Warning letter · FDA Warning Letters, Historical Archive

Mr. Pink Collections, LLC: FDA Warning Letter 593395 (Nov 22, 2019)

Agency action: Nov 22, 2019Record ID: fda_warning_-88c00c1a71f7982e
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What happened

Original notice title

Mr. Pink Collections, LLC MARCS-CMS 593395, November 22, 2019

From the archived source record

The claims on your website and social media websites establish that your “CBD Oil Drops,” “CBD Gummies,” and "CBD Vape Pen" products are unapproved new drugs sold in violation of sections 505(a) and 301(d) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act), 21 U.S.C. 355(a) and 331(d). Furthermore, these products are misbranded drugs under section 502(f)(1) of the FD&C Act, 21 U.S.C. 352(f)(1). Pink Natural CBD Oil for Pets” product is an unapproved new animal drug that is unsafe under section 512(a) of the FD&C Act, 21 U.S.C. 360b(a), and adulterated under section 501(a)(5) of the FD&C Act, 21 U.S.C. 351(a)(5). FDA is not aware of any evidence that would call into question its current conclusion that CBD products are excluded from the dietary supplement definition under sections 201(ff)(3)(B)(i) and (ii) of the FD&C Act, but you may present FDA with any evidence bearing on this issue . [3] Unapproved New Drugs Based on our review of your website, your “CBD Oil Drops,” “CBD Gummies,” and "CBD Vape Pen" products are drugs under section 201(g)(1) of the FD&C Act, 21 U.S.C. 321(g)(1), because they are intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease, and/or intended to affect the structure or any function of the body. Misbranded Drugs Your “CBD Oil Drops,” “CBD Gummies,” and "CBD Vape Pen" products are also misbranded within the meaning of section 502(f)(1) of the FD&C Act, 21 U.S.C. 352(f)(1), in that their labeling fails to bear adequate directions for use. The introduction or delivery for introduction into interstate commerce of these misbranded drugs violates section 301(a) of the FD&C Act, 21 U.S.C. 331(a). 301(ll) and Adulterated Human Foods We note that your “CBD Gummies” product also appears to be promoted as a conventional human food.

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
f0b4864bd668

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
CBD Oil Drops; CBD Gummies; CBD Vape Pen; Vegan Bacon Flavored Pet CBD Oil; Mr. Pink Natural CBD Oil for Pets; CBD Oil Drops” and “CBD Gummies” products as dietary supplements
Company
Mr. Pink Collections, LLC
Lot / identifier
The source does not specify this field.
Market / distribution
The source does not specify this field.