What does essential oil regulation look like?
You might have heard a company claim “our oils are FDA approved” as if this is supposed to make a difference in the quality of the oil. What if I told you the FDA doesn’t regulate essential oils, at least not in the way anyone is thinking. So the “FDA approval” is a myth and essential oils aren’t FDA approved, because they simply aren’t regulated in that way.
The FDA doesn’t regulate essential oils as a category, rather if they fall under a category that they do regulate then essential oils can be subject to labeling or marketing laws. In short, the FDA can have a say in HOW an essential oil is labeled or marketed but they do not have a hand in how they are produced or acquired and they do not care how pure an essential actually is when the bottle says “100% pure essential oil”. This is why you will buy cheap oils in the grocery store or from Amazon and find that they smell synthetic, less than therapeutic or are just downright chemically. These would be fragrance oils masquerading as essential oils and sadly a lot of these fake oils lurk all over because of their ability to label the bottle however they want. This includes labeling an adulterated, diluted or synthetic oil as “100% pure” when it’s not really an essential oil.
This is also why some oils vary in the information that is on the bottle and why some companies will offer more details on their oils while others simply slap “lavender” on a bottle and call it a day. But how does the FDA decide what they are going to have a say in and what they will allow to pass under the radar? It has to do with how a product is marketed and what the FDA can actually regulate.
Cosmetics: if an essential oil product is is marketed as a cosmetic than the FDA doesn’t regulate or approve this. As cosmetics do not have to to be approved by the FDA to be on the market, most essential oil products marketed as a cosmetic are safe. Some products might qualify as a cosmetic and a drug.
Drugs: When an essential oil is making health claims then the FDA steps in and has a standards of approval. As essential oils are not a drug they are generally not regulated in this manner. Although if they are making health claims they could be subjected to be inspected by the FDA and/or taken off the market. For this reason, a lot of products on the market that are cosmetics but could potentially have therapeutic purpose state on the label that they MAY help alleviate pain. Or the product says “supports” on the label. This way, the product or company isn’t actually making a medical claim, rather letting the consuming know that this product might be good for this but it is not a guarantee or that it will support already existing things your body does. This is also why some products openly announce they are not FDA approved and do not make any claims. It all seems tedious but just another way to keep big brother from knocking.
Supplements: These are not regulated by the FDA but there are some labeling laws that need to be followed or the FDA will definitely step in. Young Living experienced this when they advertised their oils to be safe to consume, so they created their FDA compliant line of “supplements” aka the exact same essential oils clearly marked as a supplement. However the FDA didn’t care beyond the labeling and doesn’t approve oils for consumption or approve the Young Living line of “supplements” they just required them to openly label essential oils for consumption as a supplement. Fun fact, the Young Living vitality line is the exact same oils as the ones in the regular line, except that the vitality line (peppermint) is about $15 for 5ml and the regular (peppermint) is $33 for 15ml. I will let you do the math on that one, but the vitality line is much more expensive for the exact same oil. (all pricing is based off the retail price)
Some fragrances are also regulated by the consumer product safety commissions (CPSC) which can include air fresheners, candles, laundry detergents and household cleaners. So for things like cosmetics or fragranced items you are required to list the fragrance, however you do not have to elaborate on that. This is why some products simply say “fragrance” and they claim a trade secret to be able to hide any number of synthetic chemicals that make up that particular smell. Fun stuff, right? CPSC allows requires fragrance allergens to be listed if they are above a certain amount, and labeling laws can also simply vary based on which state you live in.
Now, while I love that essential oils aren’t regulated so it makes it easy for the consumer to purchase them, I also don’t love the lackadasical manner in which labeling happens with essential oils. This leaves dishonest companies to be sneaky and lie about what their product is. Many companies will list synthetic fragrances as pure or natural because they were derived from a natural source or made to emmulate a natural source. The contents of the bottle are far from pure though and is incredibly misleading because labeling it pure is leading people to believe what is in the bottle is unadulterated or non-synthetic.
If a company doesn’t release the GC/MS reports on their oils willingly, don’t buy them. I firmly believe that GC/MS reports should be available to the consumer before purchase as well, although many companies will happily provide them when you give a batch number. Too often companies cut corners and get away with it because no one is telling them to knock it off. When essential oils are largely marketed as an aromatherapy or fragrance, they can get away without disclosing what is actually in their product, because it isn’t illegal to withhold the ingredients of fragrances. Much of the world views essential oils as simply another fragrance, so a lot of companies treat essential oils as a fragrance. Companies are allowed to make certain claims because the law allows it, it is fully legal to label something natural simply because it was derived from a natural source. That doesn’t make it natural though, have you ever looked into natural flavors? Far from natural that’s for sure, but they were derived from natural sources.
Due to the limited regulation regarding essential oils, they can’t be encouraged to be ingested, and also why some labels say “not for internal use” because labeling for ingestion is an entire process and most companies don’t want to deal with that and don’t condone the casual internal use of the essential oils. If they were to encourage ingestion of their oils they would have to get special supplement labeling and comply with the FDA. Labeling the oils as not safe for consumption eliminates this step and also protects them if someone was to ingest and something bad happened. They did warn you, so you can’t sue if you knowingly ingested something they said not to ingest.
So what does this mean for companies and people creating products with essential oils (or other similar things)? Well, we can’t make medical claims, we have to list every single ingredient in the product. If we have supplements, they need to comply with labeling laws and/or be subject to testing. In fact, depending on your state your products could be subject to testing at any time in compliance with your state sales laws. A lot of more natural products will be labeled as “may help” and “not FDA approved, this product makes no claims”. It also might be a good idea to get some business insurance if you are looking to jump into the natural product market.
These regulations (or lack there of) can make having a business more difficult as you may have to jump through hoops. Don’t think that the lack of regulation is a free pass to be able to run your business how you like, the FDA can still step in and say “we don’t like this” or “you can’t claim this” and pull out all the stops. While smaller business can get away with this more, if the business grows beyond a certain point than the FDA will be there in case you step out of line. Earthley Wellness has had to deal with this when listing what their herbal products do. Many people assume that the FDA stepping makes a company unviable but this is far from the truth.
Products without FDA approval though are not to be feared. In fact, they tend to be better as they aren’t constantly seeking the approval of arbitrary standards and the companies behind products like that tend to care about their consumer more. A lot of people are more inclined to purchase something if it says “not FDA approved” because they prefer to have the freedom of the free market and choices. While the FDA is certainly in place to keep companies in line and protect the consumer, sometimes the things they care about and regulate make little sense. Like stepping in when an essential oil was marketed for consumption but simply saying “hey just label that as a supplement” but also caring if someone list the real therapeutic benefits of an herb or essential oil.
What are your thoughts on the FDA and other large organizations of approval?
