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In 2011, the nonprofit American Herbal Pharmacopoeia (AHP) produced new
monograph standards and therapeutic compendia for American ginseng root (Panax quinquefolius) and slippery elm inner bark (Ulmus rubra). Each guide serves as an authoritative standard
for verifying its corresponding herbs’ proper identity and purity, as well as for
establishing quality and composition guidelines to be used for fulfilling Good
Manufacturing Practice (GMP) requirements. The therapeutic compendium provides
a comprehensive review of current pharmacological and safety data and contains
information on toxicology, medical indications, structure-function claims,
dosages, interactions, side effects, and more.1 This information is
essential for manufacturers who need to maintain safety and efficacy
documentation that supports their products and claims.
AHP began producing monograph standards and therapeutic compendia in 1994 for
some of the most commonly used botanicals used in Ayurvedic, Chinese, and
Western herbal medicine. The first full AHP monograph—on St. John’s wort (Hypericum perforatum)—was published in 1997 as a special
insert in HerbalGram #40. According to its
website, AHP monographs “provide standards, guidance, and validated methods
needed for all aspects of botanical identification and quality control."1 The recently released American ginseng root and slippery elm inner bark
monographs bring the total number of AHP monographs to 32.
American Ginseng Root
AHP Executive Director Roy Upton described cultivated American ginseng as “one
of the most widely adulterated herbs” in the Western herb market in a December
2011 press release.2 “We have found leaf material marketed as root,
exhausted marc being sold as crude root, and materials cut with 45% dicalcium
phosphate,” he said. “The monograph provides all the characterizations that any
quality control team requires for making an authentic and quality product.”
(Marc refers to the remaining inert herbal material [mainly fibers and/or
starch] after all or most phytochemicals have been extracted with a solvent.)
Preparations from cultivated American ginseng have been used traditionally to
support the immune system, strengthen the nervous system, and to help prevent
certain chronic conditions. Research on American ginseng has focused on blood
sugar control for type 2 diabetes and quality of life in cancer patients. A
patented, chemically defined (polysaccharide-based) extract made from
cultivated American ginseng roots has shown efficacy in helping to prevent and
treat upper respiratory tract symptoms related to colds and flu.3
Upton said consumers should be aware of potentially adulterated products when
shopping for American ginseng supplements. “If it is cheap, then it is because
cheap ingredients were used,” he said (e-mail communication, February 14-20,
2012). “If you open a capsule and it is gritty, it may contain
a large amount of flow agent or filler (e.g., magnesium stearate).”
For almost 40 years, wild American ginseng has been protected under an
international treaty known as the Convention on International Trade in
Endangered Species of Wild Fauna and Flora (CITES). The treaty requires the US
Fish and Wildlife Service (FWS) to regulate the wild herb’s export and to
ensure that it is harvested in a sustainable manner.4 According to a
2011 FWS report, the main threats to wild American ginseng are illegal harvest,
irresponsible harvest, consumption by white tail deer, invasive plant species,
and habitat loss and destruction.5
The American Herbal Products Association (AHPA), the leading trade association
dealing with herbs in the United States, released good stewardship practices
for wild American ginseng in 2006.6 The same year, FWS reverted to a
5-year age minimum for harvesting wild American ginseng—half that of the
10-year minimum briefly established in 2005—after receiving feedback from
growers, harvesters, and other industry representatives.4 AHPA’s
good stewardship brochure includes information on the plant’s life cycle,
obtaining permission to harvest, and how and when to sustainably harvest the
herb.
Wild American ginseng can be found in 34 states, but only 19 are permitted by
FWS to export the herb. In 2010, the total harvest of wild American ginseng was
32 tons, approximately 10 tons less than the amount harvested in 2009—the
largest annual harvest since 1997.5 AHPA reports that the biggest
markets for wild American ginseng are Asian countries, which import roughly 30
tons of the herb every year.6
Wisconsin, in particular, is known for its high-quality cultivated American
ginseng. During the last 20 years, Wisconsin farmers have struggled to keep up
with international competition—especially from Canada and China—and manufacturers
that falsely claim its American ginseng is Wisconsin-grown. In 1991, the
Ginseng Board of Wisconsin, a nonprofit organization representing Wisconsin
ginseng farmers, created the Wisconsin Ginseng Seal Program to identify
products that contain 100% pure and authentic Wisconsin-grown ginseng roots.7
Slippery Elm Inner Bark
AHP announced the release of monograph standards and a therapeutic compendium
for slippery elm inner bark in March 2011. This popular botanical native to
America is commonly found in throat lozenges (e.g., Thayers®; Henry Thayer Co.,
Westport, Connecticut) and herbal teas (e.g., Throat Coat®; Traditional Medicinals,
Sebastopol, California; and Essiac®; Essiac Canada International, Quebec,
Canada). Slippery elm is one of the few herbs approved by the US Food and Drug
Administration (FDA) as a safe and effective non-prescription drug ingredient
that can be sold over-the-counter (OTC) as a demulcent for soothing sore
throats.8
Upton explained some of the reasons for FDA’s approval of slippery elm as a
botanical drug. “It was originally grandfathered in as an ‘old drug,’” he said.
“Then, when FDA was reviewing ‘old drugs,’ Thayers—who was the first to
introduce the lozenge historically and [had] the primary interest in slippery
elm lozenges—was there to provide FDA with enough data to maintain the
classification.”
Other botanicals, Upton continued, have not been approved by FDA as
non-prescription drugs because of the prohibitively high cost. “It now costs
approximately $750 million to prove a drug is safe and effective,” he said. “No
one will do that for chamomile tea.”
In addition to sore throat relief, slippery elm has been used traditionally as
a topical treatment for healing wounds and skin diseases and internally to
treat inflammation of the digestive, respiratory, and urinary systems.
According to the AHP Therapeutic Compendium, slippery elm was also one of the
most widely used nutritive herbs historically, with reports of Civil War
soldiers subsisting on the bark of slippery elm for weeks, demonstrating the
plant’s nutritive as well as medicinal qualities.8 Further, according
to the National Geographic’s Guide to Medicinal Herbs,
George Washington and his troops reportedly survived for 12 days at Valley
Forge on slippery elm porridge during the American Revolution. The porridge,
with a nutritional content similar to that of oatmeal, can be made from ground
inner bark and water or milk.9
In recent years, illegal stripping of slippery elm trees has been reported in
some national forests in the United States. However, the modest price of
slippery elm has prevented it from becoming a widespread problem among illegal
harvesters. More serious threats to the tree include land development, logging,
and habitat depletion.10
AHP chose to review slippery elm inner bark, in part, because of its popularity
and occasional quality control issues. “There are significant quality issues
associated with slippery elm, including supplies—which are impacted by Dutch
elm disease—and poor quality material ([e.g.,] not meeting swelling
index-mucilage values),” Upton explained, referring to the quality of the
slippery, viscous fluid extracted from the tree’s inner bark.
One of the main goals of AHP’s monographs is to ensure consumer access to high-quality herbal materials. “As mandated by current and future [GMPs], the fields
of information [in the monographs] provide industry with a scientifically valid
means to ensure the authenticity, purity, and quality of botanical ingredients
and dietary supplements,” AHP states on its website.1
Today, the FDA-approved botanical ingredient can be found in many herbal throat
lozenges and is commonly sold in drug stores. “Slippery elm lozenge has been a
very important preparation for generations,” said Upton.
The American ginseng root and slippery elm inner bark monographs are available
through AHP’s website. PDF copies are available for $39.95 each and hard copies
can be purchased for $44.95 each. For more information, visit www.herbal-ahp.org.
References
1. AHP monographs. American Herbal Pharmacopoeia website. Available at:
www.herbal-ahp.org/documents/newsroom/AHP_Monographs.pdf. Accessed February 24,
2012.
2. AHP releases monograph standards and therapeutic compendium for American Ginsengroot (Panax Quinquefolius L.) [press release]. Scott’s Valley, CA: American Herbal Pharmacopoeia.
December 7, 2011. Available at: www.herbal-ahp.org/documents/press_releases/
American%20Ginseng%20PR%20final.pdf. Accessed February 20, 2011.
3. American ginseng. University of Maryland website. Available at: www.umm.edu/
altmed/articles/american-ginseng-000248.htm. Accessed February 20, 2011.
4. Cavaliere C. U.S. FWS reinstates 5-year age limit for exported wild American
ginseng. HerbalEGram. 2006;3.
5. Gnam R. Advice for the export of roots of wild and wild-simulated American
ginseng (Panax quinquefolius) lawfully harvested
during the 2011 harvest season in 19 states. Washington, D.C.: US Fish and
Wildlife Service; 2011.
6. Good stewardship harvesting of wild American ginseng (Panax
quinquefolius). US Fish and Wildlife Service website. Available at:
www.fws.gov/international/DMA_DSA/CITES/ pdf/2010wild-simulatedginseng.pdf.
Accessed February 22, 2011.
7. Wisconsin ginseng farmers fight to protect product reputation. HerbalGram. 2007. 75:54-61.
8. AHP releases monograph standards and therapeutic compendium on slippery elm
(Ulmus rubraMuhl.) inner bark [press
release]. Scott’s Valley, CA: American Herbal Pharmacopoeia. March 10, 2011.
Available at: www.herbal-ahp.org/documents/press_releases/
Slippery%20elm%20press%20release.pdf. Accessed February 22, 2011.
9. Johnson RL, Foster S, Low Dog T, and Kiefer D. National
Geographic Guide to Medicinal Herbs: The World’s Most Effective Healing Plants. 2011: National Geographic Press; Washington, D.C.
10. Cavaliere C. Illegal stripping and conservation of slippery elm trees. HerbalGram. 74:54-61. Available at:
http://cms.herbalgram.org/herbalgram/issue74/article3123.html.
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