Young Living has received a warning from the FDA, advising its CBD products “are drugs … intended for use in the cure, mitigation, treatment, or prevention of disease.”
The classification has been made following observation of marketing by Young Living and its distributors.
The FDA sent out its warning letter on June 10th, 2022. The letter was made public on July 19th.
The letter, addressed to Mary B. Young, specifies the drug classification applies to:
Frankincense Essential Oil
Lemon Essential Oil
Lavender Essential Oil
DiGize Essential Oil Blend
Thieves Essential Oil Blend
Natures Ultra CBD Beauty Boost
Natures Ultra CBD Muscle Rub
Natures Ultra CBD Pep Bundle
Natures Ultra Calm CBD Roll-On
Natures Ultra Cinnamon CBD Oil
Natures Ultra Citrus CBD Oil
Natures Ultra Cool Mint CBD Oil
According to the FDA, these Young Living products
are drugs under section 201(g)(1)(B) of the Federal Food, Drug, and Cosmetic Act (the Act) 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.
As explained further below, these products are also unapproved new drugs and misbranded drugs.
Introducing or delivering these products for introduction into interstate commerce violates the Act.
Specific examples of Young Living marketing its products as drugs include:
claiming CBD Muscle Rub soothes sore muscles and relieves tension
claiming Young Living’s CBD products supported a “properly functioning endocannabinoid system”, which in turn prevented depression, Alzheimer’s IBS, fibromyalgia and migraines
Young Living essential oils could treat and/or improve “mental health issues, such as depression or PTSD”
The FDA also cites examples of Young Living distributor marketing claims, dating back to 2019.
Molly Buckley Stillman (Consultant #1852080)
Molly Stillman claimed Young Living’s
Frankincense Essential Oil can be used to ease symptoms of discomfort from urinary tract infections and yeast infections, and could also be used as a “homemade sunscreen”
Lemon Essential Oil can be used to treat kidney stones, “seasonal sniffles and runny noses”, as an acne treatment, urinary tract infections and to reduce inflammation
Lavender Essential Oil can be used to treat “seasonal sniffles” and allergies
Frankincense Essential Oil can be used as a sterile antimicrobial topical for umbilical cord stumps
Carol Yeh-Garner (Consultant #1533467)
Carol Yeh-Garner is a Royal Crown Diamond, the highest distributor rank achievable in Young Living.
As per evidence collected by the FDA, Yeh-Garner claimed
“phenylpropanoids and phenols in essential oils… attack invading microbes and parasites”
taking lemon, lavender and peppermint essential oils “could help with allergy symptoms like post-nasal drip, sneezing and itchy eyes”
Hannah Leiden-Olsen (Consultant #18682287)
Hannah Leiden-Olsen, an Executive ranked distributor, claimed Young Living’s Frankincense Essential Oil could “help with” arthritis and asthma.
Madison Hollander (Consultant #12438030)
Madison Hollander claimed Young Living’s
Digize essential oil blend could treat heartburn
Lemongrass Vitality was a “go-to” for inflammation, infection, stomach upset, stuffy sinuses, high body temps, high blood pressure, high cholesterol, bladder discomfort and blood pressure
Peppermint Vitality treated headaches
Ningxia was “scientifically proven to be the highest antioxidant food source in the world”
Ningxia treated inflammation, disease and cancer, inflammation, cholesterol and high blood sugar
Tiffany Dwyer (Consultant #2472927)
Tiffany Dwyer claimed Young Living
Lavender Essential Oil “helps allergies”
Thieves essential oil blend remedied “a head cold, sneezing, watering eyes, running/stuffed nose (and) body aches”
Ningxia prevented the flu and reduced the effects of a cold
Tamara Rowe (Consultant #1744518)
Tamara Rowe claimed Young Living’s CBD oil could be used to treat addiction, Alzheimer’s, anxiety, chronic pain, depression, diabetes, drug withdrawal, epilepsy, glaucoma, inflammation, insomnia, Parkinson’s, sleep disorders, “plus more!”
Classifying Young Living’s products as drugs
Based on the cited company and distributor marketing claims, the FDA informed the company
Your “Essential Oil”, “Vitality”, Ningxia, and “Nature’s Ultra CBD” products are drugs.
We are not aware of any adequate and well-controlled clinical studies in the published literature that support a determination that any of these products are generally recognized as safe and effective (GRASE) for use under the conditions prescribed, recommended or suggested in their labeling.
Accordingly, your “Essential Oil”, “Vitality”, Ningxia, and “Nature’s Ultra CBD” products are new drugs under section 201(p) of the Act.
New drugs may not be introduced or delivered for introduction into interstate commerce without an approved application from FDA in effect.
FDA approves a new drug based on scientific data and information demonstrating that the drug is safe and effective.
No FDA-approved application is in effect for any of these “Essential Oil”, “Vitality”, Ningxia, or “Nature’s Ultra CBD” products.
Accordingly, these products are unapproved new drugs marketed in violation of sections 505(a) and 301(d) of the Act, 21 U.S.C. §§ 355(a), 331(d).
Having classified Young Living’s products as drugs, the FDA went on to also claim they are misbranded drugs.
Your “Essential Oil”, “Vitality”, Ningxia, and “Nature’s Ultra CBD” products are also misbranded within the meaning of section 502(f)(1) of the Act.
A drug is misbranded under section 502(f)(1) if the drugs labeling fails to bear adequate directions for its intended use(s).
Based on the above-referenced claims, your “Essential Oil, “Vitality”, Ningxia, and “Nature’s Ultra CBD” products are intended to prevent, treat, or cure conditions that are not amenable to self-diagnosis or treatment by individuals who are not medical practitioners, such as urinary tract infection, yeast infection, high cholesterol, high blood pressure, cancer, kidney stones, addiction, Alzheimers, anxiety, depression, chronic pain, diabetes, drug withdrawal, epilepsy, glaucoma, and Parkinsons disease.
Accordingly, your “Essential Oil”, “Vitality”, Ningxia, and “Nature’s Ultra CBD” products are considered prescription drugs under section 503(b)(1)(A) of the Act [21 U.S.C. § 353(b)(1)(A)] and adequate directions for their use cannot be written so that a layperson can use these drugs safely for their intended purposes.
Consequently, your “Essential Oil”, “Vitality”, Ningxia, and “Nature’s Ultra CBD” products are misbranded drugs under section 502(f)(1) of the FD&C Act.
What does this mean?
As I understand it, the list of Young Living products are now classified as prescription drugs in the US.
FDA-approved prescription drugs that bear their FDA-approved labeling are exempt from the requirements that they bear adequate directions for use by a layperson.
However, your products are not exempt from the requirement that their labeling bear adequate directions for use, because no FDA-approved application is in effect for your products.
This means Young Living can no longer sell the listed drugs legally.
The company can apply for FDA approval with documented evidence of its claims. That’d likely be a waste of time though as essential oils don’t do what Young Living and its distributors claim they do.
The FDA gave Young Living fifteen days to detail “specific steps that you have taken to address any violations.”
If you believe that your products are not in violation of the Act, include your reasoning and any supporting information for our consideration.
Whether Young Living has responded to the FDA’s warning letter is unclear.
The regulator warns that should Young Living ignore the letter, and/or continue to sell its prescription drug products, the FDA may take “legal action including, without limitation, seizure and injunction.”
A visit to Young Living’s website reveals that, at time of publication, the company continues to illegally sell products reclassified by the FDA.
Personally I’m cautiously optimistic about this. MLM companies and their distributors making illegal health claims has been an issue for decades.
While the FDA reclassifying Young Living’s products as prescription drugs is an escalation, it doesn’t mean anything if the regulator doesn’t follow up.
The FDA has been warning Young Living about illegal product claims since at least 2014. Eight years before doing anything is ridiculous.
And if the FDA doesn’t follow up with legal action if Young Living ignores its latest warning, will do nothing but preserve the status quo.
That is MLM companies and their distributors run around the internet making illegal health claims. Said MLM company might receive a warning letter, often years after the fact.
Publicly available social media gets scrubbed of cited examples, and rinse and repeat every few years.
This is a dangerous cycle the FDA has let go on for far too long.
Pending Young Living pulling FDA classified prescription drug products from sale, or the FDA taking further action against the company for non-compliance, stay tuned…