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Ensuring the Quality, Safety, and Health Benefits of Herbs, Mushrooms, Algae, and Lichen Botanicals

Written by Parris M. Kidd, PhD

Published November 13, 2024
Last Updated November 14, 2024

Quality Matters is a monthly column by Parris M. Kidd, PhD, designed to inform consumers and practitioners about supplement purity, efficacy, ingredients, manufacturing, and legal requirements. The views expressed in this piece are the author’s own and do not necessarily reflect those of INM.

Medicinal plants are often called “herbs,” and medicinal preparations made from them are often called “herbals.” The broader category of “botanicals” includes not only herbs and herbals but also mushrooms (which are fungi), algae, and lichens (fungi associated with algae or bacteria). This post explores effective strategies to ensure the quality, efficacy, and safety of botanical products.

Botanicals were the earliest medicines

People have been using botanicals as medicine at least since the beginning of recorded history.¹ By 2,100 BC, Sumerian clay tablets carried healing recipes that included botanicals. A 65-foot-long Egyptian papyrus from around 1,500 BC referenced some 850 botanicals.

Dioscorides’ “De Materia Medica,” written in five volumes between 50 and 70 AD, remained an authoritative source on botanicals well into the 17th century.² Christian monks helped preserve Dioscorides’ text and other early botanical works by hand copying them, and Muslim scholars expanded on this effort.¹ By the 15th century, English-language herbals began appearing in Europe. The first New World herbal manuscript was likely the Libellus or Codex Barberini, written by the Aztec physician Martin de la Cruz around 1552.³

Botanicals gave rise to the earliest drugs. At least one in every four drugs used worldwide likely originated from plants,⁴ and botanicals are still being “mined” to develop medicines that are less toxic than many modern manufactured pharmaceuticals. However, new and expanded use of complex botanical ingredients is also increasingly found in modern medicine.

Botanical quality requires documented origin, identity, and traceability

Herbal supplements and plant on beige mat

Herbs and other botanicals aren’t guaranteed safe just because they’re natural. All contain substances unfamiliar to the human body, and some can even be toxic. Ensuring a botanical’s safety for human consumption requires documented, traceable proof of its origin, biological identity, and processing history.

Botanicals that appear similar to the untrained eye can actually be different species, varying substantially in their chemical makeup. The chemistry of the same botanical may also significantly differ, with variations in genetics, growth conditions (such as available sunlight, temperature, and climate), soil quality (including mineral content, acidity, and bacterial profile), and burden of insects and other pests.⁵^,⁶

Cultivation season, subsequent processing, and specific conditions and duration of storage are equally important to botanicals’ chemistry. It’s crucial for suppliers to be aware of these variables and have accurate procedures for documenting them.⁵^,⁶

Documentation for traceability

Globally, regulatory agencies now require botanical suppliers to ensure every harvested batch of botanical is traceable.⁵ This requires the supplier to generate a detailed, signed certificate for each harvested batch.

A qualified team member must also sign the certificate, which should indicate the lot number; the binomial scientific name (genus and species); the part harvested (e.g., root versus leaves for plants, fruiting bodies versus mycelia for mushrooms); whether the botanical was cultivated or collected; country and local climactic zone; harvest date, period, or season; and any other information necessary to ensure traceability from the end-processed product back to the source.⁵

Suppliers are also strongly encouraged to establish predefined criteria for accepting or rejecting a batch of harvested botanical before additional processing. This gives the supplier confidence that the material contains enough active substances to withstand potential depletion during further processing.⁵

Freedom from contamination

Each botanical batch should be thoroughly inspected and tested.⁵ Whether collected (wildcrafted) or cultivated before harvesting, batches can become contaminated by non-medicinal or harmful plants, foreign matter (e.g., rodents), or lead and other toxic metals from soil. Pesticide or herbicide residue and other environmental pollutant contamination may also occur.

Certain botanicals naturally produce toxins that pose health risks. Comfrey, borage, and other plants have pyrrolizidine alkaloids, which can damage the liver. Rhodiola may carry lotaustralin, a compound the body can transform into hydrogen cyanide, a potentially lethal toxin, and ginkgo biloba leaves may contain toxic ginkgolic acid. When choosing a ginkgo supplement, it’s wise to ensure the label specifies that each serving contains no more than five parts per million of this natural toxin.

While experienced suppliers can manage natural contamination, intentional contamination—known as adulteration—is a growing concern. This deceptive practice, driven by financial gain,⁶^,⁷ misleads consumers and compromises product integrity. We will delve further into this issue in an upcoming column, along with the closely related topic of sustainability.

Testing for identity

Scientist extracts solution from herbal formula in lab

Many countries have pharmacopeias (manuals on medicinal substances) with detailed methods for verifying botanical identity. Understandably, some early pharmacopeial methods aren’t adequate for conclusive verification. The American Botanical Council (ABC) has led the way in combining botanical chemical analysis with other methods to ensure reliable identity verification.⁶^,⁷

DNA sequencing is powerful, but because processing often degrades or removes DNA, sequencing is only effective for determining the genus and species of relatively whole and unprocessed botanical material. The most practical current method for identifying botanical ingredients is HPTLC (High-Performance Thin-Layer Chromatography).⁸ Infrared spectrometry is no longer valid for botanical identification.

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Ensuring herbals and other botanicals are safe to use

Botanical safety should never be taken for granted. A consumer whose doctor has highlighted the dangers of herbal supplements and potential interactions with other medications might question whether they should use them at all. However, an informed healthcare professional could address these concerns by explaining that, while some herbal supplements carry risks, the right botanicals taken in safe doses can significantly improve health without interfering with other medications.

One dangerous herb–drug interaction

St. John’s Wort or SJW (Hypericum perforatum) is an herbal supplement sometimes used for managing depression. However, SJW is linked to significant herb–drug interactions that may alter the effectiveness and safety of various medications. It can activate certain enzymes that normally process drugs, accelerating clearance and lowering the drug’s intended effects.⁹For example, SJW may reduce blood levels of medicines such as amitriptyline, benzodiazepines, digoxin, fexofenadine, finasteride, methadone, and simvastatin.⁹ It can also diminish hormone levels in oral contraceptives, potentially resulting in contraceptive failure. SJW poses additional risks when used alongside anticoagulants like warfarin, certain protease inhibitor antivirals, immunosuppressive drugs, and some anticancer drugs.

As with other dietary supplement ingredients, botanicals should only be used if their safety has been clearly established. The Food and Drug Administration (FDA) now requires that any dietary ingredients introduced after 1994 undergo a filing process that includes adequate proof of safety.¹⁰

Naturopathic doctors and other practitioners professionally trained in botanicals are well-equipped to educate people about their safety and use. Many health professionals are aware, for example, that saffron is much safer than SJW and that certain saffron extracts work as well or better for depression.

It’s both appropriate and reasonable for healthcare practitioners and patients to contact the company listed on a botanical dietary supplement label to request evidence on the safety and efficacy of its ingredients. This information might include filings with the FDA or clinical studies published in reputable peer-reviewed journals.

Ensuring health benefits of herbals and other botanicals

A skeptical consumer might reasonably ask: “How do I know this herbal (or mushroom, alga, other botanical) will do anything for my health? My doctor knows nothing about it—am I wasting my money?” To help protect consumers from buying ineffective products, U.S. law requires that health benefit claims for botanicals be backed by clinical and scientific evidence.

The medical credibility of botanicals is improving as some of the world’s best researchers grasp their potential for healing without harm. In addition, the ABC and the American Herbal Products Association provide much-needed leadership for the responsible commercialization of botanical ingredients.⁵^,⁶^,⁷

Controlled clinical trials are the best method for establishing a botanical’s health benefits. Because preparations from the same botanical can differ significantly in chemistry, safety, and efficacy, ingredients used in trials should be chemically standardized. Whenever ethically possible, it’s best to conduct double-blind clinical trials, with a placebo group.

In “add-on” trials, a growing trend, patients stay on the best existing treatment regimen before being randomly allocated to one of two groups: one that receives the new ingredient or one that receives a placebo. This trial design allows for proper ingredient testing while patients continue to benefit from an established regimen.

Botanicals aren’t “magic bullets,” but they can enhance the body’s healing power. The add-on clinical trial design allows for botanicals to be part of comprehensive treatment, which preferably includes improving diet and supplementing with vitamins, essential minerals, probiotics, and other nutrients. Regular physical exercise and lifestyle changes further promote success.

For more information on the applications of botanicals to digestive issues, sleep disorders, anxiety, stress, pain management, respiratory conditions, menstrual discomfort, immune support, and cardiovascular protection, read How Naturopathic Doctors Use Botanical Medicine.

Footnotes

1
Abdel–Aziz SM, Aeron A, Kahil TA. (2016). Health Benefits and Possible Risks of Herbal Medicine. In: Garg, N., Abdel-Aziz, S., Aeron, A. (eds) Microbes in Food and Health. Springer, Cham. https://doi.org/10.1007/978-3-319-25277-3_6
2
History of Medicine Division, National Library of Medicine, National Institutes of Health, USA, 2017. Dioscorides. https://www.nlm.nih.gov/hmd/topics/greek-medicine/index.html
3
Gates W., 2000. An Aztec Herbal: The Classic Codex of 1552 (English translation of the original “Libellus” authored by Martin de la Cruz). Dover Publications, Garden City, New York. https://store.doverpublications.com/products/9780486411309?srsltid=AfmBOooT8uhEYf5AZxgA5uWeTXUe-89sngUoNc-OQ7v8Pd3B173pufXd
4
Wachtel–Galor S, Benzie IFF. Herbal Medicine: An Introduction to Its History, Usage, Regulation, Current Trends, and Research Needs. In: Benzie IFF, Wachtel–Galor S, editors. Herbal Medicine: Biomolecular and Clinical Aspects. 2nd ed. Boca Raton (FL): CRC Press/Taylor & Francis; 2011. Chapter 1. PMID: 22593939. https://www.ncbi.nlm.nih.gov/books/NBK92773
5
American Herbal Products Association. May 2023. Good Agricultural and Collection Practices and Good Manufacturing Practices for Botanical Materials. https://www.ahpa.org/files/Document Library/AHPA Guidance Documents/GACP-GMP Guidance/2021_AHPA_GACP_GMP_for_Botanical_Materials.pdf
6
American Botanical Council. October 2024. Identification of Medicinal Plants. A Handbook of the Morphology of Botanicals in Commerce.
7
Blumenthal M, Foster S. 2024. Foreword. In Identification of Medicinal Plants. A Handbook of the Morphology of Botanicals in Commerce. https://www.herbalgram.org/resources/identification-of-medicinal-plants
8
Mück F, Scotti F, Mauvisseau Q, Thorbek BLG, Wangensteen H, de Boer HJ. Three-tiered authentication of traditional Chinese herbal medicine ingredients used in women’s health provides progressive qualitative and quantitative insight. Front Pharmacol. 2024 Feb 5;15:1353434. https://doi.org/10.3389/fphar.2024.1353434
9
Czigle S, Nagy M, Mladěnka P, Tóth J; OEMONOM. Pharmacokinetic and pharmacodynamic herb-drug interactions—part I. Herbal medicines of the central nervous system. PeerJ. 2023 Nov 15;11:e16149. https://doi.org/10.7717/peerj.16149
10
Food and Drug Administration., 2024 (March). Guidance for Industry: New Dietary Ingredient Notification Procedures and Timeframes—Dietary Supplements (Final). https://www.fda.gov/regulatory-information/search-fda-guidance-documents/guidance-industry-new-dietary-ingredient-notification-procedures-and-timeframes-dietary-supplements

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This article is provided by

The Institute for Natural Medicine, a non-profit 501(c)(3) organization. INM’s mission is to transform health care in the United States by increasing public awareness of natural medicine and access to naturopathic doctors. Naturopathic medicine, with its person-centered principles and practices, has the potential to reverse the tide of chronic illness overwhelming healthcare systems and to empower people to achieve and maintain optimal lifelong health. INM strives to fulfil this mission through the following initiatives:

Education – Reveal the unique benefits and outcomes of evidence-based natural medicine
Access – Connect patients to licensed naturopathic doctors
Research – Expand quality research on this complex and comprehensive system of medicine

About The Author(s)

Dietary Supplement Quality Advisor Writer

Parris M. Kidd, PhD

Parris M. Kidd, PhD, is an advisor for the Quality Matters program and member of INM’s Research Committee. Dr. Kidd, a thought leader in dietary supplement application, has developed and overseen quality programs for multiple supplement brands. He earned his BSc from the University of the West Indies in Jamaica and completed his PhD at the University of California, Berkeley. Dr. Kidd is a steadfast advocate for ensuring product safety and efficacy through rigorous clinical research.

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Botanicals were the earliest medicines