Herbal products and regulatory categories

The herbal view

In the world of herbalism, the lines between foods, medicines, and cosmetics are wonderfully blurred.  We look at a spice rack and see both flavoring and healing possibilities.  We add cumin and coriander to flavor our beans, knowing that these spices will also support digestion.  We add turmeric to our curries, maybe adding a little extra if our joints have been giving us trouble.  We scoop out a little coconut oil to moisturize our skin. 

The regulatory view

When we begin to sell products, however, those blurred lines disappear and we are left with very clear categories.  In the eyes of regulators like the FDA, herbal products fall into the categories of food, dietary supplement, cosmetic, or drug. 

It all comes down to intended use

Which category your product falls into depends on the intended use of the product.  I’m going to repeat that because that’s the key thing to understand: it’s the intended use of your product that determines what regulatory category your products are in.  That intended use is determined by what claims you have on your product and how you’re directing people to use that product. 

If your product is intended as part of the diet, that’s a food.  If your product has a health claim beyond the basics of foods (i.e. supporting good sleep, supporting heart health, or promoting good digestion), or it supplements the diet (i.e. vitamins or minerals), then it’s a dietary supplement.  If your product is used externally, it’s most likely in the cosmetic category.  If your product claims to treat a disease, it falls into the drug category.     

Each category has different intended uses, different allowable claims, and different manufacturing regulations.  As an example, oats (Avena sativa), can be a food (oatmeal), a dietary supplement (milky oat tincture), a cosmetic (moisturizing oat-based cream), or an over-the-counter drug (colloidal oats for the relief of eczema).  Oats shows us that it’s not the ingredient that matters, but how we intend for the product to be used that makes a difference. 

So, let’s say you’re selling peppermint tea.  You get to decide if you’d like that tea to be sold as a food or a supplement.  If it’s a food, you’re technically not allowed to make any claims (though many companies do push the line and make simple claims on foods).  If you’d like to promote the benefits of peppermint, making claims that it can support digestion and alleviate gas, then you’ll be in the supplement category.   

Labeling, manufacturing, and other responsibilities

Knowing your regulatory category is important not just for claims, but also determines what regulations you follow for product labeling and manufacturing.  The manufacturing requirements can have a significant impact on how and where you set up your business.

Cosmetics have the most simple labeling and manufacturing requirements, followed by food labeling and manufacturing requirements, and then by dietary supplement labeling and manufacturing requirements.  Drugs are in a league of their own and have very strict manufacturing, labeling, and registration requirements, so are not appropriate for the vast majority of herbal product makers. 

Deciding what regulatory category your product is in is one of the first steps in regulatory compliance and can make a big difference for your business. 

Have questions on this?  Feel free to get in touch.  I love helping small businesses understand and navigate the regulations.