Substance-Based Medical Devices using Bioactive Ingredients

Botanical Products for Clinical Application

The use of nature-derived Active Ingredients (AI) for medical treatment could be traced back to the third century BCE from Samaria with plant-based recipes containing poppy, which is considered the grandfather of modern herbal medicine (morphine). In China, the first comprehensive record of herbal medicine is attributed to “The Compendium of Materia Medica” or “本草纲目“ during the Ming dynasty. Similar knowledge and medical knowhow was recorded during the ancient times in India, Egypt, Greece and the Arab Empire. 1

Today, it is estimated that 80 percent of the world population, especially in the developing countries are relying solely on herbal medicine.2 This is true in particular for chronic illnesses such as cancer and autoimmune diseases which do not necessarily have western medicine cure.

In today’s pharmaceutical industry, plants play an instrumental role in the development of modern drug discovery. It has been estimated that roughly one third of all US FDA New Molecular Entity (NME) approved drugs are derived from the isolation of an AI from natural sources 3, including mammals, fungus and plants, which comprise the majority (85 percent).4

A botanical drug is defined in the US FDA as a botanical product that is marketed as diagnosing, mitigating, treating, or curing a disease; a botanical product in turn, is a finished, labeled product that contains ingredients from plants.5 As of 2019, two botanical drugs have been approved by FDA. The first, approved in 2006, was sinecatechins, (marketed as Veregen®), to treat perianal warts. Sinecathechins is derived from a sub species of green tea (Camellia sinensis Kuntze)6. The second, in 2012, FDA approved crofelemer, (marketed as Mytesi™), an orphan drug targeting HIV-associated diarrhea. It is extracted from the blood-red latex of the South American (crotontre)7. Several others plants, such as cascara (Rhamnus purshiana), which is known for its laxative properties and senna are part of FDA’s monograph for Over the Counter (OTC).8

Botanical food, drug supplement or medical device?

Most herbs are approved as dietary supplements under the 1994 Dietary Supplement Health and Education Act (DSHEA). Under DSHEA, dietary supplements are deemed to be food. The only exception is if such products are used for an Investigational New Drug (IND) application) or Biologics License Application (BLA) and are approved as drugs as part of a New Drug Application (NDA). FDA published its first guidance for botanical drugs in 2004. It was revised in 2016. In Europe, botanical drugs are considered Herbal Medicinal Products (HMPs). Botanical products under the Federal Food, Drug, and Cosmetic Act (FD&C Act) can be classified in four different categories:

1. food (including a dietary supplement)
2. drug (including a biological drug)
3. medical device
4. cosmetics

Botanical products can in certain circumstances fall under medical device category. Medical devices are not restricted to apparatus; they can also be substances (the so-called substance-based medical devices). These products can be very similar to food supplements as far as their appearance goes (i.e., they can be capsules and tablets). The main condition for marketability as medical devices is that the products’ primary mode of effect is purely physical as opposed to pharmacological, physiological, or immunological, and that their main effect takes place outside of the human body. It is interesting to note that for the purpose of this definition, the intestinal lumen as well as the bladder and the nasal cavities, typical defined as body orifice, are not considered to be inside the human body.

1. Natnoo SA. “Flora: A Source of Traditional Medicine in Jammu and Kashmir With Special Reference to Chenab Valley.” Int J Recent Sci Res. 2014;5(12):2286-2288.
2. Chugh NA, Bali S and Koul A. “Integration of Botanicals in Contemporary Medicine: Roadblocks, Checkpoints and Go-Ahead Signals.” Integr Med Res. 2018;7(2):109-125.
3. Bozoghlanian V and Butteri M. “The Diverse and Promising World of Animal Derived Medications.” Pharos Alpha Omega Alpha Honor Med Soc. 2015;78(1):16-22. Accessed 15 October 2019.
4. Ahn K. “The Worldwide Trend of Using Botanical Drugs and Strategies for Developing Global Drugs.” BMB Rep. 2017;50(3):111-116.
6. FDA/CBER/BRT. Botanical Review of NDA #21-902 Veregen Ointment. 2006.
Accessed 15 October 2019.
7. FDA, What is a botanical drug? 2010. FDA website. Accessed 15 October 2019.
8. DHHS/FDA. Laxative Drug Products for Over-the- Counter Human Use; Proposed Amendment to the Tentative Final Monograph.

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