Echinacea to prevent colds. Ginkgo to improve memory. Flaxseed to lower cholesterol. The list of herbal remedies goes on and on.
Herbal supplements, sometimes called botanicals, aren't new. Plants have been used for medicinal purposes for thousands of years. However, herbal supplements haven't been subjected to the same scientific scrutiny and aren't as strictly regulated as medications. For example, makers of herbal supplements don't have to get approval from the Food and Drug Administration (FDA) before putting their products on the market.
Yet some herbal supplements — including products labeled as "natural" — have drug-like effects that can be dangerous. So it's important to do your homework and investigate potential benefits and side effects of herbal supplements before you buy. And be sure to talk with your doctor, especially if you take medications, have chronic health problems, or are pregnant or breast-feeding.
Herbal supplements are regulated by the FDA, but not as drugs or as foods. They fall under a category called dietary supplements. The rules for dietary supplements are as follows:
- Manufacturers don't have to seek FDA approval before putting dietary supplements on the market. In addition, companies can claim that products address a nutrient deficiency, support health or are linked to body functions — if they have supporting research and they include a disclaimer that the FDA hasn't evaluated the claim.
- Manufacturers must follow good manufacturing practices to ensure that supplements are processed consistently and meet quality standards. These regulations are intended to keep the wrong ingredients and contaminants, such as pesticides and lead, out of supplements, as well as make sure that the right ingredients are included in appropriate amounts.
- Once a dietary supplement is on the market, the FDA is responsible for monitoring its safety. If the FDA finds a product to be unsafe, it can take action against the manufacturer or distributor or both, and may issue a warning or require that the product be removed from the market.
These regulations provide assurance that herbal supplements meet certain quality standards and that the FDA can intervene to remove dangerous products from the market.
The rules do not, however, guarantee that herbal supplements are safe for anyone to use. Because many supplements contain active ingredients that have strong effects in the body, these products can pose unexpected risks. For example, taking a combination of herbal supplements or using supplements together with prescribed medications could lead to harmful, even life-threatening results. For this reason, it's important to talk with your doctor before using herbal supplements.
The FDA requires that the following information be included on the labels of all herbal supplements:
- The name of the herbal supplement
- The name and address of manufacturer or distributor
- A complete list of ingredients — either in the Supplement Facts panel or listed beneath it
- Serving size, amount and active ingredient
If you don't understand something on an herbal supplement's label, ask your doctor or pharmacist for an explanation.
An easy way to compare ingredients in products is by using the Dietary Supplements Labels Database, which is available on the National Library of Medicine's website. The database has information on the ingredients for thousands of dietary supplements sold in the United States. You can look up products by brand name, uses, active ingredient or manufacturer.
Manufacturers of herbal supplements are responsible for ensuring that the claims they make about their products aren't false or misleading and that they're backed up by adequate evidence. However, they aren't required to submit this evidence to the FDA.
So be a smart consumer and do a little homework. Don't just rely on a product's marketing. Look for objective, research-based information to evaluate a product's claims. To get reliable information about a particular supplement:
- Ask your doctor or pharmacist. Even if they don't know about a specific supplement, they may be able to point you to the latest medical guidance about its uses and risks.
- Look for scientific research findings. Two good sources include the National Center for Complementary and Alternative Medicine (NCCAM) and the Office of Dietary Supplements. Both have websites that provide information to help consumers make informed choices about dietary supplements.
- Contact the manufacturer. If you have questions about a specific product, call the manufacturer or distributor. Ask to talk with someone who can answer questions, such as what data the company has to substantiate its products' claims.
If you have health issues, it's essential that you talk with your doctor before trying herbal supplements. In fact, in some high-risk situations, your doctor will likely recommend that you avoid herbal supplements altogether.
It's especially important that you talk to your doctor before using herbal supplements if:
- You're taking prescription or over-the-counter (OTC) medications. Some herbs can cause serious side effects when mixed with prescription and OTC drugs, such as aspirin, blood thinners or blood pressure medications. Talk to your doctor about possible interactions.
- You're pregnant or breast-feeding. Medications that may be safe for you as an adult may be harmful to your fetus or your breast-feeding infant. As a general rule, don't take any medications — prescription, OTC or herbal — when you're pregnant or breast-feeding unless your doctor approves.
- You're having surgery. Many herbal supplements can affect the success of surgery. Some may decrease the effectiveness of anesthetics or cause dangerous complications, such as bleeding or high blood pressure. Tell your doctor about any herbs you're taking or considering taking as soon as you know you need surgery.
- You're younger than 18 or older than 65. Older adults may metabolize medications differently. And few herbal supplements have been tested on children or have established safe doses for children.
If you've done your homework and plan to try an herbal supplement, play it safe with these tips:
- Follow supplement instructions. Don't exceed recommended dosages or take the herb for longer than recommended.
- Keep track of what you take. Take only one supplement at a time to determine if it's effective. Make a note of what you take — and how much for how long — and how it affects you.
- Be cautious about supplements manufactured outside the United States. Herbal products from some European countries are highly regulated and standardized. But toxic ingredients and prescription drugs have been found in supplements manufactured elsewhere, particularly China, India and Mexico.
- Check alerts and advisories. The FDA and NCCAM maintain lists of supplements that are under regulatory review or that have been reported to cause adverse effects. Check their websites periodically for updates.
Nov. 17, 2011
- Overview of dietary supplements. U.S. Food and Drug Administration. http://www.fda.gov/Food/DietarySupplements/ConsumerInformation/ucm110417.htm. Accessed Aug. 17, 2011.
- Using dietary supplements wisely. National Center for Complementary and Alternative Medicine. http://nccam.nih.gov/health/supplements/wiseuse.htm. Accessed Aug. 17, 2011.
- Tips for the savvy supplement user: Making information decisions and evaluating information. U.S. Food and Drug Administration. http://www.cfsan.fda.gov/~dms/ds-savvy.html. Accessed Aug. 17, 2011.
- Dietary Supplements Labels Database. National Library of Medicine. http://dietarysupplements.nlm.nih.gov/dietary/index.jsp. Accessed Aug. 17, 2011.
- What dietary supplements are you taking? Office of Dietary Supplements. http://ods.od.nih.gov/pubs/partnersbrochure.asp. Accessed Aug. 17, 2011.
- Bauer BA. Mayo Clinic Book of Alternative Medicine. 2nd ed. New York, N.Y.: Time Inc.; 2010.