Safety and Regulations
All medical treatments entail some degree of risk and CAM therapies are no different. CAM therapies can be divided into two groups when examining safety concerns and regulatory issues. The first group contains products that a patient typically uses either internally or externally. These CAM therapies, such as Echinacea capsules or colloidal silver salve, are regulated as dietary supplements in the United States. The second group of CAM therapies consists of therapeutic processes a patient undergoes with a practitioner. Examples of these CAM therapies include reiki, massage and chiropractic medicine. When therapeutic processes are regulated, it is usually by state agencies or licensing boards. There are some practitioners, such as naturopaths, which utilize dietary supplements in addition to therapeutic processes and are affected by both categories.
Most herbs, vitamins, minerals, amino acids and other “natural” substances sold over the counter are designated as “dietary supplements” in the United States (the main exception being homeopathic drugs which are regulated separately; see Homeopathy for additional information). These products are considered dietary supplements because their use is intended to “supplement” a person’s diet; because of this distinction, they are regulated as food and not as drugs.
The Dietary Supplement Health and Education Act (DSHEA) passed by the United States Congress in 1994 formally defined “dietary supplements”, outlined guidelines for literature displayed where supplements are sold, established a new framework for safety, required ingredient and nutrition labeling, provided for “use of” claims and nutritional support statements and granted the FDA authority to establish good manufacturing practice (GMP) regulations. The law also required the formation of an executive level Commission on Dietary Supplement Labels and led to the establishment of the Office of Dietary Supplements within the National Institutes of Health.
According to the this law, the dietary supplement manufacturer is responsible for ensuring that a dietary supplement is safe before it is marketed, while the FDA is responsible for taking action against a product if it appears unsafe after introduction to the market. Manufacturers do not usually need to get FDA approval prior to selling a dietary supplement nor do they need to register with the FDA. The FDA only reviews safety and efficacy data prior to allowing a new product to be sold when it contains a new dietary ingredient (i.e., those not marketed in the United States prior to October 15, 1994). However, manufacturers must ensure that their statements are not misleading and have sufficient evidence to substantiate their product claims. A product is considered unsafe when it appears to cause acute or chronic toxicity, has interactions with medications or is contaminated with pesticides, heavy metals or prescription drugs. The FDA may issue a warning or recall for such supplements.
The FDA does not monitor manufacturing practices. It is the responsibility of the manufacturer to maintain safe production procedures in accordance with GMP and ensure that the label information is accurate. Several concerns have arisen from this lack of regulation. Some herbal products, particularly those manufactured in China, may contain pesticides, heavy metals, prescription medications and other herbs that are not listed on the products’ labels. In addition, research comparing several different brands of DHEA and ginseng products have found labeling discrepancies. One study found that few dietary supplement labels correctly identified the amount of DHEA in the supplement, ranging from no or trace amounts of DHEA to 150% of the labeled amount. Another study noted that many ginseng supplements contain the incorrect species of ginseng (e.g., American ginseng rather than Siberian ginseng). To address these concerns, the National Center for Complementary and Alternative Medicine (NCCAM) has started funding Centers for Dietary Supplement Research. Four centers will conduct research on dietary supplements and investigate manufacturing procedures that enable production of purer, more standardized products.
Many people believe that dietary supplements are safe because they are sold in health food stores and are more ”natural” than conventional pharmaceuticals. However, this is not necessarily the case. Many pharmaceutical drugs were originally derived from natural, plant sources. Hence, the active ingredients in plant or herbal sources are potentially powerful medicines that may have drug-like effects in therapeutic doses. Many natural substances such as the herb Belladonna or certain mushrooms are natural and yet poisonous enough to cause acute toxicity when eaten. Even dietary supplements that appear to be relatively safe for short-term use may be dangerous when used for extended periods of time (i.e., chronic toxicity).
Each individual may have different responses to dietary supplements. Known or unknown allergies, pre-existing conditions, diseases or organ dysfunctions may make it dangerous to take certain products (e.g., cat’s claw and autoimmune diseases). Another concern is that a patient may be taking medications (prescription or over-the-counter) that have harmful interactions with certain natural products (e.g., Gingko biloba and warafin). As with many prescription and over-the-counter medications, many dietary supplements are not safe for pregnant or breastfeeding women or young children.
Little research is available on the safety of dietary supplements. Case reports, rather than clinical studies, are usually all that are available. Physicians use these case reports, combined with inferences from folk traditions and our understanding of how the dietary supplement may work, to develop a picture of the relative safety of a dietary supplement and its contraindications. Contraindications are circumstances, either illnesses, medications, etc., in which the dietary supplement should not be taken. Some contraindications are rooted in evidence, while others are speculative.
If a product demonstrates dangerous side effects or interactions, the FDA will usually issue a warning or recall.
CAM Therapies Involving Therapeutic Processes
Practitioner certification, accreditation or licensing is generally regulated by states. Many states have regulatory agencies or licensing boards for practitioners of specific types of CAM (e.g., chiropractors, massage therapists, counselors). However, most CAM practitioners are not regulated at the state level at this time. This is changing as CAM therapies gain increasing popularity and standards are sought to ensure practitioners’ competency.
Even without formal state licensing or accreditation, many practitioners have graduated from accredited institutions (e.g., chiropractic, naturopathic, or acupuncture schools) or are members of organizations that practice self-regulation (i.e., must meet certain training requirements).
The safety of CAM therapies involving therapeutic processes depends on the CAM therapy itself and on the individual CAM practitioner. Little research has been done on the safety of most CAM therapies. Nonetheless, it is advisable for a patient to examine the scientific evidence available with regard to safety of a specific CAM therapy. An oncologist or other health care professional may be able to help interpret any scientific studies or case reports that are available.
When considering a prospective practitioner, it is important to consider their knowledge, skill and experience to minimize risk. For more information on choosing a CAM practitioner, please refer to the section Using CAM Therapies.