Center for Research on Ingredient Safety

What are botanicals?

Botanicals are any plant or plant part valued for their perceived medicinal or therapeutic properties, flavor, and or scent.

Botanicals are used to create essential oils, botanical preparations, and botanical drugs. 

What is a botanical preparation?

A botanical preparation is typically a dietary supplement made from flowers, leaves, bark, seeds, roots, twigs, or other plant parts. 
 
Botanical preparations can include teas, infusions, decoctions, tinctures, extracts, pills, powders, and more.
 
Herbal medicine, also called phytomedicine or phytotherapy, relies heavily on botanical preparations, often referred to as herbal supplements, herbal preparations, or herbal products. 
 

Are botanical preparations the same as a botanical drug?

No. The U.S. Food and Drug Administration (FDA) regulates botanical drugs in the same manner as any other over-the-counter or prescription pharmaceutical drug. It must be clinically proven to treat, cure, or prevent a medical condition. 
 
Botanical preparations are regulated as dietary supplements. Dietary supplements have not been proven to treat, cure, or prevent a medical condition and do not have the same standard for efficacy, purity, potency, dosage guidelines, and pre-market safety testing as over-the-counter or prescription drug, including botanical drugs (1,2). 
 
Botanical preparations can only be labeled and marketed as a dietary supplement (1,2).
 

Can botanicals have therapeutic effects?

Yes. Botanical drugs, regulated as over-the-counter or prescription drugs, have therapeutic properties. 
 
Botanical preparations like herbal supplements can impact our health. However, they are not regulated or tested to treat, cure, or prevent medical conditions.
 

Do botanical preparations work to aid human health?

In some cases, yes, botanical preparations can work to aid our health. For example, green tea contains caffeine, and caffeine is a stimulant ingredient. Therefore, a botanical preparation containing green tea can provide a stimulant effect (1,2). 
 
There are many botanical preparations marketed to us intended to help or improve our health (1,2). However, it’s important to remember that these botanical preparations do not currently meet the standard of medication. 
 
So, while these botanical preparations may work for specific individuals at specific dosages when meeting specific purity levels, there is a tremendous amount of variability. Therefore, we recommend seeking out a state-licensed medical professional when you’re experiencing a health concern. 
 
It’s also important to consider the potential for placebo effects when using botanical preparations.
 

Are botanical preparations regulated?

Botanical preparations are dietary supplements. There are two primary agencies responsible for dietary supplement regulation: U.S. Food and Drug Administration (FDA) and the U.S. Federal Trade Commission (FTC).

The FDA is responsible for both finished dietary supplement products and dietary ingredients; however, they are limited in their ability to regulate supplements before they are available for sale. This means supplement manufacturers are responsible for the purity of the supplement ingredients.

The FTC ensures the manufacturer's advertising and marketing supplement health claims are truthful, not misleading, and substantiated.
 

How can I ensure the botanical preparations are safe? 

Many reputable companies selling botanical preparations will have their ingredients tested for purity and potency by an independent laboratory such as NSF International, ConsumerLab, U.S. Pharmacopeia, and others. Products certified by independent laboratories will usually include a label that lets us know the manufacture had the product tested. 
 
Botanical preparations made by reputable companies will follow Current Good Manufacturing Practices (CGMP) that include protocols around hygiene, quality control, and more to ensure all products manufactured are safe and effective.
 

Where do I find botanical preparations? 

In recent years, botanical preparations have become more popular. You can find these products at any grocery store, health food store, or even pharmacy.  
 

Can botanical preparations impact prescribed medications? 

Yes. While botanical preparations are not regulated like a drug, they may still impact treatment provided by a state-licensed and certified medical professional. 
 
Before taking any botanical preparation, it’s important to talk with your doctor or your pharmacist to ensure the supplement will not impact your prescribed medications. 
 

Are botanical preparations and essential oils the same? 

Essential oils are typically derived from botanical sources. However, botanical preparations represent a different category of products mostly intended to be used as a dietary supplement, where essential oils are more often used for their scent, flavor, and other properties (1,2).
 

Is cannabidiol (CBD) a botanical preparation? 

Currently, cannabidiol (CBD) is not considered a botanical preparation recognized as a dietary supplement (1,2).
 
While it’s common to see dietary supplement language on CBD packaging, it’s currently in a gray legal area that will require action from the FDA to clarify its stance. 
 

The good news.

The U.S. National Institutes of Health launched a Consortium for Advancing Research on Botanical and Other Natural Products (CARBON) program. CARBON is researching botanical ingredients to explore their efficacy and for further potential safe uses for these ingredients. 
 
Botanicals are an exciting area, and we can expect to learn more in the coming years