PROBLEMS WITH USING ESSENTIAL OILS LIKE DRUGS

The rise in “makeover your medicine cabinet” approaches to using essential oils presents three key problems:

  1. It is the least effective way to therapeutically use essential oils.
  2. It does not address the root problem.
  3. It is illegal in the United States.

To best understand the problems we must first look at how this all got started…

A Brief History of Botanical Medicine

Humans have been employing the use of botanicals, or plants, to support and restore health for some 50,000 years. Or, you could probably say botanicals have been used as long as humans have been on the planet.  Botanical medicine has a 5,000 year written history based on the energetics of the person and the plant. You see, humans have been treating the individual long before they fully understood anatomy, physiology, and states of disease.

When the shift began in the last century to do away with this model of healing and instead treat disease and illness, the lay-person lost a valuable resource for wellness care. Prevention was tossed to the wind and we lost sight of taking care of ourselves based on our energetic makeup. And if you look around, we’re really rather suffering from the lack of wellness-based medicine in our lives and our communities, aren’t we? I certainly think so.

Botanical Medicine is Holistic at its Core

If you had an appointment today with an Ayurvedic practitioner, a Chinese medicine practitioner, a herbalist, or myself, you wouldn’t be treated for your high blood pressure, your osteoarthritis, or your migraines. While all of these symptoms are important and will be considered by the practitioner as part of a whole you’ll really be treated based on your energetic constitution and the symptoms will be viewed as clues to what’s really going on.

How do you experience the world? Are you a fire constitution expressing too much heat through chronically inflamed joints? Are you an air constitution expressing too much wind that leaves you mentally spacey during the day and with troubling insomnia at night? Has damp or dry energy patterns tipped the scales for your constitution?

Any constitution can experience similar symptoms but getting to the root of the cause takes some asking, listening, and observing (hence my 5 pages of questions on my intake form!). A fire type and an air type can both have knee pain but their origins are very different and their treatment plans should be different as well.

Replacing Drugs with Essential Oils

So you want a natural solution for [insert health complaint here]. After being steeped in treating disease states instead of the person for the past hundred years your first thought isn’t going to be: “I’ll use this essential oil because it has this energetic aspect that my body needs for balance.” Nope. You’re going to look at what western medicine would classify the essential oil for.

Let’s say you’ve got a sinus headache. It’s allergy season here in Southeastern Utah and between the mold and the plant pollens, a lot of folks are really suffering. What would be your first choice for that sinus headache from your essential oil kit? If you looked just at the chemistry you might choose, say, Peppermint. It’s rich in terpenic alcohols (aka monoterpenols) and right there on the monograph, it says “decongestant,” that’d be just the thing!

But wait, that’s only part of the story of peppermint essential oil. Peppermint’s energetics give us deeper clues as to who should be utilizing this essential oil. It’s in the pungent family (TCM, Ayurveda, AGM) and likes to move and circulate energy in the body. It’s also classified as a Yin botanical with cooling properties. So, who needs these properties? Someone with a hot and Yang temperament, yes? Aha! What if your constitution tends toward cold though? What if your dominant dosha is Vata? What if it’s a Yin and cold season and the last thing you want is to amplify that temperature in yourself? Oh, then this isn’t the right essential oil for you at all. In fact, it might exacerbate your constitution and you’ll only feel worse. Well, that’s not the relief you were looking for.

If you choose an essential oil like a drug: this essential oil for this acute health problem; the worse that happens is you feel worse, or it doesn’t work. While unpleasant, or disappointing, it isn’t necessarily life-threatening if you’re working within safe dosing guidelines. What is potentially life-threatening is when essential oils are bought and sold to advanced disease states like cancer, high blood pressure, or an autoimmune condition. There aren’t any essential oils that will replace chemotherapy, blood pressure medication, or treat multiple sclerosis. Not that these disease states cannot be improved by treating the individual, it’s just that essential oils aren’t drugs. What happens if you follow the bad advice of taking Frankincense essential oil for cancer? If you take enough to wipe out cancer it will be too poisonous a dose for your eliminatory organs to handle and you’ll go into organ failure and die. If you don’t take enough, it will likely protect the cancer cells giving them the opportunity to continue to grow and spread, and if you’re in chemotherapy at the same time it will make the chemo harder to do its job.

Essential Oils Cannot Legally be Sold or Recommended as Drugs

So, if death or worsening of a condition isn’t an indication enough that essential oils aren’t drugs and shouldn’t be used to treat from a western medicine perspective there’s the fact that it is completely illegal for essential oils to be recommended and sold as drugs in the United States. The branches of U.S. government, designed to protect consumers and the field of medicine, have created specific laws around this.

In the United States a sales representative (product rep/consultant), an employee at Whole Foods, your aromatherapist, your herbalist, or your aromatic therapies practitioner, cannot:

  • treat medical conditions – headaches, cancer, cold/flu
  • prescribe, recommend or suggest essential oils, herbs, or nutritional supplements for medical conditions
  • diagnose medical conditions

…unless they are licensed in their State to practice and prescribe medicine.

Why this is Great for You and Me

Making it illegal to use essential oils as drugs is a rather good thing for both you and me. Firstly, it protects you, the consumer, from snake oil sales folks that want to sell you a product for your medical condition. There’s no reason an untrained, unlicensed person should be practicing or prescribing medicine. Okay, we could probably argue the benefits of emergency medicine in the event of the zombie apocalypse.

It’s also great for me, as an aromatherapist, that I don’t have to practice medicine. Or prescribe medicine. I didn’t go to medical school and I have zero interest in practicing western medicine. My CPR training card doesn’t give me any authority to treat your medical condition any more than your neighbor licensed in plumbing does.

I can treat you as the wonderfully holistic person that you are – with your unique way of absorbing and expressing this beautiful life. And that’s why I’ve spent 19 years studying holistic medicine! I love tapping into the body’s own innate healing abilities by gently nudging it towards homeostasis, that balanced state it thrives in and strives for.

Eastern and Western Medicine Synergy

In closing, I want to talk about the benefits of combining modern and ancient medicine models in the practice of aromatherapy.

Eastern aromatherapy looks at the energetics of the person and the essential oil and prepares a treatment plan based on supporting the constitution of the individual. Be it grounded in Traditional Chinese Medicine, Ayurvedic Medicine, Ancient Greek Medicine, or another system, it always supports the person, not the allopathic disease state.

Western aromatherapy closely analyzes and studies the chemistry of the essential oil. This information gives us the biophysical action of the essential oil, dosing parameters, and safety information like contraindications and cautions. Then it looks at the scientific study of the human body: anatomy and physiology (A&P). A&P gives us guidance on routes of absorption, how the chemistry of the essential oil travels in the body when we smell it, when we apply it to the skin, when we use it internally, and the best methods to accomplish each of these routes for the highest therapeutic effect.

Each area gives us one half of the story, and when combined we have a holistic, modern, wellness tool that is powerful, safe, and very effective. Toss in a healthy diet, loving movement of your body, and we could quite possibly change the world with aromatherapy!

PROBLEMS WITH SELLING ESSENTIAL OILS LIKE DRUGS

This article is focusing on the problems with selling essential oils like drugs.

Some of the key problems are:

  1. Essential oils aren’t approved as drugs in the United States.
  2. A prescription is required by a medical professional licensed to prescribe medicine in his/her State.
  3. A license to practice as a pharmacist and control a pharmacy is required.

To first understand the problems we need to look at some of the ways essential oils are regulated in the United States.

Classification of Essential Oils

fdaEssential oils are regulated by the following federal agencies:

  • Food and Drug Administration (FDA)
  • Federal Trade Commission (FTC)
  • Environmental Protection Agency (EPA) and Fish and Wildlife departments
  • Customs and Border Protection (CBP)

The federal government doesn’t recognize essential oils as their own class of consumer products. Instead, the category an essential oil falls under is based on:

  1. the words you & the manufacturer use to market the essential oil – referred to as “claims” by the Food and Drug Administration (FDA).
  2. the perception of how the essential oil is to be used by the consumer.

An essential oil might be sold under one of these categories:

  • cosmetic
  • dietary supplement
  • approved drug
  • GRAS flavoring
  • soap
  • air freshener or household cleaner

As much as we love our all-in-one bottles of essential oils the federal agencies don’t. Accordingly, you can’t market the same bottle for multiple categories. It’s a pick one or none kind of deal. If an essential oil is sold as a cosmetic (topical use product) it cannot make structure/function claims. If an essential oil is sold with structure/function claims (supports the natural functioning of the respiratory/digestive system) it is classified as a dietary supplement and can be sold in pre-formulated capsules to be taken by mouth or in a dietary supplement bar clearly labeled not a food. If an essential oil is sold as a food and beverage flavoring ingredient it can only be used according to GRAS dilution standards to appear in products around 100-1000 parts per million. If an essential oil is sold as an over-the-counter drug it must be formulated according to the FDA’s monograph. If an essential oil is sold as an approved (new or old) drug it is sold by prescription by a licensed pharmacist in a licensed pharmacy that meets federal regulations for formulations and dosing.

Please note I am not covering livestock and veterinarian use of essential oil sales as that is not an area I have researched nor do I have a great deal of interest in.

Cosmetics are a classification of essential oils intended for use on the skin and body. And yes, as I’ve pointed out above, a cosmetic product cannot also be a dietary supplement and vice versa.

“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” [FD&C Act, sec. 201(i)].

Dietary supplement is a classification of essential oil constituents intended for use in the body. A good example of a product on the market that meets DSHEA guidelines and employs a C02 extraction of cinnamon is New Chapter brand’s Cinnamon Force alongside the alcohol extraction of the herb cinnamon. Remember, an essential oil cannot be sold as both a dietary supplement and a cosmetic – the same bottle cannot be sold for skin use.

Congress defined the term “dietary supplement” in the Dietary Supplement Health and Education Act (DSHEA) of 1994. A dietary supplement is a product taken by mouth that contains a “dietary ingredient” intended to supplement the diet.

GRAS flavoring is a classification of essential oils that are intended to flavor foods and beverages. There’s a good bit of confusion around GRAS and essential oils – namely that GRAS doesn’t mean it is a dietary supplement and that the FFDCA has guidelines for essential oils used in flavoring foods and beverages that generally range somewhere between 10-1000 parts per million in a finished product. To get a better idea of what this looks like I recommend you read my article: Essential Oils and GRAS: What it really means.

“GRAS” is an acronym for the phrase Generally Recognized As Safe. Under sections 201(s) and 409 of the Federal Food, Drug, and Cosmetic Act (the Act), 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. For example, substances whose use meets the definition of a pesticide, a dietary ingredient of a dietary supplement, a color additive, a new animal drug, or a substance approved for such use prior to September 6, 1958, are excluded from the definition of food additive.

Essential oils can also be sold in soaps, in perfumes (under the cosmetics guidelines), as air fresheners (regulated by the Consumer Product Safety Commission), and of course in OTC and new drugs. Just keep in mind that soaps, perfumes, air fresheners, diffuser blends can’t be sold with cosmetic, drug, or dietary supplement claims (i.e. you can’t sell a diffuser blend for immune support during cold and flu season).

Why we can’t sell essential oils as drugs

If you want to sell essential oils as drugs there are a few legal hurdles in your pathway:

  • State licensure as a pharmacy facility and as a pharmacist
  • Compliance with current good manufacturing practices (CGMP)
  • Labeling with adequate directions for use
  • FDA approval prior to marketing
  • A prescription from a medical professional with a current license to prescribe

Some folks are not prepared to go to pharmacy school to sell Lavender essential oil for headaches or a cold-flu essential oil blend. Not to mention getting essential oils approved as drugs (hundreds of thousands of dollars), and have you even priced liability insurance to work as a pharmacist in this litigious country? Yeesh!

Ways you can’t sell essential oils

Again, a disclaimer that I am not your legal adviser but am offering information based on consulting with no fewer than 7 licensed attorneys in 4 states and that I rather devour regulatory websites like romance novels, this is what it boils down to:

Ways you can’t sell a bottle of Lavender, Peppermint, Frankincense, or other essential oil:

  • You can’t make disease/condition claims without a license to practice medicine, prior approval from the FDA as a drug, a pharmacy license, and a prescription from a medical professional with a license to prescribe (since you can’t treat medical conditions, prescribe, and fill prescriptions all under the same roof). Disease/condition claims would include terms like headaches, cold/flu, cancer, high blood pressure.
  • You can’t make drug claims without prior approval from the FDA, a pharmacy license, and a prescription from a medical professional with a license to prescribe. Drug claim examples would include terms like analgesic, expectorant, antispasmodic, antimicrobial.
  • You can’t sell a bottle of essential oil with structure/function claims if it is to be applied to the outside of the body or inhaled unless you follow the guidelines of manufacturing an over the counter drug and then you wouldn’t have a bottle of essential oil anymore you’d have a topical OTC drug.

Further thoughts on ‘relaxation’ and structure-function claims

To sell Lavender essential oil with a claim of “relaxation” it must be in the form of a dietary supplement. Not a raw ingredient like a bottle of essential oil but readily available in a product that will go into the consumer’s mouth. Leaving the consumer to manage dosing and dose forms on their own is fraught with problems, namely:

  • dosing is based on the chemistry of the essential oil to determine the level of “active” ingredients in the form of specific chemical constituents.
  • dosing is measured in milligrams and based on the weight of the average adult consumer.
  • capsule selection is based on whether the capsule should dissolve in the stomach acid or in the lower bowels.

None of these is left to the consumer to guess at. And in the end you don’t have a bottle of Lavender essential oil, you have a carefully formulated bottle of encapsulated essential oil. You still have to follow current known safety guidelines, observe laws related to manufacturing, labeling, and advertising, as well as report back to the FDA adverse events consumers have experienced.

I think it is important to remember that encapsulating an essential oil doesn’t reduce potential toxicity with regards to:

  • Teratogenicity – the capability to cause malformations or defects to an embryo or fetus.
  • Hepatotoxicity – the capability to cause toxicity in the liver.
  • Nephrotoxicity – the capability to cause toxicity in the kidneys.
  • Carcinogenicity – the capability to cause cancer through the damage of genome or the disruption of cellular metabolic processes.

The responsibility to make every effort to avoid poisoning the general population through careful regard for dosing (amount and length of use) and delivery systems is on the company’s shoulders. Think companies aren’t responsible for this? Head on over to the U.S. Department of Justice and see for yourself what kind of hot water you can get into when you combine greed, unsafe ingredients, and not following labeling laws. Scrutiny in the dietary supplements industry has skyrocketed in the past few years as consumers are reporting more adverse reactions, raw ingredients are being adulterated or contaminated, and companies are not following federal and state laws when manufacturing products for consumers.

Will we lose access to essential oils in America?

There is a concern felt in many branches of the essential oil and aromatic therapies industry that we may lose access to essential oils if they continue to be sold as unapproved drugs. If essential oils are deemed too dangerous because people are drinking them in water and recommending their use for ebola would it surprise any of us that the FDA pulls them all off the market?

We have this amazing wellness tool and it would break my heart if we lost access to it. Not simply because my livelihood revolves around access to essential oils in my practice, aromatherapy but because they do play a role in my personal wellness care.

How do you sell essential oils in the United States?

So, dear reader;  If you need a space to commiserate on the challenges of retailing essential oils here I’m totally cool with that. I do respectfully ask that you don’t use the comments section to complain that essential oils should be legal to sell as drugs, or that so-and-so or such-and-such company is violating X number of federal laws, or to get on your soapbox about big pharma or government agencies or conspiracy theories. I appreciate your thoughtful replies and look forward to hearing from you!