Herbal Certification: Does It Help Consumers?

By Linda Diane Feldt

This article was first printed in the Winter 2003 Issue of PFC Connection – the Newsletter of the People’s Food Co-op, Ann Arbor Michigan. You may copy it for personal use, but please contact the author for reprint permission which will be freely given.

It has been hundreds of years since herbs have been as popular as they are today, and used by so many people for health care. Herbal use is thousands of years old, and was the only healing choice for our ancestors. But unlike our long ago ancestors, the herbs we use today are mostly picked, processed, and packaged for us. Very few people actually grow or wildcraft what they then use for medicine.

Not only have we given over the acquisition of our herbs, our sources for herbal information have switched from wise women and local experts to TV ads and mass marketing. With such a dramatic rise in the use, production, and sale of herbs, accompanied by nearly all herbal consumers relying on small and large companies to gather and prepare their herbs, there are of course questions about potency, quality, effectiveness and safety of the herbs we use.

What is in herbal products? Are they in a form that works? Has processing affected their effectiveness? These questions remain. Even a “guarantee of potency” may not specify WHEN the herb was potent – it may have been before it was dried, before it was crushed; and the effect of capsules, extraction methods, and other common processing may not be factored in.

There is a new voluntary certification for herbal products that may address some of these concerns, but leaves many questions remaining. While drugs are regulated by the U.S. Food and Drug Administration, herbs are classified as dietary supplements, along with vitamins and minerals, and the FDA has limited jurisdiction.

Herbal products have never been an easy fit for the FDA In a brief overview of the major decisions, it is clear that very little has been done and the effects have been minimal. In the last century, herbal use was affected by the 1906 Food and Drugs Act that outlawed misbranding and adulteration. The Food Drug and Cosmetic Act of 1938 required that drugs be proven safe before being marketed to the general public, and also prohibited false and misleading labeling. In 1958 the Food Additives Amendment required that the manufacturer of any new food additive or dietary supplement must show the safety of that ingredient. An important change was in 1962 under the Kefauver-Harris Amendments: herbs were made not patentable, they were not to be considered a drug, they were no longer regulated by the FDA, and they would be confiscated if labeled as a drug.

 In 1973 the FDA proposed regulating vitamin products as drugs, but the court prevented this action. In 1993 the FDA considered removing herbs from the market. This proposal generated such an outpouring of consumer protest that the idea was dropped. However, in 1994 the Dietary Supplement Health Education Act (DSHEA) was passed. This act greatly affected how herbs were labeled and what claims manufacturers could make, but in practical terms very little else was changed. The consumer may notice a lot of products bearing the caveat that the FDA has not evaluated this herb or the statement made, and what an herb does is no longer listed on the label other than in vague and rather imprecise statements.

Dietary supplements, which include herbs and herbal products, do not have to be proven safe before they can be marketed. The FDA would be involved if claims for the herb are false or unsubstantiated, or if a company claims their herbs can cure a disease. Most of the effect of FDA involvement and regulations are to affect labels, not product content.

Within the last few years, there has been growing interest in “certifying” herbal products. This interest coincides with revelations that manufactured herbal products may contain hazardous materials including heavy metals in some traditional Chinese herbal preparations. Yellow dock root has been substituted for the more expensive Goldenseal, and other herbs tested have been found to be adulterated, or even missing.

Using the above example, while the consumer may be certain with certification that if a jar is labeled “Goldenseal” then they are indeed getting goldenseal, there is no assurance that it was harvested at the time when the root would be most potent, the potency itself is not known (which is of particular importance with the goldenseal herb), it may be processed with heat or other methods that damage the effect, and the packaging itself may not be the ideal delivery method (capsules are usually a poor delivery mechanism especially for roots). The concern that goldenseal is an endangered herb puts one more wrinkle in the whole question of what herbs to choose – a wrinkle that certification would not address.

So far, certification programs primarily examine an herbal product’s contents, confirming that “Good Manufacturing Practices” (GMP) were employed, and that the contents have not been adulterated. Because of the limits to certification there is great potential to further confuse the consumer. These certifications do not address the potency, manner of delivery, or other concerns for herbal use. A similar problem exists with the continuing widespread misunderstanding of the term “UL Approved” with electrical appliances. Underwriters Laboratory (UL) tests many products and parts for safety but the "UL Approved" seal has a limited meaning that is not meant to endorse the whole appliance and its functioning. Likewise, with herbal "certification," more credence may be given to the certifications than they deserve.

A local firm, The National Sanitation Foundation (NSF), is a front-runner among groups entering the field of dietary supplement certification. A non-profit, non-governmental organization, the NSF is already known and respected for its programs to certify drinking water systems, pool and spa equipment, processed foods, and other areas; its web site lists a number of products that have been tested and passed NSF’s standards. A press release dated Dec. 5, 2002 announces that Kmart is the first “national retail dietary supplement brand to receive NSF certification.” The NSF certification states that “NSF has tested and Certified that these products contain the identity and quantity of dietary ingredients declared on the product label and do not contain unacceptable quantities of unwanted contaminants.”

Other testing groups include ConsumerLab.com who offers the “CL Certification”, the U.S. Pharmacopeia whose Certification is “USP”, and the National Nutritional Foods Association (NNFA) TruLabel Program. In addition to these independent third party testing groups, some manufacturers have developed their own internal “certification” claims. Usually these claims are trademarked terms that describe a range of tests and assurances, such as General Nutrition Center’s “Fingerprinted”™ designation.

The third party certification programs are typically licenses to use the certification seal or mark and the explanatory statement, for which a fee has been paid. Explanations of the various standards and testing requirements are outlined on the web sites of the organizations, and some also list the products they have approved. The consumer should be aware that certification is more meaningful when it is from an independent third party; if there are follow-up requirements, time limits or a requirement for recertification; and when the testing is on random samples rather than on products supplied to the lab from the manufacturer.

While the certification programs begin to address the concerns of product content, contamination, and adulteration, the herbal user still has many other concerns. Most consumers rely on the manufacturer to know what part of the plant is harvested and in what season. How the plant is processed or preserved is critical to whether it will be effective. While some plants are potent only while fresh, others are most effective when dried which allows the cell walls to be better penetrated. The delivery mechanism – capsule, tincture, salve, infusion, etc. – matters with each type of herb and affects how the herb will be utilized by the body for healing and/or nutrition. Ethical harvesting of plants should also be of concern to the consumer, so that the environment and the future supply of the herb are preserved. Herbal fads have the potential to actually endanger popular plants and damage their surrounding environment.

For the consumer, investigating individual herb companies for their reputation, herbal knowledge, environmental commitment, and how they prepare their products remains almost the only way to ensure good quality at all levels. Of course, the option still remains to grow and harvest your own herbs. It is indeed a time for the consumer to beware. Now that herbs are more popular and profitable, it seems that everyone wants a piece of the pie that is the consumer dollar. Being good at marketing, packaging and advertising is no recommendation for herbal knowledge, and not all Echinacea products are the same!

Based on advertising campaigns and work to promote the certification of herbs, consumers may begin to look for and even demand a “seal of approval” on their herbal products. However, many high quality herbs from reputable companies will not have these certification seals. The greater expense involved in certification for each product or label addresses only a small fraction of the concerns about herbal safety and effectiveness. Many companies will choose to forgo the additional expense, not because their products are inferior, but because the certification is limited in what it signifies. However, with the lesser known companies, or if the herbal supplier is questionable, the certification process may be important in ensuring that you are purchasing the herb or herbs listed on the label

Your Co-op supports and buys from businesses that have proven their knowledge in the herbal field, and have a long history of being trustworthy in product quality and content. While the Co-op may have done some of the initial work for you, that in no way means that your own education and knowledge aren’t essential in ensuring you are buying good products, the right products, and in the form that will work best for you.

Recommended Web sites:

U.S. Pharmacopeia: www.usp.org

National Sanitation Foundation: www.NSF.org

ConsumerLab.com: www.consumerlab.com

National Nutritional Foods Association: www.nnfa.org

Linda Diane Feldt is a Holistic Health Practitioner and Herbalist who has had a full-time private practice in Ann Arbor for 22 years. She is the author of Dying Again: Thirteen Years of Writing and Waiting and Massage: Learning to Give and Receive. Her cookbook on dark green leafy vegetables will be available by spring of 2003.