Legalities of Herbal Products Businesses in the United States & Current Good Manufacturing Practices (cGMPs)

Unlike the practice of clinical herbalism, the herbal products industry is regulated.

Whereas it’s perfectly legal to prepare your own tinctures, tea blends, and salves to share with friends and family, you must follow regulations to sell your natural products or plant-based medicines in a retail or online setting.

 

THE US FOOD AND DRUG ADMINISTRATION (FDA) has a series of regulations in place that are designed to ensure that food, drug, and cosmetic (read: herbal) products are consistently produced and controlled according to quality standards. These regulations are known as the Current Good Manufacturing Practices (cGMPs) and can be found in the Code of Federal Regulations Title 21 (21 CFR). (Note: You’ll often see the older term GMPs instead of cGMPs.) I’m going to begin with a little straight talk, because these regulations can make your head spin with all their acronyms and obtuse wording. Small herbal businesses all around the country have figured out how to be cGMP compliant, and so can you! As business coach Marie Forleo would say, it’s entirely figureoutable. Following the cGMPs will involve an initial investment of time and money: first, you’ll need to take a cGMP course, and then you need to develop your templates and procedure paperwork while making sure your facility is properly equipped. The paperwork is an ongoing task—you’ll be documenting every little step of your manufacturing process (the cGMP paperwork takes a lot of time and needs to be accounted for in your pricing).

If you decide that you don’t want to deal with the cGMPs, you can outsource production to a cGMP facility where the workers are trained in following the procedures. Some herbal companies are even providing their production facility with their own plant material—homegrown or gathered—for their products. If you do want to pursue cGMP compliance, I highly recommend finding a teacher who is familiar with the needs of a small herbal business. This is even more important if you’re going to be growing your own medicines or wildcrafting herbs, because you’ll have a whole other set of procedures for identification, harvesting, cleaning, and so forth. (Some of the courses on cGMPs are more geared toward businesses that are buying all of the raw plant material for their products.)

Though the primary aim of the cGMPs is to protect the consumer from contamination and adulteration, following them also provides some hard-won benefits for your business: compliance helps you maintain a high-integrity work environment, ensures that your products are consistently what they claim to be, and limits liability.

Compliance with the cGMPs often feels overwhelming to small business owners, and many have simply chosen to close their doors or outsource production to larger facilities. Our advice is to shoulder the task of compliance if owning an herbal products business is your dream; it is entirely possible to learn the ins and outs of the regulations—just keep in mind that it will involve lots of time and paperwork. Download our FREE 95-page ebook How to Start Your Herbal Career: The Ultimate Guide for Budding Herbalists for more resources, including where to find courses on cGMP compliance.

What Kind of Facility Do I Need to Be cGMP Compliant?

Dietary supplements have more stringent production and quality-control regulations to follow as compared to food production and, therefore, must be produced in a cGMP-compliant production facility approved for dietary supplements. Depending on where you live, this may or may not include your home (most states do not allow the production of dietary supplements at home), a shared-use commercial kitchen facility (a rentable space for small business), your own production facility, or a restaurant or other food establishment in which you work. While the FDA determines what is required within a facility to make it safe, your local and state rules have the final say as to where you are legally allowed to produce your product.

To learn more, contact your local and state Departments of Public Health and your state’s Department of Agriculture. In addition, the FDA’s Dietary Supplement FOODSAFE hotline (1-888-723-3366) is an excellent source of information.

Labeling Cosmetics and Dietary Supplements Guidelines for the US

Product labels are representative of both your personal aesthetic and the information you are required to provide to consumers. For those following the FDA guidelines in the United States, there is a hefty body of material to help you from start to finish. Here, we’ll refer you to links that will answer questions about the complexities, including text size and formatting.

Herbal products can only be labeled organic if the entire product (or at least 95% of its ingredients) has been certified organic by the National Organic Program (NOP). In this case, the “organic” label and the USDA organic seal can be used on the principal display panel of the product. Otherwise, any certified organic ingredients can be identified in the ingredients list on the product’s information panel. For more information on organic labeling, see the USDA Organic Labeling Standards. To learn more about becoming a certified organic farm or retailer, see this guide to USDA Organic Certification and Accreditation.

For more information on product labeling, see the following resources:

Dietary supplements labels:

“Cosmetics” labels:

“Drug” labels:

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