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
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.
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
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.
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.”
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.
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
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!
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
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.