The past few years have witnessed a dramatic increase in the use of herbal products as well as other methods associated with alternative and complementary medicine. What has fueled this shift toward herbal and nutritional supplements? Many patients view herbal products as offering a gentler, more natural form of therapy with fewer side effects. While this may be true for some supplements, the side effects of many herbal products have simply not been publicized adequately. In addition, the use of herbal products also puts the patient in control of his treatment, since most do not require prescriptions.
As the American public turned their attention to natural products, the political and legal environment also began to change. One key event was the passage by Congress of a major new law governing the marketing and sale of these products. This law, called the Dietary Supplement Health and Education Act of 1994 (Public Law No:103-417)10 (full text of legislation can be found at http://thomas.loc.gov), represents the result of a debate dating back to the early 1960s, between the Food and Drug Administration (FDA) and parties seeking to provide Americans with less restricted access to supplements.
Key aspects of the Act represent a different philosophy than that which had dominated the FDA:
2. 'Healthful diets may mitigate the need for expensive medical procedures, such as coronary bypass surgery or angioplasty'.
3. 'Preventive health measures, including education, good nutrition, and appropriate use of safe nutritional supplements will limit the incidence of chronic diseases, and reduce long-term health expenditures'.
4. 'There is a growing need for emphasis on the dissemination of information linking nutrition and long-term health'.
5. 'Consumers should be empowered to make choices about preventative health care programs based on data from scientific studies on health benefits related to particular dietary supplements'.
6. 'Studies indicate that consumers are placing increasing reliance on the use of nontraditional health care providers to avoid the excessive costs of traditional medical services and to obtain more holistic considerations of their needs'.
7. 'Dietary supplements are safe within a broad range of intake, and safety problems with supplements are relatively rare'.
8. 'Legislative action that protects the right of access of consumers to safe dietary supplements is necessary in order to promote wellness'.
This Act declared dietary supplements were neither foods nor drugs. Instead, they created a new category of food by specifically defining dietary supplements to include dietary ingredients, such as vitamins, minerals, herbs or other botanicals, amino acids or other dietary supplements. A dietary supplement must be intended for ingestion, such as a tablet, capsule, powder, softgel, gelcap or liquid form. The Act also specifically states that customers can be provided with publications on supplements in connection with the sale of the dietary supplements. These publications must not be false or misleading, not promote a specific brand of supplement, and provide a balanced view of the available scientific literature. In the store, it must be physically separated from the supplement. The Act allowed supplements to carry claims that they help preserve general well-being. Additionally, they can claim that they help preserve the structure or function of parts of the body. However, they can not state that the supplements are effective treatment of disease, because this would be a drug claim. This section of the Act has been the subject of discussion and litigation between the FDA and representatives of the supplement industry.
The Act specifically empowers the FDA to oversee quality control of supplements and they are given the power to remove unsafe supplements from the market. In practice, this process has not worked very well. The plain fact is that the quality of supplements on the market is very variable. Studies have shown that supplements from some manufacturers can contain 25% or less of the active ingredient than stated on the label (www.consumerlabs.com). It also appears that supplements on the market are not adequately monitored for hazardous contaminants (www.consumerlabs.com). Therefore, it would appear that there is a need for increased supervision of the supplement industry to ensure Americans of the potency and safety of the supplements they purchase. While we wait for these changes, there are some promising trends. Several major pharmaceutical firms have purchased supplement companies and this promises improvement in quality control and standardization. Additionally, several major supplement manufacturers are funding clinical trials that specifically document the value and side effects of their herbal extracts.
In summary, there is no doubt that Americans now have much greater access to nutritional or herbal supplements as a result of this Act. Additionally, Americans have much greater access to literature on nutritional and herbal supplements. However, these supplements range radically in their value. Among these supplements are therapeutic agents with a strong scientific basis and proven clinical value. Most of these lack FDA approval because no company has been willing to take them through the expensive process the FDA mandates. In contrast, other herbal products have no scientific basis, no sound clinical trial documentation of efficacy and may pose serious health risks.
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