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NIH OFFICE OF DIETARY SUPPLEMENTS

Dietary Supplements: What You Need to Know

The majority of adults in the take one or more dietary supplements either every day or occasionally. Today’s dietary supplements include , , herbals and botanicals, amino acids, enzymes, and many other products. Dietary supplements come in a variety of forms: traditional tablets, capsules, and powders, as well as drinks and energy bars. Popular supplements include vitamins D and E; minerals like and ; herbs such as and garlic; and specialty products like , , and fish oils.

The Dietary Supplement Label determine their value. The U.S. and All products labeled as a dietary supplement Administration (FDA) does not determine carry a Supplement Facts panel that lists whether dietary supplements are effective before the contents, amount of active ingredients they are marketed. per serving, and other added ingredients Safety and Risk (like fillers, binders, and flavorings). The Many supplements contain active ingredients manufacturer suggests the serving size, but you that can have strong effects in the body. Always or your care provider might decide that a be alert to the possibility of unexpected side different amount is more appropriate for you. effects, especially when taking a new product. Effectiveness Supplements are most likely to cause side If you don’t eat a nutritious variety of , effects or harm when people take them instead some supplements might help you get adequate of prescribed medicines or when people take amounts of essential . However, many supplements in combination. Some supplements can’t take the place of the variety supplements can increase the risk of bleeding of foods that are important to a healthy . or, if a person takes them before or after Good sources of information on well surgery, they can affect the person’s response include the Dietary Guidelines for Americans to anesthesia. Dietary supplements can also (http://health.gov/dietaryguidelines) and My interact with certain prescription in ways Pyramid (http://www.MyPyramid.gov). that might cause problems. Here are just a few Scientific evidence shows that some dietary examples: supplements are beneficial for overall health • K can reduce the ability of the and for managing some health conditions. For blood thinner Coumadin® to prevent example, calcium and are important blood from clotting. for keeping bones strong and reducing bone • St. John’s wort can speed the breakdown loss; folic acid decreases the risk of certain of many drugs (including birth defects; and omega-3 fatty acids from and birth control pills) and thereby fish oils might help some people with heart reduce these drugs’ effectiveness. disease. Other supplements need more study to • supplements, like vitamins NIH OFFICE OF DIETARY SUPPLEMENTS

C and E, might reduce the effectiveness of some types of Keep in Mind cancer chemotherapy. Don’t decide to take dietary supplements to treat a health condition that you have diagnosed yourself, without consulting Keep in mind that some ingredients found in dietary a health care provider. supplements are added to a growing number of foods, including • Don’t take supplements in place of, or in combination breakfast cereals and beverages. As a result, you may be getting with, prescribed without your health care more of these ingredients than you think, and more might not be provider’s approval. better. Taking more than you need is always more expensive and • Check with your health care provider about the can also raise your risk of experiencing side effects. For example, supplements you take if you are scheduled to have any type getting too much can cause headaches and of surgical procedure. damage, reduce bone strength, and cause birth defects. Excess • The term “natural” doesn’t always mean safe. A iron causes nausea and vomiting and may damage the liver and supplement’s safety depends on many things, such as its other organs. chemical makeup, how it works in the body, how it is Be cautious about taking dietary supplements if you are pregnant prepared, and the dose used. Certain herbs (for example, or nursing. Also, be careful about giving them (beyond a comfrey and ) can harm the liver. basic / product) to a child. Most dietary • Before taking a dietary supplement, ask yourself these supplements have not been well tested for safety in pregnant questions: women, nursing mothers, or children. • What are the potential health benefits of this dietary supplement product? If you suspect that you have had a serious reaction from a dietary • What are its potential benefits for me? supplement, let your health care provider know. He or she may • Does this product have any safety risks? report your experience to the FDA. You may also submit a • What is the proper dose to take? report to the FDA by calling 800-FDA-1088 or completing a • How, when, and for how long should I take it? form at http://www.fda.gov/Safety/MedWatch/HowToReport. In addition, report your reaction to the dietary supplement If you don’t know the answers to these questions, use the company by using the contact information on the product label. information sources listed in this brochure and talk to your health care providers. Quality Dietary supplements are complex products. The FDA has Talk with Your Health Care Provider established quality standards for dietary supplements to help Let your health care providers (including doctors, pharmacists, their identity, purity, strength, and composition. and ) know which dietary supplements you’re taking These standards are designed to prevent the inclusion of the so that you can discuss what’s best for your overall health. Your wrong ingredient, the addition of too much or too little of an health care provider can help you determine which supplements, ingredient, the possibility of contamination, and the improper if any, might be valuable for you. of a product. The FDA periodically Keep a record of the supplements you take in one place, just as inspects facilities that manufacture dietary supplements. you should be doing for all of your medicines. Note the specific In addition, several independent organizations offer quality product name, the dose you take, how often you take it, and the testing and allow products that pass these tests to display their reason why you use each one. You can also bring the products seals of approval. These seals of approval provide assurance that you use with you when you see your health care provider. the product was properly manufactured, contains the ingredients Federal Regulation of Dietary Supplements listed on the label, and does not contain harmful levels of Dietary supplements are products intended to supplement contaminants. These seals of approval do not guarantee that a the diet. They are not drugs and, therefore, are not intended product is safe or effective. Organizations that offer this quality to treat, diagnose, mitigate, prevent, or cure diseases. The FDA testing include: is the federal agency that oversees both dietary supplements • U.S. Pharmacopeia and medicines. • ConsumerLab.com • NSF International In general, the FDA regulations for dietary supplements are • Natural Products Association different from those for prescription or over-the-counter drugs. NIH OFFICE OF DIETARY SUPPLEMENTS

Unlike drugs, which must be approved by the FDA before they Federal Government Information Sources can be marketed, dietary supplements do not require premarket on Dietary Supplements review or approval by the FDA. While the supplement company NATIONAL INSTITUTES OF HEALTH is responsible for having evidence that their products are safe The National Institutes of Health supports research on dietary supplements. and the label claims are truthful and not misleading, they do • Office of Dietary Supplements not have to provide that evidence to the FDA before the product http://ods.od.nih.gov is marketed. The Office of Dietary Supplements provides accurate and up-to-date scientific information about dietary supplements. Dietary supplement labels may carry certain types of health- related claims. Manufacturers are permitted to say, for example, • National Center for Complementary and http://nccam.nih.gov that a dietary supplement addresses a deficiency, National Center for Complementary and Alternative Medicine supports health, or is linked to a particular body function (like Clearinghouse: immunity or heart health). Such a claim must be followed by the 1-888-644-6226 words, “This statement has not been evaluated by the Food and • National Library of Medicine Drug Administration. This product is not intended to diagnose, http://www.nlm.nih.gov treat, cure, or prevent any disease.” Medline Plus http://medlineplus.gov PubMed http://www.pubmed.gov

Manufacturers must follow certain good practices • NIH Health Information to ensure the identity, purity, strength, and composition of their http://health.nih.gov products. If the FDA finds a product to be unsafe or otherwise U.S. FOOD AND DRUG ADMINISTRATION unfit for human consumption, it may take enforcement action http://www.fda.gov/Food/DietarySupplements to remove the product from the marketplace or work with the The Food and Drug Administration issues rules and regulations and manufacturer to voluntarily recall the product. provides oversight of dietary supplement labeling, marketing, and safety.

Also, once a dietary supplement is on the market, the FDA FEDERAL TRADE COMMISSION http://www.ftc.gov monitors information on the product’s label and package insert The Federal Trade Commission polices health and safety claims made in to make sure that information about the supplement’s content is advertising for dietary supplements. accurate and that any claims made for the product are truthful U.S. DEPARTMENT OF AGRICULTURE and not misleading. The Federal Trade Commission, which http://www.nutrition.gov polices product advertising, also requires all information about a http://fnic.nal.usda.gov dietary supplement product to be truthful and not misleading. The U.S. Department of Agriculture provides information on a variety of food and nutrition topics. The federal government can take legal action against companies U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES and Web sites that sell dietary supplements when the companies http://www.healthfinder.gov make false or deceptive statements about their products, if they The U.S. Department of Health and Human Services provides an promote them as treatments or cures for diseases, or if their encyclopedia of health topics, personal health tools, and health news. products are unsafe.

Office of Dietary Supplements | 6100 Executive Boulevard | Room 3B01, MSC 7517 Bethesda, MD 20892-7517 | E-mail: [email protected] Visit our Web site for more information about ODS activities: http://ods.od.nih.gov