Young Living corporate offices in Utah has received another warning letter from the FDA over the intended use of their products. They referenced claims made on the Young Living website social media accounts as well as websites and social media accounts for several consultants.
Not the First
This isn’t the first time Young Living—and their consultants—have been warned by the FDA that the statements and claims made for their essential oils have caused the products to be unapproved new drugs.
It’s been an ongoing situation. A quick Google search will find many, many, many outrageous (and illegal) claims being made for Young Living products.
Directly from the regulations:
DRUG:
(B) articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animals; and
(C) articles (other than food) intended to affect the structure or any function of the body of man or other animals;
21 USC 321 (g)(1)
Intended Use
As I have covered (oh! so many times!) on this blog and in my books, it is the intended use use of a product that determines what it is. If the intended use is to cure, mitigate, treat, or prevent disease or to alter the function or structure of the body, then it is a drug! If it hasn’t been approved by the FDA, then it’s an unapproved new drug (and so, illegal).
The FDA looks at all available sources to determine the intended use of a product. In the case of this warning letter, the FDA looked at websites, and Facebook and Instagram accounts for both the corporate office and several consultants.
In the past, for other warning letters, the FDA has also reviewed Instagram and Twitter posts, YouTube videos, and even studies making claims that were linked to from a website.
The Claims
In this warning letter, the FDA specifically cited the following claims made for essential oils (I’ve bolded the questionable points).
- “20 Uses for Frankincense Essential Oil…”
“16. May ease symptoms of discomfort from a urinary tract infection”
“17. May ease symptoms of discomfort from a yeast infection”
“19. Great to use … for a homemade sunscreen” - “30 Uses for Lemon Essential Oil…”
“3…sometimes proves to be as effective as stone-breaking chanca piedra pills for the kidney stones.”
“19. Use (especially along with lavender and peppermint) to ease those seasonal sniffles and runny noses”
“23. Can be used to combat acne…”
“24. May ease symptoms from urinary tract infections”
“28. May reduce inflammation” - “35 Uses for Lavender Essential Oil…”
“9. Use in a vegetable capsule, a teaspoon of honey … to ease those seasonal sniffles (especially this time of year with ALL of the pollen)” - “Phenolpropanoids… The Phenolpropanoids and phenols in essential oils… attack invading microbes and parasites…found in clove, peppermint [Vitality], fennel, basil and wintergreen.”
- “…my friend… added me to a product education group where I learned that taking lemon [Essential Oil], lavender [Essential Oil] and peppermint [Vitality] could help with allergy symptoms like post-nasal drip, sneezing and itchy eyes… I used those oils to help with my allergies.”
- Video Image of Frankincense Essential Oil “…can help with arthritis…asthma…”
- “Digize [Essential Oil Blend]… heartburn”
- Image of Lavender Essential Oil – “Lavender-…Helps allergies…”
- Thieves – “…a head cold. Sneezing, watering eyes, running/stuffed nose…even body aches… Today- however, I’m still feeling a little tired, my ears don’t hurt anymore, and I feel MUCH BETTER. The remedy, thieves [Essential Oil Blend] under the tongue all day long and an overdose of YL Vitamin C… ready to beat the cold and flu season… DM ME!!!”
The Takeaway
Making statements similar to the ones above about your product (or its ingredients) says that the intended use is to treat, cure, mitigate, or prevent disease, and/or to alter the function or structure of the body. It makes your product an unapproved new drug.
What can you do? Well, DON’T make those claims! Say what’s in your product. Be truthful. Let your customer decide if the ingredients have the benefits they are looking for. Most people don’t need to be told what eucalyptus, tea tree, lavender, or many other essential oils will do. They already know and that’s why they are looking for a product containing them.
Shameless plug!
Besides labeling, there are many other laws and regulations that apply to handcrafters. To find out which ones apply to you and how to comply with them, buy my book and keep it handy!
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