If any of you are like I was, you began your essential oil journey in an earnest attempt to find the best ways to care for yourself and your family. Maybe you didn’t. Maybe you just like the way they smell as an air freshener, personal perfume, or additives to your cleaning supplies. No matter what you use essential oils for, it’s important to understand the laws surrounding them.
U.S. regulations regarding natural products are unclear, ambiguous, and often confusing. The European Union (EU) has more specific definitions but even so, still lacks total clarity. I’ll try my best to break this down and make it easier.
Let’s look at some legislative definitions so we can understand the difference between “natural” and “organic” and “cosmetic” versus “drug”.
This word is easy for us all to understand, right? This is the most challenging and complex of the definitions.
“Natural” by U.S. standards means that all of the materials used to create something are derived from nature (that “derived from” part is the loophole). This looser interpretation of natural means that so long as a product contains all natural ingredients, it can still be considered a natural product, i.e. essential oils, smoke based flavors, etc. EU standards have a more restrictive definition of the term “natural” and apply it to the manufacturing process, as well as the component ingredients. The chemicals used for extraction, as well as the exact temperature that can be used are highly regulated. Many things that are “natural” by U.S. standards would not be deemed so when applying the EU standard.
The U.S. has the Flavoring Extract Manufacturer Association (FEMA). The EU has a comparable group, the European Food Safety Authority (EFSA). They also have the European Flavors and Fragrances Association (EFFA). The EU has new regulations that further restrict ingredients by implementing a list of positive ingredients that are much easier to regulate.
The USDA “Organic” seal is protected by federal law (7 CFR Part 205.311). In order to use it companies must comply with a set of USDA standards and have official certification (USDA Organic Factsheet). Pay close attention to the labels. If a product says “organic” it means that 95% of the ingredients meet organic criteria. The only way that you know the product is totally organic is if it says “100% Organic”. Non-agricultural products are broken down into: soap (self-explanatory), cosmetic, or a drug (FD&C Act, sec. 201 (i).
The Federal Food, Drug & Cosmetic Act (FD&C Act) defines cosmetics as “articles intended to be rubbed, poured, sprinkled, or sprayed on, introduced into, or otherwise applied to the human body…for cleansing, beautifying, promoting attractiveness, or altering the appearance.”
Cosmetics are things like: moisturizers, hair products, lipstick, deodorant, makeup remover, nail polish, etc. If your cosmetic products claim to cure you of something then it is also a drug (or known as a “cosmeceutical”).
This is where it gets scary, folks, pay attention. Drugs are classified by their intended use. The FDA classifies drugs as “articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease” and “articles (other than food) intended to affect the structure or any function of the body of man or other animals”. Why should you care? Well, your essential oil products (and some cosmetics!) may actually fall into this category.
Now, why do you care?
Whether you use, purchase, or sell essential oils, listen up. If you sell someone an essential oil and tell them that the oil, peppermint, for an example, will restore hair growth, lower a fever, treat indigestion, etc, you are breaking the law. Those are considered medical claims and it makes the product a drug. Unless you are a licensed physician, you are now practicing medicine without a license (hence the breaking the law part). Is it always fair? No. There are plenty of times we all eye-roll because we know peppermint tea helps an upset stomach. Is it necessary? Yes. I will give you a very real example. If you are offended, then you are exactly the person that needs to be reading this article.
Sellers/associates of both DoTerra and Young Living were caught making egregious and unqualified medical claims. These individual sellers were stating on social media, in sales “parties”, and on their personal blogs and websites that their products could cure all manner of diseases, to include Ebola. Yes, you read that correctly! These well-intended, but grossly unqualified people were making profits by telling the world they could cure a disease that is closely regulated and has not been tested against any of those products. The result was that both companies received warning letters from the FDA, advising them of the violations and directing them to remove all marketing materials related to the claims. If not, the FDA will initiate regulatory actions. You can read the DoTerra letter here and the Young Living letter here.
I use that situation as an example of why regulation is important. It is not to pick on either company. They happen to be the largest essential oil sellers in the U.S. so it’s natural that they would get caught for violations that I’m sure many smaller companies make, as well. I am a huge advocate of people choosing to buy their products wherever they want, based on educated choices.
To be clear, I am no fan of the FDA or the USDA and have a fair amount of distrust when it comes t the motives and honesty of both. Either way, essential oils are tricky but we are still ultimately responsible for compliance. If you don’t sell essential oils or essential oil products, knowing the regulations is still worthwhile. Pay attention to who you buy them yours from and what their qualifications are. If you are purchasing from someone that does not know the law, you may want to reconsider where you source your products.