Fact checked by Nick Blackmer
Supplements don’t need FDA approval before they hit shelves.
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Supplement manufacturers are not mandated to demonstrate the safety or effectiveness of their products prior to public sale.
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This emphasizes the necessity for consumers to conduct their own research when selecting a supplement.
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Seeking third-party testing certifications and opting for products with a single active ingredient can enhance safety while shopping.
For many Americans, taking dietary supplements has become a routine part of daily life. In fact, around 74% of adults report using vitamins, minerals, herbs, or botanicals, contributing to a booming market projected to reach $69 billion by 2025.
However, unlike traditional medications, dietary supplements do not require pre-market approval from the Food and Drug Administration (FDA). This means that manufacturers do not have to prove their products are safe, effective, or even contain the ingredients stated on their labels prior to sale. While the FDA does hold the authority to remove unsafe products from the market, it must first demonstrate their potential danger.
“This creates a marketplace where companies are selling whatever they want,” notes Pieter Cohen, MD, an internist and head of the Cambridge Health Alliance Supplement Research Program, in an interview with Health. “Unless you take steps to protect yourself, you have no idea what you’re putting in your body when you take supplements.”
Fortunately, there are effective strategies to make informed decisions when shopping for supplements. Here are four key approaches:
1. Look for Third-Party Certification
One reliable way to verify that a supplement is safe and contains the ingredients listed on its label is to check for third-party testing and certification, according to Cohen.
However, not all certifications carry the same weight, warns Rick Kingston, PharmD, a clinical professor at the University of Minnesota’s College of Pharmacy. Both experts recommend seeking supplements that boast seals from reputable organizations such as USP or NSF, which are recognized for their rigorous testing methods. These seals indicate that the supplement underwent comprehensive ingredient and manufacturing process evaluations to meet quality standards.
Cohen also cautions consumers to be wary of misleading certifications that feature acronyms similar to USP or NSF, as they may be designed to deceive buyers.
2. Be Cautious of Label Claims
Dietary supplements are intended to enhance the diet, and the FDA has strict regulations on the claims that can be made. Companies are prohibited from asserting that their products can prevent, cure, or treat any diseases. If you encounter a supplement making such claims, it’s best to steer clear.
Nevertheless, supplements can make claims about how they affect bodily structures or functions, called “structure/function claims.” These might include statements like “supports healthy bones,” provided there is scientific evidence to back it up. However, such claims must be accompanied by the disclaimer: “This statement has not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease.”
Any company making a structure/function claim is required to present the pertinent scientific evidence on its website, so it’s crucial to seek this information before taking anything at face value, advises Kingston.
3. Choose Single-Ingredient Supplements
To reduce the risk of encountering hidden or unwanted ingredients, opt for supplements that contain only one active ingredient, such as a specific vitamin, suggests Cohen. His research has revealed instances of unapproved stimulants in multi-ingredient supplements.
While taking a multivitamin or a combination such as vitamin D with calcium is generally safe (with prior consultation with a healthcare provider), Cohen recommends being cautious with supplements that claim to enhance multiple functions such as memory or sleep.
“The more ingredients a supplement contains, the less robust the evidence supporting their combined effectiveness and the higher the likelihood of unapproved substances hiding within,” Cohen remarks. “Understanding the effect of a single ingredient is challenging enough; assessing the impacts of ten combined ingredients is virtually impossible.”
4. Do Your Research
Prior to taking any supplement, it’s crucial to conduct thorough research, Cohen advises. He suggests starting with the FDA Adverse Event Monitoring System, which is a publicly accessible database of serious health events associated with FDA-regulated products. This will help you check for any alerts related to the supplements you’re considering.
Other helpful resources include:
Be Sure to Consult a Doctor Beforehand
In addition to following the steps outlined above to secure a quality supplement, it is also advisable to consult a healthcare provider or pharmacist before starting any new supplement regimen. Some supplements can interact with prescription medications or may be unsuitable for individuals with certain health conditions.
As Kingston points out, “Certain seemingly safe supplements, like St. John’s Wort, can influence how mainstream pharmaceuticals work.” Consulting with a healthcare professional can ensure you receive the intended benefits while avoiding unintended side effects.
Read more at Health
