FDA WARNING_LETTER - Wellness BioSciences Rx - December 22, 2020

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The FDA issued a Warning Letter to WBRx Global on December 22, 2020, following a review of their websites in September and December 2020. The FDA observed that WBRx Global sells various CBD products, including "WBRx Metered-Dose Inhaler," "WBRx Balance Softgels CBD," "WBRx Pure Wellness CBD," "WBRx Energy Oil Drops CBD," and "WBRx Sleep Oil Drops CBD."

The FDA determined that these CBD products are unapproved new drugs, sold in violation of sections 505(a) and 301(d) of the FD&C Act, 21 U.S.C. 355(a) and 331(d), due to drug claims on their website and social media. Specifically, the "WBRx Metered-Dose Inhaler" is of particular concern due to potential inhalation risks. The products are also deemed misbranded drugs under section 502(f)(1) of the FD&C Act, 21 U.S.C. 352(f)(1), for lacking adequate directions for use and for misleading claims suggesting FDA approval.

Furthermore, "WBRx Balance Softgels CBD," "WBRx Energy Oil Drops CBD," and "WBRx Sleep Oil Drops CBD" are considered adulterated human foods under

Company: Wellness BioSciences Rx
Inspection Date: December 22, 2020
Product Type: Drugs
Office: Center for Drug Evaluation and Research
People: Donald D. Ashley (Director)
William A. Correll (Director)

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ID · 737dd2f4-ce31-4bcd-8480-759b746bc4e7

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. 321(g)(1)21 U.S.C. 321(p)21 U.S.C. 331(ll)21 U.S.C. 348(a)21 U.S.C. 342(a)(2)(C)(i)FD&C Act 201(g)(1)FD&C Act 201(p)

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