by Mark Hall
Published April 21 2001
Standardization is a complex and controversial topic. For some, standardized means a product is manufactured to ensure that a given marker compound(s) meets a specified level. To others, it is a consistent manufacturing process. For still others, it is a specified ratio of herb material to solvent or a specified amount of herb in a dosage unit. In its broadest (and increasingly popular) sense, standardization refers to the control and manipulation of every aspect of the agricultural and manufacturing process, and beyond, to ensure a consistent product. [For more on this broad interpretation, please refer to the American Herbal Product Association’s (AHPA) industry guidelines on standardization on page 48 of this issue.] Beyond an individual company’s agricultural and/or manufacturing processes, standardization extends to industry-wide acceptance of standardized:
- Common names of herbs sold in the marketplace. (Federal regulations now require use of standardized common names as listed in the 1992 edition of Herbs of Commerce.)
- Safety labeling for commercial herb products.
- Validated analytical methods to test products.
Members of the herb community debate the use of the term “standardized” in relation to the labeling of herbal products. Some recognized authorities have suggested that consumers and health professionals should use only standardized herbal preparations. Media stories frequently recommend that consumers look for “standardized herbs” to ensure proper quality.
Yet, many traditional herbalists decry standardized herbal products for allegedly lacking essential components that affect the biological activity of the herb. Some worry that standardization is tantamount to the “chemicalization” or “pharmaceuticalization” of the herbal tradition. They argue that herbs have been effective for millennia without chemical standardization.
GEP Standardized Phase Report Limitations
In the Standardized Phase of the Ginseng Evaluation Program (GEP), we focus on 13 commercial ginseng products that in some way utilized the term “standardized” on their label or claimed to contain a specified level of ginsenosides. We recognize that some readers may construe the publication of the Standardized Phase report to mean that the American Botanical Council is promoting the use of standardized herb products over, or to the exclusion of, raw herb or non-standardized herb products. This simply is not the case, and in this regard, we concur with Francis Brinker, N.D.:
“Each different type or form of plant product has its own advantages and limitations in the context of therapeutic effects, and in individual use and acceptance. The value in variety is that it allows practitioners and consumers to accommodate their needs best. Such variety should not be construed as a problem, since variations offer practical advantages for individuals with different needs.”
Products in the Standardized Phase of the GEP were purchased from 1993 through 1998. These products may or may not be available in the marketplace at this time. If they are available, their contents and/or label claims may or may not have changed. The Standardized Phase report is different from the so-called “test and tell” studies that have garnered considerable media attention in the past few years. Those reports usually test a relatively small range of products (about one or two dozen, at most) and usually are based on a single sample of each brand, although some may employ more than one sample. The Standardized Phase report covers 13 brands of standardized Asian ginseng products, and tested five lots of each. Thus, one of the unique aspects and strengths of this paper is that it reports on the consistency of five lots of the same product over an extended period of time.
The GEP scientific team has made several recommendations to members of the herb industry regarding the labeling of standardized products. One primary recommendation is that ginsenoside content of ginseng products be labeled in milligrams per dosage unit rather than as a percentage of the extract or root powder. In making this recommendation, the GEP team recognizes that this may appear to support a situation in the marketplace where manufacturers and consumers inappropriately focus on marker compounds. The authors also recognize that the primary active ingredients of many herbs have not been identified and, consequently, focusing on the known active and/or marker compounds as standardization targets may result in a “reductionistic” view that the herb’s activity and benefits depend solely on that compound(s). While we recognize that standardization, in its broadest sense, is a process that has, and should, become firmly entrenched in the development and manufacture of modern herbal preparations, we also realize that the activity of many herbs depends upon the multiple chemical components and their synergistic and/or antagonistic interplay. Therefore, we see the various types of standardization, defined in the broadest terms, as necessary and useful tools for ensuring the quality and safety of standardized as well as raw and non-standardized herbal products.
- Eisner S, managing editor. Guidance for Manufacture and Sale of Bulk Botanical Extracts. Botanical Extracts Committee, American Herbal Products Association; 2001.
- McGuffin M, Kartesz JT, Leung AY, Tucker AO, editors. Herbs of Commerce, 2nd ed. Bethesda, MD: American Herbal Products Association, 2000.
- 21 C.F.R. §§ 101.4(h)(1)–(2).
- Foster S, editor. Herbs of Commerce. Austin, TX: American Herbal Products Association; 1992.
- McGuffin M, Hobbs C, Upton R, Goldberg A. American Herbal Product Association’s Botanical Safety Handbook. Boca Raton, FL: CRC Press, 1997.
- McGuffin M. Analyzing Herbal Materials: Current Status of Methods Validation.(forthcoming).
- Hellmich N. Medicine Catches Up to “Honest Herbal” Expert. USA Today. 1997 Oct 23:10D.
- Patterson E. Standardized Extracts: Herbal Medicine of the Future? Herb Market Review. 1996:37-8.
- Minter C. Standardising of Herbal Medicine [letter]. J Austr Traditional Medicine Soc. 1997 June;3(2):71.
- Brinker F. Variations in effective botanical products: The case for diversity of forms for herbal preparations as supported by scientific studies. 1999:46;36-50.