Common Knowledge:03.How do I differentiate between the quality of botanical supplement products?Back.
This is a discussion of some of the key issues that consumers and health care professionals should consider in assessing the relative quality of a botanical supplement.
Is the extract produced using high-quality raw materials?
What measures have been taken to ensure that the botanical identity of the raw materials has been properly determined?
What procedures have been followed in the cultivation, harvesting, and processing of the raw botanical materials, in order to ensure that the raw materials have been properly cleaned, dried, and stored, and that its content and ratio of active constituents has been preserved? What steps are taken to prevent adulteration of the raw materials with other, sometimes toxic plant species?
What measures are taken to ensure that the raw materials are free of contamination by heavy metals, filth (e.g. insect parts, animal hair), pathogenic microbes, fungi, toxic herbicides, or pesticides?
Unfortunately, although all of these questions are extremely relevant to the ultimate quality of a botanical supplement, information on such questions is not easily accessible to most consumers and even most health care providers. In this situation, a consumer's best protection is to purchase products only from reputable companies. One of the chief indications of a company's reliability is their membership in the American Herbal Products Organization (AHPA). This industry trade organization, which has established stringent criteria for membership, is dedicated to the implementation of ethical and responsible standards and practices in the production, importation, manufacture, and marketing of botanical products. Companies which belong to the organization must conform to these high standards, and membership in AHPA is a good indication that one is dealing with an ethical and reputable company. Cybernauts can visit the AHPA web site.
This site includes links to member organizations who maintain a presence on the Web. Visitors to the web site can also order a membership directory, as well as other useful publications, such as the Botanical Safety Handbook (CRC Press, 1997). The cost is well worth it for anyone with a serious interest in botanical quality. Alternatively, one can also contact the manufacturer of the products of interest and inquire of their current membership in AHPA. Any company that cannot answer this question in the affirmative is probably best avoided.
A further issue related to quality control procedures followed in the manufacturing process of botanicals is related to Good Manufacturing Practices (GMP); a set of standards established by the FDA that are applicable to the manufacture of food products, pharmaceuticals, cosmetics, and medical devices. Currently, all manufactures of botanical supplements are required under FDA regulations to conform to food GMP standards. However, many botanical manufacturers have voluntarily upgraded to the far more stringent standards applied to pharmaceutical production. This trend is likely to continue as larger companies, including members of the pharmaceutical industry already accustomed to the tighter GMP standards, enter the expanding market of botanical supplements. Over time, such standards will lead to an over-all improvement in the quality of botanical supplements available in the market. The unintended consequence of this shift is that it may force smaller companies out of business if they are unable to secure the resources needed to upgrade their GMP practices to pharmaceutical standards. For further information on GMP standards in food and pharmaceutical manufacturing, visit the web site maintained by the Learning + company.
While standardization is not appropriate for all botanical supplements, it is for many since it ensures that the active constituents are present in the supplement in a defined amount. Consumers should look for a standardization statement on the label, and when afforded a choice, should purchase a standardized extract in preference to a non-standardized extract. Standardization data on the label is also evidence that GMP practices and other stringent quality control measures have been used in the manufacture of the product.
A quality botanical supplement should contain all of the label information outlined inFAQ 2. The fact that the manufacturer can supply such detailed information about the product on the label is indicative that GMP-level quality control procedures were followed in the manufacture of the product. An important caveat, however, is that labels are not always accurate. This is particularly a risk with certain imported products produced abroad, as a recent article in the New England Journal of Medicine has pointed out. A small but significant number of imported supplement products from Asia were found to be adulterated with prescription medications and other contaminants (Ko, R.J. Adulterants in Asian Patent Medicines. NEJM, vol. 339, no. 12, Sept 17, 1998). Again, the best course for the consumer is to purchase botanical supplements produced by a well-recognized, reputable manufacturer who provides detailed information on the label. If a consumer has any question about the accuracy of the information on a product label, they should not hesitate to contact the company for further information or share their questions with their pharmacist or other qualified health care professional.
Structure-function claims substantiation:
Another indication of quality is the claims that are made for the product. Under the guidelines established by DSHEA, the Dietary Supplement Health and Education Act passed by Congress in 1994, manufacturers and retailers of dietary supplements can make reasonable statements regarding the effects of their products on bodily processes and systems, as long as they do not claim to treat, diagnose or prevent any disease. Such statements are known in the industry as "structure function" claims (for a detailed look at DSHEA, go to the article elsewhere in this FAQ section entitled:DSHEA: What are the Key Provisions? Structure-function claims made under DSHEA guidelines are required to be truthful, balanced, not misleading, and based on current scientific evidence. A surprising number of botanical supplements have been well-researched, and some have been studied in clinical trials demonstrating their efficacy and safety. Manufacturers and retailers will often provide access to such information, either on request from a customer, on their web site, or in product literature. Consumers should avoid purchasing products from companies that are unable or unwilling to provide such information. In general, it is a good idea to avoid using a botanical supplement if no scientific studies exist to support its usage. Consumers should also use common sense and a healthy dose of skepticism in evaluating structure-function claims. If a claim seems too good to be true, it probably is. In such cases, the consumer should avoid using the product, or at least demand independent, reliable verification of the claims from a reputable third party source, such as a scientific study in a peer-reviewed journal.
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