Herbal Supplements: Consider Safety, Too

Introduction

Herbal supplements are a type of dietary supplement that contains herbs, either singly or in mixtures. An herb (also called a botanical) is a plant or plant part used for its scent, flavor, and/or therapeutic properties.

Many herbs have a long history of use and of claimed health benefits. However, some herbs have caused health problems for users. This fact sheet contains points you should consider for your safety if you use, or are thinking about using, herbs for health purposes. It does not discuss whether herbs work for specific diseases and conditions. To find out more about topics and resources mentioned in this fact sheet, see "For More Information".

1. It's important to know that just because an herbal supplement is labeled "natural" does not mean it is safe or without any harmful effects. For example, the herbs kava and comfrey have been linked to serious liver damage.



2. Herbal supplements can act in the same way as drugs. Therefore, they can cause medical problems if not used correctly or if taken in large amounts. In some cases, people have experienced negative effects even though they followed the instructions on a supplement label.



3. Women who are pregnant or nursing should be especially cautious about using herbal supplements, since these products can act like drugs. This caution also applies to treating children with herbal supplements.



4. It is important to consult your health care provider before using an herbal supplement, especially if you are taking any medications (whether prescription or over-the-counter). Some herbal supplements are known to interact with medications in ways that cause health problems. Even if your provider does not know about a particular supplement, he can access the latest medical guidance on its uses, risks, and interactions.



5. If you use herbal supplements, it is best to do so under the guidance of a medical professional who has been properly trained in herbal medicine. This is especially important for herbs that are part of a whole medical system, such as traditional Chinese medicine or Ayurvedic medicine.



6. In the United States, herbal and other dietary supplements are regulated by the U.S. Food and Drug Administration (FDA) as foods. This means that they do not have to meet the same standards as drugs and over-the-counter medications for proof of safety, effectiveness, and what the FDA calls Good Manufacturing Practices.




About Dietary Supplements Dietary supplements were defined in a law passed by Congress in 1994. A dietary supplement must meet all of the following conditions: It is a product (other than tobacco) intended to supplement the diet, which contains one or more of the following: vitamins; minerals; herbs or other botanicals; amino acids; or any combination of the above ingredients. It is intended to be taken in tablet, capsule, powder, softgel, gelcap, or liquid form. It is not represented for use as a conventional food or as a sole item of a meal or the diet. It is labeled as being a dietary supplement.



7. The active ingredient(s) in many herbs and herbal supplements are not known. There may be dozens, even hundreds, of such compounds in an herbal supplement. Scientists are currently working to identify these ingredients and analyze products, using sophisticated technology. Identifying the active ingredients in herbs and understanding how herbs affect the body are important research areas for the National Center for Complementary and Alternative Medicine (NCCAM).



8. Published analyses of herbal supplements have found differences between what's listed on the label and what's in the bottle. This means that you may be taking less--or more--of the supplement than what the label indicates. Also, the word "standardized" on a product label is no guarantee of higher product quality, since in the United States there is no legal definition of "standardized" (or "certified" or "verified") for supplements.



9. Some herbal supplements have been found to be contaminated with metals, unlabeled prescription drugs, microorganisms, or other substances.



10. There has been an increase in the number of Web sites that sell and promote herbal supplements on the Internet. The Federal Government has taken legal action against a number of company sites because they have been shown to contain incorrect statements and to be deceptive to consumers. It is important to know how to evaluate the claims that are made for supplements. Some sources are listed below.

Source: http://nccam.nih.gov

Botanical Dietary Supplements ......

What methods are used to evaluate the health benefits and safety of a botanical dietary supplement? Scientists use several approaches to evaluate botanical dietary supplements for their potential health benefits and safety risks, including their history of use and laboratory studies using cell or animal studies. Studies involving people (individual case reports, observational studies, and clinical trials) can provide information that is relevant to how botanical dietary supplements are used. Researchers may conduct a systematic review to summarize and evaluate a group of clinical trials that meet certain criteria. A meta-analysis is a review that includes a statistical analysis of data combined from many studies. What are some additional sources of information on botanical dietary supplements? Medical libraries are one source of information about botanical dietary supplements. Others include Web-based resources such as PubMed (http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?holding=nih) and FDA (http://www.cfsan.fda.gov/~dms/ds-info.html). For general information about dietary supplements see Dietary Supplements: Background Information (http://ods.od.nih.gov/factsheets/dietarysupplements.asp) from the Office of Dietary Supplements (ODS), available at ods.od.nih.gov.		About ODS General Safety Advisory Disclaimer Print-friendly version Posted Date: 6/21/2003 Updated: 4/11/2006 2:59 PM
Disclaimer Reasonable care has been taken in preparing this fact sheet and the information provided herein is believed to be accurate. However, this information is not intended to constitute an "authoritative statement" under Food and Drug Administration rules and regulations. About ODS The mission of the Office of Dietary Supplements (ODS) is to strengthen knowledge and understanding of dietary supplements by evaluating scientific information, stimulating and supporting research, disseminating research results, and educating the public to foster an enhanced quality of life and health for the U.S. population. General Safety Advisory The information in this document does not replace medical advice. Before taking an herb or a botanical, consult a doctor or other health care provider-especially if you have a disease or medical condition, take any medications, are pregnant or nursing, or are planning to have an operation. Before treating a child with an herb or a botanical, consult with a doctor or other health care provider. Like drugs, herbal or botanical preparations have chemical and biological activity. They may have side effects. They may interact with certain medications. These interactions can cause problems and can even be dangerous. If you have any unexpected reactions to an herbal or a botanical preparation, inform your doctor or other health care provider.

Does a label indicate the quality of a botanical dietary supplement product?

It is difficult to determine the quality of a botanical dietary supplement product from its label. The degree of quality control depends on the manufacturer, the supplier, and others in the production process.

FDA is authorized to issue Good Manufacturing Practice (GMP) regulations describing conditions under which dietary supplements must be prepared, packed, and stored. FDA published a proposed rule in March 2003 that is intended to ensure that manufacturing practices will result in an unadulterated dietary supplement and that dietary supplements are accurately labeled. Until this proposed rule is finalized, dietary supplements must comply with food GMPs, which are primarily concerned with safety and sanitation rather than dietary supplement quality. Some manufacturers voluntarily follow drug GMPs, which are more rigorous, and some organizations that represent the dietary supplement industry have developed unofficial GMPs.

Are botanical dietary supplements safe?

Many people believe that products labeled "natural" are safe and good for them. This is not necessarily true because the safety of a botanical depends on many things, such as its chemical makeup, how it works in the body, how it is prepared, and the dose used.

The action of botanicals range from mild to powerful (potent). A botanical with mild action may have subtle effects. Chamomile and peppermint, both mild botanicals, are usually taken as teas to aid digestion and are generally considered safe for self-administration. Some mild botanicals may have to be taken for weeks or months before their full effects are achieved. For example, valerian may be effective as a sleep aid after 14 days of use but it is rarely effective after just one dose. In contrast a powerful botanical produces a fast result. Kava, as one example, is reported to have an immediate and powerful action affecting anxiety and muscle relaxation.

The dose and form of a botanical preparation also play important roles in its safety. Teas, tinctures, and extracts have different strengths. The same amount of a botanical may be contained in a cup of tea, a few teaspoons of tincture, or an even smaller quantity of an extract. Also, different preparations vary in the relative amounts and concentrations of chemical removed from the whole botanical. For example, peppermint tea is generally considered safe to drink but peppermint oil is much more concentrated and can be toxic if used incorrectly. It is important to follow the manufacturer's suggested directions for using a botanical and not exceed the recommended dose without the advice of a health care provider.

Are botanical dietary supplements standardized?

Standardization is a process that manufacturers may use to ensure batch-to-batch consistency of their products. In some cases, standardization involves identifying specific chemicals (also known as markers) that can be used to manufacture a consistent product. The standardization process can also provide a measure of quality control.

Dietary supplements are not required to be standardized in the United States. In fact, no legal or regulatory definition exists for standardization in the United States as it applies to botanical dietary supplements. Because of this, the term "standardization" may mean many different things. Some manufacturers use the term standardization incorrectly to refer to uniform manufacturing practices; following a recipe is not sufficient for a product to be called standardized. Therefore, the presence of the word "standardized" on a supplement label does not necessarily indicate product quality.

Ideally, the chemical markers chosen for standardization would also be the compounds that are responsible for a botanical's effect in the body. In this way, each lot of the product would have a consistent health effect. However, the components responsible for the effects of most botanicals have not been identified or clearly defined. For example, the sennosides in the botanical senna are known to be responsible for the laxative effect of the plant, but many compounds may be responsible for valerian's relaxing effect.

Can botanicals be dietary supplements?

To be classified as a dietary supplement, a botanical must meet the definition given below. Many botanical preparations meet the definition.

As defined by Congress in the Dietary Supplement Health and Education Act (http://www.fda.gov/opacom/laws/dshea.html#sec3), which became law in 1994, a dietary supplement is a product (other than tobacco) that

• is intended to supplement the diet;
• contains one or more dietary ingredients (including vitamins; minerals; herbs or other botanicals; amino acids; and other substances) or their constituents;
• is intended to be taken by mouth as a pill, capsule, tablet, or liquid; and
• is labeled on the front panel as being a dietary supplement.

Source: http://ods.od.nih.gov

What is Botanical?

A botanical is a plant or plant part valued for its medicinal or therapeutic properties, flavor, and/or scent. Herbs are a subset of botanicals. Products made from botanicals that are used to maintain or improve health may be called herbal products, botanical products, or phytomedicines.

In naming botanicals, botanists use a Latin name made up of the genus and species of the plant. Under this system the botanical black cohosh is known as Actaea racemosa L., where "L" stands for Linneaus, who first described the type of plant specimen. In the Office of Dietary Supplements (ODS) fact sheets, we do not include such initials because they do not appear on most products used by consumers.