The Facts

So, you’re probably wondering what that nifty disclaimer that’s so very conveniently located at the bottom of every supplement bottle actually means. “These statements have not been evaluated by the Food and Drug Administration, and this product is not intended to diagnose, treat, cure, or prevent any disease.” Surely, this disclaimer is enough to warrant suspicion.  Actually, it’s quite the opposite as we’ll explain a little further down in this short article.

Firstly, why is this disclaimer there?

It’s quite simple. The FDA (a US Federal Agency involved in promoting and preserving public health) has made it incumbent upon nutritional companies to clearly state that their products have not undergone the rigorous approval of the Food and Drug Administration. The catch 22 here is that the FDA categorizes dietary supplements under the subset of food products, and not as a pharmaceutical drug as such it does not require approval. However, this means nutritional supplements cannot claim, imply or insinuate that their products will treat, prevent or cure medically recognized diseases, hence the need for a public disclaimer.

What does a lack of regulation mean for the supplement industry?

It gives any individual or company the legal right to produce, distribute and market their own line of nutritional dietary supplements.  But, you can put all your worries aside because the FDA (as loyal as they are) didn’t just leave us all in the dark about what’s in our vitamins and supplements.

The FDA behaves like an enforcement and regulatory agency within the supplement industry. They enforce certain regulations such as cGMP standards and GRAS protocols to hinder the sale of unregulated and dangerous dietary supplements.

cGMP (General Good Manufacturing Practices) approval by the FDA is pretty hard to obtain and comes through rigorous inspections of the manufacturing site, and the quality and type of ingredients being used.  Proper adherence to cGMP standards assures the identity, strength, quality, and purity of the ingredients by requiring that manufacturers adequately control manufacturing operations.  So, you’re pretty much safe so long as your product has a cGMP stamp of approval.

GRAS protocols are another easily identifiable way of determining the safety of your vitamin or supplement. This stands for Generally Recognised as Safe, and is designated to chemicals, substances or food additives added to supplements that are generally considered safe for human consumption. However, personally, we don’t see the real value of adding synthetic ingredients, colorants or preservatives to our products. The idea of including synthetic ingredients to a supplement otherwise designed to boost and improve health just seems a little paradoxical to us.

Lastly, can any supplement gain FDA

approval?

The short answer: No.  The long answer: The FDA does not consider nutritional dietary supplements to be pharmaceuticals, it considers them a subset of food products. The FDA only approves pharmaceutical drugs.  The FDA does, however, continuously monitor the sale, packaging, and labeling of dietary supplements to ensure their compliance with The Dietary Supplement Health and Education Act of 1994 (DSHEA). This act outlines the nutritional and therapeutic claims (if any) which can be made of any vitamin or supplement. 

The FDA has also addressed potential ambiguities which can arise within the bracket of disease, such as illnesses which may be precursors for disease rather than the disease itself.  The disclaimer shown above is used by nutritional companies to reflect their compliance with FDA regulations, which is always a good thing right? The last thing you’d want is a company that has no idea what it’s actually doing, or what the industry requirements in it’s industry actually are.