Wednesday, January 21, 2015

Why the Essential Oil "Crackdown" is a Good Thing

You may have heard the story--on the 22nd of this September 2014, the FDA sent warning letters to both doTerra and Young Living Essential Oils. (See the original letters here, and here.)

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.

The Law


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
There are exemptions from drug testing requirements for herbs, supplements, and vitamins, but these substances have to be very clearly marked as supplements and have to use very specific language with their claims. For instance you can claim, "supports immune system" but you can't claim that something is anti-viral. You can claim "supports hormonal balance" but can't claim to cure PCOS. [This is from my understanding of the law; if you're selling supplements please make sure you do all your legal due diligence.]

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."

The Fallout


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.)

Insider's View


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.

Bottom Line


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.


20 comments:

Anonymous said...

Thank you , I had a Young Living rep coe to my house and he made claims that I thought were on the edge of illegal and low and behold they were. I am a seasoned homeopathic and natural remedy consumer, So you know I am in favor of natural remedies.

ReNew Botanicals said...

Very well stated, thank you.

Anonymous said...

Good logic. Of course the FDA relying on studies from drug makers is inherently flawed, so you can't trust a broken system like that and therefore their true intentions. Drug makers create 'studies' that play up the 'benefits' and play down the side-effects, so the FDA reps cannot determine what's real or fake to a large extent. Hence why millions die each year from side-effects. My only source for health truth is https://theHealthFoodGuru.com

Anonymous said...

Stephanie is so smart and reasonable. Love her point of view.

Anonymous said...

Thank you for this education. You allude to it, but what IS the proper way to use essential oils like these?

Nan T said...

I totally agree, perfectly written, thank you

Carlos Alvarez said...

Great article and clarification on NO testing done by the FDA.

They do not spend on that :)

Carlos

Mara said...

I agree completely with your post. Thanks!

Anonymous said...

Wonderfully written article and the truth, to boot! Thanks for a great read.

Liz said...

Thanks, Stephanie, for, once again, bringing clarity and reason to a misunderstood topic/issue. Too often, people speak without knowing, either, all the facts or how to state them in a professional, respectful manner without falling prey to black-or-white thinking. It's interesting that the US government is geting flack for trying to ensure the companies follow laws already in place, but, no one is alarmed about the LOCAL governments involvement which is enabling these companies to play fast and loose with people's health.

I sometimes wish that education had been your calling, Stephanie, because, despite your high intelligence, vast knowledge and deep understanding of so many matters, you have such a straightforward, succinct way of explaining things in layman's terms so that EVERYONE can understand it. You make it all seem simple, which, to this scientifically-challenged individual, is both MUCH appreciated AND needed. :)

Anonymous said...

As a professional aromatherapist, I want to give you a huge "thank-you".
Combating false and/or incomplete information supplied by YL & DT reps is not easy, and it makes me happy to see there are still folks that do their homework.

So again, thank you!

drandrea said...

great article! as an integrative doctor, i am frustrated daily by all sides, especially with the ridiculous rhetoric and misinformation from many alternative health sources- on the other hand i love companies like yours that are straightforward and doing great helpful work making products i use myself and can recommend to my family and patients! thanks for publishing your insights :)

No Name said...

Hi Stephanie - can you advise who compiled the adverse side effects list please. Thanking you kindly - great info. Regards - Ellen.

Stephanie Greenwood said...

@No Name--I believe it is the Atlantic Institute of Aromatherapy. http://www.atlanticinstitute.com/injury-report-2014

Ellen Cox said...

Hi Stephanie - thank you so much for your response and link, that is very helpful. Regards - Ellen

Anonymous said...

Let's clarify a couple things. #1 the FDA does NO testing on anything, be it an oil, supplement or drup. PERIOD.
#2 the FDA warning letters were NOT generated because of injury by any oil company

The FDA bases their approval ONLY on testing done by the manufacture of the product seeking the thumbs up. Ie: a new prescription is tested by the manufacture, that information is then submitted for review by the FDA. The decision for approval or not, is based soley on THAT information.

The warning letters were addressing medical claims made by certain independent disttributors, individuals representing the companies yes, however, those websites as well as any other website, blog or social media outlet, do not necessarily reflect the company. They had nothing to do with injury, and everything to do with those particular few having their websites, blogs, posts being repeatedly submitted to the FDA by individuals who were doing their due diligence in reporting medical claims. PERIOD

Anonymous said...

I am so happy to have found your blog. I actually found it while researching makeup and found an older blog you had written. (And yes, I rec'd my Lauren Brookes samples a couple days ago and love them. I have Vapour samples coming too. And now...after reading your blog, I'll have to try a few more!)

Anyway, This post really made me feel confident in you as a blogger. I am not happy with the claims many of the reps make - and there are a lot out there that are endangering lives. I prefer to buy my oils from Aromatics International as I know exactly what batch I am buying from and they provide the GC/MS report for each batch. Anyone who is recommending EO's, especially to infants, children and the elderly, should get the book "Essential Oil Safety: A Guide for Health Care Professionals" or contact a licensed Aromatherapist.

Thank you so much for the great blog!

Kay

Anonymous said...

Hi Stephanie,
Thank you so much for this blog and for all the great things we can learn from you! Thanks also for the great products you make.
I have a question about a perfume I have. What do you think of it?
Ingredients: alcohol denat. (from organic sugar cane), fragrance/parfum (100% naturally derived), aqua/water/eau, d-alpha-tocopherol acetate, amyl cinnamal, farnesol, geraniol, limonene, linalool.
The website (SowGood) says that the perfume is phalate-free. I have a feeling it's still not that great, especially since its staying power is "too good to be true" for anything good. I'd really appreciate your opinion.
- Rachel

Stephanie Greenwood said...

Thanks for your question!

Well, it is possible to have naturally-derived perfume compounds. It would be better if it was all certified organic so you'd know for sure. One thing that I'd do is email the company with some questions and see how they respond. If it seems like their customer service is good and they're not hiding anything, it could be ok. :)

Anonymous said...

Thanks, Stephanie. I just might send them an e-mail! Do the other ingredients sound okay?

I just received my B&B package yesterday! The remainder of my day consisted of washing my hands, applying lip balm, and putting orange vanilla deodorant cream on my arms 'cause it smells so good. (Hope that's okay.) Not sure if that perfume company will keep my business! When I put the lip balm on I was like, "Wow...what IS this stuff?" Lol. :) Very nice and smooth.

I do have a question. You mention adding baking soda to the shampoo (in your hand) if you have hard water... would it clog the foamer bottle if I add a bit in there and shake it up well? My husband and I and our four kids would go through it quite quickly (maybe there are product-changes concerns too?).

Thanks for your wonderful products, and for making it affordable! Thank you, thank you!
- Rachel