FDA has given Young Living doTERRA 15 days to reply stating the problems are resolved.

FDA Warning Letters: Young Living, dōTERRA Consultants Must Cease Marketing Claims That Essential Oils Fight Disease

Young Living and dōTERRA distributors were reprimanded Monday after the Food and Drug Administration FDA issued warning statements via overnight delivery to CEO Gary Young and David Stirling. Young Living and dōTERRA both use independent distributors as a sales-force. The majority of complaints the FDA issued in the warning letters involved the way some independent distributors marketed the companies’ products. Primarily, the FDA was concerned with Young Living and dōTERRA consultants’ online marketing material for the brands’ essential oils.

According to FDA regulations, neither dietary supplements nor essential oils are allowed to be marketed by the company in such a way that suggests the products can prevent, cure, or treat any disease. If a company does market in that manner, the product is considered a drug by the FDA. If a product is a drug, it must be approved by the FDA. So, any product marketed to cure, treat, or prevent a disease, that is not already an FDA approved drug, is considered an illegal, unapproved drug by the FDA.

The FDA found that Young Living essential oils were marketed for “viral infections (including ebola), Parkinson’s disease, autism, diabetes, hypertension, cancer, insomnia, heart disease, post-traumatic stress disorder (PTSD), dementia, and multiple sclerosis.” Meanwhile, dōTERRA consultants made claims that their therapeutic grade oils could treat “viral infections (including ebola), bacterial infections, cancer, brain injury, autism, endometriosis, Grave’s Disease, Alzheimer’s Disease, tumor reduction, [and] ADD/ADHD.”

Given these marketing claims, the FDA sent out the warning letters allowing the companies 15 days to rectify the illegal marketing and respond before facing any punishment.

In a statement to the Washington Post, a spokesman for Young Living said company officials are “cooperating fully with the FDA regarding its inquiry.” Young Living distributors, according to the statement, are instructed about marketing regulations. “We have already contacted each of the Members cited in the FDA letter to help get them into compliance.”

However, Young Living’s CEO was reprimanded for more than just consultants’ claims. Young Living’s own website made claims that promoted products in such a way that the federal government would classify the products as drugs, according to the FDA.

“FDA also reviewed a 2012-2013 product guide found on your website http://www.youngliving.com. Based on our review, FDA has determined that many of your Young Living Essential Oil products, such as, but not limited to, ‘Thieves,’ ‘Cinnamon Bark,’ ‘Oregano,’ ‘ImmuPower,’ ‘Rosemary,’ ‘Myrtle,’ ‘Sandalwood,’ ‘Eucalyptus Blue,’ ‘Peppermint,’ ‘Ylang Ylang,’ ‘Frankincense,’ and ‘Orange,’ 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)], because they are intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease.”

“Oftentimes with public health incidences, like Ebola or even during H1n1, we see products that are marketed, often online, that claim to treat or cure the disease…without FDA approval,” FDA spokeswoman Stephanie Yao told the Washington Post.

“Unfortunately, during outbreak situations, fraudulent products claiming to prevent, treat or cure a disease almost always appear,” the FDA said in a statement, according to Regulatory Focus.

While many studies on the National Institute of Health‘s own online library of medicine demonstrate examples of non-specific brands of essential oils or essential oil components exhibiting the ability to fight many diseases, the FDA is clear about what claims are prohibited when sellers and companies are marketing their own products.

The FDA states on an informational page, “If a product is intended for a therapeutic use, such as treating or preventing disease, or to affect the structure or function of the body, it’s a drug.”

According to Organic Home Health, while some dōTERRA consultants claim their products are FDA approved as therapeutic, the company itself does not officially state that. The FDA does not actually approve dietary supplements or essential oils, according to the administration, and there is not even an actual regulatory definition for “essential oils.”

Some consultants will boast dōTERRA’s “Certified Pure Therapeutic Grade” stamp. The certification, according to the company’s website, is self-awarded. In 2009, however, Winged Seed bloggers published an alleged email which reads, in the opinion of the author, that a company representative stated to a potential customer that the CPTG is something the FDA grants.

“We apologize if one of our consultants has mislead you in anyway (sic),” the alleged email read. “All of our oils are FDA approved as being Certified Pure Therapeutic Grade (CPTG).” CPTG stamps, as dōTERRA’s website clarifies, are actually registered trademarks (as word marks) belonging to DoTERRA Holdings.

“Although there are good essential oils available to consumers, many products claiming to be essential oils often are not pure aromatic extracts and often contain fillers and non-aromatic compounds.” Mark Wolfert, General Counsel for dōTERRA at that time explained in the comments area of the Winged Seed article. “The name dōTERRA and CPTG registered trademark represent our guarantee of 100% pure essential oil extracts and accurate product labeling.”

As writer Lee Tea points out though, many pure aromatic extracts produced or sold by reputable companies also do not contain such fillers and non-aromatic compounds.

“By the way, it is totally possible to buy a 1/2 ounce of pure, unadulterated, undiluted, therapeutic grade Frankincense essential oil for about 20 bucks a bottle,” Lee Tea wrote, linking to Mountain Rose Herbs, a company that is, according to the author, a trusted name in essential oils. A similarly sized bottle of Frankincense essential oil from of dōTERRA might run about $70 and from Young Living could cost more than $90, according to Google product searches.

Mountain Rose Herbs is just one essential oil distributor that boasts a large organic selection, uses 100 percent pure aromatic extracts, and offers much lower prices than Young Living and dōTERRA. Other essential oil producers and distributors claiming purity in their products also exist in the U.S. and are available in health food stores, grocery stores, and online shops, though Young Living and dōTERRA both claim excellence and industry bar-setting procedures.

Young Living and dōTERRA consultants are expected by their respective company rules to practice marketing in ways that to not violate FDA or FTC regulations.