This guide will educate Minnesotan botanical producers so that they can start production, expand operations, and/or launch new value-added products. Here, you will find the information needed to navigate the legal and regulatory landscape of botanical products. Botanical producers must pay attention to usage and efficacy claims, labeling requirements, and safe production practices. Furthermore, considering the real risk of product liability and regulatory compliance actions, entrepreneurs should carefully consider the nuances of insurance and forming a separate business entity. This guide addresses all of this and more! 

Our intended audience is producers who grow some or all of their own inputs and create value-added goods that are for the health, wellness, and/or beautification of their customers. The guide will enhance the competitiveness of producers of fruits, herbs, spices, medicinal herbs, mushrooms, beeswax, honey, and maple syrup. As to value-added ventures, this guide will exclusively focus on dry teablends, tinctures, syrups, oxymels, and hydrosols, all of which are specialtycrops when they contain 50% or more specialty crops by weight, exclusive of added water.  

Why ‘Botanicals’? 

We’ve chosen to use the catch-most phrase ‘botanicals’ to refer to all the inputs we mentioned above. Generally, ‘botanicals’ are plants or plant parts that are valued for their medicinal or therapeutic properties, flavors, or scents. This is the plant matter that serves as the input for the ‘botanical product’ created. The inputs that are related to plants but aren’t technically plant matter that are included in this guide include beeswax, honey, and maple syrup.  

This guide is focused on botanical products that can be classified as ‘dietary supplements’ or ‘cosmetics,’ as those terms are defined by Federal law. To fit the legal definition, botanical dietary supplements must (1) contain herbs or other botanicals, (2) be intended to be taken by mouth as a pill, capsule, powder, tablet, or liquid, and (3) be labeled as such. This includes capsules, tinctures, oxymels, and some blended teas. A cosmetic is something intended to be rubbed, poured, or sprinkled on the skin for the purpose of cleansing, beautifying, or promoting attractiveness. These include creams, lotions, powders, hydrosols, essential oils, or similar products.  

Further Context for This Project 

Consumer demand for products, processes, foods, and supplements perceived as immune-supportive and health-boosting has skyrocketed in recent years due to the global pandemic. Simultaneously, COVID severely disrupted supply chains of globally sourced botanical products at all levels, from growing (as farms struggled for workers) to processing (as facilities diverted to pharmaceutical production) to shipping (as global trade was altered). The increased demand, paired with supply disruption, prompted a shift to buyers seeking US-based supplies and botanical products.  

As new businesses stepped in to meet the growing consumer demand, the government took notice. The Food and Drug Administration (FDA) changed its enforcement strategy during the pandemic, reviewing marketing claims on products, websites, and ads at unprecedented rates. Any new farming business entering this sector must be aware of regulations covering marketing, composition, and production.  

This guide will address the applicable regulatory frameworks to provide critical educational support to producers who might be confused by or unaware of the regulations facing botanical producers. This project was generously funded by the Minnesota Department of Agriculture.