Today the FDA (U.S. Food and Drug Administration) sent doTerra and Young Living Inspections, Compliance, Enforcement, and Criminal Investigations Warning Letters. This is huge news. In light of the comment wars that went on in my blog post Warning dōTERRA and Young Living Won’t Tell You it is clear that many misunderstand the law as it applies to essential oils.
- FDA Warning Letter to dōTERRA
- FDA Warning Letter to Young Living
WARNING: Do Not Follow Blindly
In my book The Art, Science and Business of Aromatherapy I addressed the FDA laws regarding claims, labeling, usage and so forth in Chapter 11 titled Cosmetics, Drugs and Soaps . . . Oh My! I am including an excerpt here to explain today’s FDA action.
To explain my stance regarding essential oils being classified as a cosmetic rather than medicine I have included an excerpt from Chapter 10, Do Not Pass Go Without Collecting Safety Information below.
In my early years as an aromatherapist, I longed for the day when essential oils would become part of traditional medicine, or at least be considered as over the counter drugs. After years in the cosmetic industry, I am grateful that aromatherapy remains an alternative treatment available to everyone. I have been through the process of manufacturing an OTC sunscreen and learned that the cost, paperwork, and regulation of making essential oils into OTC drugs would put the majority of aromatherapists out of work.
Below is an excerpt from Chapter 11 Drugs, Aromatherapy and Cosmetics from The Art, Science & Business of Aromatherapy.
NOTE: All italics that follow were added by me as examples and not official FDA comments. All quotes are from the FDA.
What is a Cosmetic?
A cosmetic is defined in the Federal Food, Drug, Cosmetic Act, Section 201 (i) as being:
“Articles intended to be rubbed (serums, moisturizers, etc.), poured (bubble baths, oils, etc.), sprinkled (body powders, bath powders, etc.), or spray on (body deodorant, perfumes, body mists, etc.), introduced or otherwise applied to the human body or any part thereof for cleansing (cleansers, exfoliants, etc.), beautifying (exfoliants, moisturizers, makeup, etc.), promoting attractiveness (makeup, perfumes, deodorants, etc.) or altering the appearance (cleansers, exfoliants, serums, moisturizers, makeup, etc.)”
Cosmetics: are not as regulated as drugs. They do not require pre-clearance by FDA, and GMP is not required. Cosmetics have simple labeling regulations, and voluntary adverse effects reporting. You cannot make any claims other than cosmetic usage even if it is accurate or nature’s wonder “drug.”
The Cosmetic Legality Principle does not require pre-market approval or notification of products or ingredients, clearance of products safety, or substantiation of product performance claims (moisturizing, cleansing, deodorizing, etc.). Mandatory establishment or product registration is currently voluntary.
Cosmetics exclude soap, but if your soap claims to be “cleansing, beautifying or moisturizing,” it is a cosmetic and must be labeled appropriately. This means you are required to include a full International Nomenclature of Cosmetic Ingredients (INCI) ingredient list on every bar of soap and follow all cosmetic regulations ONLY if you make claims that go above and beyond cleansing, beautifying, or moisturizing. The Manufacturer is responsible for making cosmetics safe and they must not be adulterated or misbranded.
Adulterated is defined as harmful or injurious to user under customary conditions of use such as microbiology, unapproved color additive, chemical contaminant or prohibited ingredient.
Misbranded is defined as when labeling is false or misleading; Package does not exhibit labeling information required by statute or regulation; Packaging not in compliance with 1970 Poison Prevention Packaging Act (PPPA). All cosmetic ingredient lists must use INCI (International Nomenclature of Cosmetic Ingredients) names for all cosmetic ingredients in a finished product. The use of trade or common names is not allowed on cosmetic ingredient lists.
What is a Drug?
A Drug is defined in Federal Food, Drug, Cosmetic Act, Section 201 (g) as being:
“Articles intended for use in the diagnosis, cure (anti-wrinkle, antibacterial, anti-fungal, anti-acne etc.), mitigation (pain reliever, headache reducer, muscle relaxant, etc.), treatment (acne treatment, fungal treatment, wrinkle cures, psoriasis and eczema, anti-cancer treatments, etc.) or prevention (anti-scar, wrinkle cure, cancer prevention, anti-perspirant, etc.), of disease. Articles (other than food) intended to affect the structure (wrinkles, perspiration, scars, etc.) or any function (cell regeneration, collagen formation, etc.) of the body.”
Drugs: are highly regulated and require pre-clearance by FDA, and GMP is required. Drugs have highly regulated labeling laws (i.e. Drug Facts). They require reporting of all and any adverse effects known, and they can make proven, specific, and tested claims that follow the monographs requirements.
In the Drug Legality Principle, a product meets the definition of drug if it complies with ALL requirements for drugs (even if it also meets the definition of cosmetic). All cosmetics that meet the definition of a drug have to be registered and regulated by the FDA. A product is considered a drug if it makes claims such as being a sunscreen, antibacterial soap, anti-dandruff shampoo, anti-acne, anti-wrinkle, antiperspirant, etc.
“The FDA interprets the term “soap” to apply only when:
• The bulk of the nonvolatile matter in the product consists of an alkali salt of fatty acids and the product’s detergent properties are due to the alkali-fatty acid compounds, and
• The product is labeled, sold, and represented solely as soap [21 CFR 701.20].” FDA
What is Soap?
It is very common to find melt and pour soap, as well as true soaps, improperly labeled and containing drug claims. However, most melt and pour soaps do not meet the first standard, because the bulk of the product is not alkali salt and fatty acids.
“If a product intended to cleanse the human body does not meet all the criteria for soap, as listed above, it is either a cosmetic or a drug. For example, if a product consists of detergents or primarily of alkali salts of fatty acids and is intended not only for cleansing but also for other cosmetic uses, such as beautifying or moisturizing, it is regulated as a cosmetic.”
Melt and pour soaps consist of detergents and, according to the FDA’s definition, they are a cosmetic and not soap. Detergents are essentially defatting agents which allows them to remove fats, lipids, dirt, make-up, and debris from the surface of the skin. Detergents aren’t bad; they just aren’t soap by definition. You are required to include a full International Nomenclature of Cosmetic Ingredients (INCI) ingredient list on every bar of melt and pour soap, and you must follow all cosmetic regulations.
Your Products Intended Use Can Make Your Cosmetic a Drug
Example #1: Product’s Intended Use: Drug – A product with any of the following intended uses is a drug: antiperspirant/deodorant (stops perspiration), dandruff shampoo (treats dandruff), sunscreen/suntan preparation (prevents sunburn), fluoride toothpaste (prevents cavities), and skin protectants (helps heal cuts).
Example #2: Product’s Intended Use: Cosmetic – A product with any of the following intended uses is a cosmetic: deodorant (cover up odor), shampoo (cleanse hair), suntan preparations (moisturized while tanning), toothpastes (cleans teeth or freshens breath), skin protectants (moisturize skin). Notice that both the ingredients and the intended use of the product make a difference in whether it is considered a drug or a cosmetic.
For the most up to date information about labeling go to the FDA page to read “Is It a Cosmetic, a Drug, or Both? (Or Is It Soap?)
Three Types of Claims that Can Cause Your Cosmetic to be a Drug
- Claims that suggest physiological change – For instance, if you say “younger looking” rather than “younger” you are a cosmetic. If you say “removes” or “prevents” wrinkles, rather than “covers” your product is a drug.
- Claims that sound scientific – For instance, if you claim that your soaps are “Compounded in our laboratory under the most sterile conditions,” or “If blemishes persist, see a doctor,” your products is a drug.
- Claims that appear in an applicable OTC monograph – Sunscreen products, hormone products, acne, eczema, psoriasis, skin bleaching, etc. Even implied claims by known effects of ingredients. For example, with skin bleaching products, the presence of many ingredients automatically make your product a drug. Remember that even if a cosmetic has a drug action, it must qualify as a drug first and then a cosmetic.
If an ingredient has a monograph it automatically makes a product a drug with the intended use as described in the monograph. The FDA has published monographs for OTC ingredients stating what ingredients can be used and their intended use. Using those ingredients, in most cases, in a product makes your cosmetic a drug. Remember, if you use an ingredient with a monograph, that product then meets the definition of a drug, and it must comply with ALL requirements for drugs (even if it also meets the definition of cosmetic).
Are You Transforming Your Cosmetic Into a Drug?
The trick is this, it doesn’t matter whether the claim is true or not, it’s whether the claim transforms the cosmetic into a drug. You might know that your aromatherapy helps lighten hyper-pigmentation, your ointment helps cure eczema, your serum irons out wrinkles, but as soon as you state or imply that fact on your label, in your literature, in any print advertisement, on your website, or anywhere, you are placing your product into the drug category.
Therefore, you must follow all drug regulations and present your product to the FDA before it hits the market. You will also need to present case studies to the FDA to back up your claim. For more information on this, go to The Center for Drug Evaluation and Research (CDER) homepage.
Watch Your Advertising Claims
- Environmental Claims: Claiming something is recyclable, even if true in your area, might not be true in other areas. For example, Polyethylene caps on your containers. There are only a few recycling outlets in the entire USA that recycle PE.
- Made in America (or the USA Flag): Though your product might be made in the USA, the FTC/FDA requires that all the ingredients originate and remain in the States, too.
- Claiming to be an FDA approved product or an FDA approved facility
- Organic Claims: If you are an organic certified entity, you will be notified of what you can place on your labels. If you are not then you can state “X-percent organic content” on the back of your packaging, but you can’t state “organic” on the principal display panel. The verbiage must clearly state it is not certified.
- Natural Claims: involves almost no regulation, however, integrity is recommended.
- Product Claims Based on Ingredients: You can’t advertise the effects of a known ingredient. All test studies must be done on the product itself.
- Unsubstantiated endorsements (such as Celebrity Infomercials): Again, though a personal claim could be true, it might not necessarily be true for the average person.
- Disclaimers like “results may vary” or “not typical for the average consumer”: It is currently being noted that these disclaimers are not read, but rather the claims are just being heard. Therefore, disclaimers will probably go by the wayside.
- Using the term “cosmeceuticals”: A product can be a drug, cosmetic or a combination of both following the rules of both standards. But the term “cosmeceutical” has no meaning under the law.
- Mimicking: Just because you see another company making claims does not mean you should. If the FDA looks into your claim, you can’t use another company’s bad judgment as an excuse for your choices. And you don’t know if the other company is actually complying with the law since much of it is behind the scenes, with the exception of “drug facts” on the label.
To learn more about the art, science and business of aromatherapy and cosmetics check out my book The Art, Science and Business of Aromatherapy: Your Guide for Personal Aromatherapy and Entrepreneurship available in paperback and Kindle.
UPDATE
Recent News from Young Living
Young Living Essential Oils Announces New CEO
Recent News from doTerra
doTerra Cracks Down After FDA Warning
IF YOU ARE CURRENTLY EXPERIENCING AN ESSENTIAL OIL INJURY PLEASE READ: What to do When Injured While Using Essential Oils.
Your Link” FDA Warning Letter to dōTERRA Goes to your blog, was that on purpose, instead of to an FDA Doc?
Thanks Paul. I fixed it.
I didn’t have any problems.
Good Eliz. I fixed it after Paul noticed it. I am glad to hear the links are working correctly now.
Thanks for enlightening me. I can’t wait to read your book.
You are welcome. I wanted to explain the FDA laws so people would understand their response wasn’t out of left field.
Bam! Take that haters 🙂 Good job keeping people informed, Kayla!
Thanks Jen!
So a soap containing camphor, sulfur, thymol, vitamin E, activated charcoal, witch hazel, cocoa butter, glycerin, kaolin, lanolin, peru balsam, sodium bicarbonate, vitamin A, peppermint oil, eucalyptus oil, benzoin, pine tar, colloidal oatmeal, anise seed, catnip, chamomile, cinnamon oil, ginger, horsetail, goldenseal, st johns wort, tincture of lavender, nettle, papaya, peppermint, strawberry, woodruff, calamine, iron oxide, allantoin, aloe vera, guar gum, castor oil, bran, alfalfa, bearbeary, corn silk, couch grass, golden seal, juniper oil, nutmeg oil, parsley, saw palmetto, sucrose, uva ursi, zinc oxide, ginseng, passionflower extract, infusion of rose petals, sodium chloride, purified water, myrrh, elm bark, sugars, tolu balsam, fructose, aqueous coconut oil soap, citric acid, aromatics, clove oil, honey, sage oil, topical starch, beeswax, cornstarch, hard fat, caffeine, titanium dioxide, ascorbic acid, corn oil, kelp, flax seed, lecithin, organic vegetables, papaya enzymes, pineapple enzymes, plantago seed, sea minerals, sesame seed, soy meal, soybean protein, green vegetables, or wheat germ (sure I missed some that might be used in soapmaking but these are all found here: http://www.fda.gov/downloads/AboutFDA/CentersOffices/CDER/UCM135691.pdf)…then the soap is automatically a drug? Good grief! We might as well all close up shop now!
I didn’t read that at all. I read that if your claims about your soap go above the “cleansing, beautifying” standard, then you have to list your ingredients like a cosmetic, but unless you are saying that your soap will cure something, it’s not regulated like a drug.
My comment wasn’t about claims at all. It was about the ingredients only. And I was simply going by what Kayla stated. “Using those ingredients in a product makes your cosmetic a drug—no ifs, ands, or buts about it. Remember, if you use an ingredient with a monograph, that product then meets the definition of a drug, and it must comply with ALL requirements for drugs (even if it also meets the definition of cosmetic).” That seems pretty clear cut to me. But maybe I misunderstood. Maybe the product also has to be accompanied by drug claims? Can you please clarify Kayla?
Your comment made me realize the soap section didn’t make the cut and paste from my book. I was cutting and pasting out of the PDF so sometimes it is funky. I added it above now. And here it is in comments:
What is Soap?
It is very common to find melt and pour soap, as well as true soaps, improperly labeled and containing drug claims. However, most melt and pour soaps do not meet the first standard, because the bulk of the product is not alkali salt and fatty acids.
“If a product intended to cleanse the human body does not meet all the criteria for soap, as listed above, it is either a cosmetic or a drug. For example, if a product consists of detergents or primarily of alkali salts of fatty acids and is intended not only for cleansing but also for other cosmetic uses, such as beautifying or moisturizing, it is regulated as a cosmetic.”
Melt and pour soaps consist of detergents and, according to the FDA’s definition, they are a cosmetic and not soap. Detergents are essentially defatting agents which allows them to remove fats, lipids, dirt, make-up, and debris from the surface of the skin. Detergents aren’t bad; they just aren’t soap by definition. You are required to include a full International Nomenclature of Cosmetic Ingredients (INCI) ingredient list on every bar of melt and pour soap, and you must follow all cosmetic regulations.
True soap is exempt.
So you’re saying that true soap is exempt as long as we don’t make any drug claims for it, even if it contains ingredients with a monograph. Is that correct?
Here is what the FDA says. “Soap is a category that needs special explanation. That’s because the regulatory definition of “soap” is different from the way in which people commonly use the word. Products that meet the definition of “soap” are exempt from the provisions of the FD&C Act because—even though Section 201(i)(1) of the act includes “articles…for cleansing” in the definition of a cosmetic—Section 201(i)(2) excludes soap from the definition of a cosmetic.”
Soap is exempt from cosmetic and drug regulations as long as it is only labeled as soap. If you make any claim outside of cleansing you can change the category. It becomes a cosmetic if it “is intended not only for cleansing but also for other cosmetic uses.” It becomes a drug of it, “is intended not only for cleansing but also to cure, treat, or prevent disease, or to affect the structure or any function of the human body.” FDA.gov
I totally get the distinction between soap as just soap, soap as a cosmetic and soap as a drug (I’ve known that for years), but that’s not my question. Your sentence “Remember, if you use an ingredient with a monograph, that product then meets the definition of a drug, and it must comply with ALL requirements for drugs (even if it also meets the definition of cosmetic)” is what I’m trying to clarify. Because it implies that soaps that qualify as cosmetics that also contain ingredients with monographs would automatically be classified as drugs. Doesn’t it? Or am I missing something?
Yes. If you take the soap out of the soap classification and put it into the cosmetic classification then it changes what you can put in it. Soap is exempt from cosmetic and drug regulations as long as it is only labeled as soap.
WOW. This has huge implications for soapmakers as I don’t think most are aware of this. I know I wasn’t and I’ve been making soap for almost 20 years!
Soap marketed as a product that cleans the skin, is soap. True Soap is exempt from FDA regulations and technically, as such, does not even need to list the ingredients. Soap with cosmetic claims like “moisturizing” – is now a cosmetic – no ingredient changes, but claims. Now the product needs to follow the FDA regulations for listing cosmetic ingredients, using the proper format, language, order, and other labeling requirements. Soap sold with claims that it will treat, cure or prevent illness is a drug – either a legal drug ( if it follows an FDA approved Monograph ) or an illegal drug (misbranded). It is all about how you market and label the product.
Exactly! Thanks Sue.
Drugs are highly regulate???? This is why they kill 100 thousand people die every year from using what is REGULATED! I use essential oil in and on my body for 20 years or more and they have NEVER hurt me but have only helped me. People need to wake up and see this fda bs is all about money and control.
If essential oils become drugs they will no longer be available to laypersons. If you make medical claims about essential oils you are mis branding them as drugs.
I will repeat what I said in the above blog post:
In my early years as an aromatherapist, I longed for the day when essential oils would become part of traditional medicine, or at least be considered as over the counter drugs. After years in the cosmetic industry, I am grateful that aromatherapy remains an alternative treatment available to everyone. I have been through the process of manufacturing an OTC sunscreen and learned that the cost, paperwork, and regulation of making essential oils into OTC drugs would put the majority of aromatherapists out of work.
I believe in decriminalizing certain essential oils which can be safely used by the general public for certain over-the-counter conditions. A salesperson should not be guilty of the same crime for suggesting to their customer that they could use lavender essential oil to treat a mosquito bite or kitchen burn – as the salesperson who claims ingesting frankincense essential oil daily will prevent cancer. But right now, they are both equally illegal medical claims. There are some essential oils just as safe as current OTC drugs and amending certain monographs to all these claims is important for our industry, if for no other reason than it will help consumers to recognize the truly dangerous claims a bit easier when they know certain claims ARE legal.
The part that is criminalized is the labeling and claims. The essential oils are completely available to the public to use. Consumers can read aromatherapy books from the US, Britain, France, Germany and more with extremely descriptive uses of essential oils. In fact some of my favorite books are written for practitioners and nurses.
I respect you and the people you are working with to have essential oils added to the monographs. I have been part of the process for sunscreen products going through the entire process of OTC and would never wish the process on anyone. In my early years as an aromatherapist, I longed for the day when essential oils would become part of traditional medicine, or at least be considered as over the counter drugs. After years in the cosmetic industry, I am grateful that aromatherapy remains an alternative treatment available to everyone. I have been through the process of manufacturing an OTC sunscreen and learned that the cost, paperwork, and regulation of making essential oils into OTC drugs would put the majority of aromatherapists and cosmetic companies out of work. I have made many trips to D.C. to meet with the FDA, Congress and leaders over the years in an effort to keep essential oils and cosmetics available to both small business and large business.
If lavender was added to the monograph it would mean that all cosmetics containing lavender would become OTC drugs overnight. OTC drugs are highly regulated and require pre-clearance by FDA, and GMP is required by the manufacturer. Drugs have highly regulated labeling laws (i.e. Drug Facts). They require reporting of all and any adverse effects known, and they can make proven, specific, and tested claims that follow the monographs requirements.
“In the Drug Legality Principle, a product meets the definition of drug if it complies with ALL requirements for drugs (even if it also meets the definition of cosmetic). All cosmetics that meet the definition of a drug have to be registered and regulated by the FDA. A product is considered a drug if it makes claims such as being a sunscreen, antibacterial soap, anti-dandruff shampoo, anti-acne, anti-wrinkle, antiperspirant, etc.”
If lavender joined the monographs you would be required to follow all drug regulations and present your product to the FDA before it hits the market. You will also need to present case studies to the FDA to back up your claim.
I am no longer in the cosmetic or aromatherapy business, but I personally would rather keep essential oils available to the general public. If they become part of the monograph it is my belief that only large and mega businesses will be able to afford to include essential oils in their cosmetics and personal care items. Much like sunscreen is rarely ever made by small companies due to the expense and regulation.
You wrote “If lavender was added to the monograph it would mean that all cosmetics containing lavender would become OTC drugs overnight.”
Not according to my research. Take beeswax for example – hundreds of companies use beeswax in lip balms but they do not label or marketing or claim their lip balms are drugs, but beeswax is an FDA approved active ingredient in products which are sold as over-the-counter drugs as lip protectants.
Same for honey – honey is also an FDA approved active ingredient, but cosmetics such as sugar scrubs use honey as an ingredient and their products do not automatically become an OTC drug.
And for eucalyptus oil is FDA approved as an active ingredient already, but not approved as a stand alone ingredient.
In past years I had meetings and phone conversations with the FDA regarding using ingredients on the monograph. I always clarified with them if I was crossing a line by using a specific ingredient that was on the monograph. One thing that became abundantly clear is that the water became very murky once something was on the list.
If you look at beeswax on the monograph it has very specific usage and even sales numbers. I would hate to make a ointment for poison ivy expecting sales to stay below $25,000 and be wrong about sales numbers. You could expect a product to do very little and have it take off. At 25,001 the product becomes an OTC and require pre-clearance, testing and so forth.
As it stands now if you made drug claims for eucalyptus in a product you would transform that product into an OTC drug. From what I understand from your comment is that you want to allow medical claims to be made on a product using essential oils. The very act of making the medical claim would make it an OTC requiring pre-clearance of every product by FDA, GMP manufacturing (which is a huge can of worms for small and micro-businesses) and mandatory registration of your establishment. It would require following highly regulated labeling laws and labeling all products with Drug Facts. Also all products would require reporting of all and any adverse effects known, and they can make proven, specific, and tested claims that follow the monographs requirements. That means you would have to have an insert with their products like drugs to list every possible reaction including allergies.
While there may be a loophole here and there it would not be big enough for most small businesses to pass through. Even I threw up my hands and gave up on the process of making an sunscreen after successfully formulating one. The paperwork, the expense, the liability and the headache were not worth it. Sunscreen can stay with the big boys . . .but I personally want to be able to use essential oils without any red tape associated with it.
Your comments really did put on the breaks as far as my original plans to move forward as far as getting FDA monographs amended. I am discussing the issues with a SENIOR REGULATORY MANAGER at the FDA to get clearer guidance. As I said to him in my recent email – “Every class, course, and book about essential oils – not to mention many websites – tell consumers how to use essential oils for everyday first aid use.” But when selling an essential oil that very same information becomes an illegal medical claim…there must be some way to decriminalize first aid advice for a product. There is FAR more risk from the essential oils being sold as dietary supplements with no basis in fact for the nutritional, dietary, as well as structure/function claims which are being made – than the risk from properly diluted topical applications of essential oils for basic first aid purposes!
Good luck with your research Sue. I am glad to hear you are digging deeper into the implications of getting the monographs amended. Keep digging and digging until you find a clear answer.
Excellent post, Kayla! I do wish people would understand that the goal here is to inform and educate on the safe recommendations and uses of essential oils and the legal ramifications of not doing so. Those who thumb their noses at or disregard safety measures, the laws and the lawmakers are not doing themselves, others or the industry a favor. They are just opening it up for heavier regulations or possibly even bans on essential oils and products made with them such as soap and cosmetics. This is not something that any of us, regardless of what our views of safe usage, want. Wake up and grow up, folks! Tantrums and rhetoric will get no one anywhere that is a good place to be. The simple fact is that you cannot make drug claims without FDA testing and approval. You cannot give medical advice or treatment recommendations if you are not qualified and licensed to do so. Both are against the law! It is also extremely irresponsible and dangerous to do either as well. And you cannot twist facts or outright lie to fit fiction that will support and help you meet your end goals. That is just wrong on so many levels.
Yes! “The simple fact is that you cannot make drug claims without FDA testing and approval. You cannot give medical advice or treatment recommendations if you are not qualified and licensed to do so. Both are against the law!” Ginger.
That just needed repeating.
Hey Kayla! Funny how NONE of the nasty people who left comments before have anything to say NOW.
Things that make you go hmmmmmmm…….
Keep educating! You are the best!
I’m still braced for an attack. For some reason teaching the truth, laws, regulations and safety makes me a bad guy.
Thanks!
I believe that if a toothpaste contains fluoride and makes the claim that it will prevent cavities it is considered both drug and a cosmetic.
I don’t think claiming that a soap cleanses or cleans puts it into the cosmetic category. That is what soap is supposed to do. Now if a claim is made that it has astringent properties or tones the skin that would be another matter.
Exactly!
What you do not mention is that the letter from the FDA dealt with 4 Wellness Advocates who made drug claims on their Facebook page.
doTERRA goes to great length to train its advocates. The FDA letter had nothing to do with how oils are used aromatically, typically, or internally. I mention that due to the fact that you lead with that in this blog.
If you read the entire FDA letter to doTerra and Young Living they both have this paragraph:
“The violations cited in this letter are not intended to be an all-inclusive list of violations that exist in connection with your products. While FDA has mentioned specific dōTERRA Essential Oil products in this letter, there are drug claims being made by your consultants for a wide range of your dōTERRA Essential Oil products. As such, the cited violations in this letter should not be viewed to apply solely to the specific products mentioned in this letter. It is your responsibility to ensure that all of your products are in compliance with all requirements of the Act and federal regulations. You should take prompt action to correct the violations cited in this letter. Failure to implement lasting corrective action on violations may result in regulatory action being initiated by FDA without further notice.”
There are hundreds, if not thousands of reps misrepresenting aromatherapy and practicing dangerous practices. I am aware that a few lines in the MLM companies do teach safe use of essential oils. If you did a simple search online today you would find countless websites and social media pages teaching incorrectly and breaking the law. I think it would be wise of all reps to clean up their websites and social media pages since the FDA letter says, “Failure to implement lasting corrective action on violations may result in regulatory action being initiated by FDA without further notice.” Do not be lulled into believing that they are only aware of 4 Wellness Advocates.
I have watched many training videos by doTerra and witness incredibly dangerous teaching by Dr. Hill. In one video Dr. Hill on the doTerra corporate YouTube suggested using DigestZen (Features a propietary blend of Ginger, Peppermint, Tarragon, Fennel, Caraway, Coriander and Anise essential oils) on a newborn. The language used said to “consider diluting.” If you look at the list of essential oils commonly suggested by certified and/or registered aromatherapists for use on newborns you will not find any of those essential oils listed as safe for infants diluted or undiluted. Those who have studied aromatherapy suggest a dilution rate of 0.2 – 0.5% for newborn babies. And the only essential oils most aromatherapists would even consider using on a newborn highly diluted are: Chamomile Roman, Chamomile German, Lavender, Mandarin and Dill. Even more conservatively many will say only Lavender and the chamomiles. That was a video straight from corporate dT. I watched several others. One putting undiluted Basil essential oil in your child’s ear with a fingertip or cotton ball. Basil doesn’t even make the list as safe diluted for children until after 11 years old.
Hey Kayla, I just discovered your blog from SoapQueen. It’s great! I also have to give major kudos to people like you and Anne-Marie who understand aromatherapy &/or herbal supplements and tell it like it is. As a pharmacist, I understand that if any product: drug, herb, essetial oil, etc actually works, it almost always has side effects/toxicities/interactions and whatnot. If it is billed as “perfectly safe” and without any side effects or interactions, can be used in any way (internally/externally) in any quantity that makes you happy, and can somehow be used for a vast multitude of unrelated health issues, chances are the product in question either doesn’t work or the one doing the claims is a liar and a con-artist. Products that really work have to be used safely and only in certain ways/doses.
Ever since the dawn of time there have been snake oil salesmen and quacks who create useless or worse, dangerous potions and pills and pawn them off on poor, unsuspecting sick people. Sometimes these quacks actually think they’re creating a wonderful and miraculous product, usually they know darn well what they’re selling is a fraud. I became aware of Do Terra and Young Living a year or so ago and was agahst to see the downright dangerous nonsense they were telling people. The BS regarding YL’s Thieves Oil was the worst. A little research into their claims and the history of those oils showed that their Thieves Oil story was mostly fabricated. I actually knew someone who ended up in the hospital after ingesting that junk.
I always appreciate those who understand how alternative therapies work, and undertand that they require caution and knowledge to be used safely. I am always happy to see people like you remind people that all-natural does not always mean safer or healthier. After all, snake venom is all-natural. I too like alternative therapies, but I won’t use anything unless I do my own research, and I never trust any claim from a salesperson unless I verify it myself from a source not related to the company.
Keep up the education and good work!
Thank you Gwen!
This information is all very interesting. I personally make homemade body scrubs and bath salts…I’m not sure if all the FDA regulation trickles down to me, but it will make me very aware of the information I use in my product listings. Currently I list some of the “benefits” of the essential oils, tea, or carrier oils I use in my products. It might be better if I change the wording to “commonly thought properties” or something like that. I do have a disclaimer making it clear that I am not a physician and suggesting that a user of my products discuss use with their physician beforehand if needed, to rule out any allergic or medical reactions.
While I believe most FDA regulation is good and necessary, I also feel there is over-regulation with intentional mazes and hoops to jump through. This is possibly done to deter any significant profit from being taken away from the drug industry, I don’t know. I do feel the FDA is justified in their warning letters included above if the two companies or their reps are making definite healing and prevention claims. I do not feel there should be restriction on explaining and even claiming natural properties that herbs or oils have.
I personally suffered severely painful migraine attacks for about 20 years. After years of every drug the doctors could imagine being shoved into me (making me even worse and not helping the attacks at all) I decided to make a couple of lifestyle changes. I quit my job, getting myself away from many triggers that would spark an attack, and I started using essential oils around the house. For years I could not smell any manufactured cleaning product, soap, shampoo, any bath product at all, candle, sprays, perfumes…you name it. If I did, I would have an immediate attack that could last up to 7 days each for at least 3 weeks out of each month. 20 years of that misery ended when I started using essential oils. My body has now actually retrained itself with those oils and even man-made products are much better tolerated that they used to be with no migraine attack. This is a personal experience that I know to be true, and I also realize that this may not be a result other migraine sufferers would obtain by using essential oils, but I would find it very selfish not to at least let others know of my experience. This is NOT something that should be regulated by the government.
Basically, people have brains…we can decide if we want to try a more natural approach to prevention and healing. We can also make ignorant decisions to believe everything that we read or are told. Still, those are our decisions. If I want to buy home baked bread or soap from the little old lady down the street, I do it with a basic understanding that her kitchen is probably similar to mine and she isn’t baking her bread in a completely sterilized room wearing a sterilized operating room robe and mask. I choose to take a chance that the product might be less than perfect.
The FDA regulations do trickle down to even homemade products. Depending on where you live there may also be local regulations as well. I am not pro-regulations. But I am for following the ones we have in place now in order to prevent huge regulations that have been threatened by Congress for many years. If people don’t follow the laws already in place they are putting the entire industry at risk of even further regulations. You can follow the history of threatened legislation back to 2010 on Personal Care Truth.
My concern as a independent consultant for Young Living is less the issue of cleaning up our social media sites of claims, I do agree we must be careful not to cross that legal line, though it is a challenge with 1,000’s of representatives. What is concerning me is the loss of freedom of speech regarding true testimonies. We can no longer allude to the E.O. helping us with anything remotely close to disease related. Weight loss success is too close to the disease of obesity, or finding relief form pain could be construed as making claims certain oils help Arthritis. So it will be very difficult for people searching the internet looking for help to find it. Oh well guess that’s the idea, after all there’s no deaths and side effect from O.T.C. or prescription drugs, but must be in the thousands people damaged from E.O’s of course, how could I forget, what was I thinking, The truth goes marching on, where though is the question… please forgive my spelling, my computer wouldn’t allow a correction.
The law was in place long before YL started. Thousands of aromatherapy companies thrive within the legal limitations.
Hi Kayla. I was pointed to your blog from a book I was reading about the soap making business. I am so glad I did. I am early in the process of getting my certification in aromatherapy and the information you present here is fantastic. Keep up the excellent work. I just wanted to show my support because I was just reading the comments from your controversial blog post and it was making me SICK. I applaud your professional cool-headedness and fact based arguments in response to getting attacked. I am someone with experience in cGMP (at 3 major pharma co’s) and YL/dT are doing a tremendous disservice to the EO industry with their blatant law breaking. While part of me smirks at the fact that they probably don’t realize just what kind of hot water they are in, the rest of me is pretty irritated because if the FDA keeps encountering deceptivenss of this sort, we will all pay the price.
I will be purchasing your book and cannot wait to read it! Thank you for being a voice of reason.
Thank you Joanna!
Hi Kayla, enjoyed the post. I have a question though along the lines of what Maggie Hanus, Soap Bartender was asking. She listed a long list of ingredients on the FDA’s monograph list, ingredients that soap and cosmetic makers very commonly put into their products. She was asking if these ingredients, included in a soap, make it a drug, (since it is almost impossible to avoid these ingredients when making soap). I understand your reply to her stating how it’s okay to use these things in soap, it’s when they are used in cosmetics that they make the cosmetic a drug. So what about for things like bath bombs, lotion, scrubs, whipped butters, etc. that aren’t soap? Since they aren’t soap, they are by default cosmetics, correct? But since they are cosmetics, if they have any of the monograph ingredients included, they are by default drugs?? The monograph ingredients of citric acid and purified water would put just about every lotion and bath bomb in the country out of business if the inclusion of these ingredients makes the product a drug. Is this true? Because if it is, then I know a lot of bath product makers who are actively selling drugs at this minute who should be put out of business by the FDA. Thanks for your help on this!
When you look at the monograph and see citric acid all the uses are internal. http://www.fda.gov/downloads/aboutfda/centersoffices/cder/ucm135691.pdf
So when you use it in cosmetics it isn’t being used as a weight loss, antacid or oral relief agent. I don’t see purified water when I do a search.
I hope that helps.
Thank you, Kayla, for your answers! I still do not understand though. In your article, you said about ingredients with monographs, “Using those ingredients in a product makes your cosmetic a drug—no ifs, ands, or buts about it.” But in your reply to me you said about citric acid, “when you use it in cosmetics it isn’t being used as a weight loss, antacid or oral relief agent”. That is an “if, and, or but” right there. Do you mean that a product with an OTC ingredient in it only becomes a drug if you also state that the OTC ingredient has some healing power as stated on the monograph? In other words, if I use citric acid in a bath fizzie and don’t put any claims about it on the label, it’s fine. But if I use citric acid on the label and say it helps with weight loss, oral relief or as an antacid, then my bath fizzie becomes a drug? If this is what you are saying about monograph ingredients, then saying that “Using those ingredients in a product makes your cosmetic a drug—no ifs, ands, or buts about it,” doesn’t make any sense.
If that’s not the case, then I’m still really confused about what you’re saying and don’t understand whether I can use these monograph ingredients in my soap and cosmetics or not.
Thank you, Kayla, for your help, I hope you can clarify to me!!
Olivia,
You have talked me into modifying that sentence. The difference is that you are using citric acid in a topical application and not an internal application. The monographs are for both topical and internal usage. Since that technically is an, “if, and, or but” I have modified the sentence to say, ” Using those ingredients, in most cases, in a product makes your cosmetic a drug.”
Your products intended use makes a huge difference. If you soap is technically a soap and you stick to only soap claims it keeps things even easier. But if you soap is technically a cosmetic be careful with your claims.
Example #1: Product’s Intended Use: Drug – A product with any of the following intended uses is a drug: antiperspirant/deodorant (stops perspiration), dandruff shampoo (treats dandruff), sunscreen/suntan preparation (prevents sunburn), fluoride toothpaste (prevents cavities), and skin protectants (helps heal cuts).
Example #2: Product’s Intended Use: Cosmetic – A product with any of the following intended uses is a cosmetic: deodorant (cover up odor), shampoo (cleanse hair), suntan preparations (moisturized while tanning), toothpastes (cleans teeth or freshens breath), skin protectants (moisturize skin). Notice that both the ingredients and the intended use of the product make a difference in whether it is considered a drug or a cosmetic.
The recent action against Dr. Bronner’s by the FDA is a clear example of a safe ingredient for cosmetics and food being misbranded due to the claims and language used. It changes a food into a drug simply by the labeling. http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2014/ucm408739.htm
This is starting to come clearer now. Let me see if I understand this correctly: it is okay to use a monographed ingredient in a soap or cosmetic as long as you do not make any claims about that soap or cosmetic that correspond to what the ingredient is monographed for. Is that right? Thank you for taking the time to explain this to me, Kayla. The FDA warning letter against Dr. Bronner’s was a helpful example.
what is the follow up on DoTerra? do you know their response to this I know some websites have changed but does this only affect an essential oil website if somewhere they are offering to sell the same oil they somewhere claim to have properties. They still on their own website claim on Guard to “essential oils is an active component in a first line of defense for immune support. It is a non-toxic and superb way to support the immune system.” oregano says supports health digestion and others say boosts the immune system. Is this just careful wording or are they still in violation? What about the emotional claims on each of their oils?
Be nice to know the out come of all this. seems like to me they have not complied except to remove references to specific illnesses.
Bothers me when us little guys have to change our product descriptions and the big guys don’t.
Two weeks ago, I applied Young Living Bergamot Essential Oil undiluted on my arm as perfume. Later that day I went to a tanning salon and the next day noticed my arms were sensitive and red. It quickly escalated to bright red with blisters that grew by the hour. I went to the doctor first thing the next morning and everyone in the waiting room said I should’ve went to the Emergency room…. however the doctor treated me for 2nd degree chemical burns that were huge and painful. Wish I could post pictures here because it is unbelievable how badly this product burned me. After follow up with my dr. He has now referred me to a plastic surgeon to try to help prevent scarring and discoloration. My arms are now healing bright red with a brown pigment scar around it…. I have no idea if it will go away or be forever hyperpigmented and scarred. I am to start on Silicone patches next week as per the Plastic Surgeon. I am emotionally devastated by this and only wish that the Natural Practioner that recommended Bergamot Oil to me had warned me that it is a photosensitive oil and the dangers of it. I had trusted the person that I purchased from. Many people including nurses that worked at the doctor’s office said they also use essential oils and were unaware of this dangerous photosensitivity/phototoxic effect that it can have. These type of products are being sold on their positives but many people have no idea how incredibly dangerous they can be.
Hi Kayla,
I found this information very interesting. I was searching around trying to find information on essential oils and landed here. I started out with YL and didn’t like their underlying smell. Went to dT and liked them pretty well. But then wondered if there was others. As I searched I noticed they all said 100% pure. I know the oil is pure but how much of the oil is actually in the bottle with something else I wondered. Example: I can have the juice of 1 lemon in a 12oz. glass of water and it’s still 100% lemon juice. I also tried MRH and like them a lot and their prices. But from what I understand all the companies get their oils from 1-2 distilleries? Can you tell me if this is true? What are the best oil companies? And, does your book explain this?
Lisa,
Great questions! There are far more than 1-2 distilleries. Essential oils come from all over the world. The plant material is generally harvested and turned into essential oils in the country, on or near the farm it was harvested from, or at least in the same region. I sold me aromatherapy company in 2011 and just re-entered the industry. I’m biased to my own brand since I was extremely vigilant in choosing essential oils based on the best country of origin and suppliers.
I’m sorry, I did not know you had your own line. Thank you for the information and the link.