Warning letter · FDA Warning Letters, Historical Archive

PotNetwork Holdings, Inc.: FDA Warning Letter 564030 (Mar 28, 2019)

Agency action: Mar 28, 2019Record ID: fda_warning_-26d98a3e03cdc13f
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What happened

Original notice title

PotNetwork Holdings, Inc. MARCS-CMS 564030, March 28, 2019

From the archived source record

In addition, the Federal Trade Commission has reviewed your website for potential violations of Sections 5(a) and 12 of the FTC Act, 15 U.S.C. §§ 45(a) and 52. A drug is misbranded under section 502(f)(1) of the Act [21 U.S.C. § 352(f)(1)] if the drug fails to bear adequate directions for its intended use(s). Accordingly, your products “Liquid Gold Gummies (Sweet Mix),” “Liquid Gold Gummies (Sour Mix)” and “blue CBD Crystals Isolate 1500mg,” fail to bear adequate directions for their intended uses and, therefore, the products are misbranded under section 502(f)(1) of the Act [21 U.S.C. § 352(f)(1)]. The introduction or delivery for introduction into interstate commerce of these misbranded drugs violates section 301(a) of the Act [21 U.S.C. § 331(a)]. For example, two such substantial clinical investigations include GW Pharmaceuticals’ investigations regarding Sativex and Epidiolex. [1] FDA considers a substance to be “authorized for investigation as a new drug” if it is the subject of an Investigational New Drug application (IND) that has gone into effect. The violations cited in this letter are not intended to be an all-inclusive list of violations that exist in connection with your products. You are responsible for investigating and determining the causes of the violations identified above and for preventing their recurrence or the occurrence of other violations. The FTC is concerned that one or more of the efficacy claims cited above may not be substantiated by competent and reliable scientific evidence. Violations of the FTC Act may result in legal action seeking a Federal District Court injunction or Administrative Cease and Desist Order. With regard to the advertising claims discussed above, please notify Richard Cleland, Assistant Director of the FTC’s Division of Advertising Practices, via electronic mail at rcleland@ftc.gov within fifteen (15) working days of receipt of this letter, of the specific actions you have taken to address FTC's concerns.

What the official notice says to do

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Status and source details

Status recorded in the archive
Historical warning letter; closeout not established by annual index
Source checked
Jul 16, 2026
Record revision
3eb5063e604a

This is a dated record. Its current status may have changed since the source was captured. A record applies to its stated scope; it is not a safety rating for every product from a company.

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What is affected

Product
Liquid Gold Gummies (Sweet Mix); blue CBD Crystals Isolate 1500mg; Liquid Gold Gummies (Sour Mix)
Company
PotNetwork Holdings, Inc.
Lot / identifier
The source does not specify this field.
Market / distribution
The source does not specify this field.