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WARNING LETTER
•Young Living Essential Oils Corporate

Young Living Essential Oils Corporate – FDA Warning Letter

Record Details

The FDA issued a Warning Letter to Young Living in August 2014, following a review of their websites, social media accounts of their distributors, and a 2012-2013 product guide. The FDA determined that numerous Young Living Essential Oil products, including "Thieves," "Cinnamon Bark," "Oregano," and "Frankincense," are promoted for conditions that classify them as unapproved new drugs under the Federal Food, Drug, and Cosmetic Act.

The violations stem from claims made by Young Living's consultants on their websites and social media, promoting the essential oils for the diagnosis, cure, mitigation, treatment, or prevention of diseases such as viral infections (including Ebola), Parkinson's disease, cancer, diabetes, and autism. These conditions are not amenable to self-diagnosis and treatment.

The FDA cited that these products are "new drugs" because they are not generally recognized as safe and effective for their promoted uses and lack FDA-approved applications. Furthermore, some products are deemed "prescription drugs" due to potential harmful effects requiring professional supervision. The products are also misbranded because their labeling lacks adequate directions for use by a layperson, which is impossible for prescription drugs without FDA approval.

Young Living was instructed to take prompt action to correct these violations and notify the FDA in writing within 15 working days of the corrective actions taken, including documentation and a timetable for any remaining corrections. Failure to comply may result in further regulatory

Company
Young Living Essential Oils Corporate
Product type
Drugs
Office
Denver District Office
People
  • Latonya Mitchell (District Director)
  • Cari Caraway
  • Sarah Biskobing
  • Julie Behling-Hovdal
  • Leslie Bartlett
View Company Profile

ID · aeb73454-d313-46ec-a0a5-0ee8ee2cb715

Violation Codes10
21 U.S.C. 321(g)(1)(B)21 U.S.C. 331(d)21.U.S.C. 355(a)21 U.S.C. 321(p)21 U.S.C. 353(b)(1)(A)21 U.S.C. 352(f)(1)21 U.S.C. 321(ff)(2)(A)(i)21 CFR 201.12821 CFR 201.521 CFR 201.100(c)(2)

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Other documents for Young Living Essential Oils Corporate
  • WARNING_LETTER - 2022-06-10June 10, 2022

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