How Are Nutritional Supplements Regulated?

Person in lab coat wearing blue latex gloves has their hand open and filled with white capsule supplement pills.

The Reality

As many of you may already know, the United States Food and Drug Administration (FDA) does not withhold the authority to mandate the regulation of every dietary supplement for their safety and effectiveness before they are released onto the market for consumers to purchase. This may seem scary to many, considering most of us would like to know that what we are about to put into our body is not going to harm us, and there are indeed supplements out there that may contain very unsafe ingredients or even hidden drugs that could have the potential to negatively affect your body. However, there are also many supplements on the market that are very well understood and established, and have been regulated by the FDA under provisions of DSHEA, the Dietary Supplement Health and Education Act. 


How do I know if a company’s supplement products are safe?


Before purchasing and consuming any supplements, I strongly suggest that you do your research first. Many supplement companies out there will tell you on their website specifically how their products are regulated and reviewed, on their packaging by different certification stamps, or you can contact the manufacturer directly to gain more information that support the claims, safety, and effectiveness of their products. However, not every company may provide you with this information up front. Therefore, researching each ingredient specifically, especially if you do not know what it is, to make sure it has no negative side effects or strong biological effects that may conflict with a medicine you may already be taking, or to make sure it may not interfere with any underlying medical condition you may already have, would be one way to make sure your supplements are safe. I also suggest leaning towards dietary supplements that have been regulated by the FDA under the DSHEA, or have been certified by some third-party certification company. 


Why are supplements not required to be tested by the FDA before they are released onto the market?


The FDA does not have the authority to regulate all supplements because dietary and nutritional supplements are classified as edible food products or natural substances that are believed to have health benefits, but are not produced to “treat, diagnose, prevent, or cure diseases,” specifically defined by the FDA itself. Therefore, since dietary supplements are not considered medicines, they cannot be regulated by the standards that govern the manufacturing and sales of over-the-counter or prescription drugs. 


However, ever since the Dietary Supplement Health and Education Act was implemented in 1994, supplements that pose a serious risk of injury have been prohibited, and DSHEA has allowed the Secretary of Health and Human Services to issue bans on any substances that are hazardous. The FDA has since then been allowed to implement good manufacturing practice guidelines. All of this information regarding the benefits of the DSHEA have been taken from an article posted in the American Public Health Association, which can be found here


The FDA is only allowed to investigate the manufacturing of a company’s supplements if there has been a reasonable amount of evidence put forth about its products inflicting harm on people. Therefore, the actual harm from a certain supplement has to cause severe adverse effects on someone or multiple people before it can even be examined by the FDA. Companies are required to report any of these severe side effects that their products may have on consumers, but this still does not give the FDA the authority to act upon this discrepancy until after a certain person or persons has experienced these harmful effects.


Is there any way to know which supplements are safe vs. unsafe? 


Yes, there is indeed a way to know which supplements are safer versus others without taking the time out of your busy schedule to research every ingredient one by one. Because the FDA cannot regulate whether or not supplements contain the ingredients that are written on the bottle, other companies have taken on this role. These so-called third-party companies have developed quality certification programs in order to test different supplements for the safety of their ingredients. Informed Sport, Informed Choice, and the NSF International Certified for Sport program are a few examples of these types of companies that conduct certified testing for supplements, specifically for athletes who are wanting to make sure the ingredients in their supplements will not show up on a drug test. 


How does ISN regulate their supplements?


At Innovative Sports Nutrition, producing athlete-safe, laboratory tested supplements is a priority. ISN is currently using a company called Informed Sport to certify its products. ISN’s Whey Protein and Energy+ Pre-Workout  has already been certified, and the rest of the supplements offered by ISN are on their way. With Informed Sport’s certification process, supplements undergo a pre- and post-certification process that consists of four different stages: 1) product and manufacturing review, 2) pre-certification sample testing, 3) product certification, logo use, and web listing, and 4) post-certification requirements and testing. To learn more about what goes on during each of these four certification steps with Informed Sport, click here. When an Informed Sport logo is found on our website or packaging labels, you can rest assured that every batch of this product has been tested for prohibited substances within sports and that the product was made in a safe environment with quality systems that are appropriate for sports nutrition manufacturing. 


To check out more of our athlete-safe, laboratory tested supplements click here to browse the selection. 




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