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 them under a very different classification than drugs. The DSHEA says that dietary supplements may not contain anything that could have “a significant or unreasonable risk of illness or injury” when the supplement is used with normal use. This means that supplements do technically fall under the large FDA umbrella. However, instead of being held to the same safety standards as OTC and prescription medications, it is in a separate category under the umbrella of food.


So, Who is Watching Out For Our Safety?

In theory, the FDA is quietly monitoring supplements to watch for any problems that arise. However, this leaves many of us pretty concerned. If it requires a problem, meaning adverse reactions or worse, to heighten the level of awareness on a specific supplement, is supplementation even safe? Some manufacturers do take steps to ensure that the end product is both safe and effective. This is why it is very important to find a supplement company that you can trust with your family’s health.



How Can You Choose a Safe Supplement Brand?

There are a few important things to look for in a supplement brand.

#1: Make sure the supplement company chooses their ingredients carefully:   Many supplement manufactures prefer not to clue you in on the how and where of their ingredients. Chances are this is because they use synthetic ingredients and those not from the best sources. A company that sources natural ingredients from the best possible locations will take steps to let the consumer know that the ingredients are of the best quality.


#2: Look into whether they test for safety and effectiveness:  A definite must when choosing your vitamin brand is to find a company that puts both ingredients and the final product through rigorous testing. This is the only way to know that what you are taking is safe and effective. If the company doesn’t outline what tests they use, keep looking!


#3: Be on the lookout for a careful manufacturing process:  A big part of supplement safety is how supplements are made. Some companies take painstaking steps to make sure that nothing impacts the safety of the supplement during the manufacturing process, while others do not. These precautions ensure that no extra, unwanted ingredients (like trace amounts of heavy metals) end up in your vitamin.


#4: Supplements made in a pharmaceutical grade plant are best:  Companies that go to the lengths of using a pharmaceutical grade manufacturing facility take safety seriously. This means that every possible protection is in place to keep you safe and healthy.


While the FDA plays some role in the moderation of vitamins and supplements, it is a very minimal one. This puts the ownership on the manufacturers to make sure that what they put on shelves is safe. For those of us with a high level of concern about what goes into your bodies, much of this responsibility falls on us. Make sure to choose a vitamin company that keeps your health as their top priority.

Supplements, on the other hand, are considered safe until some piece of information comes to light that proves otherwise.


David’s passion for optimal health, wellness, and prevention started as a research analyst covering the industry. David specialized in nutritional supplements, pouring over clinical studies, touring manufacturing facilities, and immersing himself in the supplement and wellness industry on all levels. He developed a passion for the industry and educating people, and became driven to start Previnex. Previnex is a prevention-based health and wellness company committed to using science, clinically-tested ingredients and going above and beyond the testing and production standards required to bring to life nutritional supplements products of unparalleled quality, safety, and effectiveness.

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