FDA Sends Warning Letters to Two Essential Oil MLMs

FDA.jgpI have posted numerous times, including here and here, about FDA warning letters concerning “drug claims” used for supposedly cosmetic products.  After those posts went up, I had a number of people tell me about several national companies selling essential oils that were making all sorts of claims, and asking why they could get away with it.  Apparently, they can’t (and rightfully so).

The Denver Regional Office of the FDA recently sent warning letters to Young Living ( see here) and doTERRA (see here), both Utah based essential oil multi-level marketing companies.  Both the letters cited numerous statements making claims that the essential oils sold could combat, treat, cure and prevent a myriad of medical conditions including:

  • “Top on my list is Thieves. Thieves is highly anti-microbial . . . it could help against Ebola.”
  • “Viruses (including Ebola) are no match for Young Living Essential Oils”
  • “Rosemary research in regards to Alzheimer’s disease showed aromatherapy as a potential treatment for the cognitive (eg, memory) impairments caused by dementia.”
  • “Myrtle is a wonderful antiseptic . . . It has been known to protect against tetanus . . ..”
  • “[M]yrtle . . . can help with sexual dysfunction issues such as impotency . . . and ED.”
  • “[T]he Ebola virus cannot survive in the presence of a therapeutic grade Cinnamon Bark and Oregano essential oil.”
  • “Eucalyptus Blue essential oil has antiviral and anti-inflammatory properties.”
  • “Peppermint oil has so many more uses . . . asthma, autism, brain injury . . . Crohn’s disease . . . multiple sclerosis, paralysis . . ..”
  • “Ylang Ylang is used medicinally . . . for the treatment of . . . arterial hypertension . . . diabetes . . . insomnia, heart palpitations, and tachycardia.”
  • “Many have found a protocol of essential oils and supplements have helped ease the symptoms of autism-related issues”
  • “Melaleuca: Melaleuca (also known as tea tree oil) has been clinically shown to inhibit the replication of the influenza virus. Some of melaleuca’s primary uses include . . . athlete’s foot . . . canker sores, chicken pox, cold sore, colds, flu, fungal infections, Herpes simplex, MRSA, shingles, warts and viral infections.”
  • “Oregano: Oregano is effective in inactivating MNV (non-enveloped murine norovirus) within 1 hour of exposure.”
  • “Eucalyptus: Eucalyptus has demonstrated an ability to inhibit the Herpes simplex virus. Some of the primary uses for eucalyptus include Influenza, Measles, Neuralgia, Neuritis, Pneumonia, respiratory viruses rhinitis, shingles, sinusitis and tuberculosis.”
  • “Clove: . . . rheumatoid arthritis . . .”
  • “Wintergreen: Arthritic pain, bone pain, joint pain”
  • “Lemongrass: Grave’s Disease, Hashimoto’s Disease . . .”
  • “Geranium: Diabetes, endometriosis, osteoarthritis, rheumatoid arthritis”
  • “Lavender: . ..cancer, inflammation, insomnia, pain, rheumatoid arthritis”
  • “Clary Sage: Cramps . . . Endometriosis, Estrogen Balance, Hormonal Balance, PMS, Pre-menopause”
  • [Frankincense] “Lowers High Blood Pressure” and “Helps Symptoms of Crohn’s, Arthritis, & Epilepsy”

and that’s just a very partial list of all the claims that were cited!

Both the warning letters explain that the cited claims made for the essential oils make it clear that the products are drugs because “they are articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease.”  The letters go on to clarify that these are “new drugs” because they are not generally recognized as safe and effective for use under the conditions prescribed, recommended or suggested in the labeling.”

Labeling, as defined by the FDA, includes “all labels and other written, printed or graphic material on or accompanying a product in interstate commerce or held for sale”.  What I found particularly interesting about these warning letters was that they referenced as “labeling” not only claims made on the official company websites and print materials, but also on consultants’ websites, Facebook posts and pages, twitter posts and even Pinterest pages. When I went to look at the websites, all had removed the questionable text and had generic “we’re revamping our website” content.

Take-Away Lessons

There are some things to be learned from this.

First, just because someone is doing something wrong apparently “getting away with it,” doesn’t mean that they will continue to be able to do it that way.  Setting up a business model that depends on “getting away with it” isn’t one that is likely to last. These businesses, and their consultants, have been making wild and outrageous claims for years – now they are going to have to completely regroup on the way they sell products in order to comply with the regulations.

Second, regardless of what someone tells you is okay to do (either explicitly or by example), it’s your responsibility to ensure that you understand the applicable law and regulations, and to operate within them.  If someone tells you it’s okay to go 60 mph in a school zone just because “no one is watching,” YOU, as the driver, is still the one who will get the ticket and pay the fine (and maybe lose your license).  It’s best to operate within the law to the best of your understanding and ability. I expect that the consultants for these companies that had websites and promotional materials based on the information they got from the home office will be scrambling to make changes and get compliant, no doubt causing an unplanned drain on resources.

So, if you are selling – or making and selling – products, know what your rights and responsibilities are.  Keep in mind that:

  • All consumer commodities (products purchased by the consumer that can be used up) must be labeled in accordance with the Fair Packaging and Labeling Act.
  • For cosmetics, drugs, food, and dietary supplements, the regulations for labeling under the FPLA are created and enforced by the FDA.
  • For other products (such as soap or household fragrance products), the regulations for labeling under the FPLA are created and enforced by the Federal Trade Commission (FTC).
  • The FDA determines what a product IS based on the intended use, as stated on the product label and in the materials that accompany the product in print and on the internet.
  • Food, drugs and dietary supplements have very specific requirements for their manufacture (including registration of the facility and following good manufacturing practices as defined in regulations) and detailed limitations about the claims that may or may not be made about them.

 

 

Comments

  1. I want to print out this email & pass it out to everyone! We recommend your blog constantly to soap & product makers. This post is only one of the many, many reasons.

  2. Thank you for the article! I am enrolled in an online aromatherapy school and I was hoping to sell my own blends for therapeutic purposes. Is there any legal way I can? My desire is to educate people about the blend or oils before I sell to them and have that information in print for them to take with them. This desire was born out of going to a MLM “oil party” where they were teaching some CRAZY things and even giving people oils to take internally!

    I want to do things right, regardless of what others do. I just need to know if this idea I have about selling oils can continue or if I should just give up my idea.

    How should a label look if I had a blend for, lets just say PMS containing clary sage, lavender, and sage?
    So instead of a blend labeled like this: PMS Relief
    Could I call it For Women (or something like that) ?

    For the description, how can that be done? Can phrases like “These oils have traditionally been used for…” or “clary sage is known for…”

    And for directions??

    If there is a way please tell me. 🙂

    Thank you so very much!!!!!

    1. Author

      There’s a fine line between the claim that a product can “treat, cure, mitigate or prevent” disease general improvement that falls in the realm of “attractive”. “PMS Relief” definitely tells me that it would be something that would treat or mitigate PMS symptoms. “For Women” is a bit more vague … it doesn’t make any claims.

      If you really want to make a go of it, you might want to consult an attorney who could navigate the fine legalities on the claim (and back you up if you ever got called into question).

      1. This is so frustrating. I am trying to understand how to do the right thing. I am doing my best to develop formulas for lip balms, face creams, etc. I am working to educate myself to use top quality ingredients, and dry skin on my hand I can make a lotion for but dry skin on my lips I can’t make a “lip balm” for. MEN buy lip balms. If I make the exact same formula, and call it a lip moisturizer, or part of my lip tint line there is no way my brother or father would stick it in their pocket and take it to the gun range – it would look like they took their wives’ lipsticks. And don’t get me started on structure and function claims. The big companies pay writers big bugs to spin the description so it stays just on the correct side of a structure or function claim. As a sole proprietor just starting out it’s overwhelming. And by the way. just because we want to avoid it, the advance of years is not a disease. That’s probably not a legal defense but it should be. Thank you for your web site.

      2. Just to clarify, having read about 5 of your articles , and the FDA’s page, the net effect is sheer frustration. Not at you, at them. If I could get clear guidelines of what I COULD write, it would be better. Plus they totally ignore common sense… to call a lip balm a drug, is beyond credulity. Lip balm, WITH MEDICINE, ok, that’s a drug because a medicine is included, but a standard oil and wax blend intended to protect from the elements and soothe – NOT MEDICINE any more than a hand creme.

      3. Author

        According to the FDA, you can use the term “lip balm” PROVIDED you don’t make any medical claims for it. A “skin protectant” is considered a drug, in that it is changing the function/structure of the body. A “lip balm” that “protects against chapped lips” is considered a skin protectant. A lip balm that just keeps your lips moisturized is a cosmetic. Two different things in the eyes of the FDA. Difficult to work with, but those are the rules.

  3. Hi Marie,

    Your blog is very informative and so easy to read. I really enjoyed every part of it. Thank you!
    I have made a salve that permanently inhibits hair growth. It’s makes the skin soft and hair free after continuous 3-4 months use. Beauty about my salve is that it doesn’t discriminate against any hair color or skin pigment. I have made it for friends and family to try and now the word of the mouth has spread like fire and everybody wants to get some. I don’t own a cosmetic business and I make soaps and creams in my kitchen and give them away as holiday gifts.
    I would like to sell my salve and would Like to word it it in a way that it removes/reduces hair permanently or that it reduces hair growth without violating FDA regulations?
    Thank you!

    1. Author

      I’m glad you liked the blog.

      The article Removing Hair Safely on the FDA website is directed to consumers, but it specifically says that diplilatories are cosmetics, not drugs (improving the appearance). It’s not so clear about something that permanently stops hair growth (that might be a drug since it changes body function).

      If you decide to go forward with the product, you might want to check with an attorney if you are going to make any other claims than hair removal.

  4. Hi Marie, I want to start selling home made toothpaste , would this be considered a cosmetic? As well, im having trouble trying to figure out where can I rent a place to make my products (im in Florida… so I cant make it at home :'( ) Any suggestions? I am not sure if an office space would work and retail is usually expensive to say the least. About claims.. I want to sell oil face wash for oil cleansing, can you say things like : helps with oily skin? or helps moisturize dry skin? What about helps with signs of aging or rejuvenate your skin for eye serums?

    I would really appreciate your help! Thank you

    1. Author

      Toothpaste is definitely a cosmetic, so long as the only claims are that it cleans and makes the teeth LOOK better (whiter, brighter, etc). Any claims that it reduces or prevents cavities or gum disease makes it a drug.

      In order to make cosmetics in Florida you’ll need to get your facility inspected. From what I’ve seen, they seem to look along the lines of typical Good Manufacturing Practices — do you have a suitable space? Can it be kept clean? Do you have adequate storage space? Are incoming materials inspected, labeling and properly stored?… so you’ll need to ahve a suitable manufaturing facility (not just an empty garage somehwere). You might look at a place with a commercial kitchen or a place with suitable electrical and plumbing that you can put the necessary equipment in.

      My book, Good Manufacturing Practices for Soap and Cosmetic Handcrafters, covers a lot of the basics.

      As for claims … just make sure that you are sticking to claims that are cleansing, beautifying and promoting attractiveness. Moisturizing is good; cleanses oily skin is okay; “helps” oily skin could go to cleansing OR to changing it’s functionality depending on how you say it and what else you say. “Helps” with signs of aging, again depends on whether you’re talking about making it LOOK better, or actually treating the skin in some way to make it BE better. “Rejuvenating” your skin implies changing the function or structure; “Making your skin appear younger and more vibrant” is purely an appearance thing.

      There’s a fine line between “makes wrinkles less” and “makes wrinkles appear less” — but it’s the difference between a drug and a cosmetic.

  5. love your blog had to say first, I make soaps and a variety of different salves and lotions I have been approached to sell in a local store but am worried the because i make plantain salve that might be considered a drug or can i just word it as relief of bug bite and poison ivy i understand how to get around the rest of the labelling but concerned about the plantain salve . pls advise

    1. Author

      Actually, if you say that it includes plantain but say NOTHING about what the plantain will do, you are probably much safer than if you say it is “relief” of bug bite or poison ivy. “Relief” implies that it is mitigating the (physical) effects of bug bites or poison ivy. A drug is defined as:

      A product that is intended for use in the cure, mitigation, treatment or prevention of disease and articles intenfd4ed to affect the structure or any function of the body.

      While bug bites and poison ivy aren’t what we would typically consider “disease” they are still within the broad scope of the definition. Additionally, “relief” from their effects is changing the function and/or structure of the body — so a product with the intended use of reducing (mitigating) the effects of bug bites or poison ivy could very likely be considered an unapproved new drug.

      My advice: Be very careful with the presentation and wording on labels and labeling for your product, and make sure the actual intended use is as a cosmetic, not a drug.

  6. I have a question… I put a drop of Thieves in the roof of my mouth 2 times today, as a preventive, so I don’t catch whatever my husband is coming down with…
    When I sat down around 5:30 after some strenuous activity in the yard, I noticed that my heart was POUNDING, like I’d drunk 6 cups of coffee. (I avoid all caffeine)
    My heart rate was very elevated. Three hours later, it’s still very high, and I’m just sitting.
    The last time I used a drop in my mouth was 5 hours ago… Ever heard of this happening???

    Use of Thieves Essential Oils is brand new to me…

    Very concerned…

    1. Author

      No essential oil should be ingested without a thorough understanding of the potential effects. They are very strong plant essences. Some plants are safe, some plants are toxic in large doses, some plants are poison when eaten; some plants cause physical or allergic reactions in some or all people.

      If you are having physical symptoms that cause you concern, you should check with a doctor or emergency room.

  7. This is the same FDA that states Monsanto treated crops are safe, hogwash. If the FDA can’t make money from it, they are out to block and discredit.

  8. I agree with Lisa. The FDA spends billions of dollars lobbying against all that is natural to push their synthetic drugs. It’s all about the money…

    1. Author

      I agree that getting natural products approved is difficult – mostly because of the cost and the inablility to recoup the costs by patenting a unique product. The FDA doesn’t “lobby against all that is natural to push their synthetic drugs”. that would be the pharmaceutical companies.

  9. You people do know that the FDA and possibly the person providing these articles are controlled by the big drug companies. They want you to thing the all natural solutions including essential oil, supplements, etc are evil and that you should only take thier drugs, which actually keep you sick and have so many side affects that they then have to give you more drugs to counter act the damage from the side affects. Your body was created to heal itself if you just feed it the right nutrition through clean organic non-GMO foods, plant based supplements and yes essential oils, which are also plant based nutrition in condensed form. Once the FDA and other government agencies are no longer allowed to be controlled by big Pharma and the true medical research is allowed to be made public they will no longer be able deny the medical research and evidence showing how the claims made by natural healing methods like essential oils do indeed have the ability to heal as claimed. Just so you know I don’t work for either Company mentioned buy have myself been healed and seen first hand that the health claims being made do in fact work.

    1. Author

      Yes, the FDA does has connections to big Pharma, and it’s difficult and expensive to get natural solutions recognized.

      However, I can quite certainly and with great emphasis state that any control exerted by “big drug companies” does not extend to the writer of these articles (that would be me).

  10. Believe or not.. I was unlucky enough to buy a house with Stachybotrys Black Mold. Drs would do zero to help me. I’d cry, they would do nothing but assume I was crazy. I had no choice but to turn to holistic means to try and save my life.

    It has taken two years to come close to detoxing. At the worst part of it, I could use essential oils and YES…. I could get a little bit of relief and have a day of being out of bed. This was the only little bit I could find. It’s the mainstream chemical prescriptions that are killing people.

    So.. unless you have been there, you do not know!

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