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Are Supplements Safe?

Dietary supplements can be beneficial to your health — but taking supplements can also involve health risks. While some dietary supplements are well understood and established, others need further study. Before making decisions about whether to take a supplement, talk to your healthcare provider.

What are dietary supplements?

Dietary supplements include ingredients such as vitamins, minerals, herbs, amino acids and enzymes. Dietary supplements are sold in forms such as tablets, capsules, softgels, gelcaps, powders and liquids.

What are the benefits of dietary supplements?

When supplements are advised by your healthcare provider to target specific needs, they can be beneficial to health. Some supplements have shown to be beneficial for certain population groups including folic acid taken by women of childbearing age to reduce incidence of birth defects and iron for anemia.

For someone who is generally healthy and eats a wide variety of foods, supplements are not worth the expense. Supplements aren’t intended to replace food because they don’t include all of the nutrients and benefits of whole foods, such as the fiber and phytochemicals found in fruits and vegetables. However, for those with certain health conditions it is not always possible to eat a variety of foods to meet their nutritional needs. Talk to your healthcare provider before using dietary supplements to determine how much is safe to take based on individual needs.

Are there any risks in taking supplements?

Yes. Many supplements contain active ingredients that have strong biological effects in the body. This could make them unsafe in some situations and hurt or complicate your health. For example, the following actions could lead to harmful – even life-threatening – consequences:

  • Combining supplements
  • Using supplements with medicines (whether prescription or over-the-counter)
  • Substituting supplements for prescription medicines
  • Taking too much of some supplements, such as vitamin A, vitamin D, or iron
  • Some supplements can also have unwanted effects before, during and after surgery. Be sure to inform you healthcare provider, including your pharmacist about any supplements you are taking.

Unlike drugs, supplements are not intended to treat, diagnose, prevent or cure diseases. That means supplements should not make claims, such as “reduces pain” or “treats heart disease.” Claims like these can only legitimately be made for drugs, not dietary supplements.

The supplement industry has a long history of impure products. Do you remember ‘ephedra’ from back in the 90’s? This stimulant was linked to organ damage and death and was consequently banned in 2004. A more recently banned substance, methylsynephrine, has been found in supplements that did not list it on the label. It is not approved for use in the US as either a supplement or prescription drug. Recent research found that 14 out of 27 brands of dietary supplements contained the banned substance in a range of doses. In some cases, if consumers took the recommended dose listed on the label, they could potentially experience side effects including vomiting, agitation and cardiac arrest. And methylsynephrine is just one potentially unlisted additive found in supplements.

Who is responsible for the safety of dietary supplements?

The manufacturers and distributors of dietary supplements are responsible for making sure their products are safe before they go to market. FDA is not authorized to review dietary supplement products for safety and effectiveness BEFORE they are marketed. 

If the dietary supplement contains a new ingredient, manufacturers must notify FDA about that ingredient prior to marketing. However, the notification will only be reviewed by FDA (not approved) and only for safety, not effectiveness.

Manufacturers are required to produce dietary supplements in a quality manner and ensure that they do not contain contaminants or impurities, and are accurately labeled according to Current Good Manufacturing Practice (CGMP) and labeling regulations.

If a serious problem associated with a dietary supplement occurs, manufacturers must report it to FDA as an adverse event. FDA can take dietary supplements off the market if they are found to be unsafe or if the claims on the products are false and misleading.

How can I be a smart supplement shopper?

If you are advised by your health provider to start a supplement, follow these guidelines:

  • When searching for supplements on the internet use credible, noncommercial sites (e.g. NIH, FDA, USDA) rather than doing blind searches.
  • Watch out for false statements like “works better than [a prescription drug],” “totally safe,” or has “no side effects.”
  • Be aware that the term natural doesn’t always means safe.
  • Ask your healthcare provider for help in distinguishing between reliable and questionable information.
  • Use caution and look for independent quality assessment seals and third-party verification for added safety.
  • Always remember – safety first!

Sources: Food and Nutrition Magazine article “A Lesson in Safety: What to Know About What’s Not On Supplement Labels” by Ginger Hultin, MS, RDN, CSO & U.S. Food and Drug Administration (FDA)