Warning letter · FDA Warning Letters, Historical Archive

Daddy Burt Hemp Co: FDA Warning Letter 593866 (Nov 22, 2019)

Agency action: Nov 22, 2019Record ID: fda_warning_-2604e9d78cff8ecf
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What happened

Original notice title

Daddy Burt Hemp Co MARCS-CMS 593866, November 22, 2019

From the archived source record

The claims on your website and social media websites establish that your “Full Spectrum CBD Oil,” “Pure CBD Oil,” “CBD Gummies,” “Skin Rejuvenation CBD Lotion,” and “Joint & Muscle Relief CBD Cream” 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). FDA has also determined that your “CBD Oil for Pets (250 mg Bacon Flavor)” 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). The Agency is particularly concerned that you market your unapproved new drug products for uses for children. For example, children may be at greater risk for adverse reactions associated with certain drug products due to differences in the ability of children to absorb, metabolize, distribute, or excrete such drug products or their metabolites. CBD can also help manage the original inflammation and pain that led to the use of prescription drugs like opioids in the first place.” “CBD may help rehabilitate addicts over prescription opioids, heroin, and other illegal street drugs by reducing dependence and alleviating the withdrawal symptoms.” “CBD has also been shown to reduce the rewarding aspects of multiple drugs of abuse, such as cocaine and amphetamine according to a 2004 research study.” “A 2018 study shows that CBD may help reduce some of the withdrawal symptoms of alcohol addiction such as insomnia, anxiety, and nausea. Not only can it be a pain reliever to help people avoid them in the first place, but can ease withdrawal as well.” Additional claims observed on your Facebook social media site www.facebook.com/daddyburt/ include, but are not limited to, the following: October 1, 2019 posting – “Have you or anyone in your life tried Daddy Burt Hemp Co. products for arthritis?

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
61d0dc426a37

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
Full Spectrum CBD Oil; CBD Oil for Pets (250 mg Bacon Flavor); CBD Gummies; Skin Rejuvenation CBD Lotion; Joint & Muscle Relief CBD Cream; Using CBD for Autism Spectrum Disorders; Pure CBD Oil; 500mg CBD Oil – Full Spectrum; 500mg CBD Oil – THC Free (CBD Isolate); 750mg CBD Oil – THC Free (CBD Isolate) Natural Flavor; 750mg CBD Oil – THC Free (CBD Isolate) Peppermint Flavor; CBD Lotion - Rejuvenation Skin Lotion (400mg CBD); CBD Cream - Joint & Muscle Relief (400mg CBD); CBD Isolate; Pure CBD Oil (THC Free); and “CBD Gummies” products as dietary supplements; webpages “750mg CBD Oil – THC Free (CBD Isolate) Natural Flavor; and “Standard Strength CBD Oil - Full Spectrum (750mg) Peppermint Flavor; webpage “CBD Cream - Joint & Muscle Relief (400mg CBD)”: “While CBD
Company
Daddy Burt Hemp Co
Lot / identifier
The source does not specify this field.
Market / distribution
The source does not specify this field.