Why Doesn’t the FDA Monitor Supplements/Vitamins?

Why Doesn’t the FDA Monitor Supplements/Vitamins?

The US Food and Drug Administration is responsible for the testing and regulation of food, food ingredients, cosmetics, veterinary products, prescription medications, over-the-counter medications and tobacco products. They test, monitor and regulate to make sure that each ingredient is safe for consumption. With such a broad scope of what they are responsible for, this leaves many people asking – why they don’t also monitor vitamins and supplements?

The FDA’s Role in Monitoring Supplements and Vitamins

According to the FDA, they are responsible for regulating finished dietary supplement products and dietary ingredients. However, they note that their role is to regulate dietary supplements under a different set of regulations than those that cover “conventional” foods and drug products. On their website they state, “manufacturers and distributors of dietary supplements and dietary ingredients are prohibited from marketing products that are adulterated or misbranded.  That means that these firms are responsible for evaluating the safety and labeling of their products before marketing to ensure that they meet all the requirements of DSHEA and FDA regulations.” They go on to say that it is in their jurisdiction to take action against any manufacturer that violates these safeguards.

 

Innocent Until Proven Guilty

There is one very important distinction to make when looking at the difference between how the FDA monitors drugs versus how they monitor supplements. In the case of medication testing and regulation, drugs are considered harmful until thorough testing can prove that they are both safe and effective. This means that the drug must go through rigorous clinical testing to make sure it does what it is supposed to do and doesn’t cause any harm.

Supplements, on the other hand, are considered safe until some piece of information comes to light that proves otherwise. This means that manufacturers are not required to submit to any type of clinical trials or testing in order to put their product on store shelves. Should a problem be experienced with use of a supplement, it is the role of the FDA to step in and see what is occurring.

 

Why Don’t Supplements Fall Under Their Umbrella?

In 1994 the Dietary Supplement Health and Education Act (DSHEA) passed and created a new definition for how dietary supplements would be approached. They are now considered a category of food, which put th