your doctor is unsure about possible side effects or drug interactions, you may want to research information to share with your doctor. The following websites are good places to start:
http://www.nlm.nih.gov/medlineplus/dietarysupplements.html#cat42
U.S. National Library of Medicine and National Institutes of Health, “Medline Plus: Dietary Supplements”
http://ods.od.nih.gov/factsheets/DietarySupplements.asp
National Institutes of Health Office of Dietary Supplements, “Dietary Supplements: Background Information”
http://nccam. nih. gov/ health/bottle
National Institutes of Health National Center for Complementary and Alternative Medicine, “Get the Facts: What’s in the Bottle? An Introduction to Dietary Supplements”
http://dietarysupplements.nlm.nih.gov/dietary
National Institutes of Health and U.S. National Library of Medicine Dietary Supplements Labels Database
REGULATION OF DIETARY SUPPLEMENTS
If you believe the U.S. Food and Drug Administration (FDA) approves dietary supplements, you are not alone. A 2002 poll showed that 58 percent of Americans believe that government agencies, such as the FDA, must approve herbal products before they can be sold to the public.
However, dietary supplements do not need FDA approval. Under legislation passed in 1994, called the Dietary Supplement Health and Education Act, supplements are considered foods, not drugs. Therefore, supplements do not have to undergo the same stringent approval process as drugs. Supplement manufacturers do not have to prove the safety, quality, or efficacy of their products before they arrive on shelves.
This reclassification has resulted in serious consequences. Sometimes contaminants or substitutes have been found in products. For instance, some diabetes products have been contaminated with lead, and other products touted as being “herbal” have contained prescription drugs.
How do these dangerous lapses occur? Because of the Dietary Supplement Health and Education Act, the FDA does not routinely analyze the contents of dietary supplements for their safety or efficacy. The manufacturer—not the government—is responsible for ensuring that the label is accurate and the ingredients are safe. Indeed, the FDA would have to prove that a supplement were unsafe in order to be allowed to remove it from the market.
LABELS AND CONTENTS
Although limited in its oversight, the FDA requires manufacturers of dietary supplements to follow certain guidelines when describing their products. For example, manufacturers of dietary supplements can make claims regarding the ability to maintain “structure and function” of the body, but cannot make claims regarding diagnosis, treatment, cure, or prevention of disease. The label must include the following statement: “This statement has not been evaluated by the Food and Drug Administration (FDA). This product is not intended to diagnose, treat, cure, or prevent any disease.” The manufacturer must notify the FDA within 30 days after a product is on the market if it bears such a label.
The FDA also bans implied, as well as expressed, disease treatment claims. In other words, claims made by a manufacturer that a buyer could misconstrue as indicating treatment or prevention of a disease are no longer allowed. In new regulations, a product may make health maintenance claims but not disease treatment claims (i.e., “maintains a healthy prostate” is allowed, but “treats benign prostatic hyperplasia” is not).
The FDA requires that supplement labels (see Figure 1) contain certain information, so look for these details when you shop for products.
• Name of the product
• Name and address of the manufacturer
• Complete list of ingredients, including a “Supplement Facts” panel, which identifies each ingredient in the product. If an ingredient is not listed on the “Supplement Facts” panel, it must be listed in the “other ingredients” statement below the panel.
• Directions for use
• Net quantity of the contents
FIGURE 1.
Sample Supplement Label
Despite these requirements, the labels of dietary supplements can be confusing and misleading. A study of more than 800 bottles of popular herbs sold in retail stores found that over half the products were inconsistent in reporting benchmark ingredients and recommended daily doses.
In addition, the actual contents of products may not be reflected in the packaging. A study of the popular botanical Echinacea, which is taken to relieve cold symptoms, found numerous discrepancies in the ingredients listed on products. Ten percent of “Echinacea” products contained no measurable Echinacea.
INDEPENDENT TESTING
ORGANIZATIONS
Luckily, a handful of independent organizations accuracy Luckily, a handful of independent organizations test the accuracy of the labels and contents of dietary supplements. They offer “seals of approval” that you may want to look for when shopping for supplements. However, keep in mind that these organizations do not test the efficacy of products.
U.S. Pharmacopeia (USP) Dietary Supplement Verification Program
The “USP-verified mark” on the label indicates the label product ingredients are accurate and that the product is pure, will dissolve properly, and has been manufactured using good manufacturing practices. The USP website also lists manufacturers that have undergone the evaluation process (www.usp.org).
NSF International
Formerly known as National Sanitation Foundation, NSF International verifies the accuracy of supplement labels and contents, checks for purity and contaminants, and audits the manufacturing process for good manufacturing practice compliance (www.nsf.org).
Consumer Lab
Consumer Lab tests supplements for the accuracy and purity of their ingredients (www.consumerlab.com).
The Consumers Union
The Consumers Union also tests certain reports findings in its publication, Consumer Reports www.consumerreports.com ; subscription required for some content).
The Natural Products Association
The Natural Products Association has launched a good manufacturing practice program (www.naturalproductsassoc.org).
SIZING UP THE PRODUCT AND MANUFACTURER
It’s best to use a dietary supplement that comes in a pure, standardized
