I’m sure you’ve come across this disclaimer to your left. What the heck does this even mean and why is it on the dietary supplement? I will answer that today for you, but more importantly, from this, I tell you how you can avoid the quack products out there! Let’s take a closer look..
So you’re at your local grocery store, at the dietary supplement aisle, and you pick up a fancy looking bottle of fish oil softgels. You notice the benefits on the label:
- Lowers cholesterol*
- Reduces the risk of heart disease*
- Helps fight arterial plaque*
- Antioxidant to fight cancer*
Or you see something even more interesting..like this!
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.
And so, there you are, scratching your head thinking, if this product isn’t to treat or prevent any diseases, then why does it say it can? and why the heck is FDA not approving these statements??
Well let’s take a moment to figure out what’s going on here.
Did you know…
FDA does not evaluate dietary supplements (or its claims) before a product goes to market. FDA views dietary supplements as a food. So much like how an orange or a pack of Cheetos aren’t evaluated by FDA before it’s sold, same goes for a dietary supplement. The FDA expects manufacturers to comply with Good Manufacturing Practices and the dietary supplement regulations (and if they don’t comply, they can recall a product, sue the manufacturer, etc) but there’s no formal approval or veto process for a given product.
Did you know…
Under the Dietary Supplements regulations (DSHEA), a dietary supplement cannot make disease treatment claims, or claims that treat, mitigate or reduce the risk of a disease. Yep, so that means if the fish oil supplement says it lowers your cholesterol (indicative of treating heart disease), then the FDA sees the product as a drug, that is misbranded as a dietary supplement. Instead of saying it can lower cholesterol; the product should say that it helps maintain healthy cholesterol already in the normal range. You’ll notice, this claim is not saying it will lower cholesterol, but just maintain cholesterol in the normal range assuming, it’s already healthy. In essence, it’s saying it’ll keep you healthy, but it won’t fix your health problem.
Did you know…
FDA will allow you to make claims on dietary supplements that affect the structure/function of the body, but without implying it will cure or treat a disease. (For example, a supplement can say glucosamine supports healthy joints, but it can’t say it can rid you of arthritis). However, under the condition to add the disclaimer: 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.
Why all this trouble?
Essentially, the FDA has created a framework that categorizes dietary supplements as foods. As just as that bottle of olive oil you cook with can’t make claims to cure a disease and just like a bag of apple chips doesn’t tell you to eat a maximum of 24 chips per day, supplements are treated similarly.
Under the FDA framework, supplements are meant to supplement the diet, not treat a disease and they’re meant to be consumed rather freely.
Do you agree with this? Perhaps not.
Like many others, you may see supplements and foods as healing.
While a case could be made for that… supplements or foods would then be viewed as drugs because they’re healing.
Think about that for a moment.
If it heals, the supplement is actually like a drug, which means..
- We’d then have to consider the potential for drug interactions (eg. fish oils have a blood thinning effect, so you don’t want to take it with other blood thinners or alcohol)
- Setting a maximum daily dose (eg. you don’t want to OD!)
- Adverse effects must be taking into account (eg. vitamin C can upset the stomach),
- The possibility of consumers self-diagnosing and possibly putting themselves at risk by NOT going to see a health care professional (eg. checking a website and thinking I have the flu, when really I have an infection).
Wouldn’t it be weird to buy a can of salmon and the label says you can only eat 1 can per day, to lower cholesterol and treat arthritis? It also says that I’m to seek advice from my doctor before eating this can of salmon.
You can see, it’s incredibly difficult to ‘regulate’ these things..
But what can you take away from all this?
Just know that when you see a dietary supplement that contradicts everything I just said, you should STAY AWAY from them.
They do not know the regulations, choose to ignore the regulations or are trying to take advantage of you. IF they’re willing to do that, just imagine the lack of quality built into the supplements themselves. Stay away from dietary supplements that say FDA APPROVED or promise to cure you of depression.
Bottom Line: Dietary supplements are considered foods NOT drugs. Therefore, such products can’t make claims to treat, mitigate, reduce the risk or cure a disease. Dietary supplements are NOT approved by the FDA. Stay away from all products that make such claims. It just goes to show that such brands/manufacturers do not know the rules, expect you to not know the rules, and are hoping to make a quick buck off you.