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WARNING LETTER
•Natural Native LLC•November 25, 2019

FDA WARNING_LETTER - Natural Native LLC - November 25, 2019

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Record Details

The FDA issued a Warning Letter to Natural Native in November 2019, following a review of their websites (www.naturalnative.com, wa.naturalnative.com) and social media (www.facebook.com/naturalnativecbd) in October 2019. The letter identifies multiple violations related to the marketing and sale of various CBD products for human and animal use.

Specifically, products like "20 oz. Native CBD Water," "CBD Baby Bears," "CBD Big Bears," "CBD Hemp Oil, Raspberry, 300mg," "Liposomal CBD Extract Spray," "Native 225 mg Raspberry – 15 ml Broad Spectrum CBD Spray," and "CBD Balm – 250mg" are deemed unapproved new drugs under sections 505(a) and 301(d) of the FD&C Act, and misbranded drugs under section 502(f)(1) due to inadequate directions for use. The FDA expressed particular concern about marketing these unapproved drugs for infants.

The "20 oz. Native CBD Water" is also cited as an adulterated human food under section 402(a)(2)(C)(i) and a prohibited act under section 301(ll) because it contains CBD, an unsafe food additive not generally recognized as safe (GRAS).

Furthermore, "Native Pet CBD Oil (150mg,

Company
Natural Native LLC
Inspection Date
November 25, 2019
Product Type
Food
Office
Center for Food Safety and Applied Nutrition
People
  • Donald D. Ashley (Director)
  • Eric M. Nelson (Director - Division of Compliance)
  • William A. Correll (Director)
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ID · c3c7a640-f1e7-470f-bbe5-2dd90d29d7af

Violation Codes10
21.U.S.C. 355(a)21 U.S.C. 331(d)21 U.S.C. 352(f)(1)21 U.S.C. 360b(a)21 U.S.C. 351(a)(5)21 U.S.C. 342(a)(2)(C)(i)21 U.S.C. 331(ll)21 U.S.C. 321(ff)21 U.S.C. 321(ff)(3)(B)(i)21 U.S.C. 321(ff)(3)(B)(ii)

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