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WARNING LETTER
•Kingdom Harvest•May 4, 2022

FDA WARNING_LETTER - Kingdom Harvest - May 04, 2022

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Record Details

The FDA issued a Warning Letter to Kingdom Harvest after reviewing their website and social media from October 2021 to April 2022, identifying numerous violations related to unapproved human and animal drugs, misbranded drugs, and adulterated foods containing CBD and Delta-8 THC.

The company markets various products, including "D8 sublingual oil," "Delta 8 Disposable Vape Cartridge," "Whole-Spectrum Hemp Extract," "CBD Vape," "Blood Sugar Support," "CBD Gummies," "Stella’s Baby Care Diaper Cream," "Pain Relieving CBD Cream," "Pain Relieving Cream," "CBD & Menthol Pain Freeze Roll-On," "Immune Boost Water Soluble Mix," "Broad-Spectrum THC Free Organic Honey," "CBD Fair-Trade Coffee," "CBD Infused Organic Tea," "Delta 8 Chewing Gum," "Delta 8 Gummies," "Delta 8 Peanut Brittle," "Delta 8 Syrup," "Ranch & Livestock Natural Whole-Spectrum Hemp Extract," "Canine Whole-Spectrum Hemp Extract," "Feline Chicken Flavor Zero THC Hemp Extract," "Pet Essentials Joint Support Tablets," "CBD Infused Pet Shampoo," and "CBD Infused Pet Paw Balm."

The FDA determined that the human products are unapproved new drugs under sections 505(a) and 301(d) of the FD&C Act (21 U.S.C. 355

Company
Kingdom Harvest
Inspection Date
May 4, 2022
Product Type
Drugs
Office
Center for Drug Evaluation and Research
People
  • Donald D. Ashley (Director)
  • Neal Bataller (Division Director)
  • Ann M. Oxenham (Director)
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ID · 506b0df1-cc76-4c45-81ea-01a08bc19448

Violation Codes10
21 U.S.C. 331(a)21.U.S.C. 355(a)21 U.S.C. 331(d)21 U.S.C. 352(f)(1)21 U.S.C. 342(a)(2)(C)(i)21 U.S.C. 331(ll)21 U.S.C. 360b(a)21 U.S.C. 351(a)(5)21 U.S.C. 321(ff)21 U.S.C. 321(g)(1)

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