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 botanical products’ legal and regulatory landscape. Botanical business owners must be careful about usage and efficacy claims, labeling obligations, and food safety regulations. Further, considering the real risk of liability, 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 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 project will exclusively focus on dry tea blends, tinctures, syrups, oxymels, and hydrosols, all of which are specialty crops 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. Of course, there are other inputs that aren’t plant matter but that are included in this guide, beeswax, honey, and maple syrup, for example.

This guide is focused on botanical products that can be classified as dietary supplements or cosmetics. 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 health-boosting skyrocketed in the last three years. For example, sales by the brand Gaia for elderberry and echinacea increased by 3852% and 531%, respectively, year over year for March-October of 2020. Simultaneously, supply chains of globally sourced botanical products have been disrupted at all levels, from growing (as farms struggled for workers) to processing (as facilities divert to pharmaceutical production) to shipping (as global trade is altered). This has prompted a shift to US-based supplies with the potential for longer-term stability.

As new businesses have stepped in to meet the growing consumer demand, FDA enforcement actions have increased. Products are being sold with impermissible health-related claims or adulterated. This guide will address this knowledge gap and provide critical educational support through relevant examples, easy-to-understand information, and tangible solutions so that botanical producers and businesses can thrive. This project was generously funded by the Minnesota Department of Agriculture.