doTerra is drugging YOUR children!

Back in 2015 when I was the webmaster for Aromatherapy United, I wrote a follow up post on the doTerra company essential oil Drug Claims: doterra-drug-claims

About a month ago, I reported a doTerra salesperson to the FDA for making drug claims. I decided to see whether the doTerra corporate claims that they are “policing their own” is true, and copied them, too.

They replied. They missed the point – focusing on making sure their salespeople are competing with each other fairly, but my point was made. doTerra cannot continue to claim they have no idea these claims are being made, because my email reply proves otherwise.

Things are not getting better – in fact they are getting worse.

Now thousands and thousands of doTerra salespeople are not just putting their individual customers in danger, they are putting entire classrooms of children in harms way by pushing EOs as drugs to be introduced into childrens bodies without parents knowledge.

Complete and total disregard for the fact that salespeople and other parents drugging other peoples children is illegal, they continue to promote EOs to treat, cure, mitigate or prevent medical conditions and now YOUR childs’ brain may be chemically altered, your child with asthma may be at risk of dying, and your child’s immune system may be impacted by diffusing essential oils in the classroom!

Inhalation is the most effective method for treating systemic medical conditions, using essential oils. When inhaled, they directly impact the brain by triggering the olfactory bulb.

In addition, they reach the bloodstream via the lungs and are one of the class of chemicals which can pass the blood/brain barrier.

Salespeople for this company are promoting the practice of putting chemicals so strong they are used off-label as drugs, into your little childs’ body, and no one is doing a thing to stop it…including the management of doTerra who know their Diamond Level Salespeople are promoting this practice!

I looked at the profile for Administrator for this Facebook Group – she is promoting essential oils as drugs on her personal Facebook profile.

I googled her – here is a graphic from the website for one of the people she is credited for recruiting into the doTerra company – yup – doTerra DRUG CLAIMS including Alzheimer’s diseasecancerpneumonia and more.


The FDA needs the public to report these illegal drug claims for essential oils by salespeople. The aromatherapy industry is self-regulated, and in order to maintain the freedom we currently have to purchase and use essential oils safely, we need to all work together to enforce the laws against those individuals who jeopardize our rights with their false and illegal claims for essential oils and aromatherapy products.

NOTE: you do not need to be injured or experience an adverse effect, to report dangerous products.

“If you find a website you think is illegally selling human drugs*, animal drugs, medical devices, biological products, foods, dietary supplements* or cosmetics* over the Web, please select one of the three options below to report to FDA.”

 

*An essential oil sold in any way that implies it can treat, cure, prevent, mitigate or cure a medical condition, is being sold as a misbranded human drug. Medical conditions include issues which are often treated using over-the-counter drugs including help acne, ease pain, relax muscles, aid sleep, etc.

 

RECOVERED – My FDA complaint – Ava Anderson NonToxic

Originally Posted in 2012 – here is a link to the Blog Post I wrote about my FDA Complaint against Ava Anderson NonToxic:

https://web.archive.org/web/20131129211933/http://gogreenct.wordpress.com:80/2012/06/05/my-fda-complaint-against-ava-anderson-nontoxic/

The comments to this Blog Post are a big part of this article so instead of republishing it, I am posting a link.

I even had a comment Posted by Anonymous on August 13, 2013 at 12:04 am who claimed to be an “Executive” with Ava Anderson NonToxic!


UPDATE: The USDA investigation confirmed allegations “that AA (Ava Anderson) marketed its Essential Oil product as organic, in violation of the USDA organic regulations“.

I was also quoted in that article:

 

http://www.golocalprov.com/business/ava-anderson-hit-by-usda-for-false-claims-of-organic-is-new-company-selling

RECOVERED – Why now?

I am in the process of recovering old articles I wrote about Ava Anderson Nontoxic [later rebranded as Pure Haven Essentials]. Why now? The answer is, freedom of speech.

I used to have a Greenwashing Blog where I would share articles about the companies I reported to the FDA or the USDA, articles exposing Greenwashing in cosmetic company claims (like labeling perfumes as 100% essential oils when they contained synthetic fragrances), marketing products as Organic when the products were in violation of the USDA National Organic Program laws, etc.

I’ve been asked why I deleted these articles and then removed the blog.

The answer is, I was threatened with a law suit by the management of Ava Anderson Nontoxic.

I received urgent contact by the Attorney for NYR Organic who said that my articles exposing the lies and fraud and misinformation being promoted by Ava Anderson Nontoxic, put me in violation of the rules for Members of the Direct Selling Association (DSA). As an Independent Consultant, I alone was responsible for the costs of fighting any law suit in court, the company would not defend me or support me because even though everything I was posting may have been completely true and my intent was to protect consumers from potential harm from believing these false claims, rules are rules. As a person who represented NYRO, I had the responsibility to follow the DSA rules. If I wanted to stay with NYR Organic, I had to remove my blog. I really believed I had a future with the company. I was only half joking when I told the Attorney “My Dream Job would be to move to Concord and work at the Home Office.” That was then, this is now.

Since that time, I have been very disappointed in the direction taken by the US Management. People I respected suddenly left the company. The one person who promised me that they would take my concerns seriously, including concerns about the misinformation about essential oils on our websites (the company still categorizes absolutes as essential oils and their aromatherapy training falls short in many key and basic areas), suddenly left the company prior to the last annual convention. No explanation. The emphasis in the past few months has been on multi-level-marketing and not on aromatherapy education, not on the “why” natural is better, and tips for how to hold a home party and recruiting seem to take center stage. Fellow NYR Organic consultants had been reaching out to me for answers to their questions about essential oil marketing, about safety issues, and about FDA regulations. MY efforts to engage with fellow consultants on the private, consultant-only Company managed Facebook group was disappointing to say the least. Questions I had about the company crossing the line from making cosmetic claims into medical claims were either deleted or never approved. Lively and informative discussions about issues related to the essential oil industry here in the USA were shut down – and the only topics encouraged were about sales figures, recruiting numbers, and consultant incentives for successfully multi-level-marketing.

I got one of those “perhaps we need to speak privately” messages from the new Vice President of Sales and Training. I looked her up on LinkedIN. I found a strong background in “home party” sales and marketing. Pampered Chef, handbags, and – OMG –  she is the former Vice President of Ava Anderson Nontoxic. I was shaking. When we talked, I was direct – “were you the one responsible for threatening me with a law suit, potentially financially ruining my family, when you were with Ava Anderson Nontoxic?” She admitted she was.

I have spent months trying to get past this fact, and I did give her the benefit of the doubt that she would actually care about essential oils and aromatherapy and learn what she did not seem to know about natural cosmetics. But the direction the company is taking is generic – they appear to me to only care about sales – not WHAT they are selling. The mission to me, seems to be the same as if they were selling purses or kitchen equipment or candles.  And that is not the foundation this company was built upon.  Neal’s Yard Remedies foundation was holistic health, natural skincare, herbal medicine, and in the UK they seem to still care about that – while in the USA they adopt pretend “standards” invented by fellow consultants with *connections*.

They jump on the October breast cancer bandwagon and donate a few pennies from the sale of certain products to a “charity” whose own mission is to WARN consumers about many of the very ingredients that are in Neal’s Yard Remedies products!  That lack of homework speaks volumes.

Our websites still list absolutes as essential oils, even though the new VP also promised this would be corrected.

The FDA warns about cosmetic companies making anti-aging claims, and my questions remain unanswered about how NYR Organic is legally able to make structure and function claims for a topical product (which the FDA considers to be medical claims) such as “it works to visibly lift, plump and recontour skin that’s starting to show the second signs of ageing.” (I suspect it is because they throw in words like *appears* and *feels* to attempt to make structural changes to the skin just cosmetic and not actually changing anything)

I have been told more times than I can count, “PERFECT IS THE ENEMY OF GOOD”.  I get it, I really do.  And if NYR Organic was “good enough”, I would still be a consultant.  But it simply isn’t.  Not any more.

So…now that I am not bound by the DSA rules for not disparaging member companies – I am recovering all my old Ava Anderson Nontoxic articles.  And THAT feels good.

 

MLMs – A Public Health Hazard

I wish everyone would listen to this exceptional short lecture by David Crow!

Learn more about David Crow here: http://www.floracopeia.com/David-Crow/


NOTE: I did not receive any products at a discount or free in exchange for my review, nor have I been compensated in any way. I am just a fan! I have no material affiliation with any of the websites in this blog post.

Happy Thanksgiving

Happy Thanksgiving. I am grateful to have had the opportunity to post about essential oil and aromatherapy and herbal topics that are of interest to me both here on this blog and in my Facebook Group.

As of today we have 2,552 members in that Group, but with so little member participation, I have decided to direct my energies in a different direction. Teachers make a ton of money teaching courses to students, authors make money selling books, essential oil salespeople make money selling products.

I realize that my “ethics” are not in harmony with too many in this industry.

I’m not willing to turn a blind eye to the damage done to children, customers, and the industry itself by companies like doTerra – and stand silent while people make money, or promote their projects, or get their five minutes of “fame” in a self-serving *movie* – then be called a *hater* by exposing the hypocrisy in all of this. Educators who see the MLMers as their meal ticket with a “if you can’t beat them, join them” mentality. Men who finally open their mouths and take a stand – but when things get hot – let the women in their lives take the heat and they worry more about their reputation and so back pedal instead of stand strong and confront the challenges. I’m not an aromatherapist or an herbalist – I am a consumer and a blogger and I have always been offended by those who say things like “if people want to harm themselves with EOs, let them – thin the herd – natural selection – personal choice.” I’m done.

I’m going back to my herbal studies because I see a level of ethics, communication, unity of purpose, and professionalism in that community that is seriously lacking in every facet of the aromatherapy community and for my own personal wellness – I cannot take one more moment of people characterizing my passion for exposing FACTS about companies who are HARMING others as being a “hater” and when I am called a “HATER” – I realized not one single person in this industry that I considered to be an ally or friend – had my back. I’ve been the one to do the “dirty work” for too long. I should have known back in 2014 when a small group of us started discussing how to combat the dangerous marketing of essential oils as drugs – but one by one people were too afraid that putting their name out there would hurt THEIR book sales – or when it came down to SIGNING the online Petition – signing their name might cost them future students – that I would be left alone as the only person willing to SIGN the actual FDA complaint with my name. I took pride in that but I also thought doing all the hard work would align with others mission to promote safety. I was very naive. So this was a very eye opening experience to say the least.

No more free advice.

No more time spent exposing the lies and the fraud and the schemes that others use for personal gain.

I am done. THANK GOODNESS

Reputations Count!

If you have been buying essential oils since the 1980’s or so, you probably used many tools to help choose which brands to purchase. Personally? I bought a lot of books, and looked in the back of the books for Resource Guides. Most books about aromatherapy had lists of companies the author would recommended. I also spoke to teachers of aromatherapy, and asked what companies they recommended. I honestly don’t know of a single consumer, aromatherapist or essential oil educator from the *early days* who relied on getting a GC/MS test result BEFORE they decided to buy an oil! That kind of testing was certainly used people in the wholesale supply chain – both to determine purity and quality. But not on the retail consumer level!

Things changed a bit thanks to self-proclaimed “experts” coordinating crowd-funded “3rd Party Testing” of a series of essential oils starting in 2013. The result? All hell broke loose! Yes, a few companies were found to be selling (knowingly or unknowingly) adulterated products. But some legitimate companies were defamed and damaged. How? One popular brand was selling a boutique oil from a small distiller. It was analyzed and compared to the library sample of a “pure oil” which was from a completely different country of origin! This so called “expert” declared the oil to be “adulterated” when in fact, it was 100% pure.

In another incident, a well known MLM brand of peppermint oil tested as adulturated with ethyl vanillin. Well known expert and affiliate of the same MLM (he was *their* contract chemist) disagreed with the analysis of the test results.

[ref. https://www.facebook.com/notes/10152519141798083/]

I use this as an example of how experts can test the same sample, or even evaluate the same test results, and reach different conclusions. These tests are scientific, but they are still quite dependent on the individual doing the analysis, not just the skill or expertise of the lab running the actual test.

So why have we become so dependent on these tests, as consumers? In my opinion, the reason is fear.

Fear and folks preying upon that fear to make consumers increasingly reliant on “lab tests” to make decisions on which products to purchase. They set up crowd funding schemes or “non profit” companies (more about that later**) and convince their fans and followers to send them money to pay for testing, and convince them there is no other way to determine if the oil is pure or good quality (rarely if ever with a criteria *for* good quality I must add).

I recently read that there is even a school which teaches “if a brand does not include a GC/MS test result with your bottle, don’t trust them.” I’m sure this school has loads of new students who think they can’t buy a bottle of lavender oil unless they complete a course on understanding these test results! FOLLOW THE MONEY!

Lets say you regularly stock Lemon EO from ten different batches, and sell retail sized bottles all across North America and Eastern Europe. You have test results from each batch on file, of course.  But to also produce flyers to insert in boxes, and match up those flyers to each specific batch number as the product goes through the assembly line, is both unrealistic and would dramatically increase the price of these retail bottles.  And for what?  A consumer pacifier, because while the retail customer may have no idea what the report says, some blogger or teacher claims they should not trust the brand unless this information is available to them?  It’s both unrealistic and actually increases the incentive to provide fraudulent reports.

Example – you buy a bottle of lavender and get this report with it {used for editorial purposes only}. If you are not trained to evaluate the report – for all you know – it’s not even lavender! [It is].

It is also naive to believe that just because one bottle of EO tested pure, or with specific constituents in certain percentages, that the next batch will be the same. If a company wants to cheat, they are going to cheat!

Dr. Pappas of Essential Oil University writes in his article “The Proper Protocol for Utilizing EO Analysis Reports“:

“Lastly, its very important for anyone selling essential oils to know that if you have an analysis done on a pre-ship sample for the purposes of making buying decisions, then you CANNOT use that report on the pre-ship sample to represent the actual bulk lot that is purchased and received in, even if your supplier says it’s the same lot. If you want to forgo having your actual received lot analyzed because you trust your supplier to send the same thing they sampled you then that is fine, but you CANNOT use that pre-ship sample report to represent the oil that you sell to your customers because you did not have the actual bulk lot analyzed once it came in your door. This is very important because it frequently happens that a supplier sends one lot as a pre-ship sample but the actual oil that is shipped in bulk to fill the order does not match the pre-ship sample. I know it sounds crazy but this happens all the time.”

So what percentage of EOs that come with reports, are unsuspecting essential oil consumers purchasing based on the “school of thought” that as long as the bottle comes with a GC/MS or they can download it from the suppliers website, it’s some guarantee of purity or quality. These customers may be fooling themselves!

So how do you choose a good, reliable, high quality brand?  Go back to basics!

  • History – has the brand been around for many years?  That’s a positive.
  • Affiliations – does the company & staff belong to professional associations*
  • Education – who are the owners of the company, and where did they study aromatherapy?
  • Marketing & Labeling – truthful, legal, industry standards:
    • Common name for the Plant
    • Latin name
    • Plant part
    • The extraction process
    • “Keep out of reach of children”
    • “External Use Only”or “Not for Internal Use” or “Not for Ingestion”
    • An expiration date or date of manufacture or Batch Number
  • Reputation – A good reputation among professionals in the aromatherapy field is critical.
    • A bad reputation is rarely without cause in this industry.
      • Look for honesty and transparency if there was an issue with a product in the past
      • Watch out for prices which seem too good to be true – that is a big red flag!
      • Watch out for salespeople who claim their product is organic, without Certification
      • BEWARE of companies that claim their essential oils are “Therapeutic Grade” or “Clinical Grade” or “Pharma Grade” or “Certified Pure Therapeutic Grade” – there are no such grades! THESE CLAIMS ARE LIES.

*American Herbal Products Association (AHPA), The Aromatherapy Trade Council (ATC) and owners or employees who belong to the International Federation of Professional Aromatherapists (IFPA), Alliance of International Aromatherapists (AIA), or National Association for Holistic Aromatherapy (NAHA).


In conclusion, during every step of the supply chain, proper testing using standard methods for essential oil analysis should be mandatory. If someone is a formulator making perfume, or cosmetics, or soap, or OTC Drugs, naturally they need to know the exact chemistry in the essential oils they are using to formulate their products and obtaining a GC/MS that is batch specific can be critical. But those people are not buying small retail sized (and priced) bottles of EOs. They buy wholesale. Professionally trained aromatherapists or massage therapists who use essential oils on a regular basis, probably also usually buy in larger sized bottles and retail off-the-shelf sizes, and they also might need to have access to test results.  But the average retail customer, using the recommendations above, can almost always avoid brands which are likely to be adulterated.


**Following the money includes businesses that claim they are charities but which are not!  We are a country of laws and the IRS does not allow a business to accept money and claim they are “donations” and pretend they are a charity unless the IRS has reviewed the application for non-profit status as a 501[c][3] tax-exempt organization and approved the application.

In this case, being affiliated with well-respected members of the aromatherapy community does not give this organization credibility, by contrast, it seriously damages anyone affiliated with them!

dis-Honest “natural” claims

This is a proposed Class Action Complaint against The Honest Company (“Honest”) for falsely, misleadingly, and deceptively labeling its products as “natural,” “all natural,” “naturally derived,” and/or “plant-based,” and for falsely, misleadingly, and deceptively labeling these products as containing “no harsh chemicals, ever!” when these products in fact contain a spectacular array of synthetic and toxic ingredients (collectively, the “Falsely Labeled Products”).

Yes! The Honest Company (of Jessica Alba fame) was presented with at least one Class Action Law Suit for selling products they said were natural, but which actually contained synthetic ingredients!

Instead of allowing the suit to proceed, both sides have agreed to settle the original dispute to avoid burdensome and costly litigation. What does that mean?

Consumers are able to submit claims and potentially receive a check or a Settlement Credit. Learn more here: http://www.thcmarketingsettlement.com/home


Does this mean other companies which market their products as natural, can be sued?  It sure does!

So all those companies which claim that no one regulates the term natural, or they use this term loosely when they sell you their soap, cosmetics, household cleaners, or other products – just might want to educate themselves about what natural means – and more importanly – does NOT mean!

Young Living & “Intent” to sell drugs

Young Living has been trying to reign in their zillions of consultants ever since the Petition to Protect the Future of Aromatherapy and the resulting FTC and FDA complaints by Aromatherapy United, resulted in Warning Letters to the company.

petition-closed

 

Some things they have done in the best interest of their finances, like label certain essential oils as “dietary supplements” in order to legally make structure and function claims. That serves no one but themselves, and eventually the FDA will catch up to the fact that most of the structure and function claims they make are unsubstantiated and that there is no reason to ingest essential oils on a daily or even regular basis. It may take a few more deaths, but I believe it will happen.

But other things are done well, and while also with the ultimate goal of protecting the company, has the positive side benefit of protecting consumers from misleading SNAKE OIL sales pitches and dangerous advice, which have led to so many adverse reactions over the past years. [example see the Injury Databases at Aromatherapy United].

Here are a couple examples from a publicly available Young Living presentation from last year.

YLftc

Funny, some people just don’t get the message. So I took a couple screen shots off Facebook yesterday and I’ll be adding to the ongoing File of complaints with both the FTC and the FDA!

This particular consultant is making “pain relief” testimonial claims for topically applied YL essential oils, in spite of the fact that pain relief products are a category of over-the-counter drugs.

  • It does not matter if the essential oil is labeled and sold for topical use – making it a cosmetic;
  • it does not matter if the essential oils is labeled and sold as a “dietary supplement”:
  • pain relief is a DRUG CLAIM.

So unless that bottle is labeled according to FDA regulations for OTC Drugs – it is illegal to imply it will work to relieve pain.

It is dangerous enough that this company casually sells Wintergreen Essential Oil with no hazard warnings, but when their consultants continue to promote it as a drug – well – the company still has a long way to go before consumers are safe from their “consultants”!

So the next time a Young Living consultant tells you it is healthy to ingest essential oils – whether the bottle they are trying to sell you is labeled according to the FDA regulations for cosmetics, or labeled according to the FDA regulations for “dietary supplements”… you can tell them Young Living themselves says

“There are no health claims approved for essential oils”!

ylEO

Wintergreen EO – Buyer Beware

WINTERGREEN

Wintergreen (Gaultheria procumbens) essential oil

CAS 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

CHIP detailsXn; R22, 36; 0%; S26 (A26) – “Ingestion can cause severe poisoning and death, Lethal doses with children  at 10 ml, adults at 30 ml.” — Guenther, volume II, page 640

Wintergreen Essential Oil contains 85-99% of methyl salicylate, the same component of aspirin.

Thirty ml (about an ounce) of wintergreen oil is equivalent to about 171 adult aspirin tablets or about 60 grams of aspirin.

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

“How does it work?

Wintergreen leaf contains an aspirin-like chemical that might 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.

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.

When applied directly to the skin, wintergreen oil can cause skin irritation.

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 aspirinallergy, 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.”

http://www.webmd.com/vitamins-supplements/ingredientmono-783-WINTERGREEN.aspx?activeIngredientId=783&activeIngredientName=WINTERGREEN

INTERACTIONS http://www.webmd.com/vitamins-supplements/ingredientmono-783-WINTERGREEN.aspx?activeIngredientId=783&activeIngredientName=WINTERGREEN

“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 DRUGSCHAPTER I–FOOD AND DRUG ADMINISTRATIONDEPARTMENT 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


Originally Published on: Oct 4, 2014 @ 06:03

UPDATED 8/21/2016

wintergreen

NOTE: when Wintergreen EO is sold with medical claims, such as referring to pain relief – the product is being sold as a misbranded drug.  Wintergreen products which contain more than 5% methyl salicylate (and 100% pure Wintergreen EO is 85-99% of methyl salicylate) – are required to have very specific WARNINGS. Does the brand you buy have these warnings?

poisonousplants

There is a reason to keep EOs out of the reach of children, and take their use seriously.  These are wonderful products when used properly and safely.  Potential poisons when not.  Wintergreen is one of the EOs which due to it’s chemical nature – is absorbed through the skin and may reach the bloodstream.  Many people have been hospitalized and there is at least one death, attributed to topical application of wintergreen oil or products which contain it as an ingredient.  That is why products with Wintergreen are supposed to be labeled as OTC or prescription drugs, and contain dosages, contraindications, “when to seek medical attention” and all the other labeling requirements of DRUGS.

Essential Oils as Food Flavors

If you eat prepared foods, or eat peppermint candy for example, you have ingested essential oils.

That’s not snarky, that’s a fact.

There is a HUGE difference between the internal therapeutic use (oral, vaginal or rectal) of essential oils and “ingestion” of essential oils as food flavorings.

The Alliance of International Aromatherapists does not recommend internal therapeutic use “unless recommended by a health care practitioner trained at an appropriate clinical level. An appropriate level of training must include chemistry, anatomy, diagnostics, physiology, formulation guidelines and safety issues regarding each specific internal route (oral, vaginal or rectal).

Herbal medicine
Herbal medicine

In the USA there a law called DSHEA which was introduced in order to allow certain ingredients or combinations of ingredients to be sold as “Dietary Supplements”. This is a great thing, it is why we can buy herbs, and vitamins without a prescription and without them being regulated as over-the-counter drugs. But it is also an unfortunate loophole for the suppliers who sell essential oils, and who do so with certain claims which are not allowed for essential oils sold for topical use.

An essential oil labeled according to the Trade Requirement & Guidance Policy of the American Herbal Products Association will have:

  • Common name;
  • Latin name;
  • Plant part;
  • The extraction process;
  • “Keep out of reach of children”
  • “External Use Only”or “Not for Internal Use” or “Not for Ingestion”

These product labels and their marketing, cannot make any medical claims, nor can they make any “structure or function” claims, because products sold for topical use with structure or function claims, are automatically considered drugs (OTC or prescription). [Example – FDA Warning Letter to Young Living]

So certain companies have decided to market and label their essential oils “as” dietary supplements for the sole purpose of being able to make structure function claims!

Nothing different about the ingredient itself is requiredthe only difference is the labeling.

THAT is why people – in my opinion – who are purchasing essential oils, need to understand the FDA regulations, whether they *believe* in the FDA or not.

There are also companies which sell essential oils as food flavorings.

The food industry is the largest consumer of essential oils next to the perfume industry. Essential oils sold as food flavorings are often standardized, because foods need to taste the same from batch to batch, year to year. So the industrial use of essential oils requires the ingredient fit a standard, often the ISO standard. So a certain year’s peppermint might be a bit off and so constituents from other essential oils are added to make the oil fit the required profile. But most people in the practices of  aromatherapy  want 100% pure essential oils – as they come off the still – not standardized for consistency. Standardization is considered to be a form of “adulturation” in the aromatherapy world.

And here is where the discussion took a confrontational turn.

Stating the fact that essential oils can and are used safely as food flavorings is not even remotely the same as saying that essential oils can be ingested safely as dietary supplements (or medically for that matter, unless one is properly trained in Aromatic Medicine).

“…I think that it gets confusing because people often refer to GRAS status, so they will say that this essential oil has GRAS status which means that it is generally recognized as safe by the EPA and the FDA. But actually what that applies to is the use of essential oils in food flavorings; specifically this only applies to food flavorings and not to other uses such as medicines. So GRAS status doesn’t mean this essential oil is safe to ingest, it means this essential oil is safe to use in food flavors, which yes does result in ingestion but the word ingestion is where the confusion happens because it is not a way of saying that this is OK to use as a medicine.” Robert Tisserand

There IS no diet which is missing essential oils, no diet which needs to be supplemented with essential oils. PERIOD.

There is no biological reason to ingest essential oils daily, or regularly for dietary or nutritional reasons or to improve the structure or function of the body. The marketing of essential oils for the purpose of improving the structure or function of the body is selling them as SNAKE OIL. It’s a money making scheme and nothing more.

When people use essential oils as food flavorings, they are adding perhaps a drop or two of oregano to an entire pot of spaghetti sauce or a drop of peppermint in an entire batch of chocolate frosting – where it is incorporated into the fats and other ingredients and can be ingested safely. It is never safe or appropriate to drink essential oils in water or add them to sports drinks. People have died from drinking lemon EO in water. It has been covered up, but they have died of liver failure. Other people have been near death in liver failure from ingesting “blends” sold as dietary supplements by MLMs.

This is one of the reasons professional aromatherapists avoid the big two MLMs, not just because both companies have been accused (and scientifically proven in many instances) to have sold adulturated EOs, but because the corporate culture of these companies puts not only their customers at risk, but risks the future for the entire aromatherapy industry.