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The FDA has issued a warning to Young Living, informing them that its CBD products “are pharmaceuticals… intended for use in the cure, mitigation, treatment, or prevention of illness.”

Following observation of Young Living and its distributors’ marketing, the categorization was developed.

On June 10th, 2022, the FDA gave out its warning letter. On July 19, the letter was made widely available.

The letter sent to Mary B. Young, details which drug the drug categorization covers.

Essential Oil of Frankincense

Essential Oil of Lemon

Essential Oil of Lavender

Essential Oil Blend DiGize

Blended essential oils of thieves

Green Tea Vitality

menthol vitality

Ningxia

Pure CBD Beauty Boost from Nature

Muscle Rub with Extra CBD by Nature

Ultra Natural CBD Pep Package

Natural Ultra Cinnamon CBD Oil Natural Ultra Calm CBD Roll-On

CBD Oil Citrus by Nature

Natural CBD Oil in Ultra Cool Mint

The FDA says these Young Living products

Because they are intended for use in the treatment, mitigation, prevention, or curing of illness, they fall under the definition of medications under section 201(g)(1)(B) of the Federal Food, Drug, and Cosmetic Act (the Act).

The labeling, promotion, and distribution conditions of a product, among other factors, can all affect how it is supposed to be used.

These goods are also misbranded medications and newly approved unapproved pharmaceuticals, as will be further detailed below.

It is against the Act to introduce or transport certain goods for introduction into interstate commerce.

Young Living has marketed its products as medications in the following instances:

Claims CBD Muscle Rub eases stress and relaxes tight muscles The CBD supplements from Young Living promoted a “fully functioning endocannabinoid system,” which in turn reduced migraines, IBS, fibromyalgia, and Alzheimer’s.

“Mental health disorders, such as depression or PTSD” may be improved or treated using Young Living essential oils.

Additionally, the FDA provides instances of marketing claims made by Young Living distributors going back to 2019.

Molly Stillman Buckley (Advisor #1852080)

According to Molly Stillman, Young Living’s

Frankincense essential oil may be used as a “homemade sunscreen,” as well as to relieve the discomfort caused by yeast infections and urinary tract infections.

Kidney stones, “seasonal sniffles and runny noses,” acne, urinary tract infections, and inflammation can all be treated with lemon essential oil.

Allergies and the “seasonal sniffles” can be treated with lavender essential oil.

For umbilical cord stumps, sterile antibacterial topical application of frankincense essential oil is possible.

Consultant #1533467 Carol Yeh-Garner

Carol Yeh-Garner holds the highest distributor position available in Young Living, the Royal Crown Diamond.

Yeh-Garner asserted that the FDA’s evidence supported his assertion.

“Essential oils’ phenylpropanoids and phenols combat invasive bacteria and parasites”

Itchy eyes, post-nasal drip, and sneezing are examples of allergy symptoms that consuming lemon, lavender, and peppermint essential oils “may aid with”

(Consultant #18682287) Hannah Leiden-Olsen

Young Living distributor Hannah Leiden-Olsen stated that the company’s Frankincense Essential Oil might “assist with” asthma and arthritis.

12438030 Madison Hollander is a consultant.

According to Madison Hollander, Young Living’s

The essential oil combination Digize may be used to relieve heartburn.

Inflammation, infection, nausea, nasal congestion, high body temperatures, high blood pressure, high cholesterol, bladder pain, and blood pressure were all treated with Lemongrass Vitality.

Headaches were addressed with peppermint vitality.

“Ningxia is the greatest antioxidant dietary source in the world, scientific research has shown,”

Ningxia cured cancer, cancer, inflammation, excessive cholesterol, and blood sugar.

Consultant No. 2472927 is Tiffany Dwyer.

According to Tiffany Dwyer, Young Living

The essential oil of lavender “helps allergies”

A head cold, sneezing, watery eyes, running/stuffed nose, and body pains were all relieved by the Thieves essential oil combination.

Ningxia lessens the symptoms of a cold and the flu

Consultant No. 1744518 is Tamara Rowe.

According to Tamara Rowe, Young Living’s CBD oil may be used to treat a variety of conditions, including addiction, Alzheimer’s, anxiety, chronic pain, depression, diabetes, drug withdrawal, epilepsy, glaucoma, inflammation, insomnia, Parkinson’s, and sleep problems, “and more.”

Drug classification of Young Living products

The FDA contacted the firm based on the distributor and corporate marketing statements.

Your “Nature’s Ultra CBD,” “Essential Oil,” “Vitality,” and “Ningxia” items are all medicines.

A determination that any of these products are generally recognized as safe and effective (GRASE) for use under the circumstances specified, advised, or suggested in their labeling is not supported by any adequate and well-controlled clinical studies that have been published in the literature, to our knowledge.

Therefore, under section 201(p) of the Act, your “Essential Oil,” “Vitality,” “Ningxia,” and “Nature’s Ultra CBD” goods are “new medicines.”

Without an active FDA-approved application, new medications may not be distributed or provided for distribution in interstate commerce.

A new drug’s FDA approval is based on evidence from science and information proving its efficacy and safety.

None of these “Essential Oil,” “Vitality,” “Ningxia,” or “Nature’s Ultra CBD” products have an active FDA-approved use.

In light of this, these goods are unapproved novel medications that are being promoted in violation of Act sections 505(a) and 301(d), or 21 U.S.C. (d).

The FDA declared Young Living’s goods to be pharmaceuticals and added that they were misbranded medications.

According to section 502(f)(1) of the Act, your “Essential Oil,” “Vitality,” “Ningxia,” and “Nature’s Ultra CBD” goods are also misbranded.

If a drug’s labeling lacks sufficient instructions for its intended use, it is misbranded by section 502(f)(1) of the law (s).

According to the aforementioned claims, your “Essential Oil”, “Vitality”, “Ningxia”, and “Nature’s Ultra CBD” products are meant to prevent, treat, or cure conditions 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 that are not treatable by people who are not medical professionals.

Therefore, by section 503(b)(1)(A) of the Act [21 U.S.C. 353(b)(1)(A)], your “Essential Oil”, “Vitality”, “Ningxia”, and “Nature’s Ultra CBD” goods are regarded as prescription medications. Neither can sufficient instructions for their usage be provided, making it impossible for the average individual to utilize these medications safely for their intended uses.

Therefore, under section 502(f)(1) of the FD&C Act, your “Essential Oil,” “Vitality,” “Ningxia,” and “Nature’s Ultra CBD” goods are misbranded medicines.

Why does this matter?

According to what I understand, several Young Living products are now regarded as prescription medicines in the US.

Prescription medications that have received FDA approval and are labeled accordingly are free from the requirement that they include clear instructions for use suitable for laypeople.

Due to the lack of an FDA-approved application for your items, they are not exempt from the need that their labeling to provide acceptable usage instructions.

As a result, Young Living is no longer able to lawfully sell the specified medications.

With supporting documentation for its claims, the corporation may submit an FDA application. But given that essential oils don’t work as Young Living and its dealers say, doing so would probably be a waste of time.

Young Living was given fifteen days by the FDA to explain “the exact actions you have taken to remedy any breaches.”

Include your justification and any proof you have if you think your items do not violate the Act for our consideration.

Uncertainty exists over Young Living’s possible response to the FDA’s warning letter.

The watchdog forewarns Young Living that the FDA may take “legal action, including, without limitation, seizure and injunction” if it disregards the letter and/or continues to market its prescription medicine items.

Young Living continues to offer items that have been improperly categorized by the FDA, according to information found on the company’s website as of the time of publishing.

I have a cautious sense of optimism about this. Making false health claims by MLM businesses and their distributors have been a problem for years.

Although the FDA’s decision to categorize Young Living goods as prescription medications is an escalation, it is meaningless if the agency doesn’t take any more action.

Since at least 2014, the FDA has warned Young Living about false product claims. It’s absurd to wait eight years before taking any action.

And if Young Living disregards the FDA’s most recent warning, the FDA will do nothing more than maintaining the status quo.

This is how MLM businesses operate, with their distributors spreading false health claims online. A warning letter may be sent to that MLM firm, frequently years after the event.

Every few years, referenced examples are removed from publicly accessible social media, followed by a rinse and repeat process.

The FDA has allowed this risky cycle to continue for far too long.

Stay tuned if Young Living removes prescription medicine goods from the sale that are FDA-classified or if the FDA takes additional enforcement action against the business.

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