If you read sources like Health Impact News you might think that the government is "targeting" essential oils and natural substances and trying to keep us from using natural remedies. (Read their article here.) You might think that the FDA and Big Pharma feel threatened by essential oils. But today I'd like to offer an alternative and "inside" view as to what's really going on behind the warning letters and why they're actually a good thing.
According to US law, there are three categories of substances: Drugs, Cosmetics, and Supplements.
Any product or ingredient that claims to treat, cure, or prevent disease is considered to be a drug. All active drug ingredients must go through very specific testing procedures and the FDA approval process before they can legally become a drug. When you make a drug claim but the product/ingredient hasn't gone through the approval process, that product then is considered a "misbranded drug" by the FDA. This law was written several decades ago and has nothing to do with the current drug marketplace or corporations that have ties to the FDA.
|Young Living Billboard in Salt Lake City|
The third category under the law is cosmetics. Cosmetics are meant to cleanse, moisturize, and beautify the body. (Skin, hair, teeth, etc.) As a company that manufactures cosmetics, we have to be careful in the claims that we make. For instance, we can make a cleanser that's meant for cleansing skin, however, saying that the product will treat acne would be making a drug claim. We can make a moisturizer with skin hydrating and softening properties, but can't claim it will be anti-aging, because that is a drug claim.
Are Essential Oils Drugs, Supplements, or Cosmetics?
Most essential oils haven't gone through the necessary testing and approval process to be drugs, so they're not seen by the law as such. Also, they're not intended solely for internal use (and shouldn't be!) so they're not supplements either. So, the category that essential oils are regulated under is cosmetics. Because cosmetics are not meant to treat disease, they cannot claim to prevent the common cold, treat the flu, cure ebola, or have antibacterial action. They are meant to simply smell nice, refresh your room, or perhaps calm your mood. This is why the companies received their warning letters. You can't state that essential oils are going to treat infections, prevent a cold, stop ebola, or cure cancer within the realms of the law. doTerra and Young Living have been marketing their essential oils illegally for years.
Not a Government Conspiracy
There are hundreds of companies breaking FDA regulations on a daily basis. So many that the FDA really doesn't have the manpower to really regulate every single one. It's really only until a company has really hurt someone with their product or is reported several times that the FDA takes notice. And that is exactly what happened with Young Living & doTerra. With a growing list of people that have been injured by reactions due to bad advice from essential oil reps and a petition supported by Aromatherapy United that was circulated and submitted to the FDA, it's no surprise that after years of breaking the law, they finally got a warning.
NOT because the FDA wants us to stop using essential oils. NOT a government conspiracy to promote "Big Pharma."
Comments in response to the news of the warnings have ranged from supportive to outrage. One argument that I've heard is that it's unfair of the government to come in and stop companies from promoting natural substances, and that the essential oil market should be self-regulated. But, in my view, an industry can't be self-regulated if major players in the market are blatantly breaking the law. If you have an industry that's consistently following the country's regulations, the government is going to spend less time worrying about what you're doing. Clearing out the law-breakers from the industry is a step towards self-regulation.
One article in response to the controversy stated that the FDA "refuses to conduct any testing on natural or alternative therapies in order to find out whether they work or not." Well, yeah...that's because the FDA doesn't do ANY testing. Companies that are bringing a new drug to the market do the testing--not the FDA. The FDA simply reviews the studies that the companies submit to them and decide whether or not a substance is approved and how it should be labeled and marketed. (Listing of side effects, etc.)
|Governor Herbert on a Young Living Wagon during the 4th of July Parade|
I don't feel bad at all for doTerra and Young Living. These are companies based in my home state of Utah. I've seen their multi-million dollar headquarter buildings, freeway billboards, and the millions of dollars they rake in every year. With the business that they do around here, it's hardly the big mean government picking on the little guys. These companies have our local government in their pockets because they are major players in our state's economy. In fact, the Governor's Office of Economic Development gave doTerra a contract for a tax incentive to build their headquarters in 2013 and just announced a state tax credit and contract with Young Living. These companies may have been served with a slap on the wrist from the FDA, but they have the full support of the governor.
I support essential oils and I don't have anything against the actual products doTerra and Young Living offers. I think it's great that people are looking for alternatives to drugs and are looking to live more holistically. However, I have seen dangerous advice being given out (ingesting certain essential oils, applying it IN people's eyes, applying it straight to the skin) for years by the reps of these companies and people have been hurt. The warning letters are a step toward safety and self-regulation within the aromatherapy community. As a manufacturer of cosmetics who tries to obey the law, I'd rather see a level playing field and everyone striving to label and market products that adhere to the laws of our country.