Are Essential Oils Safe? FDA, GRAS, CPTG and dōTERRA.

There is a great tumult buzzing through the world right now on the uses of essential oils. In some countries, essential oils are a significant part of the culture used for religious, therapeutic, and even in medical settings. Here in my country, the United States of America, essential oils have been some what of a hidden treasure, not commonly known through the country for any thing other than what crunchy or hippy people do. Not until recent years has the use of essential oils for therapeutic benefits in America come into true popularity.

The purpose of this blog post is to outline the use of essential oils in Modern American Culture, what the rules set by the U.S. Food and Drug Administration (FDA) are and what they mean, what the FDA means when they say Generally Recognized As Safe (GRAS) and dōTERRA's Certified Pure Therapeutic Grade (CPTG) standard, and how they are the fastest growing and highest retaining essential oil company in the world right now.

Edward Burch, from ABC 30/40 in the Birmingham Alabama area reported that "The use of essential oils has boomed among families who want to stay free of pharmaceutical drugs and antibiotics."[1] Christiana Molina, writer for Elle, mentioned the rising essential oil trend. Molina writes "The surging popularity of essential oils and aromatherapy may seem like a New Age trend". Molina also points out that essential oils have "... actually been around for centuries. Long heralded for improving health and overall well-being, essential oils can be used as an alternative natural treatment for a wide variety of mild maladies." [2]

While these oils have become a popular alternative in healthcare, the FDA has not placed its approval on these essential oils for medicinal uses, regardless of if they work or not, even though many of modern medicine's foundation's can be found in essential oils and plant abstracts. This, as Burch reported, is because "unlike today's medicine, these oils lack research and clinical trials" [1]. According to pediatric doctor, Bill Hardwick: "The question always is, 'what is the safety information and the quality of the product?' So, safety wise there is very little information about widespread use of these products". Dr. Hardwick goes on to talk about 'special populations' saying "Pregnant women, nursing moms. There's very limited information about the safety of those products within those populations". [1]

An even bigger concern by many people is that a good portion of essential oil distributors and promoters are not doctors, nurses, pharmacists, aromatherapists, herbalists or any kind of healthcare practitioner, (though there are many in all the above who are involved in essential oils). But a good portion of these distributors and promoters are stay-at-home moms, bloggers, blue collar workers, or your average Joe. This raises concern because many people believe that only a professional in the healthcare industry can know enough about health to practice. This belief however, is folly. Someone who has applied themselves, especially in this, the 'Information Era' can find themselves as well informed, or even more so than a healthcare professional. The difference is that, one who goes through the necessary training for licensing will be accredited and recognized by a governing body as proficient in the subject, and the other will not be accredited or recognized.

Moving on, we will talk about some of the trends throughout the United States with essential oils.

According to a study done by the American College of Healthcare Science (ACHS) in 2012 on trends of essential oil usage. 1,534 surveys were sent out to aromatherapists who were members of the National Association of Holistic Aromatherapy (NAHA) Alliance of International Aromatherapists (AIA) and the Aromatherapy Registration Council (ARC), as well as Aromatherapy graduates from ACHS. Only 191 returned the surveys. From these surveys, we find some interesting trends in recent years as far as essential oils go.

[3]

 

As you can see, the professional background of these aromatherapists are various. The ones I want to focus on are the "Other" and "All Other Responses" selections. Because in these two, you will likely find those individuals who are just someone who wanted to learn a little about aromatherapy so they can show people that they know what they are talking about. If you take the two and combine them, they will reach far past all the other options. Now imagine, if these extra courses to become an aromatherapist are primarily being taken by the "Other" group, how many of the "Other" group, not included in the survey, are there who haven't taken courses to become recognized as an aromatherapist out there? Is it possible that they far surpasss any other group?

Again, people like to see credentials, and don't care as much when you 'just do' studies independently. That doesn't mean that the individual with the credentials knows more. After all, what formal education accredited by the government of the time did Hippocrates have?

Another reason for great alarm is when people disregard or don't pay attention to the legal aspects of what they are talking about.

Some people are worried that essential oils will be outlawed, others that the reputation will be destroyed, all because someone may say that "[so and so] essential oil can protect and treat [insert disease here]". Whether it's true or not is not the point. The point is that at this point, you are claiming that the essential oil can be used as a drug, and according to the FDA "If a product is intended for a therapeutic use, such as treating or preventing disease, or to affect the structure or function of the body, it’s a drug. For example, claims that a product will relieve colic, ease pain, relax muscles, treat depression or anxiety, or help you sleep are drug claims". [4] The problem is not that you are making a drug claim, the problem is that you are making a drug claim on a product that has not received approval by the FDA to say it is a drug. Even if you are not calling it a drug, to the FDA, you are.

When talking about the use of essential oils, it is important to note that whether or not they work for you in caring for your ailments is not the concern. It is what you are claiming they do. If you say it cures, heals, or protect against a sickness, you have just made a drug claim. And the FDA will come knocking at your door (which I personally view as a violation of first amendment rights, but that's a topic for another day).

The FDA has come down on many essential oil companies in recent years in regards to representatives (wholesalers, distributers, retailers, etc...) who are making these clams.

Now, to answer the question, "are essential oils safe?" according to the FDA many essential oils are GRAS (Again, that's Generally Recognized as Safe). This means that though essential oils many not have been approved by the FDA for medicinal use, there are some uses that they are approved for.

From the same study done by ACHS we touched on earlier, we find what the most common uses are these aromatherapist use essential oils for.

[3]

It is interesting to note that the surveyors reported that they used essential oils externally and orally, and that the aromatic use was not reported (though it could possibly be implied in the section "Prepare products for clinical use").

The biggest 3 questions on safety are:

1. Are they safe aromatically?
2. Are they safe internally?
3. Are they safe topically?

Aromatically.

I believe the answer to this question has already been answered affirmatively by the previous content in this post. So, I will move on to the biggest question out of the three, internal or oral safety.

Internally.

There are many essential oils that have been named GRAS. According to the FDA, a GRAS product is "any substance that is intentionally added to food is a food additive, that is subject to premarket review and approval by FDA, unless the substance is generally recognized, among qualified experts, as having been adequately shown to be safe under the conditions of its intended use, or unless the use of the substance is otherwise excluded from the definition of a food additive." also " the use of a food substance may be GRAS either through scientific procedures or, for a substance used in food before 1958, through experience based on common use in food." [5]

Below is a list of essential oils that could fit the GRAS description produced by dōTERRA:

• Bergamot
• Black Pepper
• Cardamom
• Cassia
• Cinnamon
• Clary Sage
• Coriander
• Cumin
• Fennel
• Geranium
• Ginger
• Grapefruit
• Jasmine
• Juniper Berry
• Lavender
• Lemon
• Lemon Grass
• Lime
• Marjoram
• Melissa
• Orange
• Peppermint
• Roman Camomile
• Rose
• Rosemary
• Spearmint
• Tangerine
• Thyme
• Ylang-Ylang

[6]

(For the full list of GRAS essential oils you can visit the FDA's webpage by clicking here.)

Topically.

When you think about putting something on topically, you typically think about locations, deodorants, perfumes, and colognes. The topical use of essential oils is a practice that extends far in to ancient times. Common use in biblical writings includes anointing feet, head, wounds, etc...

Earlier we talked about how the FDA classifies essential oils for internal use. When essential oils are applied topically, this is what they say:

"If a product is intended only to cleanse the body or to make a person more attractive, it’s a cosmetic. So, if a product such as a shower gel is intended only to cleanse the body, or a perfume or cologne is intended only to make a person smell good, it’s a cosmetic." [4]

"The law doesn’t require cosmetics to have FDA approval before they go on the market. But FDA can take action against a cosmetic on the market if we have reliable information showing that it is unsafe when consumers use it according to directions on the label, or in the customary or expected way, or if it is not labeled properly." [4]

Pretty self explanatory, this is the legal stance of the United States Government in regards to topical application of essential oils. But what about topical use for ailments or treating symptoms? The FDA says, "Some products are both cosmetics and drugs. For example, a baby lotion marketed with claims that it both moisturizes the baby’s skin and relieves colic would be both a cosmetic and a drug. Such products must meet the requirements for both cosmetics and drugs." [4]

So again, we are back to the drug claim issue. The law is what the law is, and we have to abide by it, whether or not the evidence is in opposition to it. The only way to fix that is by changing the law (which is a topic for another day).

By now you're probably getting the FDA picture and you are ready to get on with the program. Good! So am I! So lets talk about CPTG and dōTERRA. (And I actually will let dōTERRA do most of the talking, seeing as they say it better than I ever could.)

We already know that many essential oils are on the GRAS list, and that is great! But according to dōTERRA everyday "...doTERRA recognizes that there are many uses of essential oils outside of these [FDA regulated] parameters. Because there are no governmental bodies or organizations that approve or certify essential oil quality, doTERRA has chosen to follow a specific standard in producing essential oils through our Certified Pure Therapeutic Grade quality control process. This standard ensures that our essential oils are the top quality available on the market today and completely pure." [7]

"dōTERRA CPTG Certified Pure Therapeutic Grade^® essential oils represent the safest, purest, and most beneficial essential oils available today. They are gently and skillfully distilled from plants that have been patiently harvested at the perfect moment by experienced growers from around the world for ideal extract composition and efficacy. Experienced essential oil users will immediately recognize the superior quality standard for naturally safe, purely effective therapeutic-grade dōTERRA essential oils." [8]

"dōTERRA International sources essential oils from responsibly managed farms throughout the world where growing, harvesting, and distilling methods meet dōTERRA’s strict internal standards for purity (CPTG—Certified Pure Therapeutic Grade®). Because organic certification varies from country to country, province to province, and in the US, from state to state, it is not currently possible to acquire all oils under certified organic status. However, dōTERRA’s ongoing commitment to the highest quality production means that all our essential oils are analyzed and cross-tested by independent laboratories. This cross-testing (GC/MS—Gas Chromatograph and Mass Spectrometry) ensures that our green product offering contains pure aro¬matic extracts and are a step above organic. CPTG essential oils are free of pesticides, chemical residues, fillers, herbicides, extenders, and solvents." [9]

Like I said, they say it better than I ever could. dōTERRA has been a company that I have come to trust when it comes to their purity in essential oils. I have been through many other companies and never been so satisfied as I have with dōTERRA. Is dōTERRA the only place to get pure essential oils? No. However, as I just said, they are a trustworthy brand. The fact that they are the fastest growing essential oil company in the world should speak volumes about the quality of their products. Am I saying that dōTERRA is the only way to go? No. But they are the best when compared to most of the other companies.

If you haven't yet experienced the dōTERRA difference and would like to, please visit www.FarleyEssentialOils.com. If you would like to learn more, please feel free to look around, and ask questions. You can email us at journeytopersonalfreedom@gmail.com

References

1. Burch E. Essential oils continue to grow in popularity. Abc3340com. 2014. Available at: http://www.abc3340.com/story/25475363/essential-oils-continue-to-grow-in-popularity. Accessed April 3, 2015.

2. Molina C. Everything You Need to Know About Essential Oils. ELLE. 2014. Available at: http://www.elle.com/beauty/makeup-skin-care/tips/g8781/essential-oils-loccitane-aromachologie-collection/?. Accessed April 3, 2015.

3. Petersen D. What's Hot And What's Not: U.S. Trends In Aromatherapy Essential Oils Choices. 1st ed. American College of Healthcare Sciences; 2012. Available at: http://ACHS.edu. Accessed April 3, 2015.

4. Fda.gov. Aromatherapy. Available at: http://www.fda.gov/Cosmetics/ProductsIngredients/Products/ucm127054.htm. Accessed April 3, 2015.

5. Fda.gov. Generally Recognized as Safe (GRAS). Available at: http://www.fda.gov/Food/IngredientsPackagingLabeling/GRAS/. Accessed April 3, 2015.

6. Accessdata.fda.gov. CFR - Code of Federal Regulations Title 21. Available at: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=182.20. Accessed April 3, 2015.

7. Doterraeveryday.com. Are doTERRA essential oils organic?. Available at: http://www.doterraeveryday.com/are-doterra-essential-oils-organic/. Accessed April 3, 2015.

8. Doterra.com. What Is an Essential Oil?. Available at: http://www.doterra.com/sgen/essentialDefinition.php. Accessed April 3, 2015.

9. Doterraeveryday.com. Are essential oils FDA approved? Are they organic?. Available at: http://www.doterraeveryday.com/are-essential-oils-fda-approved-are-they-organic/. Accessed April 3, 2015.