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This factsheet helps botanical producers make informed decisions about how to best market and manufacture their products to avoid unknowingly triggering additional product regulations.
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This factsheet aims to help botanical producers make well-informed decisions about how to market and manufacture their products. Familiarity with dietary supplement regulations will allow botanical businesses to continue to thrive. Botanical products can exist in a gray area between food and dietary supplement regulations. Botanical producers unaware of dietary supplement regulations risk violating labeling, cGMP, or marketing rules. Consequences could include:
Determining whether a particular botanical product will be regulated as a ‘food’ versus a ‘dietary supplement’ can be challenging. The key factors in making this determination are the product’s intended use and marketing. This means that what is said about the product can be more important than what the product is made of in determining what regulations apply.
For purposes of this factsheet, we define botanical producers as those who grow some or all of their own inputs and create value-added goods for their customers’ health, wellness, or beautification. These producers could grow fruits, spices, medicinal herbs, mushrooms, beeswax, honey, or maple syrup. The value-added products include but are not limited to dry teas (blends or single herbs), tinctures, syrups, oxymels, salves, and hydrosols.
Tobacco, cannabis, and hemp are all regulated separately and are not covered in this factsheet.
Botanical products might be legally classified as foods, dietary supplements, cosmetics, or even (potentially) drugs. For example, a producer could sell a dried herbal tea blend as a food; many producers do just that. However, if the producer changes the tea’s marketing to include a statement that the tea “supports a healthy immune system,” then the tea would be regulated as a dietary supplement rather than a conventional food. If the marketing claim were even bolder, saying the tea would “cure the common cold,” then the product would be regulated as a drug. Finally, if the producer incorporates the same dried herbs into a salve and markets it as a topical moisturizer, it would be regulated as a cosmetic.
Another common example is elderberry. The fruit is often made into syrups, dried teas, or jelly. Depending on how they are marketed, most of these could be classified as conventional foods or dietary supplements. Elderberry syrup, for example, could be sold as a food with the suggested use of pouring it over pancakes. More often, we see elderberry syrup marketed as a dietary supplement, with the suggested use of ingesting it by the tablespoon for immune-supportive benefits.
This resource assumes botanical producers want to avoid drug classification because drugs require FDA pre-approval. But the other categories—cosmetics, conventional foods, or dietary supplements—are all valid options for botanical producers. Each classification has different rules on labeling, production and manufacturing, allowable health-related claims, and even state taxes.
Botanical producers must ask themselves a series of questions about their products to determine whether they will be classified as conventional foods or dietary supplements. The flow chart on the next page will help clarify if a product is a dietary supplement, conventional food, or cosmetic and explain basic regulatory information about each category.
Once we know how a product is classified, we can figure out how it’s regulated.
As you consider whether your botanical product is a food, dietary supplement, or cosmetic, do a gut check against the legal definitions provided below. If the flowchart and legal definitions align, we have a pretty good idea of the classification of the botanical product.
Dietary Supplement: a subcategory of food that is subject to both food regulations and specific dietary supplement regulations. Dietary supplements are defined as a product:
Cosmetic: articles intended to be rubbed, poured, sprinkled, or sprayed on, introduced into, or otherwise applied to the human body or any part thereof for cleansing, beautifying, promoting attractiveness, or altering the appearance.
The flowchart and definitions above should get producers closer to understanding how their product is classified. Once we understand how a product is classified, we can explore how each category is regulated.
Botanical producers may want to tout the health-related claims of their tinctures, salves, and other products. Using this kind of marketing requires producers to follow federal marketing regulations. This is true whether the health-related claim is on the product’s label, in advertisements, or on a website blog.
Producers can make two main types of marketing claims for their botanical products: structure/function claims or disease claims.
Only drugs (or certain medical devices) can use disease claims. Any botanical product (conventional food, dietary supplement, or cosmetic) that claims to treat, mitigate, or cure a disease would be regulated as a drug. Therefore, a cosmetic that claims to “treat eczema” could be considered a misbranded drug and be subject to FDA enforcement action.
Cosmetics are very limited in what claims can be made about them; even structure/function claims are not allowed. Advertising that a cosmetic can “increase collagen production” would be prohibited marketing because it implies it can change the skin’s structure. No cosmetic can claim to impact the structure or function of the body because it is only used outside or on the body. The law doesn’t recognize the ability of any topically applied product to absorb into the body and impact any bodily structures or functions. The few allowed descriptions for cosmetics include (but are not limited to) words like “cleansing,” “beautifying,” or “moisturizing.”
Any cosmetic claiming to impact the structure/function of the body or claiming to treat, mitigate, or cure a disease will be regulated as a drug. Producers should also be aware the U.S. is unique in regulating all sunscreens as drugs. This means no cosmetic can claim to have sun-protective qualities. Lastly, the regulation on the term “antimicrobial” might be surprising. Claims that a botanical kills or prevents microbial growth are considered drug claims.
Conventional foods can use structure/function claims in one limited way. For example, a claim based on nutrients, like “calcium builds strong bones,” can be used to market foods, but only if the food has calcium meeting or exceeding the established Daily Value (DV). DVs are established by the FDA as the recommended amounts of nutrients to consume or not to exceed each day. Conventional foods that use a structure/function claim that isn’t a nutrient claim, like “supports wellness,” would be considered a dietary supplement and would no longer be regulated as a conventional food.
Dietary supplements have the most flexibility in using structure/function claims in their marketing strategy. This is one benefit of producing dietary supplements—the producer can market the product by sharing how the supplement benefits the customer’s health and general well-being. If applicable, dietary supplements can also make nutrient content claims, like in the case of vitamins with established DVs.
This flexibility comes at a cost. Crafting an allowed dietary supplement structure/function claim can take time and effort. Still, once farmers understand the general guidelines, they can assert that a botanical positively impacts the body’s structure (e.g., bones) or function (e.g., immune system).
Producers can start learning to craft allowed structure/function claims by eliminating what they cannot say.
Health-related claims for dietary supplements cannot:
A botanical producer cannot make a St. John’s Wort tincture and market it with the phrase “treats mild to moderate depression.” There are two problems with this claim. First, the claim says that the product can treat a disease. Secondly, it blatantly mentions a disease—depression. This claim is a disease claim, not a structure/function claim, and would cause the botanical to be regulated as a drug.
Even implying that a product relieves a disease by describing symptoms can be prohibited. For example, a botanical product cannot claim to “reduce cholesterol.” From a legal standpoint, this claim implies that the reduction is from high cholesterol, and the FDA considers that a symptom inextricably tied to cardiovascular disease.
What can a farmer say about their botanical products marketed as dietary supplements? Legally, all that can be said in marketing is that botanical products support the normal or healthy functioning of the body. In practice, what does this mean?
Let’s look at some allowed structure/function claims:
A claim must, of course, be true. In fact, producers need reliable scientific evidence to back up their marketing claims. Since the FDA doesn’t pre-approve structure/function claims, producers are not required to present this evidence to start selling. However, producers are expected to have this evidence and be able to provide it if the FDA asks for it.
These dietary supplement structure/function claims must be accompanied by the FDA disclaimer: “This [or these] statement[s] have not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease.” This disclaimer does not remove the producer’s responsibility to ensure the health-related claim complies with the regulations.
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Cosmetics do not require the FDA disclaimer because it qualifies a structure/function claim. Structure/function claims aren’t allowed for cosmetics anyway, so the qualifier isn’t relevant! |
Finally, a producer making a dietary supplement structure/function claim must notify the FDA within 30 days of putting the product up for sale. Botanical producers do not need FDA approval before making structure/function claims on their products. However, the FDA requires businesses to notify them about any such claims. No later than 30 days after first marketing the dietary supplement, companies must send a notification letter to the FDA, which includes the text of the structure/function claim you’ve made. Here is an FDA guide to submitting these notifications. Submitted notification letters are publicly available on the database described above.
If a producer makes a disease-related claim about a botanical, the law will classify that botanical as a drug. Drugs must follow strict pre-approval processes and health and safety regulations designed for pharmaceuticals. If a product is marketed as a drug without complying with these processes and regulations, it will be subject to FDA enforcement, which could include product seizures and fines.
The initial enforcement mechanism for disease claims on products that aren’t approved drugs is a “courtesy letter” from the FDA. This letter states which marketing claims were prohibited and why. Businesses are expected to immediately alter the product’s label and all advertisements, websites, and other materials to remove the prohibited claims.
Botanical producers using structure/function claims must automatically follow other dietary supplement-specific rules. These include federal marketing regulations, dietary supplement labeling, and cGMP regulations.
No person in Michigan can use the title “apothecary,” “pharmacy,” “drugstore,” or “medicine store,” to name a few, without being licensed as a pharmacist. Furthermore, Michigan, like all states, has a law making it illegal to practice medicine without a license. Generally, these statutes define practicing medicine rather broadly, including practices that are obviously in a doctor’s wheelhouse, like surgery, but also adding to the definition of relatively more common acts like diagnosing, treating, and curing. Michigan’s statute defines the practice of medicine as “diagnosis, treatment, prevention, cure, or relieving of a human disease, ailment, defect, complaint, or other physical or mental condition, by attendance, advice, device, diagnostic test, or other means, or offering, undertaking, attempting to do, or holding oneself out as able to do, any of these acts.”
A minority of states, eleven in total, have passed bills that help protect farmers, among others, growing and selling herb products from claims of practicing medicine without a license. Michigan is not one of those states.
Due to the broad language of these statutes and the lack of an exception in Michigan for herbalists and other healers, many different types of healing arts—traditional healers, herbalists, and those touting the health benefits of foods—are limited in what they can do and how they can describe their services. Farmers who suggest herbs they’ve grown or processed could heal or treat an illness in a customer may violate this statute. Botanical producers should be aware that advising customers in a way that could be construed as diagnosing or offering treatment could create legal vulnerability.
A variety of state and federal laws control how a botanical product must be produced or manufactured. Similar to marketing regulations, production and manufacturing regulations also differ depending on whether the product is a conventional food, a cosmetic, or a dietary supplement.
The Modernization of Cosmetics Regulation Act (MoCRA) regulates cosmetics. Small businesses with gross annual sales of less than $1 million are exempt from the legally defined cosmetic good manufacturing practices, as well as facility registration and product listing requirements. Producers developing cosmetics that exceed the annual sales threshold should use a web browser to search for the FDA’s website with more information on MoCRA.
Dietary supplements are subject to rules around their manufacture. These rules are called current Good Manufacturing Practices, or “cGMPs” for short. cGMPs are a set of rules that describe (among many things) the equipment that must be used, quality controls implemented, tests made, and other standards around the production of these products. However, the FDA does not enforce cGMPs for herbalists who prepare products for individual clients. All other producers—including those selling tinctures at the local farmers’ market and wholesale value-added products to retailers—must follow the cGMPs.
Many farmers are already familiar with production regulations through the Food Safety Modernization Act’s Preventative Controls Rule. Dietary supplement cGMPs are similar. For example, they have many of the same sanitation, material choice, and worker health and safety rules. However, cGMPs for dietary supplements have additional requirements focused on product purity and consistency that are more stringent than conventional food cGMPs.
Dietary supplement cGMPs are stricter because of the unique characteristics of botanicals. Too much cheese in a cheese cracker will only impact the product’s taste, not its safety. However, many ingredients in a dietary supplement could be dangerous if too concentrated. Misidentified herbs could be harmful, and the concentration of the end product can vary based on the part of the plant used. These botanical qualities necessitate a different cGMP approach.
A foundational aspect of the dietary supplement cGMPs is product specification. The botanical producer determines the specifications (ingredients, concentrations, etc.) for each of their own products. Once those specifications are set, each batch must be tested against the producer-established specifications. Therefore, botanical producers have the freedom to set their parameters but are, after that, constrained and held to the specifications they set. Each product batch must be tested, and one sample from each batch must be retained for 2 years.
The most burdensome part of a cGMP program is often the paperwork. Producers must log the sanitation, maintenance, and training steps they take. Any facility producing dietary supplements must also register with the FDA. For more information on the full dietary supplement cGMP program, see the FDA’s Guidance Documents.
Botanical producers who do not want to comply with dietary supplement cGMPs can pursue alternative ways to market their products. Some options include selling unprocessed botanicals wholesale to other companies who produce dietary supplements, reevaluating product lines and marketing strategies so that you are only producing botanical products that can be marketed as conventional foods or cosmetics, or outsourcing processing of your farm-grown botanicals to a facility that provides cGMP compliance.
Federal food safety regulations have authority over food sold in interstate commerce. Traditionally, states have regulatory control over food safety regulations for foods sold within their state borders. Despite this state and federal division, all states rely on the FDA Food Code as a starting point for their own state-level food codes. Therefore, food safety regulation is similar across states, but states do add their own requirements and exemptions.
State rules typically require licenses/permits, food safety training and inspection. Food safety is regulated on the federal level by FSMA’s Produce Safety Rule (PSR) and Preventive Controls Rule (PCR). FSMA’s PSR applies to farm-grown botanicals that are merely dehydrated and sold whole. However, these botanicals cannot be cut or mixed with other botanicals. Any processing beyond dehydration (other than packing and labeling) makes the product subject to PCR cGMP regulation.
For example, cutting, mixing, cooking, fermenting, or baking means the producer will have to follow the PCR cGMPs. The PCR has exemptions for certain low-risk manufacturing and processing conducted by small businesses on farms for specific low-risk foods, retail food establishments, and qualified facilities. Many producers will still need to register with the FDA, however. cGMPs under the PCR address worker health and safety, sanitation, equipment requirements, traceability programs, recall readiness, and more.
Here are some examples of botanical products and the health and safety or cGMP regulations that might apply to them.
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Application of Botanical Regulations cGMPs = current Good Manufacturing Practices, PSR = FSMA Produce Safety Rule, PCR = FSMA Preventive Controls Rules, MoCRA = Modernization of Cosmetics Regulation Act |
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Example |
Do cGMPs apply? |
Notes |
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An herbalist works 1:1 with clients and prepares tinctures for them based on an individualized assessment. |
No |
FDA exercises its enforcement discretion to allow these botanical producers to prepare botanical products for 1:1 clients without adhering to DS cGMPs. |
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A farmer grows herbs and makes tinctures to sell at the farmers’ markets. The products are marketed with phrases such as “supports a healthy immune system,” “promotes restful sleep,” and “maintains healthy breathing.” |
Yes |
These are marketed as dietary supplements and are subject to the federal dietary supplement cGMPs. This botanical producer must follow the dietary supplement cGMPs. |
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A farmer grows herbs and then dehydrates them on-farm to sell at the local farmers’ market. |
No |
If covered by the PSR, this farmer will only be subject to the food safety rules found in the PSR. These activities fall within the definition of ‘farm.’ |
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A farmer grows multiple herbs, dehydrates them, cuts them, sifts them, and mixes them for tea blends that are sold at retail. |
Depends on claims made |
Are structure/function claims made? The tea will be subject to the federal dietary supplement cGMPs.
If there are no structure/function claims made, then the farmer will be subject to the cGMPs of the PCR… if not eligible for a PCR exemption. |
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A botanical producer grows herbs and processes them into hand creams, salves, and hair rinses they sell at their farm stand. |
Depends on size of business |
These products would be cosmetics and subject to MoCRA. However, if the producer grosses less than $1 million/year, they are exempt from the cosmetic cGMPs and registration requirements. |
States can decide whether some foods can be made in home kitchens without the need to obtain a license or be subject to state food safety inspection. States make these exemptions explicit by passing ‘cottage food laws.’ Each state has different rules on which products are cottage foods, often limiting which foods qualify or how much can be sold.
Botanical producers who want to process their products at home or on-farm may assume they could if they comply with Michigan’s cottage food laws. However, if the product is a dietary supplement, the producer must follow the federal dietary supplement cGMPs. A home or on-farm kitchen will likely not comply with federal dietary supplement cGMPs.
Michigan’s cottage food law only allows low-risk foods that do not require refrigeration after preparation. Some botanical products, like teas, would be allowed under the cottage food law. Below, we will discuss what botanical products may qualify as cottage foods in Michigan. But first, we’ll look at other cottage food criteria.
Michigan cottage food producers cannot sell more than $25,000 a year. All cottage foods must be sold directly to consumers at farmers’ markets, farm markets, roadside stands, or similar outlets. They cannot be sold in retail stores, restaurants, over the Internet, through the mail, or to wholesalers. Orders can be taken over the phone, but any product must be delivered in person to the customer. Essentially, no one else can sell your homemade products for you.
Home kitchens producing cottage foods are not subject to inspection, but they must still follow safe, good handling guidelines outlined in the Michigan Food Law. Even though not all food safety regulations apply to cottage foods, the law still requires that food be safe and unadulterated. This includes protecting against contamination due to unsanitary conditions. Producers are not required to get recipes pre-approved or to lab test their products.
The kitchen used to produce cottage foods must be the kitchen of the producer’s primary residence. A nonprofit, for example, does not have a primary residence and, therefore, would not be able to produce cottage foods. Other states cannot sell their cottage foods in Michigan.
There are no application forms or registration required. Producers are not required to take a food handler’s course. The home kitchen used must have potable water. If a home is on a well, that water should be tested to ensure its potability.
Labels for cottage foods in Michigan must include the name and physical address of the operation, product name, ingredients in descending order by weight, allergen information, and the warning, “Made in a home kitchen that has not been inspected by the Michigan Department of Agriculture & Rural Development.” Labels can be handprinted, if legible.
Botanical producers can make products that fall under Michigan’s cottage food law, but the options are limited. Examples of cottage foods are breads and other baked goods, extracts for food flavoring, fruit jams and jellies, flavored vinegars, dry herb mixes, or snacks.
Therefore, botanical producers could grow, dry, mix, and sell their herbs as herb mixtures to flavor food or for teas. Herbs or other botanical materials could be incorporated into products that otherwise qualify as cottage foods. Remember that these products cannot have any health-related claims. If they did, they would become dietary supplements.
Michigan does not allow any extracts that aren’t intended to flavor foods. Tinctures or other herbal extracts are not considered conventional foods and, therefore, cannot be cottage foods.
Elderberries are a common botanical product, well-known for their medicinal purposes. For that reason, it is important to note that elderberries are classified as a low-acid food with an average pH of 4.9. Therefore, elderberry jams or jellies are typically not considered safe for home production.
Any wild mushrooms are required to be collected and identified by a certified expert. They also have specific labeling requirements. If these criteria are met, then wild mushrooms can be offered for sale without a license. The recognized expert who collected the mushrooms can process wild mushrooms into a shelf-stable product, like dried mushrooms. They should be labeled according to the requirements under that program.
Michigan otherwise doesn’t allow beverages, home-canned products, vegetable jams, or jellies as cottage foods. For more information, visit the Michigan Department of Agriculture & Rural Development (MDARD)’s website on Cottage Foods.
If gross sales of either product are under $15,001, then retail outlets and processing facilities operated by the honey or maple syrup producer are exempt from licensure. However, this doesn’t mean that honey and maple syrup are considered cottage foods. However, the labeling requirements are identical to cottage food labeling requirements. Honey and maple syrup producers are not limited to direct-to-consumer sales, as they can wholesale their products.
Honey and maple syrup producers must meet all requirements of Michigan Food Law, despite not needing a license.
If any cottage food product is marketed with a structure/function claim like “supports wellness,” it will be regulated as a dietary supplement. That means compliance with dietary supplement cGMPs will be expected, regardless of whether the product would otherwise be considered cottage food.
Talking to a Food Inspector in Your State
For more information, visit the Michigan Department of Agriculture & Rural Development (MDARD)’s website on Cottage Foods. You can call a food inspector in your area at 800-292-3939. Speaking with a food inspector might be the fastest way to get your questions answered about whether your products can be made in a home kitchen.
Contact your local government to determine if local regulations will affect your business, including zoning restrictions or business licenses or permits. Some farmers’ markets may require vendors to have a food establishment license or meet other requirements that go beyond the cottage food law.
Michigan has a regular rate of sales and use tax of 6%. “Food for human consumption” is exempt from this tax. This exemption includes dietary supplements but not prepared foods or cosmetics.
Michigan’s Department of Revenue issued a Private Letter Ruling confirming that vitamins and dietary supplements, as defined in the Federal regulation, should be included in the definition of food for human consumption. This includes products containing herbal extracts, vitamins, and similar components.
The sales tax exemption does not cover prepared foods. They are defined as “food sold with eating utensils provided by the seller” and would be taxed at the regular sales tax rate.
Michigan does not allow city or local governments to impose sales taxes, so if your botanical products are exempt from the state sales tax, no other sales taxes will be applied to them.
Reflect to Move Forward
Take some time to consider the ways you describe each of your botanical products on labeling and marketing materials, including print and digital:
Now that we’ve covered key details about how the different types of botanical products are regulated, what action steps do you need to take to boost the legal resilience of your botanical products?
Many botanicals are foraged or harvested from the wild or areas that weren’t cultivated or tended during the plant’s growth. For most of human history, people survived by foraging. The rise of agriculture, colonialization, urbanization, and commercial food production caused foraging to become discouraged or outright prohibited by law. Now, botanical producers interested in foraging must be aware of the relevant federal, state, local, and Tribal regulations.
Most foraging rules allow some foraging for personal use without a permit. The quantities allowed are often limited to what a household could consume in a week. Producers who intend to sell what they forage will have to get further permits to do so, if available.
To determine what foraging is allowed on a particular parcel, the forager must first determine who owns the land they want to forage. Is it private land, federally owned, state-owned, or owned by a municipality? One will often need to know even more about the land’s management. For example, if it is federally owned, which agency manages it? If state-owned, how is the land classified?
Private land can only be foraged with the express permission of the owner. A producer seeking to forage private land should get written permission from the landowner. Any foraging agreement should spell out specific terms. For example, how long will the agreement last (one season, one year, or multiple years), and what plants are you allowed to harvest? Are there quantity limitations? When will you be able to access the land? And, are there any particular concerns about your use of the land? For example, are there gates that need to be closed after use? A written agreement outlining the terms of a producer’s permission to forage on the private land will help protect the producer’s botanical sourcing.
See below for rules on foraging on public lands in Michigan.
Mushrooms, berries, and edible fruits or nuts can be foraged in Michigan state-owned lands for personal use only. That means other plant parts, for example, the leaves of medicinal herbs, cannot be wild harvested in state parks.
About 75% of U.S. National Parks do allow foraging of some kind. It is up to each individual park whether or not wild harvesting is allowed. For example, at Isle Royale, visitors can forage apples by hand for personal consumption at the rate of two gallons of apples per person per day. Beach peas, chokecherries, cranberries, currants, elderberries, hazelnuts, juneberries, pin cherries, rhubarb, rose hips, strawberries, and wintergreen berries can be foraged by hand for personal use at the rate of one quart per person per day. Finally, visitors can harvest four quarts per person per day of blueberries, raspberries, thimbleberries, and mushrooms. These wild crops must be harvested by hand and only for personal use and consumption.
Also of note, since 2016, the National Park Service has allowed members of federally recognized Indian Tribes to gather and remove plants or plant parts for traditional purposes. Unless Tribes have other treaty or statutory rights specifically authorizing plant gathering, they must have a plant gathering agreement with the NPS that specifies which plant, the amounts be foraged, and what individuals of the Tribe are permitted to do so. However, none of this collection can be for commercial purposes.
Now that you have an idea of how foraging is regulated across Tribal, Federal, State-owned, and private lands, it’s time to assess what you need to do to build your resilience moving forward.
Reflect on the questions below to help you identify your next steps:
The work was supported by USDA/NIFA under Award Number 2023-70027-40444.
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