American Botanical Council Publishes Online Version of The Identification of Medicinal Plants Book

Online access to identification book provides new quality control resource for herb industry

AUSTIN, Texas (October 19, 2017) — The American Botanical Council (ABC) announces a new benefit for its members around the world: the online publication of The Identification of Medicinal Plants: A Handbook of the Morphology of Botanicals in Commerce, a manual that addresses the macroscopic assessment of 124 medicinal plants used in North America and Europe.

The book was originally co-published in 2006 by ABC with the Missouri Botanical Garden in St. Louis. It was written by Wendy Applequist, PhD, associate curator at the Missouri Botanical Garden’s William L. Brown Center, and illustrated with botanically accurate black-and-white line drawings by artist Barbara Alongi.

Accurate identification of the correct genus and species of botanical raw materials is the first step in quality control of botanical preparations. While several methods of identification are addressed in the introduction — including macroscopic taxonomic identification, microscopy of plant cells, chemical analysis of plant constituents, and molecular analysis of the plant’s DNA — it is Applequist’s opinion that macroscopic analysis of whole plants and plant parts (when possible) is often a preferred method of species identification because it is quick and relatively inexpensive.

The drawings by Alongi emphasize various morphological features of plant parts to aid in the identification process. In some cases (e.g., to estimate the actual size of a plant part, or to illustrate small details), such drawings can be more useful than actual photographs.

“ABC is pleased to be able to make this important book available to its members, particularly those in academic analytical research and in the herb industry,” noted ABC Founder and Executive Director Mark Blumenthal. “Because many botanical raw materials used in the current herb industry are either cut plant parts (e.g., for use as teas) or powders (to be made into capsules or tablets), many companies never receive and process whole plants or whole plant parts. In such cases, microscopy, chemical analysis, and/or genetic (DNA) testing are required analytical methods. But for growers, wildcrafters, collectors, processors, and others who deal with whole plants and their whole parts, this manual is a highly valuable quality control resource.”

Part 1 of the text provides a succinct discussion of the main morphological features of medicinal plants; practical plant identification, including necessary tools and how to deal with dried plant materials; botanical nomenclature and its importance in the identification process; and a description of the format of the botanical entries included in the book.

Part 2 provides a detailed macroscopic description of each of the 124 plants included. Ordered alphabetically by Latin binomial, each entry includes the standardized common name per the American Herbal Products Association’s Herbs of Commerce, 2nd edition, other common names, family, a brief taxonomic representation, plant parts in commerce, a description of the plant and key morphological characteristics, organoleptic characteristics such as taste and odor, information on potential adulteration, references, and botanical illustrations. Each plant entry a downloadable PDF for ease of use.

“Morphological identification of unprocessed botanicals, when it is feasible, is the most rigorous possible form of authentication and the lowest-cost and quickest,” said Applequist. “I hope that ABC’s making this work available online will help to encourage people who work with herbs to develop the skill of old-fashioned botanical identification.”

Stefan Gafner, PhD, ABC’s chief science officer, added: “Macroscopic identification is an essential step in the identification of whole or cut crude herbal materials. Visual inspection not only helps to authenticate the material, but it also enables the detection of excess amounts of foreign matter such as dirt or sand, and improperly handled material that is rotten or filthy. Resources that help with the training and education of analysts in macroscopic analysis are scarce, and, as such, this is a very valuable book and one of the few texts in which information on macroscopic identification of many commercial botanical ingredients is gathered in one place.”

An appendix contains general references, a glossary that defines botanical terms, and illustrations of common leaf and flower characteristics. Finally, an index is included to facilitate easy access to the materials.

The Identification of Medicinal Plants will be available online to ABC members at the Professional level and above effective October 20, 2017. To become an ABC Member or upgrade membership levels, visit ABC’s membership page or call 512-926-4900.

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Essential Oil Adulteration Information Posted by Botanical Adulterants Program

AUSTIN, Texas (September 13, 2017) — A book chapter on “The Adulteration of Essential Oils,” from the award-winning 2016 book Handbook of Essential Oils, 2nd edition (Taylor & Francis), is now available in the new “Essential Oil Adulteration” section of the ABC-AHP-NCNPR Botanical Adulterants Program (BAP) website.

Essential oils (EOs) are volatile materials produced by specialized secretory structures in many medicinal and aromatic plants, often giving each plant its characteristic fragrance and flavor. EO-containing materials have been used for thousands of years as fragrances, incenses, and food flavorings, and are currently used for a variety of medicinal, personal, household, and industrial purposes.

Because a relatively large amount of plant biomass is often required to produce a small amount of EO, the cost of many of these EOs has traditionally been very high. High prices for commodities have often led to adulteration, at the economic benefit of the seller and frequent detriment to the buyer or user. Adulteration occurs when a labeled ingredient is substituted or diluted with a different, undeclared, lower-cost material, creating an ingredient or product that does not have the features and/or does not provide the benefits claimed by the seller and expected by the buyer.

The entire book chapter, written by Erich Schmidt and Jürgen Wanner, two leading European essential oil experts, is available here. In addition, Schmidt has written a brief (ca. 2,700-word) summary of the chapter, available here.

According to American Botanical Council (ABC) Chief Science Officer Stefan Gafner, Ph.D., “Essential oils have always been a precious and highly prized commodity. While EOs and EO-containing ingredients have a history of adulteration, the high costs of many of these oils continue to make these oils attractive targets for adulteration by fraudulent suppliers.”

“Adulteration may involve the addition of lower-cost essential oils or vegetable oils, natural or synthetic EO isolates, or various diluents,” Gafner added. “Although analytical methods to detect falsification have improved, so has the sophistication by which EOs are adulterated, demanding manufacturers to use additional (and often more costly) quality control methods.”

Mark Blumenthal, founder and executive director of ABC, noted that essential oils have become an increasingly popular category of consumer products in the past decade. “As consumer demand grows for these products, we at the Botanical Adulterants Program are energizing our research and educational efforts to help provide members of industry and practitioners with the tools to help ensure that they are purchasing appropriately labeled essential oils and their products,” he said. “Such useful tools include the essential oil adulteration chapter, and its summary, that we’ve made available to the public on our website.”

BAP recently published a Botanical Adulterants Bulletin (BAB) on tea tree oil, a popular essential oil that is used in personal care and household products, some of which has been confirmed to be adulterated with lower-cost essential oils and synthetic chemicals. This is the program’s first BAB on an essential oil.

In March 2017, the 2016 ABC James A. Duke Excellence in Botanical Literature Award was presented to the authors of the Handbook of Essential Oils, 2nd edition: Professor Hüsnü Can Başer, Ph.D., of Near East University in Nicosia, Northern Cypress, and Professor Gerhard Buchbauer, Ph.D., of the University of Vienna.


About the ABC-AHP-NCNPR Botanical Adulterants Program

The ABC-American Herbal Pharmacopoeia (AHP)-National Center for Natural Products Research (NCNPR) Botanical Adulterants Program is an international consortium of non-profit professional organizations, analytical laboratories, research centers, industry trade associations, industry members, and other parties with interest in herbs and medicinal plants. The program advises industry, researchers, health professionals, government agencies, the media, and the public about the various challenges related to adulterated botanical ingredients sold in commerce. To date, more than 190 United States and international parties have financially supported or otherwise endorsed the program.

To date, the program has published 33 extensively peer-reviewed articles, BABs, Laboratory Guidance Documents, and Botanical Adulterants Monitor e-newsletters. All of the program’s publications are freely available on the program’s website.

Botanical Adulterants Program Publishes Bulletin on Tea Tree Oil Adulteration

New bulletin provides review on adulteration of tea tree oil with lower-cost essential oils or natural or synthetic chemicals

AUSTIN, Texas (September 5, 2017) — The ABC-AHP-NCNPR Botanical Adulterants Program announces the publication of a new Botanical Adulterants Bulletin (BAB) on tea tree oil.

Tea tree (Melaleuca alternifolia or M. linariifolia) oil is the essential oil obtained by distillation of the leaves of tea tree, a small tree native to the eastern coast of Australia. Tea tree oil is used topically to treat minor wounds and cuts and to relieve symptoms of the common cold. It is also a popular ingredient in personal care, home care, and cosmetic products.

Adulteration of tea tree oil appears to be fairly widespread. One recent scientific study found that roughly half of 43 commercial samples tested in three analytical laboratories did not have the appropriate chemical composition consistent with authentic samples of Australian tea tree oil.

In some instances, tea tree oil adulteration may be due to confusion regarding the common name: A number of plants are known as “tea tree,” including species in the genus Melaleuca and the closely related genus Leptospermum, plus species in the genera Kunzea and Baeckea from Australia and New Zealand.

However, most of the adulteration of tea tree oil is believed to be for financial gain. Economically motivated adulteration includes dilution with lower-cost by-products derived from eucalyptus (Eucalyptus globulus and other species of Eucalyptus) oil and other essential oils, or the addition of pure chemical compounds derived from plant material, fermentation, or chemical synthesis.

Stefan Gafner, Ph.D., chief science officer of the nonprofit American Botanical Council (ABC) and technical director of the Botanical Adulterants Program, explained: “With prices ranging from $30 to $34 per kilogram and an increasing demand, tea tree oil is a prime target for economically motivated adulteration. Materials that are offered at a substantially lower price should be viewed with suspicion.”

The bulletin was authored by Ezra Bejar, Ph.D., an expert in botanical research in San Diego, California, and peer-reviewed by 19 experts with knowledge of tea tree oil, medicinal plants, analytical chemistry, and related scientific disciplines. The tea tree oil bulletin includes information about the production and market importance of tea tree oil, a list of known adulterants, data on adulteration frequency, and analytical approaches to detect adulterants.

“Tea tree oil has become a highly popular ingredient in numerous consumer health and household products in the past few decades,” said ABC Founder and Executive Director Mark Blumenthal, who is also director of the Botanical Adulterants Program.

“The information we have collected in our tea tree oil Botanical Adulterants Bulletin confirms what many people in the tea tree and essential oil industry have suspected for a long time: that some sellers of ‘tea tree oil’ are either unknowingly or intentionally selling adulterated, fraudulent material incorrectly labeled as ‘tea tree oil,’” Blumenthal continued. “Hopefully, our bulletin will encourage more manufacturers of products containing tea tree oil to perform appropriate testing to ensure that consumers receive authentic tea tree oil in their health and household products.”

Gafner added a note for quality control personnel in industry: “The determination of the exact chemical composition of tea tree oil by gas chromatography analysis, which enables the detection of the more sophisticated types of adulteration, should be considered as a quality control method by any manufacturer that is using tea tree oil in a product.”

The goal of the BABs is to provide summaries on topics regarding botanical identity and adulteration, thus allowing quality control personnel and lab technicians in the herbal medicine, botanical ingredient, dietary supplement, cosmetic, conventional food, and other industries in which botanical ingredients are used, to be aware of adulteration problems that may be widespread and/or imply health and safety concerns.

The tea tree oil bulletin is the 10th publication in the BAB series. As with all publications of the program, the bulletins are freely accessible to all ABC members, registered users of the ABC website, and all members of the public on the program’s website (registration required).


About the ABC-AHP-NCNPR Botanical Adulterants Program

The ABC-American Herbal Pharmacopoeia (AHP)-National Center for Natural Products Research (NCNPR) Botanical Adulterants Program is an international consortium of non-profit professional organizations, analytical laboratories, research centers, industry trade associations, industry members, and other parties with interest in herbs and medicinal plants. The program advises industry, researchers, health professionals, government agencies, the media, and the public about the various challenges related to adulterated botanical ingredients sold in commerce. To date, more than 190 United States and international parties have financially supported or otherwise endorsed the program.

To date, the program has published 33 extensively peer-reviewed articles, BABs, Laboratory Guidance Documents, and Botanical Adulterants Monitor e-newsletters. All of the program’s publications are freely available on the program’s website.

ABC Requests FDA to Continue to Revise the New Dietary Ingredient Draft Guidance

Nonprofit science organization says FDA’s NDI draft guidance exceeds scope of current law and intent of Congress

On December 12, 2016, the nonprofit American Botanical Council (ABC) filed comments in response to the US Food and Drug Administration’s (FDA’s) Notice of Availability of a revised draft guidance for industry titled “Dietary Supplements: New Dietary Ingredient Notifications and Related Issues” (2016 draft guidance).1

ABC sets forth in its comments to the FDA that the draft guidance exceeds the original intent of Congress behind the Dietary Supplement Health and Education Act of 1994 (DSHEA)2 — the hallmark piece of bipartisan legislation that created a regulatory framework specific to dietary supplements — and requests FDA to revise the 2016 draft guidance to more closely align with the intent and explicit text of DSHEA.

At issue is FDA’s development of a guidance document that is intended to provide more exact instruction to industry on how to bring a “new dietary ingredient” 3 (NDI) to market.

DSHEA outlines two types of dietary ingredients that are allowed in dietary supplement products: “Grandfathered” ingredients or dietary ingredients that were marketed pre-DSHEA (before October 15, 1994), and NDIs that were not marketed pre-DSHEA. Regardless of whether a dietary ingredient is grandfathered or an NDI, a manufacturer must comply with each labeling and safety provision of DSHEA, including the adulteration4 section and current Good Manufacturing Practices (cGMPs).5

However, if the ingredient is an NDI, a manufacturer or distributor of the NDI or dietary supplement product that contains the NDI must notify the FDA 75 days before going to market with the basis for concluding that the NDI, when used under recommended conditions, will reasonably be expected to be safe.6 The FDA and various members of the herb and dietary supplement industry have a difference in opinion on what data and information are needed to satisfy the standard of “reasonably be expected to be safe.”

To demonstrate the complexity of this matter is the amount of time it has taken to get to this point. Three years after DSHEA passed in 1997, FDA issued a Final Rule7 (regulations) on the NDI provision within DSHEA that provided the procedure for NDI notifications. Then in 2004 — ten years after DSHEA passed — FDA held a meeting and solicited comments from the public and industry “concerning the content and format requirements for NDI notifications.” FDA wanted the input to clarify the type, quantity, and quality of information that should be included in the NDI notification to FDA.8 Then in 2011 FDA issued a draft NDI guidance — 17 years after DSHEA — which received a large volume of comments from the public. FDA never finalized the 2011 guidance document. Then in August of 2016, FDA issued a revised draft NDI guidance document — 22 years after DSHEA — and that version is the subject of ABC’s comments.

One of ABC’s several primary concerns with the 2016 draft guidance is FDA’s focus on — and request for significant information on — the dietary supplement product itself. ABC set forth that the language in the NDI provision in DSHEA speaks to the dietary ingredient versus the finished dietary supplement product. ABC also references historic FDA actions that support the position that an NDI notification concerns the ingredient.

ABC also expressed its concerns that FDA’s language in the 2016 draft guidance suggests that almost any change in the manufacturing process or solvent used to make an extract might require an NDI notification due to possible chemical alteration of the ingredient. ABC provided examples where such chemical alteration may justifiably warrant an NDI notification and where it can be relatively insignificant and should not require a notification.

“As an independent nonprofit research and education organization, and as the founding and lead organization in an international consortium of medicinal plant research and analytical experts focusing on herb identity and quality control, ABC supports the proposition that all botanical ingredients used in dietary supplements should be authentic, properly tested for their identity, and safe for their intended use,” said ABC Founder and Executive Director Mark Blumenthal.

“ABC wishes to see rational regulations and guidance from the government that protects consumers from inauthentic and/or unsafe products and also allows members of the industry to be able to produce supplements that meet or exceed required federal regulations for quality and safety. However, some provisions proposed by FDA go well beyond what Congress intended when it conceived of NDIs and what the law actually requires, and ABC is concerned that FDA’s proposed guidance will not result in any meaningful consumer benefit,” he added.

ABC outlined several additional areas of concern for FDA’s consideration. ABC strongly believes in a rationally regulated supplement industry and is a proponent of fully implementing the provisions of DSHEA.

Even though guidance documents are not binding for FDA or the industry, ABC believes that an FDA guidance document sets a precedent and important guardrails to industry and regulators. Therefore, ABC recommends that FDA revises the 2016 draft guidance to align with the intent of Congress and the explicit text of Section 8 of DSHEA. ABC also encouraged FDA to continue to prioritize enforcement measures on adulterated raw materials sold as dietary ingredients, adulterated and mislabeled products, and violations of government-mandated (cGMPs as these areas have a greater likelihood of positive impact on product quality and public health.

References

  1. FDA Draft Guidance. Dietary Supplements: New Dietary Ingredient Notifications and Related Issues: Guidance for Industry. August 2016 (replaces draft guidance issued July 2011). Available at:www.fda.gov/downloads/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/UCM515733.pdf. Accessed December 12, 2016.
  2. Dietary Supplement Health and Education Act of 1994 (DSHEA), Pub. L. 103–417, 108 Stat. 4325.
  3. Food, Drug, and Cosmetic Act (FDCA) §413 (21 USC §350b).
  4. FDCA §413 (21 USC §342(f)), Adulterated food.
  5. 21 CFR 111, Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements.
  6. 21 USC §350b(a)(2), New dietary ingredients.
  7. 21 CFR 190.6, New Dietary Ingredient Notification, Requirement for premarket notification (62 Federal Register 49886, Sept. 23, 1997).
  8. Food and Drug Administration, Dietary Supplements; Premarket Notification for New Dietary Ingredient Notifications; Public Meeting, 69 Federal Register 61680 (October 20, 2004).