You might have noticed that nearly every supplement has some version of the same message on its bottle stating that any health claims about the product have not been approved by the Food and Drug Administration (FDA). You may be wondering, "Are there actually any FDA-approved vitamins out there?"
Approval and regulation of dietary supplements is a tricky subject. No, the FDA does not have to approve supplements before they hit the market. That doesn't mean, however, that the world of vitamins and supplements is a free-for-all. Still, you are smart to take precautions when it comes to picking the right supplement for you.
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How Supplements Are Regulated
According to the American Academy of Family Physicians, dietary supplements are meant to do exactly what their name indicates: They supplement the diet with what's lacking. Most people can adequately get all the nutrients they need from eating a variety of foods.
But supplements can't take the place of a healthy diet, and they are not intended to cure diseases or reduce the risk of such health problems as cancer or heart disease. They are not medicine, and they are not subject to the same scrutiny that medicine is.
This is one of the reasons that "FDA-approved vitamins" would be a bit of a misnomer. Although prescription and over-the-counter drugs must be reviewed and approved by the FDA before they can be sold, dietary supplements do not.
The FDA does not determine whether vitamins and other supplements are actually effective; as the FDA itself points out, it is up to the manufacturers to make sure their products are safe and whether the claims that they print on their labels are accurate.
This is why the labels of supplements will have a note next to the health claims that says, "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."
Stopping Unsafe Supplements
There are still certain regulations. The National Institutes of Health explains that the manufacturer must have proof of its product's safety, and that it is not being misleading in its health claims. More importantly, the FDA will take action against dietary supplements that are unsafe.
One specific instance of this was in December 2017 when the Food and Drug Administration Office of Criminal Investigations announced an agreement that the Department of Justice reached with GNC, the largest retailer of dietary supplements. In this specific situation, GNC sold a product without testing or certifications to confirm that the ingredients in the product were lawful.
GNC agreed to reform its practices and undertake efforts to fix the quality and purity of its products. This agreement was formed to resolve the retailer of its liability for selling supplements that had been produced by a company under indictment. In addition to the agreement, GNC had to pay the U.S. government $2.25 million.
What Are FDA-Approved Supplements?
If all of this makes you a little wary of supplements, don't worry. The Food and Drug Administration actually calls the choice to use supplements "a wise decision that provides health benefits," but it does acknowledge that supplements could be unnecessary or harmful in certain situations and that people should educate themselves before taking a supplement.
For example, supplements could provide the body with excess amounts of certain nutrients if a person is already getting enough through their diet, which can be dangerous in some circumstances. Excess iron can make a person nauseated or even hurt their liver.
Additionally, certain vitamins can interfere with medical treatment. For example, you shouldn't take vitamin E when you're on blood thinners because this could thin the blood too much and cause internal bleeding. If a vitamin is an antioxidant, such as in the case of vitamin C and vitamin E, it could hinder chemotherapy treatment.
Even if the FDA does not review or approve supplements, it has established certain manufacturing practices, according to the National Institutes of Health. These good manufacturing practices were established to ensure that the manufacturer doesn't do something irresponsible or dangerous like include the wrong ingredient, improperly label the product or allow the product to be contaminated.
However it is up to the manufacturer to enforce these practices. The FDA will make periodic inspections of the facilities to enforce good manufacturing practices, however this is often dependent on public reports that might warrant the need for an investigation.
There are other independent organizations beside the FDA that will give their approval of supplements despite there being no official FDA-approved supplements. Like the FDA, however, these organizations won't guarantee that the products are safe or effective — just that they have the ingredients they say they do and don't have any contaminants.
Examples of these organizations are U.S. Pharmacopeia, ConsumerLab.com and NSF International. In fact, Harvard Health emphasizes the importance of selecting a dietary supplement that has been approved by one of these three organizations.
In lieu of the FDA's approval, you might be inclined to jump on the internet and read some multivitamin reviews written by people who have used the product. This would be unwise, as any multivitamin reviews written by an inexpert consumer could be exaggerated, misstated or completely made up.
Multivitamin reviews sound like they might be reliable, but you're safest getting medical guidance from the person who knows your situation best — your doctor.
Because FDA-approved supplements don't exist but are most beneficial to people with specific dietary needs, or people who have certain medical conditions, your doctor can help you determine what supplements are best for you, how much you should take (it might be different from what's on the package), whether it will interfere with any medical treatment you're already receiving, or anything else that's specific to your situation.
This way, you're getting the approval of someone who has the best understanding of your body and your specific needs.
- Food and Drug Administration: “Tips for Dietary Supplement Users”
- American Academy of Family Physicians: “Dietary Supplements: What You Need to Know”
- National Institutes of Health: “Dietary Supplements: What You Need to Know”
- Food and Drug Administration Office of Criminal Investigations: “GNC Enters Into Agreement With Department of Justice to Improve Its Practices and Keep Potentially Illegal Dietary Supplements Out of the Marketplace”
- Harvard Health Publishing: “What Patients — and Doctors — Need to Know About Vitamins and Supplements”
- Food and Drug Administration: "Facts About the Current Good Manufacturing Practices (CGMPs)"