Bailey’s Wellness, LLC dba Bailey’s CBD - 701066 - 04/07/2025

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WARNING LETTER

April 7, 2025

RE: 701066

Dear John V. O’Keefe III and Aaron A. Argueta:

This letter is to advise you that the U.S. Food and Drug Administration (FDA) reviewed your website at the Internet address baileyscbd.com, and has determined that you take orders there for various animal and human products, including those that you promote as products containing cannabidiol (CBD). We have also reviewed your social media webpages at www.facebook.com/baileyscbd and www.instagram.com/baileyscbd; these webpages direct consumers to your website baileyscbd.com to purchase your products.

The claims on your website and your social media webpages establish that your products, Hemp Pellets for Horses and Livestock, also referred to as “CBD Pellets for Horses”; CBD Oil for Horses; CBD Oil for Dogs (all varieties¹ and strengths); Calming CBD Yummies (all strengths); Hip & Joint CBD Soft Chews (all strengths); Omega Hemp CBD Soft Chews (all strengths); Hemp Infused Paw & Nose Balm, also referred to as “CBD Paw & Nose Balm”; CBD Oil for Cats; and Calming CBD Cat Chews [hereinafter collectively referred to as “CBD-containing products for animals”], which you promote as products containing CBD for use in animals, are unapproved new animal drugs that are unsafe under section 512(a) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act), 21 U.S.C. 360b(a), and are adulterated under section 501(a)(5) of the FD&C Act, 21 U.S.C. 351(a)(5). Introduction of these adulterated drugs into interstate commerce is prohibited under section 301(a) of the FD&C Act, 21 U.S.C. 331(a).

FDA has also determined that you take orders for various human products, which you promote as products containing CBD on your website www.baileyscbd.com. Based on our review of your website, your Elevar Wellness Focus Plus 1:1 CBD & CBG Oil; HeyerPower Wellness CBD Oil Trio (Wake, Boost, & Calm); and HeyerPower Wellness 500mg CBD Oil – Wake – With Garcinia Cambogia products [hereinafter called “CBD-containing products for humans”] are unapproved new drugs introduced or delivered for introduction into interstate commerce in violation of sections 505(a) and 301(d) of the FD&C Act, 21 U.S.C. 355(a) and 331(d).

As explained further below, introducing or delivering these products for introduction into interstate commerce violates the FD&C Act. You can find specific information about how FDA regulates CBD at https://www.fda.gov/news-events/public-health-focus/fda-regulation-cannabis-and-cannabis-derived-products-including-cannabidiol-cbd.

The Agency is particularly concerned that you market the CBD product, Hemp Pellets for Horses and Livestock (also referred to as “CBD Pellets for Horses”), for food-producing animals. For example, the product name “Hemp Pellets for Horses and Livestock” indicates it is for livestock, and the product’s webpage https://baileyscbd.com/products/baileys-cbd-hemp-pellets states, “Versatile for Various Livestock … Ideal for horses, donkeys, mules, goats, sheep, swine, poultry, rabbits, and other pets.” Furthermore, your webpage https://baileyscbd.com/pages/cbd-for-pets states, “Hemp Pellets … The quick, easy, and no-mess way to incorporate CBD into the diet of your horse or livestock.” Additionally, your webpage https://baileyscbd.com/collections/cbd-for-horses states, “Bailey’s Cold Pressed Hemp Pellets … are a convenient way to add CBD to the diet of your horse or other livestock. Add to existing feeds or give by hand to horses, donkeys, sheep, poultry, and many more. … Suitable for livestock other than horses.”

In addition to raising potential concerns regarding safety for the animals themselves, CBD products for food-producing animals raise concerns regarding the safety of the human food (meat, milk, and eggs) derived from those animals. There is currently a lack of data on the formation of residues in edible products of food-producing animals in association with the consumption of CBD products by those animals and on safe levels of any potential residues for the human consumer. We request that you take immediate action to cease the sale of any unapproved CBD products for food-producing animals.

Unapproved New Animal Drugs

Based on our review of your website and social media webpages, your CBD-containing products for animals 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 in animals and/or intended to affect the structure or any function of the body of an animal. Further, as discussed below, these products are unapproved new animal drugs, and marketing them violates the FD&C Act.

Examples of claims observed on your website that provide evidence of the intended use of these CBD-containing products for animals as drugs include, but are not limited to, the following:

• On your webpage titled “CBD For Dogs With Arthritis & CBD Benefits For Dogs With Bone Conditions” at the URL https://baileyscbd.com/blogs/education/cbd-for-dogs-with-arthritis-cbd-benefits-for-dogs-with-bone-conditions:
  o “There are a variety of conditions that affect our dog’s bone health, joint function, pain, and mobility. Some of the most common bone conditions that people use CBD oil for dogs include:
   osteoporosis
   osteoarthritis
   panosteitis
   osteochondrosis
   hip dysplasia”
• On your webpage titled “Frequently Barked Questions (FBQs)” at the URL https://baileyscbd.com/pages/fbqs:
  o “Hemp for dogs is used as needed for pain, stress, anxiety, insomnia, disruptive symptoms, and acute or chronic conditions. CBD for dog anxiety and CBD for dog pain are some of the most common reasons, as well as CBD for dog allergies, CBD for dogs with arthritis, CBD for dogs with Cushing[’]s, CBD oil for dogs with seizures, and CBD for dogs with cancer.”
• On your webpage titled “CBD for Dogs: What is the Best CBD Oil for Dogs With Cancer?” at the URL https://baileyscbd.com/blogs/education/cbd-for-dogs-what-is-the-best-cbd-oil-for-dogs-with-cancer:
  o “Your dog doesn’t have to suffer in pain. Instead, you can discover the best CBD oil for dogs with cancer. By using CBD, you can ease their pain and help them fight.”
  o Under the sub-heading “Cancer-Fighting”: “CBD might help reduce the size of a tumor. Giving your dog CBD could also help enhance the tumor-shrinking abilities of radiation therapy. As a result, you can reduce their radiation dosage without decreasing the treatment’s efficiency.”
• On your webpage titled “CBD for Horses: This Is What You Need to Know” at the URL https://baileyscbd.com/blogs/education/cbd-for-horses-this-is-what-you-need-to-know:
  o Under the sub-heading “Why Should I Give My Horse CBD?”: “Does your horse suffer from anxiety, allergies, or chronic pain? Before you call your veterinarian, consider trying a CBD supplement. Here are some benefits of CBD for horses[:] ... Relieve[s] Pain and Inflammation… [and] Prevent[s] Seizures….”
• On your webpage titled “CBD For Horses” at the URL https://baileyscbd.com/collections/cbd-for-horses:
  o Under the sub-heading “Benefits of CBD for Horses”: “[H]orses can experience common health and behavioral conditions which can be prevented and treated to maintain their health and happiness. Some common ailments in horses include:
   Arthritis and joint pain …
   Allergies to dust and insects
   Digestive disorders and colic
   Equine infectious anemia virus
  These can be prevented and treated with a healthy equine care routine and regular checkups from the veterinarian. Horse owners can help support their horse’s health with natural supplements such as Bailey’s CBD for horses product collection.”
• On your product page for your Hemp Infused Paw & Nose Balm titled “CBD Paw & Nose Balm” at the URL https://baileyscbd.com/products/cbd-paw-nose-balm:
  o Under the sub-heading “Benefits & Uses of CBD Paw & Nose Balms”:
   “Natural Healing: Aids in healing rashes, hot spots, and minor wounds, promoting faster recovery.”
   “Reduces Inflammation: Helps to reduce skin inflammation and irritation, providing comfort to sensitive areas.”
   “Wart and Lesion Care: Useful in soothing and treating warts and small lesions, offering relief from discomfort.”
  Examples of claims observed on your social media webpages that provide evidence of the intended use of these products as drugs include, but are not limited to, the following:
• On your August 29, 2024 Facebook and Instagram posts:
  o Both posts contain an infographic that reads, “WATCHING YOUR DOG STRUGGLE WITH HIP DYSPLASIA IS RUFF.”
   The Facebook post includes the claim, “Learn how Bailey’s CBD can ease discomfort from hip dysplasia and get your pup back to running and playing!”
   The Instagram post includes the claim, “Is your dog struggling with hip dysplasia? Bailey’s CBD can help ease their discomfort and get them back to their playful self! … Learn more about how our products can support your pup.”

These CBD-containing products for animals are “new animal drugs” under section 201(v) of the FD&C Act, 21 U.S.C. 321(v), because they are not generally recognized, among experts qualified by scientific training and experience to evaluate the safety and effectiveness of animal drugs, as safe and effective for use under the conditions prescribed, recommended, or suggested in the labeling.

To be legally marketed, a new animal drug must have an approved new animal drug application, conditionally approved new animal drug application, or index listing under sections 512, 571, and 572 of the FD&C Act, 21 U.S.C. 360b, 360ccc, and 360ccc-1. These products are not approved or index listed by the FDA, and therefore these products are 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 introduction or delivery for introduction of these products into interstate commerce is prohibited under section 301(a) of the FD&C Act, 21 U.S.C. 331(a).

301(ll) and Adulterated Animal Foods

Furthermore, it is a prohibited act under section 301(ll) of the FD&C Act, 21 U.S.C. 331(ll), to introduce or deliver for introduction into interstate commerce any animal food to which has been added a drug approved under section 505 of the FD&C Act or for which substantial clinical investigations have been instituted and for which the existence of such investigations has been made public. Based on available evidence, FDA has concluded that the prohibition in section 301(ll) applies to CBD.²

According to your product labeling, your Hemp Pellets for Horses and Livestock (also referred to as “CBD Pellets for Horses”), Calming CBD Yummies (all strengths), Hip & Joint CBD Soft Chews (all strengths), Omega Hemp CBD Soft Chews (all strengths), and Calming CBD Cat Chews are animal foods to which CBD has been added. For example, your website refers to your Calming CBD Yummies (all strengths), Hip & Joint CBD Soft Chews (all strengths), Omega Hemp CBD Soft Chews (all strengths), and Calming CBD Cat Chews products as “treats,” and your Hemp Pellets for Horses and Livestock are referred to as “pellets” for horses and livestock. Additionally, your Hemp Pellets for Horses and Livestock claim to have nutritional value, for example, your Hemp Pellets for Horses and Livestock product page includes the claim, “Rich in plant protein, fiber, and complex carbohydrates, these pellets are a nutritious addition to your horse’s diet.” Therefore, the introduction or delivery for introduction into interstate commerce of these products is a prohibited act under section 301(ll) of the FD&C Act.

You should also be aware that, as defined in section 201(s) of the FD&C Act, 21 U.S.C. 321(s), the term “food additive” refers to any substance the intended use of which results in its becoming a component of any animal food, unless the substance is generally recognized as safe (GRAS) among qualified experts under the conditions of its intended use, or unless the substance meets a listed exception.³

Food additives require premarket approval based on data demonstrating safety. Any food additive that has not been approved for its intended use in animal food is deemed to be unsafe under section 409(a) of the FD&C Act, 21 U.S.C. 348(a), and causes the animal food to be adulterated under section 402(a)(2)(C)(i) of the FD&C Act, 21 U.S.C. 342(a)(2)(C)(i). Introduction of an adulterated animal food into interstate commerce is prohibited under section 301(a) of the FD&C Act, 21 U.S.C. 331(a).

There is no animal food additive regulation that authorizes the use of CBD. We are not aware of any information to indicate that CBD is the subject of a prior sanction (i.e., a sanction or approval granted prior to the enactment of the Food Additives Amendment of 1958 under the FD&C Act, the Poultry Products Inspection Act, or the Meat Inspection Act). Furthermore, we are not aware of any basis to conclude that CBD is GRAS for use in animal foods. FDA’s regulations in Title 21, Code of Federal Regulations 570.30(a)-(c), 21 CFR 570.30(a)-(c), describe the criteria for eligibility for classification of an animal food ingredient as GRAS. The use of an animal food substance may be GRAS based on either scientific procedures or, for a substance used in animal food before 1958, through experience based on common use in animal food (see 21 CFR 570.30).

We know of no basis for general recognition of safety for CBD based either on scientific procedures or common use in animal food prior to January 1, 1958. Based on our review of the publicly available literature, the data and information necessary to support the safe use of CBD in animal foods are lacking. In fact, literature reports have raised safety concerns for animals consuming CBD, including, but not limited to, male reproductive toxicity and liver toxicity. Therefore, based on our review, the use of CBD in animal products does not satisfy the criteria for GRAS status under 21 CFR 570.30.

FDA is not aware of any other exception to the food additive definition that would apply to CBD for use as an ingredient in animal food. Therefore, CBD added to animal food is a food additive under section 201(s) of the FD&C Act and is subject to the provisions of section 409 of the FD&C Act, 21 U.S.C. 348. Under section 409 of the FD&C Act, 21 U.S.C. 348, an animal food additive is deemed unsafe unless it is approved by FDA for its intended use prior to marketing. CBD is not approved for use in any animal food. Animal food containing an unsafe food additive within the meaning of section 409 is adulterated within the meaning of section 402(a)(2)(C)(i) of the FD&C Act, 21 U.S.C. 342(a)(2)(C)(i). Therefore, your Hemp Pellets for Horses and Livestock, Calming CBD Yummies (all strengths), Hip & Joint CBD Soft Chews (all strengths), Omega Hemp CBD Soft Chews (all strengths), and Calming CBD Cat Chews products are adulterated within the meaning of section 402(a)(2)(C)(i) of the FD&C Act. Introduction of an adulterated animal food into interstate commerce is prohibited under section 301(a) of the FD&C Act, 21 U.S.C. 331(a).

Unapproved New Drugs

Based on our review of your website, your CBD-containing products for humans 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.

Examples of claims from your website that provide evidence of the intended use of your CBD- containing products for humans as drugs include, but may not be limited to, the following:

• On your Elevar Wellness Focus Plus 1:1 CBD & CBG Oil product page https://baileyscbd.com/collections/human-cbd-products/products/elevar-wellness-cbd-cbg-oil-for-focus:
  o “What's CBG all about? Did you know studies show that CBG ... is even known to slow the growth of cancer cells? Studies also show that CBG can be beneficial in treating IBS and Crohn’s disease.”
• On your HeyerPower Wellness CBD Oil Trio (Wake, Boost, & Calm) product page https://baileyscbd.com/collections/human-cbd-products/products/heyerpower-wellness-cbd-oil-trio-wake-boost-calm-500-mg-per-bottle-3-each-2-fl-oz-tinctures:
  o “Wake - CBD & Garcinia Cambogia ... Kills Cancers Cells”
• On your HeyerPower Wellness 500mg CBD Oil – Wake – With Garcinia Cambogia product page https://baileyscbd.com/collections/human-cbd-products/products/heyerpower-wellness-cbd-oil-wake-with-garcinia-cambogia-500-mg-2-fl-oz-tincture:
  o “Benefits of Garcinia Cambogia ... Kills Cancers Cells”

Your CBD-containing products for humans are not generally recognized as safe and effective (GRASE) for their above referenced uses and, therefore, these products are “new drugs” under section 201(p) of the FD&C Act, 21 U.S.C. 321(p). Subject to certain exceptions not applicable here, new drugs may not be legally introduced or delivered for introduction into interstate commerce without an approved application from FDA in effect, as described in sections 301(d) and 505(a) of the FD&C Act, 21 U.S.C. 331(d) and 355(a). There are no FDA-approved applications in effect for any of your CBD-containing products for humans. Accordingly, these products are unapproved new drugs marketed in violation of sections 505(a) and 301(d) of the FD&C Act, 21 U.S.C 355(a) and 331(d).

Conclusion

This letter is not intended to be an all-inclusive statement of violations that may exist in connection with your products. You are responsible for investigating and determining the causes of any violations and for preventing their recurrence or the occurrence of other violations. It is your responsibility to ensure that your firm complies with all requirements of federal law, including FDA regulations.

This letter notifies you of our concerns and provides you an opportunity to address them. Failure to adequately address this matter may result in legal action including, without limitation, seizure and injunction.

Please notify FDA in writing, within fifteen (15) working days of receipt of this letter, of the specific steps you have taken to address any violations. Include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation. If you cannot complete corrective actions within fifteen (15) working days, state the reason for the delay and the time within which you will do so. If you believe that your products are not in violation of the FD&C Act, include your reasoning and any supporting information for our consideration.

Your response should be directed to U.S. Food and Drug Administration, Center for Veterinary Medicine, Office of Surveillance and Compliance, Division of Drug Compliance by e-mail to CVMUnapprovedDrugs@fda.hhs.gov. Please include “Reference 701066” in the subject line of your email.

Sincerely,
/S/

Cindy L. Burnsteel, DVM
Acting Director
Division of Drug Compliance
Office of Surveillance and Compliance
Center for Veterinary Medicine
Food and Drug Administration

/S/

Jill Furman, J.D.
Director
Office of Compliance
Center for Drug Evaluation and Research
Food and Drug Administration

_______________________

1 Including, but not limited to: Extra Strength 2:1 CBD & CBG Oil For Dogs; The Original CBD Oil for Dogs; Hip & Joint CBD Oil for Dogs; and Calming CBD Oil for Dogs.

2 CBD is the active ingredient in the approved drug product Epidiolex. Furthermore, the existence of substantial clinical investigations regarding CBD has been made public. For example, two such substantial clinical investigations include GW Pharmaceuticals’ investigations regarding Sativex and Epidiolex. (See GW Pharmaceuticals Receives Investigational New Drug (IND) from FDA for Phase 2/3 Clinical Trial of Epidiolex in the Treatment of Dravet Syndrome). 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. Under 21 CFR 312.2, unless a clinical investigation meets the limited criteria in that regulation, an IND is required for all clinical investigations of products that are subject to section 505 of the FD&C Act.

3 Under section 201(s)(5) of the FD&C Act, 21 U.S.C. 321(s)(5), new animal drugs are excluded from the food additive definition. If a new animal drug is unsafe within the meaning of section 512 because it is not approved for use in animal food, then the animal food is adulterated under section 402(a)(2)(C)(ii) of the FD&C Act, 21 U.S.C. 342(a)(2)(C)(ii).