We find that folks take supplements to aid their health. But what do consumers need to know about the regulatory landscape ensuring the safety and efficacy of supplement ingredients?
Updated January 8, 2024
What are dietary supplements?
Dietary supplements are any pill, capsule, powder, tablet, or liquid that contains one or more vitamins, minerals, herbs or botanicals, amino acids, enzymes, probiotics, or other dietary ingredients intended to aid human health.
Some examples include multivitamins, weight-loss pills, protein powders, and more.
How are dietary supplements regulated in the U.S.?
Two primary agencies are responsible for dietary supplement regulation: the U.S. Food and Drug Administration (FDA) and the U.S. Federal Trade Commission (FTC).
The FDA’s responsibility
The FDA is responsible for both finished dietary supplement products and dietary ingredients; however, the FDA is limited in its ability to regulate supplements before they are available for sale.
Unlike therapeutic medications and food additives that do not fall into the “Generally Recognized As Safe” category, the FDA does not have the authority to require or approve pre-market testing, so the FDA cannot evaluate for safety or efficacy before the supplement is available to consumers.
Supplement manufacturers are responsible for the supplement ingredients’ purity, potency, and efficacy.
As a result, the FDA can only look into and/or recall a harmful product once someone reports an adverse health event to the FDA.
If you’ve experienced an adverse reaction to a supplement, submit your experience to the FDA so they can track the supplement and potentially remove it from the market if it’s harming people.
The FTC’s responsibility
The FTC ensures the manufacturer’s advertising and marketing supplement health claims are truthful, not misleading, and substantiated. They help ensure that tainted or misleading supplements do not enter the marketplace.
It’s important to note that the FTC warns that many supplements can harm human health and rarely, if ever, produce the marketed health claim.
Again, the FTC cannot verify the safety or validity of health claims made by supplement manufacturers.
What do I need to know about supplements?
If a dietary supplement claim sounds like a miracle cure to an ailment you’re experiencing, be cautious and research the product before consuming it.
Some unscrupulous supplement manufacturers’ claims about their products are largely unscientific, untested, and, in some cases, dangerous.
If you choose to take a dietary supplement, make sure that you are purchasing a supplement tested for purity standards by a reputable, third-party laboratory or produced by a reputable company with scientific laboratories using the FDA-established Current Good Manufacturing Practices for dietary supplements (CGMPs).
While testing and adherence to CGMPs let you know that you will be consuming the ingredients labeled on the supplement packaging, it does not evaluate any of the health claims made by the product manufacturer.
So, while you may be taking the labeled supplement, it has yet to be tested to see if it will improve your health or remediate your ailment.
How do I know if a product has been tested for purity standards?
Third-party laboratories will have a logo on the product’s label that informs you the product has been tested. Popular third-party laboratories include NSF International, U.S. Pharmacopeia, Consumer Lab, and more.
Reputable companies with large distribution networks will have information about their supplements publicly available on their websites and will ensure their labels contain the necessary information.
Read labels and pay attention to the manufacturer before making supplement purchases so you can make an informed decision.
Should I take dietary supplements?
You should discuss taking dietary supplements with your state-licensed, board-certified primary medical provider. They will be able to provide you with the proper guidance and direct you to the products you may need.
People who typically require dietary supplements include pregnant people, people with vitamin deficiencies such as vitamin D, and other individuals with medically identified needs.
Again, the best course of action is to discuss your needs with a state-licensed and credentialed medical physician.
Are there health benefits to taking dietary supplements?
In some specific health situations, there are benefits to taking supplements.
For example, prenatal vitamins containing folic acid taken during early pregnancy can help prevent neural tube defects in babies.
Supplements can benefit your health if you work closely with a state-licensed, board-certified medical provider to achieve your health goals.
Are dietary supplements potent?
Dietary supplements can be potent, meaning they can cause your body to react to the supplement ingredients.
Supplement ingredients can also vary in concentration and bioavailability depending on many factors, including ingredient source, manufacturing process, inactive ingredients, your body’s unique response, and more.
It’s important to tell your medical provider any supplements you are taking because supplements can be potent and may adversely impact your medications.
Are supplements effective in treating health conditions?
Supplements do not meet the regulatory standards of medications; therefore, they do not have the same proven efficacy capacity to treat diseases. That said, a supplement like vitamin D may help improve your health, or a supplement like a prenatal vitamin with folic acid may help prevent a health condition.
While there can be a health benefit in taking supplements, it’s essential to work with your medical provider to ensure you get the proper treatment to manage your health.
Can supplements cause adverse health effects?
Yes, our body reacts to ingredients differently, and a supplement could cause our body to have an adverse health event.
Additionally, a supplement that isn’t verified for purity and potency could cause harm due to contaminants or other unknown variables. It’s important to verify your supplement’s source and ensure you’re working with a state-licensed, board-certified medical provider.
The good news.
Eating a well-balanced diet, drinking plenty of water, exercising, and getting restful sleep is enough for most people to remain healthy without additional supplements. However, if your medical provider agrees that you need a supplement, many on the market are third-party verified and may help you achieve your health goals.
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