Dietary Supplements

From the U.S. Food and Drug Administration

Dietary Supplements: What You Need to Know!

Q What are dietary supplements?
A Dietary supplements include vitamins, minerals, and other less familiar substances — such as herbals, botanicals, amino acids, enzymes, and animal extracts (see box at right). Dietary supplements are also marketed in forms such as tablets, capsules, softgels, and gelcaps. While some dietary supplements are well understood and established, others need further study.

Q What are the benefits of dietary supplements?
A Some supplements can help assure that you get an adequate dietary intake of essential nutrients; others may help you reduce the risk of disease. However, supplements should not replace the variety of foods that are important to a healthful diet — so, be sure you eat a variety of foods as well.

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

Q Are there any risks in taking supplements?
A 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 medications (whether prescription or over-the-counter)
Substituting supplements for prescription medicines
Taking too much of some supplements, such as vitamin A, vitamin D, and iron
Some supplements can also have unwanted effects before, during, and after surgery. So, be sure to inform your health-care provider, including your pharmacist, about any supplements you are taking — especially before surgery.

Q Who's responsible for the safety of dietary supplements?
A Dietary supplements are not approved by the government for safety and effectiveness before they are marketed. If the dietary supplement contains a NEW ingredient, that ingredient will be reviewed by FDA (not approved) prior to marketing — but only for safety, not effectiveness.

The manufacturers and distributors of dietary supplements are responsible for making sure their products are safe BEFORE they go to market. 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.

Manufacturers will also be required to report all serious dietary supplement related harmful effects or illnesses to FDA starting January, 2008. 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.

Q How can I find out more about the dietary supplement I'm taking?
What should I do if I have a reaction to a dietary supplement?
A You, your health-care provider, or anyone else should report a serious problem from the use of any dietary supplement directly to FDA's MedWatch Program at:

1-800-FDA-1088
(toll-free phone number)
1-800-FDA-0178
(fax)
The FDA Safety Information and Adverse Event Reporting Program3

FDA would like to know whenever the use of a dietary supplement causes you to have a serious reaction or illness, even if you're not certain that the product was the cause, and/or you did not visit a doctor or clinic.
A If you want to know more about the product you are taking, check with the manufacturer or distributor about:

Information to support the claims of the product
Information on the safety and effectiveness of the ingredients in the product

Any reports of adverse effects or events from consumers using the product

Q How can I be a smart supplement shopper?
A Although the benefits of some dietary supplements have been documented, the claims of others may be unproven. If something sounds too good to be true, it usually is.

Be a savvy supplement user. Here's how:

Watch out for false statements like:
A quick and effective "cure-all"
Can treat or cure diseases
"Totally safe" or has "no side effects"
Be aware that the term natural doesn't always mean safe.
Don't assume that even if a product may not help you, at least it won't hurt you.
When searching for supplements on the Web, use the sites of respected organizations, rather than doing blind searches.
Ask your health-care provider for help in distinguishing between reliable and questionable information.
Always remember — safety first!