mouth that contains a "dietary ingredient" intended to supplement the diet. The "dietary ingredients" in these products may include: vitamins, minerals, herbs or other botanicals, amino acids, and substances such as enzymes, organ tissues, glandulars, and metabolites. Dietary supplements can also be extracts or concentrates, and may be found in many forms such as tablets, capsules, softgels, gelcaps, liquids, or powders. They can also be in other forms, such as a bar, but if they are, information on their label must not represent the product as a conventional food or a sole item of a meal or diet. Whatever their form may be, DSHEA places dietary supplements in a special category under the general umbrella of "foods," not drugs, and requires that every supplement be labeled a dietary supplement. (Emphasis added)

Now of course, knowing that food and dietary supplements fall under the same umbrella of regulation doesn't mean that all supplements will then be safe or healthy (nor does it mean that supplements will necessarily live up to their marketing claims).  Just as not every food at our local grocery store will be "good for us," not every nutritional supplement will be good for us either.  But, it's important for the average person to explicitly recognize that the same laws which ensure the quality standards and proper labeling of food are also in place for dietary supplements.

Regulation - It's A Start

From a practical standpoint, there are two ways to look at the FDA's regulation of dietary supplements.  On one hand, we can expect most supplements to be equally as safe as food.  Supplements are regulated to see to it that they contain only substances which are present in the food supply.  It's also the FDA’s job to protect us from fraud (meaning that it's against the law for a company to lie on the label about what’s in their product) or contamination (with bacteria or heavy metals, etc.).

(Note:  This is not to give the impression that all is perfect in the land of food and supplements - far from it.  In fact, raw material quality remains a huge issue for both industries.  But, when a food or a supplement company fails to live up to the FDA's requirements, and when they distribute products which pose an imminent health risk, the FDA has the power to order a recall of the product.  These recalls are enacted with foods far more often than with supplements, and yet you rarely hear the food industry described as unregulated.  As relates to supplements, the FDA has recently established mandatory Good Manufacturing Practices for dietary supplements to be phased in over the next few years, and now requires adverse event reporting by the nutritional supplement industry - these requirements increase even further, the FDA's regulatory control over dietary supplements.)

But, the fact that nutritional supplements are regulated similarly to foods is no reason to believe that nutritional supplements will always be healthy.  In fact, some nutritional supplement products may be equally as unhealthy as the "junk foods" they're supposedly meant to replace.   

So, even though the regulations and actions of the FDA do protect us from immediate danger, it's obviously not the FDA's job to see that we chose only foods and nutritional supplements which are actually good for us.  Each of us must accept that responsibility for ourselves. 

Education Is The Key

If we value our health, it's still up to each of us to educate ourselves on what we're really putting into our bodies.  Granted, these days the average person can easily become hopelessly confused when it comes to nutrition and dietary supplements.  But you don't have to go it alone. 

We founded Integrated Supplements because we got tired of the hype and false promises which we saw dominating the nutritional supplement industry.  From our research, we knew that much of what the American public was being told about nutrition was loaded with half-truths or even outright lies.  We knew that the scientific journals were just bursting with research studies documenting not only the amazing health-promoting effects of proper nutrition, but also documenting the harmful effects of many common components of food and nutritional supplements. 

We also knew that if things continued to go the way they were going, that these studies and this information would never be seen by the American public whose health continued to deteriorate year after year. 


At Integrated Supplements we feel strongly that you shouldn't have to have a PhD to educate yourself about nutrition, and that honest, no-nonsense nutritional information, and high quality nutritional products should be available to everyone willing to seek them out.  That's why we're dedicated to bringing this research to you in a language you can understand via the Integrated Supplements Blog, and it's also why we're dedicated to producing the highest quality, all natural nutritional supplements available.

So while the supplement industry may not be quite as lawless as the Wild West after all, we do still need to take some steps to protect ourselves.  We'll give you some pointers on how to do this in upcoming posts - stay tuned.

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