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June 10, 2022

WARNING LETTER

RE: 615777

Dear Mrs. Young:

This letter is to advise you that the Food and Drug Administration (FDA) reviewed your website and social media accounts (e.g., Instagram and Facebook) for several Young Living Consultants in May 2022 and has determined that your Young Living Consultants market many of your products, including, but not limited to, Frankincense Essential Oil, Lemon Essential Oil, Lavender Essential Oil, DiGize Essential Oil Blend, Thieves Essential Oil Blend (hereinafter "Essential Oil" products), Lemongrass Vitality, Peppermint Vitality (hereinafter "Vitality" products), Ningxia (hereinafter “Ningxia” product), Nature’s Ultra CBD Beauty Boost, Nature’s Ultra CBD Muscle Rub, Nature’s Ultra CBD Pep Bundle, Nature’s Ultra Calm CBD Roll-On, Nature’s Ultra Cinnamon CBD Oil, Nature’s Ultra Citrus CBD Oil, and Nature’s Ultra Cool Mint CBD Oil (hereinafter "Nature's Ultra CBD" products) and that you take orders for these products from your websites at the internet addresses www.youngliving.com and https://naturesultra.com.

Additionally, we have also reviewed social media accounts of your Young Living Consultants at www.stillbeingmolly.com, www.instagram.com/awelllivedlife, www.instagram.com/peace.love.essentials, www.instagram.com/thehollanderhome, www.instagram.com/tiffaney_ann, and www.facebook.com/essentialoilsaddict. You market your Young Living “Essential Oil”, “Vitality”, “Ningxia”, and “Nature’s Ultra CBD” products through these paid consultants. Your compensation plan for your consultants is explained on your website at https://www.youngliving.com/us/en/company/compensation-plan. Consumers interested in your products are then redirected by your consultants to your websites www.youngliving.com and www.naturesultra.com to purchase your products and/or register as “members” (i.e., consultants).

Your "Essential Oil", "Vitality", “Ningxia”, and "Nature's Ultra CBD" products are 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 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 [21 C.F.R. § 201.128]. 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. You can find the Act through links on FDA’s home page at www.fda.gov.

Examples of claims found on your websites, as well as your Young Living Consultants’ social media account postings, that provide evidence of the intended uses of your products (as defined by 21 CFR § 201.128) as drugs include, but may not be limited to, the following:

"Essential Oil" products

On the website www.stillbeingmolly.com (Molly Buckley Stillman, Consultant #1852080), under the Essential Oil category:

• “20 Uses for Frankincense Essential Oil…”
    o “16. May ease symptoms of discomfort from a urinary tract infection”
    o “17. May ease symptoms of discomfort from a yeast infection”
    o “19. Great to use … for a homemade sunscreen”

• “30 Uses for Lemon Essential Oil...”
    o “3…sometimes proves to be as effective as stone-breaking chanca piedra pills for the kidney stones.”
    o “19. Use (especially along with lavender and peppermint) to ease those seasonal sniffles and runny noses”
    o “23. Can be used to combat acne…”
    o “24. May ease symptoms from urinary tract infections”
    o “28. May reduce inflammation”

• “35 Uses for Lavender Essential Oil…”
    o “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)”

On the social media account www.instagram.com/awelllivedlife (Carol Yeh-Garner, Consultant #1533467, Royal Crown Diamond Member)

• May 24, 2020: “Phenolpropanoids… The Phenolpropanoids and phenols in essential oils… attack invading microbes and parasites…found in clove, peppermint [Vitality], fennel, basil and wintergreen.”

• October 9, 2019: “…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.”

On the social media account www.instagram.com/peace.love.essentials (Hannah Leiden-Olsen, Consultant #18682287, Executive Member)

• March 5, 2021: Video Image of Frankincense Essential Oil “…can help with arthritis…asthma…”

On the social media account www.instagram.com/thehollanderhome (Madison Hollander, Consultant #12438030)

• March 9, 2020: “Digize [Essential Oil Blend]…heartburn”

On the social media account, www.instagram.com/tiffaney_ann (Tiffaney Dwyer, Consultant #2472927)

• February 8, 2021: Image of Lavender Essential Oil – “Lavender-…Helps allergies…”

• October 2, 2019: 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!!!”

"Vitality" products

On the social media account www.instagram.com/thehollanderhome (Madison Hollander, Consultant #12438030)

• July 28, 2020: Image of Lemongrass Vitality – “Lemongrass poses a very strong argument for being the ‘go-to’ when you find yourself not feeling well, battling inflammation, infection, stomach upset, stuffy sinuses…high body temps…high blood pressure, high cholesterol…If it’s stomach upset, bladder discomfort, cholesterol, or blood pressure that we are looking to improve, we ingest.”

• March 9, 2020: “Peppermint [Vitality]…headache…”

“Ningxia” product

On the social media account www.instagram.com/thehollanderhome (Madison Hollander, Consultant #12438030)

• December 1, 2020: Image of Ningxia – “Ningxia - scientifically proven to be the highest antioxidant food source in the world…Inflammation, disease, and cancer are all driven by Free Radicals…Antioxidants neutralize free radicals, meaning they stop them from doing damage… reduced inflammation, healthy cholesterol and blood sugar.”

On the social media account www.instagram.com/tiffaney_ann (Tiffaney Dwyer, Consultant #2472927)

• January 14, 2020: Ningxia – “…we’ve had Ningxia as part of our daily routine, we don’t get the flu, when we get a cold it’s not that bad at all and it’s short lived…”

"Nature's Ultra CBD" products

On your website www.youngliving.com

• “CBD MUSCLE RUB . . . FEATURES & BENEFITS . . . Soothes sore muscles . . . Soothes occasional tension . . . SUGGESTED USES . . . Apply topically to soothe sore muscle . . . Apply to neck and shoulders to soothe occasional tension . . . ABOUT . . . CBD Muscle Rub combines CBD, menthol, and a selection of Young Living premium essential oils such as Camphor, Clove, Lemon, Peppermint, Tea Tree, Wintergreen, and more. The result is a powerful balm that offers a cooling sensation and soothes sore muscles in seconds.” [from your webpage www.youngliving.com/us/en/product/cbd-muscle-rub]

On your website https://naturesultra.com

• “Some studies suggest [t]he most common illnesses caused by an improperly functioning ECS are depression, Alzheimer[’]s, IBS, fibromyalgia, and even migraines . . . [t]hat’s why it’s so important to ensure that you are supporting it as needed . . . CBD [an ingredient in your Nature’s Ultra CBD Beauty Boost, Nature’s Ultra CBD Muscle Rub, Nature’s Ultra CBD Pep Bundle, Nature’s Ultra Calm CBD Roll-on, Nature’s Ultra Cinnamon CBD Oil, Nature’s Ultra Citrus CBD Oil, and Nature’s Ultra Cool Mint CBD Oil] is a great way to support your ECS . . ..” [from your webpage https://naturesultra.com/blogs/posts/history-of-the-endocannabinoid-system]

• “When thinking of emotional wellness . . . [a] lot of people may think about mental health issues, such as depression or PTSD . . . [h]ow [c]an it be [i]mproved? . . . [y]ou can also try to encourage a positive and relaxing atmosphere throughout the day by using your favorite scents or oils! We highly recommend our Cinnamon CBD Oil.” [from your webpage https://naturesultra.com/blogs/posts/emotional-strength]

On the social media account www.facebook.com/essentialoilsaddict (EssentialOilsAddict) Tamara Rowe, Consultant #1744518)

• December 21, 2018: “What does CBD oil support? . . . addiction . . . Alzheimer’s . . . anxiety . . . chronic pain . . . depression . . . diabetes . . . drug withdrawal . . . epilepsy . . . glaucoma . . . inflammation . . . insomnia . . . Parkinson’s . . . sleep disorders . . . plus more! . . . Coming Soon, Young Living CBD Oil”

Unapproved New Drugs

Based on the above claims, 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 [21 U.S.C. § 321(p)]. With certain exceptions not applicable here¹, new drugs may not be introduced or delivered for introduction into interstate commerce without an approved application from FDA in effect, as described in sections 301(d) and 505(a) of the Act [21 U.S.C. §§ 331(d), 355(a)]. 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).

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 [21 U.S.C. § 352(f)(1)]. A drug is misbranded under section 502(f)(1) if the drug’s labeling fails to bear adequate directions for its intended use(s). “Adequate directions for use” means directions under which a layperson can use a drug safely and for the purposes for which it is intended [21 CFR § 201.5]. Prescription drugs, as defined in section 503(b)(1)(A) of the Act [21 U.S.C. § 353(b)(1)(A)], can only be used safely at the direction, and under the supervision, of a licensed practitioner. 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, Alzheimer’s, anxiety, depression, chronic pain, diabetes, drug withdrawal, epilepsy, glaucoma, and Parkinson’s 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.

Under 21 CFR §§ 201.100(c)(2) and 201.115, 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.

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, 21 U.S.C. § 352(f)(1).

The introduction or delivery for introduction into interstate commerce of misbranded drugs violates section 301(a) of the Act [21 U.S.C. § 331(a)].

CBD-containing Drugs

Even if your "Nature's Ultra CBD" products were considered nonprescription drugs, we note that a nonprescription drug product containing CBD cannot be legally marketed without an approved new drug application, regardless of whether the CBD is represented on the labeling as an active ingredient or an inactive ingredient. To date, no CBD-containing drug has met applicable FDA requirements to be legally marketed for nonprescription use. Nonprescription drug products that include CBD as an active ingredient are not GRASE and are new drugs which require an approved application to be legally marketed. CBD is not an active ingredient in any OTC monograph under section 505G of the Act. Even if CBD could be considered an inactive ingredient in a nonprescription drug product, that product would still need an approved new drug application to be legally marketed, because the product would not meet the general requirements under section 505G of the Act under which certain nonprescription drug products may be marketed without an approved new drug application. In particular, such a product would not meet the general requirement with respect to the safety and suitability of inactive ingredients under 21 CFR § 330.1(e).^2,3

Conclusion

This letter is not intended to be an all-inclusive statement of violations that may exist in connection with your products. You are responsible for investigating and determining the causes of any violations and for preventing their recurrence or the occurrence of other violations. It is your responsibility to ensure your firm complies with all requirements of federal law, including FDA regulations.

This letter notifies you of our concerns and provides you an opportunity to address them. Failure to adequately address this matter may result in legal action including, without limitation, seizure and injunction.

In addition, we offer the following comment:

• On the website www.stillbeingmolly.com (Molly Buckley Stillman, Consultant #1852080), under the Essential Oil category, in the “20 Uses for Frankincense Essential Oil” post: Number 15 states, “For new moms, apply one drop daily [of Frankincense Essential Oil] to the umbilical cord stump on your newborn until it falls off.” Please be aware that applying non-sterile, non-antimicrobial products topically to an umbilical cord may cause infection.

Please notify FDA in writing, within 15 working days of receipt of this letter, of the specific steps that you have taken to address any violations. Include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation. If you cannot complete corrective actions within 15 working days, state the reason for the delay and the time within which you will do so. If you believe that your products are not in violation of the Act, include your reasoning and any supporting information for our consideration.

Your reply should be addressed to the U.S. Food and Drug Administration; Attn: Hanna L. Potter, Compliance Officer; 6th Ave and Kipling St, DFC Bldg. 20, PO Box 25087, Denver, Colorado, 80225-0087 or via email at hanna.potter@fda.hhs.gov. You may reach Ms. Potter at (303) 236-3094 if you have any questions about this matter.

Sincerely,
/S/

E. Mark Harris
District Director
Program Division Director
Office of Human and Animal Food Operations –
West Division 4

Cc:

Tiffaney Dwyer (Consultant #18682287)
(b)(6)

Madison Hollander (Consultant #12438030)
(b)(6)

Hannah Leiden-Olsen (Consultant #18682287)
(b)(6)

Tamar Rowe (Consultant #1744518)
(b)(6)

Molly Buckley Stillman (Consultant # 1852080)
(b)(6)

Carol Yeh-Garner (Consultant #1533467)
(b)(6)
 

_______________________________

1 For example, under section 505G of the Act, 21 U.S.C. § 355h, certain nonprescription drug products may be lawfully marketed without an approved application if applicable conditions are met, including conformity with an applicable OTC monograph. However, your products could not be lawfully marketed under section 505G, because based on the above-referenced claims, your products are marketed for uses not considered nonprescription indications. Further, even if certain of your products, such as your Nature's Ultra CBD Muscle Rub, were marketed only for nonprescription indications, it would not meet the conditions under section 505G for lawful marketing without an approved application. For example, CBD—considered an active ingredient under 21 C.F.R. § 201.66(b)(2) due to its prominent featuring on the product labeling—is not an active ingredient in any OTC monograph under section 505G of the Act. Additionally, this product would be misbranded under section 502(ee) of the Act [21 U.S.C. § 352(ee)] because it would be a nonprescription drug subject to section 505G of the Act that does not comply with the requirements for marketing under that section and is not the subject of an application approved under section 505 of the Act [21 U.S.C. § 355].

2 21 CFR § 330.1(e) requires in relevant part that "the product contains only suitable inactive ingredients which are safe in the amounts administered". A suitable inactive ingredient generally provides a beneficial formulation function, such as a tablet binder or preservative, or improves product delivery (e.g., enhances absorption or controls release of the drug substance). CBD has no known functional role as an inactive ingredient in a finished drug product.

3 Additionally, an inactive ingredient should not exert pharmacological effects and must be safe when used at the intended dosage. CBD has known pharmacological activity with demonstrated risks. For example, the labeling for Epidiolex (cannabidiol) prescription oral solution includes risks for the drug such as liver injury, interactions with other drugs or supplements, potential for male reproductive toxicity, somnolence, insomnia, diarrhea, decreased appetite, abdominal pain, upset stomach, changes in mood, irritability, and agitation. See https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/210365s005s006s007lbl.pdf. It is unknown whether the levels of CBD used in your CBD products have pharmacological activity or pose any concern for safety events.