The FDA sent a warning to Young Living, saying that its CBD products are “drugs” that are “meant to be used to cure, lessen, treat, or prevent disease.”
The classification was made based on how Young Living and its distributors market their products.
On June 10, 2022, the FDA sent out its warning letter. On July 19, the letter was made public.
The drug classification is explained in the letter to Mary B. Young, and it says:
Frankincense Essential Oil
Lemon Essential Oil
Lavender Essential Oil
DiGize Essential Oil Blend
Blend of Thieves Essential Oil
Vitality of Lemongrass
The Nature’s Ultra CBD Beauty Boost
Nature’s Ultra CBD Muscle Rub
Nature’s Ultra CBD Pep Bundle
Nature’s Ultra Cinnamon CBD Oil; Nature’s Ultra Calm CBD Roll-On;
Nature’s Ultra Citrus CBD Oil
CBD oil from nature that tastes like mint
The FDA says that these Young Living products are safe.
are drugs under section 201(g)(1)(B) of the Federal Food, Drug, and Cosmetic Act (the Act) because they are meant to be used to cure, reduce, treat, or prevent disease.
The way a product is labeled, how it is advertised, and how and where it is sold can all tell you what it is meant to be used for.
As will be explained in more detail below, these products are also unapproved new drugs and drugs that have been mislabeled.
The Act says that it is against the law to introduce or deliver these products into interstate commerce.
Here are some specific ways Young Living markets its products as drugs:
claiming CBD Muscle Rub relieves tension and soothes sore muscles Young Living’s CBD products helped keep the “endocannabinoid system” working well, which in turn stopped depression, Alzheimer’s, IBS, fibromyalgia, and migraines.
“Mental health problems” like depression or PTSD could be treated with or helped by Young Living essential oils.
The FDA also gives marketing claims made by Young Living distributors as far back as 2019.
Molly Buckley Stillman (Consultant #1852080)
Molly Stillman said that Young
Frankincense Essential Oil can be used to ease the pain of urinary tract infections and yeast infections. It can also be used as a “homemade sunscreen.”
Lemon Essential Oil can be used to treat kidney stones, “seasonal sniffles and runny noses,” acne, urinary tract infections, and to reduce inflammation.
Lavender Essential Oil can help with allergies and “seasonal sniffles.”
Frankincense Essential Oil can be used to keep umbilical cord stumps clean and free of germs.
Consultant #1533467 Carol Yeh-Garner
Carol Yeh-Garner is a Royal Crown Diamond, which is the best rank a Young Living distributor can get.
Yeh-Garner said that the FDA’s evidence showed that
“Microbes and parasites are killed by the phenols and phenylpropanoids in essential oils.”
Using lemon, lavender, and peppermint essential oils “could help with allergy symptoms like post-nasal drip, sneezing, and itchy eyes.”
Hannah Leiden-Olsen (Consultant #18682287)
Executive-level distributor Hannah Leiden-Olsen said that Young Living’s Frankincense Essential Oil could “help” with arthritis and asthma.
Consultant #12438030 is Madison Hollander.
Madison Hollander said that Young
A blend of essential oils from Digize could help with heartburn.
Lemongrass Vitality was a “go-to” for inflammation, infection, stomach upset, stuffy nose, high body temperature, high blood pressure, high cholesterol, bladder pain, and high blood pressure.
Peppermint Vitality was used to treat headaches.
Scientists found that Ningxia has the most antioxidants of any food in the world.
Ningxia was used to treat inflammation, disease, and cancer, as well as high blood sugar and cholesterol.
Consultant #2472927 Tiffany Dwyer
Young Living was a scam, said Tiffany Dwyer.
Lavender Essential Oil “helps allergies”
Thieves essential oil blend helped with “a head cold, sneezing, watery eyes, a runny or stuffy nose, and body aches.”
Ningxia kept the flu from happening and made a cold less bad.
Consultant #1744518 is Tamara Rowe.
Tamara Rowe said that 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, and sleep disorders, “plus more!”
Putting Young Living’s products on the same level as drugs
Based on the marketing claims made by the company and distributors, the FDA told the company
Your products called “Essential Oil,” “Vitality,” “Ningxia,” and “Nature’s Ultra CBD” are all drugs.
We don’t know of any published clinical studies that are good enough and well-controlled to show that any of these products are generally recognized as safe and effective (GRASE) when used as directed, suggested, or recommended on their labels.
According to section 201(p) of the Act, your “Essential Oil,” “Vitality,” “Ningxia,” and “Nature’s Ultra CBD” products are “new drugs.”
Without an approved application from the FDA, new drugs can’t be sold in interstate commerce or sent there to be sold.
FDA gives approval to a new drug if scientific data and information show that the drug is safe and works well.
None of these “Essential Oil,” “Vitality,” “Ningxia,” or “Nature’s Ultra CBD” products have been cleared by the FDA.
So, these products are unapproved new drugs that were sold without permission, which is against sections 505(a) and 301(d) of the Act, 21 U.S.C. 355(a), 331. (d).
After saying that Young Living’s products are drugs, the FDA also said that they are drugs that have been mislabeled.
Under section 502(f)(1) of the Act, your “Essential Oil,” “Vitality,” “Ningxia,” and “Nature’s Ultra CBD” products are also misbranded.
Section 502(f)(1) says that a drug is misbranded if its labeling doesn’t give enough information about how it should be used (s).
Based on the claims above, your “Essential Oil”, “Vitality”, “Ningxia”, and “Nature’s Ultra CBD” products are meant to prevent, treat, or cure conditions that can’t be diagnosed or treated by people who aren’t doctors, like urinary tract infections, yeast infections, high cholesterol, high blood pressure, cancer, kidney stones, addiction, Alzheimer’s, anxiety, depression, chronic pain, diabetes, drug withdrawal, epilepsy, etc.
Under section 503(b)(1)(A) of the Act, your “Essential Oil,” “Vitality,” “Ningxia,” and “Nature’s Ultra CBD” products are considered prescription drugs. You can’t write good instructions for how to use them so that a regular person can use them safely for what they were made for.
Under section 502(f)(1) of the FD&C Act, your “Essential Oil,” “Vitality,” “Ningxia,” and “Nature’s Ultra CBD” products are misbranded drugs.
What’s the meaning?
As far as I know, all of the Young Living products are now on the list of drugs that need a prescription in the US.
Prescription drugs that have been approved by the FDA and have labels that have been approved by the FDA do not have to have directions for use by a layperson.
But your products aren’t exempt from having to have clear instructions on how to use them on the label because they don’t have an FDA-approved application.
This means that it is against the law for Young Living to sell the drugs on the list.
With written proof of its claims, the company can apply for FDA approval. That would probably be a waste of time though, since Young Living and its distributors lie about what essential oils can do.
The FDA gave Young Living 15 days to say “exactly what steps you have taken to fix any problems.”
If you think your products don’t break the law, tell us why and give us any other information that will help us decide.
It is not clear if Young Living has replied to the FDA’s warning letter.
The government agency warns that if Young Living doesn’t respond to the letter and/or keeps selling its prescription drug products, the FDA could “take legal action, including, but not limited to, seizure and injunction.”
When you go to Young Living’s website, you can see that, at the time of publication, the company is still selling products that the FDA has reclassified in a way that is against the law.
I think this will work out, but I’m not sure yet. Since the 1970s, MLM companies and their distributors have been in trouble for making false health claims.
Even though the FDA’s decision to reclassify Young Living’s products as prescription drugs is a step up, it doesn’t mean anything if the regulator doesn’t do anything about it.
Since at least 2014, the FDA has warned Young Living about making false claims about its products. It’s crazy to wait eight years before doing anything.
And if Young Living ignores the FDA’s latest warning, the FDA won’t be able to do anything but keep things as they are.
That means that MLM companies and their distributors make false health claims all over the internet. A warning letter could be sent to that MLM company, often years after the fact.
Every few years, cited examples are taken out of social media that is open to the public.
The FDA has let this dangerous cycle go on for far too long.
Stay tuned to see if Young Living takes off the market FDA-classified prescription drugs or if the FDA takes more action against the company for not following the rules.