This non-bylined article appeared in a professional publication for chiropractors. The author presents a discussion of quality issues in the dietary supplement field that interests consumers, chiropractors, and other health care practitioners who are concerned about consistent quality and effectiveness of products they use or offer to clients.

How an herb or botanical is harvested, how it is processed, and when and if it is tested for purity can make a major difference in the quality and effectiveness of a preparation from product to product. Unlike manufacturers of pharmaceuticals, U.S. supplement producers have no set national guidelines to follow. Draft guidelines proposed in 1997 for Good Manufacturing Practices (GMPs) by the Food and Drug Administration (FDA) under the mandate of the Dietary Supplement Health and Education Act (DSHEA) of 1994 will probably not go into effect for another year or two. [The proposed GMPs were developed by major trade associations in the herb and supplement industries, working with the FDA.]

Mark Blumenthal, founder and executive director of the American Botanical Council and editor of HerbalGram and HerbClip, points out that many supplement manufacturers already have GMPs in place, some of which meet or exceed the FDA proposal. The industry has not resisted quality control. "People realize it's good business," Blumenthal says.

Industry-wide, the National Nutritional Foods Association (NNFA), representing more than 4,000 health food and natural products businesses, has developed its own set of GMPs and a certification program to verify compliance. Based on third-party inspection and audits of personnel, plant and grounds, sanitation, equipment, quality control, production and process controls, warehouse and post-distribution practices, those who pass inspection may use the NNFA seal to promote their products. Jill Ellis, NNFA's former director of science and quality assurance, comments, "We want supplements to be safe, reproducible, efficacious, affordable, and accessible."

Supplement quality is the responsibility of manufacturers, and comes down to purity of ingredients. The recent growth of herbal and botanical products contributes to this problem, as manufacturers' level of experience may vary greatly. One problem is misidentification of species. Blumenthal points out that misidentification may occur when, for instance, inexperienced harvesters are used. Many botanicals are very similar in appearance, for example, skullcap and germander. Germander (Teucrium chamaedrys) has sometimes been accidentally included in scullcap (Scutellaria lateriflora) formulations, resulting in adverse side effects.

Very popular herbs may also be adulterated, says John Cardellina, Ph.D., vice president of botanical science for the Council on Responsible Nutrition (CRN), a trade group representing about 100 supplement manufacturers. When supply of an herb is low, unscrupulous manufacturers may try to keep up with demand by substituting other species of the same genus, adding similar-looking plants, or even using a different part of the plant than is traditionally believed to achieve the desired results.

Large, established manufacturers such as Celestial Seasonings and Nature's Way are said in this article to grow their own botanicals, but, in fact, many of these companies actgually contract with growers instead. Much of the industry relies on outside suppliers. Some growers offer a certificate of authenticity [sic] (CA), but Blumenthal points out that a CA is not a guarantee. [Actually it's called a "CofA"-Certificate of Analysis.] "A lot of human error accounts for a lot of safety issues," adds Ellis. The possibility of mistakes or substitutions makes it imperative for manufacturers to test ingredients upon arrival.

While use of outside labs to test raw materials is one option, mistakes can still be made. Many manufacturers are taking testing in-house. The FDA has hosted seminars on herbal microscopic standards, cell structure, and analysis of herbal powders for industry personnel.

According to this article, consumers, and doctors of chiropractic who sell supplements, should beware of the following "red flags":

1. Standardized formulas. Claims for "standardization" can be misleading. Without recognized, industry-wide standards, methods of standardization vary greatly, along with results. [Again, the supplement industry is ahead of regulators; about 29 companies have joined together as the Institute for Neutraceutical Advancement to develop the Methods Validation Program, chemical analysis standards to which everyone can agree.]

2. Inflated claims. If it sounds "too good to be true"; it probably is.

3. Brand name recognition. "Experience begets quality", Ellis suggests. Company specialization can also give a clue about certain products.

4. Pharmaceutical manufacturers. Making over-the-counter or prescription drugs and making supplements are very different processes. Excellence in one may not necessarily give an edge in the other.

5. Seals of Approval. Label endorsement by a respectable trade group, such as NNFA, can help decide which supplement to choose. Another good label to look for is "USP", for U.S. Pharmacopeia. USP has standards for nine botanicals in place so far, with more to come. [The USP symbol refers to standards established for raw materials, not finished products.]

6. Testing. Try to find brands that have done their own testing rather than relying on test claims of others.

7. Single herbs. Buy herbal and botanical products with just one herbal ingredient. With more than one ingredient, chances increase that the dosage of one may be inadequate. [This last recommendation is surely a bit controversial and subject to much debate. Even the Commission E has approved herbal combination products as effective nonprescription medicines in Germany.]

Consumers, chiropractors and others must make their own determination if a particular supplement manufacturer is quality conscious. The article concludes with a list of suggested questions to ask manufacturers, regarding GMPs, testing, quality assurance programs, and trade group membership. A sidebar anticipates HerbalGram's upcoming release of its six-year, $800,000 independent study comparing the purity of more than 400 different ginseng products, saying the impending results have the supplement industry "on the edge of its seat". - Mariann Garner-Wizard

Enclosure: Copyright( 1999, Journal of the American Chiropractic Association and the

American Chiropractic Association (www.amerchiro.org) , reprinted with permission. Bin #165