Are Supplements Regulated by the FDA?

by | Dec 28, 2021

You have probably heard that something along the lines of…”Supplements are not regulated by the FDA” and you would be both right and wrong. According to the The Food and Drug Administration (FDA), here is what they do:

“FDA regulates both finished dietary supplement products and dietary ingredients. FDA regulates dietary supplements under a different set of regulations than those covering “conventional” foods and drug products. Under the Dietary Supplement Health and Education Act of 1994 (DSHEA):

  • 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.
  • FDA is responsible for taking action against any adulterated or misbranded dietary supplement product after it reaches the market.” (1)

So, what does that mean?! Basically, it means that the FDA relies on the manufacturer to make sure they are providing exactly what they say they are putting into a supplement. There is no official quality control process in place by the FDA. If it is determined that a company is misrepresenting their products, their FDA can come in take action.

What does this mean for the consumer? It means that a supplement is only as good as the company making it. Since the FDA doesn’t check quality, potency or for the presence of contaminants such as lead, the companies that produce the product have the job of doing this. You can imagine that the lower priced, discount supplements are going to cut costs on this process and the higher quality products are going to have a bit higher price tag because they want to ensure that their products 1) Are what they say they are and 2) Do not contain any ingredients that might be harmful. Number 2 is especially important for products that are produced in countries that do not have strict laws about what is acceptable in manufacturing. In supplement production, lead is a big deal here. In fact, in 2016, an article was published linking 2 deaths to the consumption of lead in supplements. You can read the full article here

Clearly, we need to be aware of what we are consuming!

So, how do you make sure a company is doing a good job of protecting you against dangerous contaminants and making sure that what is advertised on the supplement is actually in the product? There are a few things to look for:

  • Independent 3rd party quality control. A good manufacturer will have an outside company checking it’s products.
  • Traceable products. A good manufacturer will also have a way to track a product from warehouse to consumer. This is important, because you want to know if your product is sitting in a hot warehouse (over 100 degrees, where supplement quality can begin to deteriorate, especially for something like a probiotic). You also want to be able to know if the product you received had been previously returned and is now being re-sold. There is simply no way to know what happened to that product in the process.
  • Free from common allergenic substances. These are things like gluten, corn, soy, dairy, shellfish and peantus tree nuts and eggs. Many people taking supplements are taking them to improve health, but never considered that their supplements might contain the very food things they are diligently avoiding in their diet!

That’s just a few ways to consider if you are getting quality supplements. Over the years, I have worked with many people and get asked every day about different brands of supplements. It can be overwhelming. About 2 years ago, I began the long process of creating my own supplements that meet my very high standards. You can check out this page to learn more and take a quiz I designed to help you select the right supplements for you.

(1) https://www.fda.gov/food/dietary-supplements

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