Watch your words! If you craft, make or sell herbal or natural products, you've likely come across many of these terms. Some you may know, and others you'll NEED to know in order to keep your operations legal and also protect yourself. These terms and definitions will guide your work in the herbal, natural and organic products industries. 

DSHEA

The Dietary Supplement Health and Education Act (DSHEA) of 1994, which amended the Federal Food, Drug, and Cosmetic Act, transformed FDA’s authority to regulate dietary supplements. Under DSHEA, FDA is not authorized to approve dietary supplements for safety and effectiveness before they are marketed. In fact, in many cases, firms can lawfully introduce dietary supplements to the market without even notifying FDA. Since DSHEA was enacted, the dietary supplement market has grown significantly. For example, the number of products has expanded nearly twenty times since 1994.

Structure Function Claim

The FDA likes language that states that a product is keeping an already healthy person healthy—rather than curing a sick person of a disease, because that’s the role of a drug, not a health supplement. So, the FDA mandates the use of words that suggest “improving or maintaining overall health” or “help provide adequate amounts of essential nutrients that the body needs to function.” You won’t see claims of curing or preventing diseases here – that’s a no-no.

Instead, promote how your product or its ingredients support the structure or the function of a healthy body. Cure heart disease? No! Instead, your product “supports healthy cardiovascular function.” Is this vague? Yes, but to avoid an FDA violation letter, you must adhere to the law and not make claims suggesting your product is actually a drug.

We go into detail about this and other labeling laws in my online course Herbal Business Compliance.

Certified Organic

Organic is a labeling term that indicates that the food or other agricultural product has been produced according to the United States Department of Agriculture (USDA) organic standards. According to its website, the USDA’s methods integrate cultural, biological and mechanical practices that foster cycling of resources, promote ecological balance and conserve biodiversity. It’s important to note that any company can slap the word organic on their label; technically they are breaking the law, but many companies do it anyway. As a consumer, it’s helpful to dig a little deeper into the company itself. Is it a B-Corp? Does it practice fair trade? Does it promote itself as an animal-welfare company? If you don’t see evidence of any of these certifications or commitments, but you see the word organic, you have every right to be suspicious.

Certified organic products (and their individual ingredients) must adhere to strict growing standards that account for pesticide use, heavy metals in the soil, crop rotation, length of time between conventional growing and organic growing, and other factors. It can be costly to become certified organic and it takes time and commitment, so some (shameful) companies will simply use the word to attract customers without actually doing the right work.

If you are an herbalist who makes products and you purchase ingredients from a vendor, be sure to get the vendor’s Certificate of Authenticity that affirms their USDA certified organic status (and other information such as pesticide use, country of origin, heavy metal levels, etc). Also know that you cannot claim your final product to be Certified Organic simply because one of the ingredients is.  For more information, check out my online course Natural Brand Certifications.

Certificate of Authenticity

When you purchase ingredients from a vendor, be sure to request a Certificate of Authenticity with your order. This is a letter verifying that the ingredient you’ve purchased has met a host of standards, often including heavy metal detection, kosher certificate, organic certificate, residue tests, and more. 

I have used Mountain Rose Herbs for decades as my primary herbal ingredient vendor and I appreciate the way they continually improve their CSR (corporate social responsibility) and working standards, including their formation as an Oregon Benefit corporation.This can be requested at the time you order with more details at this link. Because of this trust, I’ve partnered with Mountain Rose Herbs with Bellebuono School of Herbal Medicine students receiving a 10% discount.

GMP

GMPs are Good Manufacturing Practices. I talk with many herbalists who believe their business is too small to engage in handling GMPs, but it’s not the case!

Even small herbalists can (and should) do everything they can to ensure their product-making is as clean and hygienic as possible. GMP includes training your staff (including unpaid students, interns and apprentices) in all GMP standards, such as record-keeping, cleaning, storage of ingredients, handwashing, storage of personal items, clear communication, receiving shipments of ingredients or packaging, personal dress, and much more.

If you are making herbal products in your home (especially in a basement, shed or in your kitchen), you are especially encouraged to follow GMPs as closely as possible. See below for info about boards of health and state-by-state cottage laws. For even more guidance, enroll in the online course Herbal Business Compliance for best practices.

Larger herbal businesses generally put a great deal of time and effort into their GMPs, making them a priority because 1) they’re eager to avoid FDA inspection violations, 2) they genuinely wish to provide a safe and reliable product, and 3) they know that sharing this information and effort with their employees and customers favorably positions them within the growing marketplace of CSR (corporations who find true value in environmental and social responsibility).

Label Claims and FDA Violation Letters

The FDA routinely sends violation letters to businesses breaking the law by making claims that are unsubstantiated, dangerous, or false. That’s the FDA’s job, and I know many herbal companies that have received letters primarily for using language on their labels that is at odds with the FDA’s mantra of the Structure Function claim.

To keep out of the FDA’s purvue, make sure your labels are not only accurate but follow the structure function claim guidelines. This is crucial not only for businesses selling products that invite scrutiny (such as caffeine or alcohol-containing products) but also those that deal with weight loss, serious diseases such as diabetes, symptoms such as headaches, brain and mental health diseases and disorders such as anxiety or ADHD, and other issues where you’re tempted to claim that your product “treats, cures, prevents or diagnoses” an illness. This is strictly prohibited. For more guidance on labeling, check out our online course Herbal Business Compliance.

Closed-loop Manufacturing

Closed-loop refers to a number of principles. There’s closed-loop recycling, meaning that recycling of a particular material can be done indefinitely without degrading the original substance. There’s closed-loop manufacturing, where a producer makes a product that is inherently designed to be reused or taken apart and made again. (See also Cradle to Cradle design.)

There is also Circular Economy, a more modern term. This is a long-overdue concept where manufacturers design a product from the very beginning with the goal of taking it back at the end of its functional life, taking it apart, and reusing each component of the product ideally to reform a new product of the same type or, at the very least, a new useful product.

Herbalists and cosmetic makers can utilize a closed-loop philosophy by taking used containers back, cleaning and refilling them, and purchasing from manufacturers who evidence Circular Economy thinking and practice. This reduces your need to purchase new containers, keeps used containers out of the landfill or the recycling stream, and improves your connection with your customers. For a great article on this, check out A Drop in the Ocean’s blog.

Homeopathic

See this blog post.

FDA

The United States Food and Drug Administration (FDA) regulates, as the name suggests, some foods and all drugs. We herbalists need to know about it because, while it doesn’t regulate herbal products or herbal medicines, it instructs herbalists how to avoid being druggists. Basically, you don’t want to be noticed by the FDA. You want to NOT be a drug manufacturer. Being an herbalist, you are producing dietary health supplements, which are regulated by the FDA and governed by the DSHEA guidelines. See above.

Board of Health & Cottage Laws

In addition to the federal oversight of the FDA, herbalists must adhere to regulations set forth by the state in which they operate (such as Massachusetts) and their local board of health (often on a town or county level). Not every state issues Cottage Laws. Cottage laws (often called Cottage Food Laws) are state-wide laws that regulate businesses that operate out of a residential house; for instance, making jams or breads in your kitchen that you sell to the public. These laws specify where you can do it (not in a shed in your backyard!), how you can do it (not with a family pet in the home), how you must label your products, what you can do (jams and jellies but not foods that require refrigeration) and other stipulations generally put in place for health and safety.

Cottage Laws vary by state; check your Secretary of State website, or your 4H website, State Agriculture, or with your local board of health agent.

The Cottage Food Laws are important to familiarize yourself with even if you’re an herbalist (wait, I’m not selling food!). In fact, some products or ingredients (such as honey, dried spices or condiments) may be subject to cottage food regulations.

Boards of Health are much more local and often oversee activities such as setting up at farmers markets, artisans fairs, commercial kitchens, and temporary shops such as a festival tent. I encourage all herbalists to introduce yourself to your local board of health and get as much information about your local laws as possible.

Labeling Laws, Claims & Statements

When you slap a label onto your product, you must make certain it contains the information required by the FDA and NONE of the words prohibited by the FDA. In fact, it’s not just wording that is important but tone and insinuation. To stay out of trouble, make sure your products AND your website home and landing pages include the right information.

A permitted claim made on the label of a dietary supplement meets FDA rules if:

• the claim is a structure/function claim, a general well-being claim, or a classical nutrient deficiency disease claim as defined in section 403(r)(6)(A); (in other words, it’s not claiming to cure or treat a disease);
• the entity making the claim has substantiation that the statement is truthful and not misleading; (in other words, it can be backed by scientific studies that you can point to);
• the statement is accompanied by the following standard disclaimer, prominently displayed and in boldface type:  “This statement has not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease.” In fact, none of these 4 words should be anywhere on your products OR on your website. I would also advise not using the word disease.
• the statement does not claim to diagnose, mitigate, treat, cure, or prevent a specific disease or class of diseases. This is what drugs do. Herbal medicines, on the other hand, support and maintain health. Of course, we know that many herbs reverse illness and relieve symptoms; many of our herbs are “anti” herbs such as “anti-catarrhal,” “anti-inflammatory,” etc. However, for the purposes of selling a product in the US market, the FDA is strict about not claiming any of this. Given the number of violation letters I’ve seen and herbalists who have been taken to course, I think it is sensible to conform to the FDA requirements that indicate your product supports health—rather than curing disease. For more guidance, see the online course Herbal Business Compliance.

Adulterants and Contaminants

When you grow a plant yourself, you know that it is the herb you planted. It is genuine and cannot be called something else. However, once you harvest it, dry it, package it, and ship it somewhere, the recipient does not necessarily have the same assurance that the herb is what you say it is.

As an herbal manufacturer, it is up to you to ensure that herbs do not have other herbs or ingredients add to them, which are called adulterants or contaminants. For instance, when you purchase turmeric root powder, it may be straight turmeric root – or it may have other substances added to it such as cumin powder or even heavy metals that might boost its orange color. These not only are dishonest ingredients (and not marked on the label), but they might be toxic or dangerous in a product.

Organoleptic Testing

Because of the risk of contaminants, or simply being uncertain what a package of dried herb or powder contains, it is important for herbalists to be able to at least try to identify the herb before using it as an ingredient in a remedy. Because a processed plant is more difficult to identify than a whole plant, we must use other verifiable methods.

Organoleptic testing is an approved method of identification where we use our senses to determine the identity of an herbal product. Use taste, smell, sight and touch to ascertain whether the plant product is a particular herb and also to what extent its quality has been changed or altered during the packaging process.

This type of method is not a failsafe guarantee. There are many times I’ve been unable to accurately assess the identity of a plant from an unknown source, and it’s gone in the garbage. It’s up to you to use your judgement to ensure that safety is prioritized when making a remedy that another person will use. Purchasing from trusted vendors is a first step that will relieve many headaches, and of course growing the herbs yourself will alleviate the need for verification.

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