Warning letter · FDA Warning Letters, Historical Archive

CBD Gaze: FDA Warning Letter 607299 (May 26, 2020)

Agency action: May 26, 2020Record ID: fda_warning_-340d8e19089ce6a8
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What happened

Original notice title

CBD Gaze MARCS-CMS 607299, May 26, 2020

From the archived source record

Based on our review, these claims cause the Amazon associate products purchased through links on your website to be unapproved new drugs under section 505(a) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. § 355(a). Furthermore, these products are misbranded drugs under section 502 of the FD&C Act, 21 U.S.C. § 352. In addition, it is a prohibited act under section 301(k) of the FD&C Act, 21 U.S.C. § 331(k), to do any act with respect to a drug, if such act is done while the drug is held for sale after shipment in interstate commerce and results in the drug being misbranded. We request that you immediately cease promoting and participating in the sale of such unapproved and unauthorized products for the mitigation, prevention, treatment, diagnosis, or cure of COVID-19. Some examples of the claims on your website www.cbdgaze.com that establish the intended use of your Amazon associate products and misleadingly represent them as safe and/or effective for the treatment or prevention of COVID-19 include: “Find the best CBD Oil to help fight Coronavirus.” “Use CBD Oil to fight coronavirus, COVID-19!” “Let the power of CBD help you combat your illness, covid-19, coronavirus…” You should take immediate action to correct the violations cited in this letter. This letter is not meant to be an all-inclusive list of violations that exist in connection with your products or operations. We advise you to review your websites and other labeling and promotional materials to ensure that you are not misleadingly representing your Amazon associate products as safe and effective for a COVID-19-related use for which they have not been approved by FDA and that you do not make claims that misbrand the products in violation of the FD&C Act . Within 48 hours, please send an email to COVID-19-Task-Force-CDER@fda.hhs.gov describing the specific steps you have taken to correct these violations.

What the official notice says to do

Check the original notice for the instructions that apply to the named product, company, and affected lots.

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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
44051ca10952

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.

Sources, dates, and coverage →

What is affected

Product
or cure COVID-19 [2] in people
Company
CBD Gaze
Lot / identifier
The source does not specify this field.
Market / distribution
The source does not specify this field.