Safety & Warnings

FEATURED AUTHOR: Lora Cantele

Lora Cantele is a Registered Aromatherapist and Swiss Reflex Therapist, in addition to being an author. Lora is the co-author of one of the books in the AEOTA Recommended Reading List: The Complete Aromatherapy and Essential Oils Handbook for Everyday Wellness By Nerys Purchon, Lora Cantele. Her resume includes being the Editor/Publisher of The International Journal of Professional Holistic Aromatherapy (IJPHA), a peer-reviewed professional journal.

“During her tenure at the AIA (2006-2012) she successfully lead the development and implementation of AIA’s aromatherapy educational standards to take the level of aromatherapy education in the USA to new heights.”

The AEOTA is very pleased to include Lora’s book on our Recommended Reading List as well as to offer a file to download with updates to the book, for anyone who may already own this book.

To download the updates, just click the image below and download a PDF.

BookUpdates

ARC announces “Raindrop” Policy

The Aromatherapy Registration Council hereby formally clarifies its prohibition on the use or the teaching of “Raindrop Therapy”.

raindrop

Read the complete official Statement of Policy http://aromatherapycouncil.org/wp-content/uploads/2010/12/ARC-LH-RDT-Policy-Statement-Final-.pdf

To read the complete White Paper on Raindrop Therapy go to

Thank you to AEOTA Member, Kristin Barber, co-author of the White Paper, for her valuable contribution to our knowledge about the safe use of essential oils and practices.

Sensitization

Sensitization – “exposure to allergen that results in the development of hypersensitivity.” [1]

essential oil female back spa

So what is hypersensitivity? Is a hypersensitivity reaction the same as an allergic reaction?

Answer, yes. They are synonyms, BUT there are four different types of allergic reaction:
“a local or general reaction of an organism following contact with a specific allergen to which it has been previously exposed and sensitized; immunologic mechanisms gives rise to inflammation or tissue damage. Allergic reactions are classified into four major types: type I, anaphylactic and IgE dependent; type II, cytotoxic; type III, immune-complex mediated;type IV, cell mediated (delayed).”[2]

For the purposes of aromatherapy safety, any essential oil can become an allergen by using it undiluted on the skin; and this risk is there for all essential oils, including lavender. So while there are certain essential oils which have a known reputation for being potential allergens or with a reputation for sensitization, using any essential oil neat (undiluted) sets the individul up for a potential allergic reaction, leading to sensitization, and forever being allergic to that essential oil.

 

Robert Tisserand explains:

 

“Yes, sensitization is the process that takes place in the body that leads to an allergic reaction. They are not the same thing, but they are not totally different either. There are 4 types of allergic reaction, [3] but only two are relevant to essential oils. Type 4 (delayed hypersensitivity) accounts for 90% of allergic reactions. Type 1 is immediate hypersensitivity (generally not anaphylactic) and accounts for the other 10%. You could say the risk is potentially there for all essential oils, but this is a little unfair on the majority of oils, that have never been known to cause such reactions. I don’t like to assume risk that may not exist. The less you dilute the more you increase risk, but that doesn’t mean that undiluted copaiba oil is a greater risk than 1% cinnamon bark oil. It isn’t.”

To learn more, see the video which is a sample from Webinar 4 “Irritation and Allergy” from Essential Oils and the Skin 10-Day Series by the Tisserand Institute: https://www.facebook.com/video.php?v=898998096798059

1. Miller-Keane Encyclopedia and Dictionary of Medicine, Nursing, and Allied Health, Seventh Edition. © 2003 by Saunders, an imprint of Elsevier, Inc. All rights reserved
2. Farlex Partner Medical Dictionary © Farlex 2012
3. http://emedicine.medscape.com/article/136217-overview

You are NOT DETOXING!

If you have spent any time online, learning about or shopping for essential oils, you may have run across testimonials or advice regarding concerns pertaining to side effects. Too often, instead of good, professional information, you may read that these adverse reactions or side effects are the result of “detox“. They aren’t. They CAN’T BE…because that is not the way the human body works. One of the best explainations I found was not actually on an aromatherapy site or holistic health site, but one about smoothies!

“The idea that there are accumulated toxins in your body waiting to be released (usually with the aid of an expensive detox product) is misleading because your body is always in a state of detox. Whether you eat the purest of pure diets, or your live on pizza, beer and ice cream, your body never stops detoxification. As long as you have a functioning liver, kidney and colon, your body is removing toxins.” 

Side effects such as nausea, headaches, itchiness, skin irritations, excess mucous, diarrhea, and more are NOT DETOX REACTIONS.

Any reaction to an essential oil that was not intended could be viewed as an adverse effect. These effects can range from minor and discomforting to much more serious and permanent. 

To learn more, visit the Aromatherapy United page; What is an ADVERSE EFFECT from an Essential Oil?

We invite comments, and will allow them as long as they remain respectful and do not contain marketing or promotional material for any specific brands of essential oils. We invite readers to continue this discussion in our American Essential Oil Trade Association Facebook Group.

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https://phytonutrition-sante.com/da/musculin-active-anmeldelse/
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Eighteen Years Later…

Who is Steering Eighteen Years Later?

“The “Purdue initiative” was the name given to a group of people involved in the aromatherapy industry who took the Aromatherapy program at Purdue in 1996 and 1997. The group showed concern for:

  • A perceived lack of education standards in the aromatherapy industry
  • Instances of unsafe practices
  • The prospect of the FDA regulating the sale of essential oils if the FDA perceived a need to act to protect public safety
  • The prospect of governmental regulation if the industry was not able to provide a self regulation system.
  • The lack of any independent credential available to a person in the industry.” [ref. http://aromatherapycouncil.org/?page_id=75]

Eighteen years later and the essential oil industry and the aromatherapy community are still facing the exact same challenges.

The education standards in the aromatherapy industry range from an afternoon of sales and marketing training in selling essential oils, to 30 hours for a Foundation Level set by NAHA to 100 hours for the exact same “Foundation Level” set by the AIA. And in reality, these standards are not enforced…people still refer to themselves as an aromatherapist with no actual training, and any multi-level-marketing salesperson can hand her classroom of recruits a certificate titled “Certified Aromatherapist” when they leave with their new sales kit!

Unsafe practices have led to liver failure, permanent scarring, sensitization, comas and even death. And the only national association in the USA in the field of aromatherapy, not only failed to keep records of injuries reported to them, they disbanded their safety committee entirely! Keeping track of this data has fallen to volunteers as a result!

The FDA has sent Warning Letters for medical claims ranging from life threatening claims such as marketing essential oils to treat cancer, to ones which are not only safe – but appropriate – like using tea tree for acne.  And yet the FDA DSHEA allows for the most hazardous and fraudulent marketing of essential oils as nutritional supplements to be ingested in water on a daily basis, and yet that is all completely legal.

The industry not only does not self-regulate effectively, but attempts to establish a realistic and appropriate system of self regulation, this American Essential Oil Trade Association, is viewed by some with fear. We have contributors who to this day, choose to remain anonymous because of threats made against them if they show us any public support.

Promoting SAFETY is characterized by some, as “fearmongering”. Empowerment is valued over education by big business. Our industry has completely lost the holistic aspect of holistic aromatherapy, essential oils are pushed like drugs…except it’s often friends and family we trust doing the pushing, or people with a reputable standing in the community; pretty bottles and slick packaging, instead of white powder in baggies.

The only measurable progress made in 18 years is an independent credential available to a person in the industry, that of Registered Aromatherapist™. The Aromatherapy Registration Council which evolved out of the “Purdue initiative” and the original Steering Committee which followed, has been successful in creating a standard, with recognized credentials and true meaning within the Aromatherapy Community. But, until the other titles people appoint themselves, such as Certified Aromatherapist, are also defined and credentialed, consumers are going to continue to assume anyone who refers to themselves as a Certified Aromatherapist, has some measurable and acceptable base of knowledge about essential oils and aromatherapy.  There needs to be some *thing* in between no education other than marketing, and the level required to sit for the exam and become a Registered Aromatherapist™.

A criteria needs to be set and a title which indicates a basic foundation of knowledge, established and trademarked. Someone who has a 30-hour basic foundation level understanding of aromatherapy and essential oil safety should be able to document that, by some standard which is recognized. But this is not the role of the AEOTA.  NAHA or the AIA should set some kind of criteria for the title Certified Aromatherapist, or come up with some other title and credentials which has meaning in our industry. Waiting 18 years is long enough.

About Dietary Supplements

Under section 201(ff)(2)(A)(i) of the Act [21 U.S.C. § 321(ff)](2)(A)(i)], a Dietary Supplement is defined, among other things, as a product intended for ingestion.

Dietary supplements are neither evaluated nor regulated for efficacy or safety under the Dietary Supplement Health and Education Act (DSHEA) of 1994. In addition, FDA approval is not required for dietary supplements to be marketed.

Topical products and other products that are not intended for ingestion are not dietary supplements.

Whether or not they are intended for ingestion, medical claims make a product a drug under section 201(g)(1)(B) of the Act; meaning a dietary supplement with medical claims, is no longer a dietary supplements under section 201(ff) of the Act. Both Young Living and doTerra were warned by the FDA for selling essential Oil products which they marketed as dietary supplements, but which are offered for topical use and/or intended for inhalation.

A *true* dietary supplement will be formulated to provide nutritional benefits missing from the diet – that is why they are called dietary supplements – they supplement the diet. The FDA regulation DSHEA also allows products to be formulated for and marketed with claims that they will impact the structure or function of the body. What is a structure/function claim? This page answers that question: 

One thing I have read more than a few times, which is false, is that the FDA Mandatory Disclaimer mean the FDA has approved the product. It ACTUALLY means the opposite!

” If a dietary supplement label includes such a claim, it must state in a “disclaimer” that FDA has not evaluated the claim. The disclaimer must also state that the dietary supplement product is not intended to “diagnose, treat, cure or prevent any disease,” because only a drug can legally make such a claim. “

This is basically a consumer WARNING not a FDA endorsement!

Essential oils sold as “dietary supplements” are doing so in order to take advantage of two *loopholes*: many essential oils are Generally Recognized as Safe as food flavorings, and the laws regulating dietary supplements [DSHEA] allows them to be marketed with the structure or function claims which are not allowed for essential oils sold for topical or inhalation use. They are NOT selling them as “dietary supplements” because they actually supplement the diet in any way. No ones diet is missing essential oils. They do not contain vitamins.

ds

Essential oils are occasionally ingested for medicinal/therapeutic purposes. Oral dosing has risks which often outweigh any potential benefits.

Dripping herbal essence of a vial over a spoon

FDA send Warning Letters to dōTERRA and Young Living

The need for strong, self-regulation for the sales of essential oils was reinforced by the recent FDA WARNING LETTERS sent to dōTERRA and Young Living in September 2014.

Independent Salespeople from these companies have been misleading consumers for too long. Dangerous claims and unsafe usage advice have led to horrific stories of liver failure, chemical burns, and hospitalizations. [See examples from the recent injury data collection: http://aromatherapyunited.wordpress.com/category/injury-reports-2014/]

The marketing claims made by these companies and their salespeople are dangerous. They are not selling essential oils with truthful sales and marketing claims.

Peoples health and safety are at risk when a salesperson tells them they should use essential oils to treat Ebola, protect against Tetanus, cure Parkinson’s, prevent Alzheimer’s, fix Autism or Brain Injury or cure Breast Cancer. Unless we self-regulate as an industry, the burden will fall to the FDA whose actions will effect us all.

“Your products, “Thieves,” “Cinnamon Bark,” “Oregano,” “ImmuPower,” “Rosemary,” “Myrtle,” “Sandalwood,” “Eucalyptus Blue,” “Peppermint,” “Ylang Ylang,” “Frankincense,” and “Orange,” are prescription drugs as defined in section 503(b)(1)(A) of the Act [21 U.S.C. § 353(b)(1)(A)] for some of the claims made for them because, in light of their toxicity or other potentiality for harmful effect, the method of their use, or the collateral measures necessary to their use, they are not safe for use except under the supervision of a practitioner licensed by law to administer it.” – FDA Warning Letter sent to Young Living

We need to act quickly before the actions of these companies force the FDA into a corner and they decide that essential oils SHOULD be PRESCRIPTION DRUGS!

CNN reported the U.S. Food and Drug Administration states:

“We have a program at FDA that monitors the Internet to look for health fraud products, products not approved by FDA that claim to cure or treat disease,” said Howard Sklamberg, the FDA’s deputy commissioner for global regulatory operations and policy.”

 

“We are continuing to monitor the internet and monitor how these three companies respond,” Sklamberg said. “They have 15 working days to take corrective action. If they don’t take the corrective action, we can take enforcement action against them…seizure, injunction, criminal prosecution.” – CNN http://www.cnn.com/2014/09/26/health/ebola-fake-drugs/

Every time a salesperson makes a dangerous and illegal medical claim such as those examples in the FDA WARNING LETTERS, the entire essential oil industry is put at risk of increased FDA regulations.

Clove essential oil

Clove oil (Eugenia caryophyllataor Syzygium aromaticum)

Syzygium_aromaticumThe main constituents of the clove bud essential oil are phenylpropanoids such as carvacrol, thymol, eugenol and cinnamaldehyde.

“Clove oil is an essential oil from the dried flower buds, leaves and stems of the tree Syzygium aromaticum (Eastern Hemisphere) or Eugenia caryophyllata and Eugenia aromaticum (Western Hemisphere).1 There are only small differences between these species and many consider them to be essentially the same.”

CLOVE Side Effects & Safety

“6.2.1 Health Effects

Clove oil is considered safe in small quantities (< 1,500 ppm) as a food additive. However, clove oil is toxic to human cells. If ingested in sufficient quantity or injected, it has been shown tocause life-threatening complications, including Acute Respiratory Distress Syndrome, Fulminant Hepatic (Liver) Failure, and Central Nervous System Depression; the lethal oral dose is 3.75 g per kg body weight.”

“6.2.1.C Acute Effects – Systemic Poisoning

Clove oil is toxic to the liver and nervous system …

A two year-old child suffered hepatocellular necrosis following ingestion ofclove oil. A three month-old infant developed fulminant hepatic failure after ingesting less than 8 mL of clove oil. A fifteen month-old boy developed fulminant hepatic failure after ingesting 10 ml of clove oil in an aromatherapy product. A 7- month-old child developed central nervous system depression after the accidental oral administration of clove oil”

http://www.marinwater.org/documents/Chap6_CloveOil_8_28_08.pdf

“Recent growth in aromatherapy sales has been accompanied by an unfortunate increase in accidental poisoning from these products. Clove oil warrants special attention. Ingesting as little as 10 ml causes hepatotoxicity which can be treated with N-acetylcysteine.” – http://www.ncbi.nlm.nih.gov/pubmed/15895251

Journal of Toxicology
CLINICAL TOXICOLOGY
Vol. 42, No. 1, pp. 89–92, 2004

Clove oil is one of many essential oils known to be potentially toxic to humans

Toxicity in children has been reported with doses of less than 5 mL.”

“We present a 3-month-old female who developed fulminant hepatic failure after ingesting less than 8 mL of clove oil. Initial treatment involved gastrointestinal decontamination, supportive measures, and admission to hospital. She subsequently developed fulminant hepatic failure and was treated with intravenous N-acetylcysteine (N-AC) according to a protocol used for acetaminophen poisoning. Over the next 72h her liver synthetic function and clinical status improved, and she made a complete recovery. Previous reported cases of clove oil toxicity and the potential role of N-AC therapy are reviewed.”

http://pinnaclife.files.wordpress.com/2012/05/clove-oil-hepatic-failure.pdf

“Special Precautions & Warnings: Children: In children, clove oil is UNSAFE to take by mouth. It can cause severe side effects such as seizures, liver damage, and fluid imbalances.” – WebMD

From Essential Oil Safety by Robert Tisserand: Drug interaction: may inhibit blood clotting, moderate risk of skin sensitivitiy and of mucous membrane irritation.  Dermal use: caution for children under 2 yrs of age.    Maximum dermal use 0.5% due to eugenol (adults).

Wintergreen essential oil

Wintergreen (Gaultheria procumbens) essential oil

wintergreenCAS numbers
USA: 68917-75-9; EINECS: 90045-28-6

EPA Reason for Regulation: Chemical in Commerce
Synonym: Wintergreen oil
List Name: Inert Ingredients in Pesticide Products

Ingestion can cause severe poisoning and death, Lethal doses with children  at 10 ml, adults at 30 ml.”  – Guenther, volume II, page 640

Natural Wintergreen Essential Oil contains 97-99% methyl salicylate. While this is not exactly same as aspirin (the chemical name for aspirin is acetylsalicylic acid) all salicylates do tend to be teratogenic in elevated doses.

Members of the International Federation of Aromatherapists take a “vow” not to use Wintergreen essential oil.

In 1967, an ADI (acceptable daily intake) for methyl salicylate was set at 0.5 mg/kg body weight by the Joint FAO/WHO Expert Committee on Food Additives, and this was reviewed in 2001. The same ADI was adopted by the Council of Europe Committee of Experts on Flavoring Substances. The Health Canada maximum for methyl salicylate is 1% in topical products (Health Canada Cosmetic Ingredient Hotlist, March 2011).” Robert Tisserand

How does it work?

Wintergreen leaf contains an aspirin-like chemical (methyl salicylate) that may reduce pain, swelling, and fever.

WINTERGREEN Side Effects & Safety

Wintergreen is safe in the amounts found in foods, and seems safe for most adults when used as a medicine. For medical use, the oil is UNSAFE to take by mouth. Taking wintergreen oil or large amounts of wintergreen leaf can cause ringing in the ears, nausea, vomiting, diarrhea, headache, stomach pain, and confusion.

sweetbirch

Graphic Courtesy Robert Tisserand

Special Precautions & Warnings: Children: Wintergreen leaf and oil can be poisonous for children. Taking 4-10 mL of wintergreen oil by mouth can be deadly. Don’t even use wintergreen oil on the skin of children less than 2 years old.

Pregnancy and breast-feeding: Wintergreen is safe in amounts found in food, but there’s not enough information to know if it’s safe in the larger amounts that are used as medicine. Don’t take it by mouth or put it on your skin, if you are pregnant. If you are breast-feeding, don’t take wintergreen by mouth or put it on your skin. Wintergreen products might be toxic to nursing infants.

Stomach and intestinal inflammation: Taking wintergreen by mouth might make these conditions worse.

Salicylate or aspirin allergy, asthma, or nasal polyps: Wintergreen might cause an allergic reaction in people who are allergic to aspirin or other salicylate compounds, or have asthma or nasal polyps. Use wintergreen with caution if you have one of these conditions.” — WebMD

INTERACTIONS

“Methyl salicylate must be absolutely avoided by anyone taking blood-thinning drugs, as it increases the action of the drug, and this causes blood to leak into tissues and  internal bruising occurs. Knowing a lethal dose tells you very little about what (a) a therapeutic dose would be or (b) a safe dose would be, but it does tell you what dose not to use!”

http://roberttisserand.com/2012/03/wintergreen-oil-safety/

TITLE 21–FOOD AND DRUGS
CHAPTER I–FOOD AND DRUG ADMINISTRATION DEPARTMENT OF HEALTH AND HUMAN SERVICES
SUBCHAPTER C–DRUGS: GENERAL
PART 201 LABELING
Subpart G–Specific Labeling Requirements for Specific Drug Products

Sec. 201.303 Labeling of drug preparations containing significant proportions of wintergreen oil.

(a) Because methyl salicylate (wintergreen oil) manifests no toxicity in the minute amounts in which it is used as a flavoring, it is mistakenly regarded by the public as harmless even when taken in substantially larger amounts. Actually, it is quite toxic when taken in quantities of a teaspoonful or more. Wintergreen oil and preparations containing it have caused a number of deaths through accidental misuse by both adults and children. Children are particularly attracted by the odor and are likely to swallow these products when left within reach.

(b) To safeguard against fatalities from this cause, the Department of Health and Human Services will regard as misbranded under the provisions of the Federal Food, Drug, and Cosmetic Act any drug containing more than 5 percent methyl salicylate (wintergreen oil), the labeling of which fails to warn that use otherwise than as directed therein may be dangerous and that the article should be kept out of reach of children to prevent accidental poisoning.

(c) This statement of interpretation in no way exempts methyl salicylate (wintergreen oil) or its preparations from complying in all other respects with the requirements of the Federal Food, Drug, and Cosmetic Act.

and

(g)(1) The label of any drug containing more than 5 percent methyl salicylate (wintergreen oil) should bear a conspicuous warning such as: “Do not use otherwise than as directed.” These drug products must also include the “Keep out of reach of children” warning and the accidental ingestion warning as required in 330.1(g) of this chapter.

(2) If the preparation is a counterirritant or rubefacient, it should also bear a caution such as, “Caution: Discontinue use if excessive irritation of the skin develops. Avoid getting into the eyes or on mucous membranes.” (See also 201.303.)

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/cfrsearch.cfm?cfrpart=201&showfr=1&subpartnode=21:4.0.1.1.2.7