I see the word "natural" on a lot of supplement labels. Does "natural" always mean "safe"?
There are many supplements, as well as many prescription drugs, that come from natural sources and are both useful and safe. However, "natural" does not always mean "safe" or "without harmful effects." For example, consider mushrooms that grow in the wild--some are safe to eat, while others are poisonous.
The FDA issues warnings about supplements that pose risks to consumers, including those used for CAM therapies. Examples include kava, comfrey, and ephedra. The FDA found these products of concern because they:
1. Could damage health--in some cases severely.
2. Were contaminated--with other unlabeled herbs, pesticides, heavy metals, or prescription drugs.
3. Interacted dangerously with prescription drugs.
Does the Federal Government regulate supplements?
Yes, the Federal Government regulates supplements through the FDA. Currently, the FDA regulates supplements as foods rather than drugs. In general, the laws about putting foods (including supplements) on the market and keeping them on the market are less strict than the laws for drugs. Specifically:
- Research studies in people to prove a supplement's safety are not required before the supplement is marketed, unlike for drugs.
- The manufacturer does not have to prove that the supplement is effective, unlike for drugs. The manufacturer can say that the product addresses a nutrient deficiency, supports health, or reduces the risk of developing a health problem, if that is true. If the manufacturer does make a claim, it must be followed by the statement "This statement has not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease."
- The manufacturer does not have to prove supplement quality. Specifically:
- The FDA does not analyze the content of dietary supplements.
- In addition, at this time, supplement manufacturers must meet the requirements of the FDA's Good Manufacturing Practices (GMPs) for foods. GMPs describe conditions under which products must be prepared, packed, and stored. Food GMPs do not always cover all issues of supplement quality. Some manufacturers voluntarily follow the FDA's GMPs for drugs, which are stricter.
- Some manufacturers use the term "standardized" to describe efforts to make their products consistent. However, U.S. law does not define standardization. Therefore, the use of this term (or similar terms such as "verified" or "certified") does not guarantee product quality or consistency.
- The FDA does not analyze the content of dietary supplements.
- If the FDA finds a supplement to be unsafe once it is on the market, only then can it take action against the manufacturer and/or distributor, such as by issuing a warning or requiring the product to be removed from the marketplace.
What's in the Bottle Does Not Always Match What's on the Label
A supplement might:
- Not contain the correct ingredient (plant species). For example, one study that analyzed 59 preparations of echinacea found that about half did not contain the species listed on the label.
- Contain higher or lower amounts of the active ingredient. For example, an NCCAM-funded study of ginseng products found that most contained less than half the amount of ginseng listed on their labels.
- Be contaminated
Is NCCAM supporting research on supplements?
Yes, NCCAM is funding most of the nation's current research aimed at increasing scientific knowledge about supplements--including whether they work; if so, how they work; and how purer and more standardized products could be developed. Among the substances that researchers are studying are:
- Yeast-fermented rice, to see if it can lower cholesterol levels in the blood
- Soy, to see if it slows the growth of tumors
- Ginger and turmeric, to see if they can reduce inflammation associated with arthritis and asthma
- Chromium, to better understand its biological effects and impact upon insulin in the body, possibly offering new pathways to treating type 2 diabetes
- Green tea, to find out if it can prevent heart disease
Source
NCCAM Clearinghouse Toll-free in the U.S.: 1-888-644-6226 International: 301-519-3153 TTY (for deaf or hard-of-hearing callers): 1-866-464-3615 E-mail: info@nccam.nih.gov NCCAM Web site: nccam.nih.gov Address: NCCAM Clearinghouse, P.O. Box 7923, Gaithersburg, MD 20898-7923
