FDA warns Young Living & doTerra for false product claims
The FDA recently sent letters to both Young Living and doTerra, warning them that they had observed instances of their products being
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)], because they are intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease.
As one might expect, the FDA found the products being inappropriately marketed on affiliate websites. They also however found both companies to be pushing the disease angle in their inhouse marketing too.
In their letter to Young Living, dated September 22nd, the FDA wrote
This is to advise you that in August 2014 the U.S. Food and Drug Administration (FDA) reviewed websites and social media accounts (e.g., Facebook, Twitter, and Pinterest) for several Young Living essential oil consultants that your firm refers to as “Young Living distributors.”
(The) FDA also reviewed a 2012-2013 product guide found on your website.
Your consultants promote many of your Young Living Essential Oil Products for conditions such as, but not limited to, viral infections (including ebola), Parkinson’s disease, autism, diabetes, hypertension, cancer, insomnia, heart disease, post-traumatic stress disorder (PTSD), dementia, and multiple sclerosis, that are not amenable to self-diagnosis and treatment by individuals who are not medical practitioners.
Consumers interested in your Young Living Essential Oil products are then redirected by your consultants to your website, to purchase your products and/or register as members.
One Young Living affiliate website cited as an example is “The Oil Dropper”:
On the website, theoildropper.com, under the heading, “Young Living Versus Ebola Virus”:
Under the subheading, “Be Prepared”:
-“Since I have become an avid Young Living essential oil user I have learned all about the anti-microbial properties of so many oils, including ANTI-VIRAL constituents in many of our essential oils.”
–“Viruses (including Ebola) are no match for Young Living Essential Oils”
Under the subheading, “Top Oil Choices for Viruses”:
-“Top on my list is Thieves. Thieves is highly anti-microbial . . . it could help against Ebola.”
-“Ebola Virus can not live in the presence of cinnamon bark (this is in Thieves) nor Oregano.” [sic]
-“ImmuPower by Young Living would be a top choice as well. ImmuPower is a blended oil containing (oregano, clove, frankincense, ravintsara, cistus, mountain savory and hyssop). Every single one of these individual oils has anti-viral properties.”
On the website, theoildropper.com, under the heading, “Rosemary Essential Oil by Young Living”:
-“[R]egular use of rosemary essential oil may . . . help prevent diseases associated with free radicals, including cancer and heart disease.”
-“Rosemary research in regards to Alzheimer’s disease showed aromatherapy as a potential treatment for the cognitive (eg, memory) impairments caused by dementia.”
-“Rosemary . . . has antimicrobial and antiseptic qualities than [sic] may help eliminate . . . eczema and dermatitis.”
On the website, www.theoildropper.com, under the heading, “Myrtle Essential Oil Uses & Benefits”:
-“Myrtle is a wonderful antiseptic . . . It has been known to protect against tetanus . . ..”
-“Myrtle . . . is also beneficial for other conditions that affect the nerves such as Parkinson’s, Alzheimer’s . . ..”
“[M]yrtle . . . can help with sexual dysfunction issues such as impotency . . . and ED.”
-“Cancer protection…According to a study . . . Myrtle inhibited prostate and breast cancer cells along with Sandalwood at very low concentrations. Sandalwood essential oil ranked number one for inhibiting growth of breast cancer at 98.1% and Myrtle was at 95.2%.”
The Oil Dropper website domain is registered to a “Cari Caraway”, who is presumably a Young Living affiliate.
Since receiving the FDA letter, Caraway has taken the offending version of the Oil Dropper website offline. A message on the site now reads:
Big Things are Coming!
This has been an exciting week for THE OIL DROPPER to say the least! I have decided to re-vamp my pages so stay tuned for more great content.
There is no mention of the FDA or the offending health claims.
Two other Young Living affiliate websites are also cited, along with marketing pitches on Twitter, Facebook and Pinterest.
Claims about Ebola in particular appear to be a popular marketing technique for Young Living affiliates.
As for Young Living themselves, the FDA took issue with the way certain essential oils were labelled:
“Thieves,” “Cinnamon Bark,” “Oregano,” “ImmuPower,” “Rosemary,” “Myrtle,” “Sandalwood,” “Eucalyptus Blue,” “Peppermint,” “Ylang Ylang,” “Frankincense,” and “Orange” are also “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 the 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 the drug. FDA approves a new drug on the basis of scientific data and information demonstrating that the drug is safe and effective.
Your products, “Thieves,” “Cinnamon Bark,” “Oregano,” “ImmuPower,” “Rosemary,” “Myrtle,” “Sandalwood,” “Eucalyptus Blue,” “Peppermint,” “Ylang Ylang,” “Frankincense,” and “Orange,” are prescription drugs as defined in section 503(b)(1)(A) of the Act [21 U.S.C. § 353(b)(1)(A)] for some of the claims made for them because, in light of their toxicity or other potentiality for harmful effect, the method of their use, or the collateral measures necessary to their use, they are not safe for use except under the supervision of a practitioner licensed by law to administer it.
Your Young Living Essential Oil products, “Thieves,” “Cinnamon Bark,” “Oregano,” “ImmuPower,” “Rosemary,” “Myrtle,” “Sandalwood,” “Eucalyptus Blue,” “Peppermint,” “Ylang Ylang,” “Frankincense,” and “Orange,” 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.
The FDA’s warning to doTerra meanwhile cites a host of examples from the affiliate website “Anytime Essentials” (anytimeessentials.com).
Owned by Candace Anderson, the Anytime Essentials website is currently displaying the following message:
I’m glad that you are here, but sorry I don’t have a website for you. I am in the process of reworking some of my articles so that I am in full compliance with the FDA.
I had been following a very well loved book that us doTERRA Wellness Advocates use, but unfortunately that wording isn’t okay here on the Internet. So…things they are a changin’ around here.
Stay tuned for an even better Anytime Essentials.
Additional examples from Twitter, Facebook and Pininterest are also cited.
Both Young Living and DoTerra have been given 15 days to notify the FDA ‘of the current status of (their) corrective actions and the specific steps (they) have taken to correct the noted violations.
In response to the FDA’s warning, a Young Living spokesperson told the Washington Post:
the company was “cooperating fully with the FDA regarding its inquiry.
“Young Living “members,” the statement continued, “are provided specific instructions on how to promote our products to their customers.
In the coming days we will be contacting all our membership to ensure that they understand how to best use our products and remain compliant with regulatory directives.
“We have already contacted each of the Members cited in the FDA letter to help get them into compliance.”
I wonder how Young Living will address the labeling challenges they’ve been presented with…