Ha! The FDA is taking on doTerra (essential oils cure Ebola)

[debatethis]

Pixy edit, here's a news article related to the letters below: www.washingtonpost.com/news/to-your-health/wp/2014/09/24/fda-warns-three-companies-against-marketing-their-products-as-ebola-treatments-or-cures/

I saw this posted elsewhere and starting laughing.

www.fda.gov/ICECI/EnforcementActions/WarningLetters/2014/ucm415809.htm
September 22, 2014


WARNING LETTER



VIA OVERNIGHT DELIVERY
RETURN RECEIPT REQUESTED


dōTERRA International, LLC
Attn: David Stirling
389 South 1300 West
Pleasant Grove, Utah 84062


Dear Mr. Stirling:

This is to advise you that the U.S. Food and Drug Administration (FDA) reviewed websites and social media accounts (e.g. www.anytimeessentials.com, Facebook, Twitter, Pinterest, YouTube) used to promote your dōTERRA Essential Oil products in August 2014. Based on our review, FDA has determined that several of your dōTERRA Essential Oil products including, but not limited to, “Melaleuca,” “Oregano,” “On Guard,” “Clove,” “Eucalyptus,” “Frankincense,” “Geranium,” “Lavender,” “Lemongrass,” “Myrrh,” “Peppermint,” “Rosemary,” “Wintergreen,” “Clary Sage,” and “Vetiver” are promoted for conditions that cause them to be drugs under section 201(g)(1)(B) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 321(g)(1)(B)]. The therapeutic claims establish that these products are drugs because they are intended for use in the cure, mitigation, treatment, or prevention of disease. The intended use of a product may be determined by, among other things, its labeling, advertising, and the circumstances surrounding its distribution, 21 C.F.R. § 201.128. As described below, the marketing of your dōTERRA Essential Oil products with drug claims and without FDA approved-applications is in violation the Act.

Your products are marketed through the website www.anytimeessentials.com/ and through paid "consultants," www.anytimeessentials.com/work-home/, otherwise referred to as "wellness advocates," www.mydoterra.com/. Your consultants promote your above mentioned dōTERRA Essential Oil products for conditions including, but not limited to, viral infections (including ebola), bacterial infections, cancer, brain injury, autism, endometriosis, Grave’s Disease, Alzheimer’s Disease, tumor reduction, ADD/ADHD, and other conditions that are not amenable to self-diagnosis and treatment by individuals who are not medical practitioners. Moreover, your consultants redirect consumers to your website, www.doterra.com, to register as a customer or member (i.e., consultant), and to purchase your dōTERRA Essential Oil products.

Examples of claims observed on your various consultant websites and social media accounts that establish the intended uses of your essential oil products include, but are not limited to the following:

On the website, http://www.anytimeessentials.com:

Under the heading, “Fight Your Virus with Essential Oils”:

• “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. Some of the primary uses for oregano include athlete’s foot, candida, canker sores, Ebola virus, intestinal parasites, MRSA, ringworm, staph infection, viral infections, warts, and whooping cough.”
• “On Guard: On Guard is a blend of dōTERRA oils and it has been lab tested to decrease symptoms of the flu. Some of the primary uses of On Guard include antiviral, cold sores, colds, flu . . . infection, lupus, MRSA, pneumonia . . . and warts.”
• “Clove: Clove has been investigated on Herpes simplex and hepatitis C viruses and was found to be antiviral. Some of the primary uses of clove essential oil include candida, herpes simplex, lupus . . . viral infections, and warts.”
•“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.”

Under the heading, “Essential Oil for Inflammation”:

• “Cancer, Autoimmune Diseases . . . Diabetes, Inflammation, Alzheimer’s Disease, Neurological Diseases, Arthritis, Pulmonary Diseases”
• “Clove: . . . rheumatoid arthritis . . .”
• “Eucalyptus: . . . bronchitis, ear inflammation, iris inflammation, general inflammation, neuralgia”
• “Frankincense: Alzheimer’s Disease, arthritis, cancer, inflammation . . .”
• “Geranium: Diabetes, endometriosis, osteoarthritis, rheumatoid arthritis”
• “Lavender: . ..cancer, inflammation, insomnia, pain, rheumatoid arthritis”
• “Lemongrass: Grave’s Disease, Hashimoto’s Disease . . .”
• “Melaleuca: Bronchitis . . . infections, inflammation”
• “Myrrh: Gum disease, hyperthyroidism, infection, skin ulcers”
• “Peppermint: Asthma, Crohn’s Disease . . . Irritable Bowel Syndrome”
• “Rosemary: Arthritis, Bell’s Palsy, diabetes . . . inflammation, osteoarthritis”
• “Wintergreen: Arthritic pain, bone pain, joint pain”

On social media accounts (e.g. Facebook, Twitter, Pinterest, and You Tube):

• In August 3, 2014 posts by dōTERRA consultant, “Mrs. Skinny Medic” to Twitter (www.twitter.com/MrsSkinnyMedic);


“Ebola Prevention?”
“Treating the symptoms of Ebola Virus with DoTERRA Essential Oils.”
“Many Essential Oils are highly Anti-viral. I list here a few of them those (sic) oils that could help prevent your contracting the Ebola virus . . ..”
The video includes claims, including the following examples:

• “On Guard is very anti-viral…”
• “Melaleuca . . . highly anti-viral”

• In June 12, 2014 posts titled, “Common Uses for Essential Oils” to the Facebook and Twitter accounts, accessible at www.facebook.com/anytimeessentials and twitter.com/atessentials:

o Both posts include a link to the website, www.anytimeessentials.com where disease claims can be found and where consumers can purchase products from your webpage, www.mydoterra.com/anytimeessentials.

Disease claims include, but are not limited to, the following:

o “Clary Sage: Cramps . . . Endometriosis, Estrogen Balance, Hormonal Balance, PMS, Pre-menopause”
o “Lemongrass . . . Reduce high cholesterol”
o “Rosemary Asthma, Antimicrobial, Bronchitis, Diuretic . . .”
o “Frankincense: Sciatic Pain . . . Anxiety, Depression . . . Infections”
o “Wintergreen Analgesic, Anti-Inflammatory, Joint Pain . . . Arthritis”
o “Vetiver: . . . ADD/ADHD . . . Anxiety”
o “Oregano: Antibiotic, Athlete’s Foot . . . Canker Sores, Fungal Infections, Inflammation, MRSA, Staph Infections”

In a December 27, 2013 post to the Facebook account, www.facebook.com/EverydayEssentialOils which includes a link to where consumers can purchase your products from your www.mydoterra.com website:

o “Frankincense helps with Crohn’s and digestive diseases, Heart disorders of all kinds, liver concerns . . . cirrhosis recovery . . ..”
o Under the heading “Frankincense”:

• “Anti-inflammatory”
• “Anti-Cancer Properties”
• “Neurological Issues”
• “Tumor Reduction”
• “Immune System Strengthener”
• “Lowers High Blood Pressure”
• “Helps Symptoms of Crohn’s, Arthritis, & Epilepsy”


• In a post titled, “how to use peppermint essential oil” accessible at

:

o “Asthma/Congestion”
o “Autism”
o “Bacterial Infections”
o “Brain Injury”
o “Cold Sores”
o “Fever”
o “anticarcinogenic”

It is clear from the above claims that your “Melaleuca,” “Oregano,” “On Guard,” “Clove,” “Eucalyptus,” “Frankincense,” “Geranium,” “Lavender,” “Lemongrass,” “Myrrh,” “Peppermint,” “Rosemary,” “Wintergreen,” “Cassia,” “Clary Sage,” and “Vetiver” are promoted for conditions that cause them to be drugs under section 201(g)(1)(B) of the Act because they are articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease. Moreover, your products are “new drugs” under section 201(p) of the Act [21 U.S.C. § 321(p)] because they are not generally recognized as safe and effective for use under the conditions prescribed, recommended, or suggested in their labeling. Under sections 301(d) and 505(a) of the Act [21 U.S.C. §§ 331(d) and 355(a)], a new drug may not be introduced or delivered for introduction into interstate commerce unless an FDA-approved application is in effect for it. Your sale of these products without approved applications violates these provisions of the Act. FDA approves a new drug on the basis of scientific data and information demonstrating that the drug is safe and effective.

Your products are prescription drugs as defined in section 503(b)(1)(A) of the Act [21 U.S.C. § 353(b)(1)(A)]) for some of the claims made for them because, in light of their toxicity or other potentiality for harmful effect, the method of their use, or the collateral measures necessary to their use, they are not safe for use except under the supervision of a practitioner licensed by law to administer them.

Your dōTERRA Essential Oil products, “Melaleuca,” “Oregano,” “On Guard,” “Clove,” “Eucalyptus,” “Frankincense,” “Geranium,” “Lavender,” “Lemongrass,” “Myrrh,” “Peppermint,” “Rosemary,” “Wintergreen,” “Cassia,” “Clary Sage,” and “Vetiver” are also misbranded under section 502(f)(1) of the Act [21 U.S.C. § 352(f)(1)], in that the labeling for these products fail to bear adequate directions for use for all of their claims. "Adequate directions for use" means directions under which a layperson can use a drug safely and for the purposes for which it is intended (21 C.F.R. § 201.5). Prescription drugs can only be used safely at the direction, and under the supervision, of a licensed practitioner. Therefore, it is impossible to write "adequate directions for use" for a prescription drug to be used by a layperson. As previously mentioned, these dōTERRA Essential Oil products are offered for conditions, such as ebola virus infection, that are not amenable to self-diagnosis and treatment by individuals who are not medical practitioners. Therefore, adequate directions cannot be written so that a layman can use these drugs safely for those intended uses. FDA-approved prescription drugs which bear their FDA-approved labeling are exempt from the requirement that they bear adequate directions for use by a layperson (21 C.F.R. §§ 201.100(c)(2) and 201.115). Because there are no FDA-approved applications for these products, the labeling of these products fails to bear adequate directions for their intended use and, therefore the products are misbranded under section 502(f)(1) of the Act. Accordingly, the introduction or delivery for introduction into interstate commerce of your misbranded dōTERRA Essential Oil products is a violation of section 301(a) of the Act [21 U.S.C. § 331(a)].

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.

We note that some of your products are marketed as dietary supplements, but are marketed for topical use. Under section 201(ff)(2)(A) of the Act [21 U.S.C. § 321(ff)](2)(A)], a dietary supplement is defined, among other things, as a product intended for ingestion. Topical products are not dietary supplements. In any case, the claims referenced above in this letter are drug claims, which are not suitable claims for dietary supplements. As such, whether or not they are intended for ingestion, the above-mentioned dōTERRA Essential Oil products are drugs under section 201(g)(1)(B) of the Act and not dietary supplements under section 201(ff) of the Act.

We request that you notify this office in writing within 15 working days from your receipt of this letter of the current status of your corrective actions and the specific steps you have taken to correct the noted violations. In your response, include documentation of your corrective actions. If you cannot complete all corrections before you respond, we expect that you will explain the reason for your delay and please include a timetable for the implementation of any remaining corrections.

If you need additional information or have questions concerning any products distributed through your website, please contact the FDA. You may respond in writing to LaTonya M. Mitchell, District Director, Denver District Office, Building 20 – Denver Federal Center, P.O. Box 25087, 6th Avenue & Kipling Street, Denver, Colorado 80225. If you have any questions concerning this letter, please contact Thomas R. Berry, PharmD, Compliance Officer, at 303-236-3028.


Sincerely,
/S/
LaTonya M. Mitchell
Denver District Director



cc:

Candace Anderson
www.mydoterra.com/anytimeessentials/
(b)(6)
[e-mail]

Candice J. Easter
www.mydoterra.com/skinnymedic/
(b)(6)
[e-mail]

Tiffany Harms
www.mydoterra.com/everydayessentialoilsaz/
[e-mail]

Jenn Attaway (aka “Wellness Empress”)
www.mydoterra.com/wellnessempress/
[e-mail]

[cinnamoncox]

Ugh. I can't even tell you how I cringe at Facebook so regimes. It's not the oils but a different type of MLM company.
People will post in the group oh, a potential client said their doctor told them not to take such and such (one of their products) because of xyz, what do I tell them? And I'm all ok cool there are 50 comments, someone must be the voice of reason here, and all the comments are "doctors don't want you to know about products they aren't paid for" and "tell. Her my doctor sells the products at her office, time for a new doctor!" and "oh sure like the FDA never makes mistakes, tell her if she doesn't want to get healthy, NEXT, and move on, some people just don't care to be healthy, sigh"

It makes me want to freaking explode.

Eta: regimes=many times

[eclaires]

They sent one to YL too!

[eclaires]

Also, I imagine this will happen a lot more and the FDA will be scrutinizing these companies closely. Because the people who sell it use social media for all these claims, so it's all right there.

[memenee]

I love, love, love this!!!

Yay FDA! Oily people and oily families pls stop. Not interested. Stay off my IG. Your oils heal nothing. And certainly not my friends Stage IV cancer.

[pixy0stix]

This makes me gleeful inside.

[pixy0stix]

So, to be clear, they're asking the EO companies to stop selling their oils without medical prescriptions, correct?

This is going to effectively shut down the companies.

[aurademystere]

My SIL believes this nonesense hook, line, and sinker. She told me the other day that the essential oil from lemons cured depression. M'kay. I'm sure I'll see a FB rant about this.

[cattledogkisses]

I hope this is the end of this nonsense. I had someone of my Facebook pushing oils instead of flu shots the other day and my head about exploded.

[memenee]

My dds classmates mother is going to the school to protest the flu vaccination requirement. She said her oils (rubbed on the bottom of her daughters feet) will be equally effective.

[FloFTW]

YEEEEEEESSSSSS! Although the crazies that sell this snake oil don't give any shits about the FDA.

Grumbles.

[cinnamoncox]

Sept 25, 2014 9:14:52 GMT -5 pixy0stix said:

So, to be clear, they're asking the EO companies to stop selling their oils without medical prescriptions, correct?

This is going to effectively shut down the companies.

I don't know, maybe *just* not make medical claims. The MLM I witness on my Facebook just says they can't say oh take this it'll cure you of xyz, they're just supposed to say this has such and such in it and this has been my experience with it, and they can give anecdotes from other users. They aren't allowed (per "compliance" within the company) to make any claims such as it'll treat or cure. This doesn't stop distributors from making the claims, it just allows the company to say we don't allow them to say it but we can't control what all of the distributors say.
But I've never once seen the "leaders" say one word to any of the distributors who are making such claims. It comes down to, well if someone doesn't want these products, it's because they don't care to be healthy.

There are so many distributors of these products and I think the fact that they are independent and not employees of the companies really gives the company a lot of leeway or distance from any sort of trouble, for lack of a better word. It's like they can just blame the individual distributor for misrepresenting.
I hope I'm making sense here.

[debatethis]

Sept 25, 2014 9:14:52 GMT -5 pixy0stix said:

So, to be clear, they're asking the EO companies to stop selling their oils without medical prescriptions, correct?

This is going to effectively shut down the companies.

From how I read it, they either need to stop making medical/dietary supplement claims or totally revamp their sales pitch. Given that their entire premise is EOs can replace Western medicine, I think you are correct re: it shutting them down.
Edited bc words are hard.

[pixy0stix]

I edited the post to include a news article.

[sunny]

I love this

[pixy0stix]

Sept 25, 2014 9:37:40 GMT -5 @mx said:

Can I ask a question about the history of this? How did this become such a huge thing in the suburban SAHM/evangelical/crunchy-but-totally-not crunchy crowd?

Because until very recently when I heard about essential oils I immediately thought of middle aged black men (often but not always wearing Afrocentric garb) selling them on public transit and in some neighborhoods. I feel like those two groups don't overlap socially much, so I'm curious what the Venn diagram looks like!

It's an offshoot of the anti-vax crowd. Sort of a competition for the uber-mommies - How long can I go without taking my kid to the doctor?

[cinnamoncox]

As always, don't read the comments.

[cville]

I mean, normally you don't think of the FDA as a kickin' ass, takin' names type of organization. But, way to get real FDA. Way to go.

[memenee]

......essential oils and other natural remedies can "help prevent your contracting the Ebola virus" and in at least one instance, "effectively kill the Ebola virus."

Did anyone actually believe this??? Apparently I've been giving people too much credit.

[niemand88f]

Sept 25, 2014 9:48:55 GMT -5 cinnamoncox said:

As always, don't read the comments.

I was actually pleasantly surprised by comments on local news stories, considering DoTerra and Young Living are both based in Utah. The majority of comments were happy with this news and skeptical of the claims.

I drive past one of the Young Living farms on road trips and never knew it was so woo until recently (really, ebola??? I guess you can say its an effective preventative if you don't catch ebola in the middle of nowhere, USA ). It looks just like a normal farm, even beautiful when the lavender is blooming.

[cinnamoncox]

Sept 25, 2014 9:54:40 GMT -5 niemand88f said:

Sept 25, 2014 9:48:55 GMT -5 cinnamoncox said:

As always, don't read the comments.

I was actually pleasantly surprised by comments on local news stories, considering DoTerra and Young Living are both based in Utah. The majority of comments were happy with this news and skeptical of the claims.

I drive past one of the Young Living farms on road trips and never knew it was so woo until recently (really, ebola??? I guess you can say its an effective preventative if you don't catch ebola in the middle of nowhere, USA ). It looks just like a normal farm, even beautiful when the lavender is blooming.

I meant the comments on the article pixy linked in the op. There were only ten, but it was things like they should be cracking down on big pharma, and why don't they just wash their hands (clean water is an issue in Ebola hard hit areas), and the govt has known high doses of vitamin c cures polio so why not try it on Ebola, oh wait no profit it in, etc.

Using essential oils in the bath to relax, fine, saying it'll cure and or prevent Ebola? Irresponsible to say the least.

[MrsAxilla]

Sept 25, 2014 9:37:40 GMT -5 @mx said:

Can I ask a question about the history of this? How did this become such a huge thing in the suburban SAHM/evangelical/crunchy-but-totally-not crunchy crowd?

Because until very recently when I heard about essential oils I immediately thought of middle aged black men (often but not always wearing Afrocentric garb) selling them on public transit and in some neighborhoods. I feel like those two groups don't overlap socially much, so I'm curious what the Venn diagram looks like!

Essential oils used to be big in the pagan/Wiccan/astrological type communities.  A different type of woo, I suppose.

Although tea tree oil DOES help with pimples.  Just ask my forehead.

[andrealynn]

I have a friend with cancer. She posted something about it on FB and a mutual friend that is a Doterra pusher replied "YGPM..." and I was seriously enraged, because I am 99% sure she was going to tell cancer friend to buy some oils.

I'm probably an asshole and she was just going to bring by a meal or something, but IJC with the claims some of these people make.

[Scout'sHonor]

I'm so glad to see this. I had to hide on FBer who claimed her oils were going to keep them safe from the Enterovirus going around.

[meshaliuknits]

Sept 25, 2014 9:51:42 GMT -5 cville said:

I mean, normally you don't think of the FDA as a kickin' ass, takin' names type of organization. But, way to get real FDA. Way to go.

I do, but they audit me. If they ever got some real funding they would be a terrifying force.


I'm not overly surprised by the course of action, though. They made General Mills change their labeling on Cheerios when they first pulled out the heart healthy thing. This is in a similar vein.

[ijack]

can they please send a letter to my SIL who sells ple.xus, which according to her cures everything from asthma to ADHD?

[osulori]

I have a number of FB friends that are loud purveyors of this stuff. I can't WAIT for the meltdowns!

[meshaliuknits]

Sept 25, 2014 13:22:30 GMT -5 @cookiemonster03 said:

this was posted on my FB twice, once kind of "lol" and the other all "LOOK AT THE GOVERNMENT INVADING OUR LIVES". Guess who got blocked?

THIS  IS THE FDA'S ENTIRE JOB!!!

[Michelle]

Sept 25, 2014 9:37:40 GMT -5 @mx said:

Can I ask a question about the history of this? How did this become such a huge thing in the suburban SAHM/evangelical/crunchy-but-totally-not crunchy crowd?

Because until very recently when I heard about essential oils I immediately thought of middle aged black men (often but not always wearing Afrocentric garb) selling them on public transit and in some neighborhoods. I feel like those two groups don't overlap socially much, so I'm curious what the Venn diagram looks like!

i bet there is a Venn diagram circle labeled "spent time in tribal or indigenous communities of Africa or the Carribean islands, particularly in areas of high evangelical Christian mission work."

Edited to close quote

[epphd]

Hey, if the oils really are medicinal and DO work, then why would these companies not invite the opportunity to prove it? If big bad western medicine has to do it, why not them? Look at the bright side - if they products work they might actually be able to make real money.