Reading a Dietary Supplement Label
The food and drug administration (FDA), as well as health professionals and their organizations, receive many inquiries each year from consumers seeking health-related information about dietary supplements. Clearly, people choosing to supplement their diets with herbs, vitamins, minerals, or other substances want to know more about the products they choose so that they can make informed decisions.
In response to new legislation, dietary supplement labels have changed over the past several years.
Supplement Labeling
Ingredients. Like other foods, dietary supplement products must bear ingredient labeling. This information must include the name and quantity of each dietary ingredient, or for proprietary blends, the total quantity (by weight) of all dietary ingredients in the blend.
Labeling of products containing herbal and botanical ingredients must state the part of the plant from which the ingredient is derived (i.e., root, stem, leaves). Although many herbal products list the binomial name of the herb, herbal supplements are not required to do so. Because it is important to use the same products that have been tested and shown effective in clinical trials, this information can be very important in distinguishing between similarly named products that may have very different effects. Ginseng products offer a good example of this possible confusion: Which ginseng product should you purchase: Panax ginseng (Asian ginseng) or Panax quinquefolius (American ginseng)?
Supplement Facts. Dietary supplements also are required to include facts about the nutritional content of the product. This information can be found in the "Supplement Facts" box on the label. All ingredients that are present (except inert ingredients) in the product must be listed in this box; ingredients for which the FDA has established a daily consumption recommendation must include the percent daily value they provide.
Claims and Disclaimers. Under the Dietary Supplement and Health Education Act of 1994 (DSHEA) dietary supplement manufacturers can make three types of claims about their products: health claims, structure/function claims, and nutrient content claims.
Health claims describe a relationship between a food substance and a disease or health-related condition. "Diets high in calcium may reduce the risk of osteoporosis" is an example of a health claim. Examples of authorized health claim statements can be found at: www.cfsan.fda.gov/~dms/flg-6c.html.
DSHEA created the structure/function category of claims. These statements may claim a benefit related to a nutrient deficiency disease (e.g., vitamin C and scurvy), as long as the statement also tells how widespread such a disease is in the United States. Structure/function claims also may describe the role of a nutrient or dietary ingredient intended to affect a structure or function in humans (e.g., "calcium builds strong bones"). In addition, they may characterize the means by which a nutrient or dietary ingredient acts to maintain such structure or function (e.g., "fiber maintains bowel regularity" or "antioxidants maintain cell integrity") or they may describe general well-being from consumption of a nutrient or dietary ingredient.
The manufacturer is responsible for ensuring the accuracy and truthfulness of these claims; they are not approved by the FDA. For this reason, dietary supplement labels that include such a claim must state in a disclaimer that the FDA has not evaluated the claim. The disclaimer also must state that the dietary supplement product is not intended to "diagnose, treat, cure, or prevent any disease" only a drug can legally make such a claim.
Foods and dietary supplements also can use nutrient content claims. These claims describe the level of a nutrient or dietary substance in the product, using terms such as "good source," "high," or "free." Nutrient content claims may only be made if the FDA has a regulation specifying the criteria that a food must meet in order to use the claim. With few exceptions, nutrient content claims can be made only for nutrients or dietary substances that have an established daily value. The requirements that govern the use of nutrient content claims help ensure that descriptive terms, such as "high" or "low," are used consistently for all types of food products and are meaningful to consumers.
For more information about structure/function and nutrient content claims, go to www.cfsan.fda.gov/~dms/ ds-labl.html.
Manufacturer’s Information. Manufacturers of dietary supplements are required to include their address and telephone number in the labeling. If you cannot tell whether the product you are purchasing meets the same standards as those used in research studies you read about, contact the manufacturer. It is the manufacturer’s responsibility to determine that the supplement it produces or distributes is safe and that there is substantiated evidence that the label claims are truthful and not misleading.
Source: Food and Drug Administration. Available at: www.cfsan.fda.gov/~dms/supplmnt.html.
How to Identify a Problem and What to Do
Dietary supplements may not be risk-free under certain circumstances. If you are pregnant, nursing a baby, or have a chronic medical condition, such as diabetes, hypertension, or heart disease, be sure to consult your doctor or pharmacist before purchasing or taking any supplement. Although vitamin and mineral supplements are widely used and generally considered safe for children, you may wish to check with your doctor or pharmacist before giving these or any other dietary supplements to your child.
If you plan to use a dietary supplement in place of drugs or in combination with any drug, tell your health care provider first. Many supplements contain active ingredients that have strong biological effects and their safety is not always assured in all users. If you have certain health conditions and take these products, you may be placing yourself at risk.
Under certain circumstances, taking a combination of supplements or using these products together with medications (whether prescription or over-the-counter [OTC] drugs) could produce adverse effects, some of which could be life-threatening.
Be alert to advisories about these products, whether taken alone or in combination. For example: Coumadin (a prescription medicine), Ginkgo biloba (an herbal supplement), aspirin (an OTC drug) and vitamin E (a vitamin supplement) can each thin the blood, and taking any of these products together can increase the potential for internal bleeding. Combining St. John's wort with certain HIV drugs significantly reduces their effectiveness. St. John's wort also may reduce the effectiveness of prescription drugs for heart disease, depression, seizures, and certain cancers, and oral contraceptives.
It is important to fully inform your doctor about the vitamins, minerals, herbs, or any other supplements you are taking, especially before elective surgery. You may be asked to stop taking these products at least 2-3 weeks ahead of the procedure to avoid potentially dangerous supplement/drug interactions—such as changes in heart rate, blood pressure, and increased bleeding—that could adversely affect the outcome of your surgery.
You, your health care provider, or anyone may report a serious adverse event or illness directly to the FDA if you believe it is related to the use of any dietary supplement product, by phone (800) FDA-1088, fax at (800) FDA-0178, or on-line at: www.fda.gov/medwatch/how.htm.
FDA would like to know whenever you think a product caused serious problem, even if you are not sure that the product was the cause, and even if you did not visit a doctor or clinic.
Source: Food and Drug Administration. Available at: www.cfsan.fda.gov/~dms/ds-savvy.html.
Reading a dietary supplement label. Altern Med Alert 2002;5(suppl):S1-S2.You have reached your article limit for the month. Subscribe now to access this article plus other member-only content.
- Award-winning Medical Content
- Latest Advances & Development in Medicine
- Unbiased Content