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  5. Holista LLC dba HolistaPet - 699082 - 04/07/2025
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WARNING LETTER

Holista LLC dba HolistaPet MARCS-CMS 699082 —

Delivery Method:
Via Email
Product:
Animal & Veterinary
Food & Beverages
Recipient:
Recipient Name
Dareh Zadoorian
Recipient Title
Chief Executive Officer/Registered Agent
Holista LLC dba HolistaPet

United States

support@holistapet.com
support@holistapet.co
Issuing Office:
Center for Veterinary Medicine

United States

WARNING LETTER

April 7, 2025

RE: 699082

Dear Dareh Zadoorian:

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

The claims on your website www.holistapet.com and your social media webpages establish that your products, including CBD Pellets for Horses (all flavors), CBD Oil for Horses, CBD Oil for Dogs (all flavors and strengths), CBD Oil for Cats (all flavors and strengths), CBD Dog Treats for Anxiety (all strengths), CBD Dog Treats + Joint and Mobility Care (all strengths), CBD Wellness Dog Treats, CBD Cat Treats (all flavors), CBD Calming Chews for Dogs (all strengths), CBD Calming Chews for Cats, CBD Mobility Chews for Dogs (all strengths), and CBD Capsules for Dogs and Cats (all strengths) [hereinafter collectively referred to as “CBD-containing products”], 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).

As explained further below, introducing or delivering these products for introduction into interstate commerce violates the FD&C Act. You can find the FD&C Act and FDA regulations through links on FDA’s home page at www.fda.gov. 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 CBD products for food-producing animals. Specifically, on your website www.holistapet.com, the product page for your CBD Pellets for Horses (all flavors) includes the claim, “Aside from horses, you can also use these CBD hemp pellets for many different species, including donkeys, mules, goats, sheep, swine, poultry, rabbits, dogs, and caged pets such as birds and pocket pets.” Similarly, the product page for your CBD Oil for Horses includes the claim, “Formulated for horses & other livestock.” Further, your blog post titled “CBD for Puppies: How Cannabinoids Help Your Pup Become Their Best” includes the claim, “Even animals as large as horses and livestock may benefit from pet CBD oil!” Finally, on your Pinterest page www.pinterest.com/holistapet, the pin titled “How to Use CBD Horse Pellets” includes the claim “Our CBD Horse Pellets helps promote the over all [sic] health of your horse or livestock, no matter their size, breed, or class.” 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 websites 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 www.holistapet.com that provide evidence of the intended use of these products as drugs include, but are not limited to, the following:

  • On your blog post titled “Phenobarbital and CBD Oil for Dog Seizures Explained [Update]” at the URL https://www.holistapet.com/blogs/home-remedies-for-dogs/phenobarbital-for-canine-seizures:
    o “Cannabidiol treatment can be used in conjunction with phenobarbital and it also can be used to replace it.”
    o “Emerging therapies like CBD oil offer promising alternatives, especially for refractory epileptic seizures, providing hope for improved seizure control and quality of life in dogs.”
  • On your blog post titled “CBD for Puppies: How Cannabinoids Help Your Pup Become Their Best” at the URL https://www.holistapet.com/blogs/dog-care/cannabinoids-for-puppies:
    o “Other reasons to give your puppy CBD are:
     Help with certain medical conditions - Colorado State University’s college scientists have found evidence that CBD consumption may be a promising treatment for seizures in dogs. CBD also has anecdotal evidence that it can help dogs with neuropathic pain and lowered blood pressure.”
  • On your blog post titled “Dog Ringworm Treatment Home Remedies [Easy Tips Inside!]” at the URL https://www.holistapet.com/blogs/home-remedies-for-dogs/ringworm-treatment:
    o “Ringworm causes scabbing, inflammation, hair loss, and some itching in dogs. CBD oil as a natural treatment or ringworm home remedy can help soothe a dog’s irritated skin and decrease swelling, which can result in a decrease of itchiness and scratching.”
  • On your blog post titled “Hemp For Cats: Why This Super Plant May Change Your Cat’s Life” at the URL https://www.holistapet.com/blogs/cat-care/hemp-for-cats:
    o “Cats can get anxiety from extremely loud noises such as fireworks and lightning. Separation anxiety is another common concern for cat parents. CBD calm [sic] cats in a very effective way….”
  • On your blog post titled “Best Home Remedies For Horse Colic [Full List]” at the URL https://www.holistapet.com/blogs/horse-care/home-remedies-for-equine-colic:
    o “…CBD oil for horses is the ideal choice for dealing with colic.”
  • On your CBD Oil for Horses product page under the header “Can CBD Oil Help Horses?” at the URL https://www.holistapet.com/products/cbd-oil-for-horses:
    o “Below are several common conditions in horses. Although CBD is not yet federally approved as a treatment for any conditions, we can take a look at how the [endocannabinoid system] comes into play in these certain cases.
     Gastric Ulcers…
     Laminitis…
     Colic…
     Desmitis…[and]
     Skin Conditions And Allergies….”

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 May 1, 2024 Instagram post:
    o Depicting several of your CBD-containing products for animals: “[H]ere’s 5 reasons why your dog NEEDS Holistapet [hemp treats:]
     first it has anti inflammatory properties[,]…it is known to REDUCE inflammation[;]
     next it has analgesic effects[,]…[h]elp [sic] treats can alleviate any pains[;]
     it also has anxiolytic effects[,]…which means it has anti anxiety properties[;]
     next it has neuroprotective effects[,]…[h]emp treats can PROTECT nerve cells from damage and degeneration[;]
     it also has antiametic [sic] effects[,]…which just [sic] can alleviate nausea[.]”
  • On your April 29, 2024 Instagram post:
    o Highlighting the following customer review: “So grateful for this company and the folks behind the scene! My dog suffered terrible seizures, 2-3 times a week. Started giving him Holistapet CBD oil and products. Seizures are now 1-2 a year and very mild! Grateful and satisfied with the products and service I receive!! – (b)(6)”
  • On your Pinterest page:
    o There are multiple pins with the HolistaPet logo that link back to the www.holistapet.com website, with titles such as “Using CBD for Dog Diarrhea Works,” “CBD for Dogs with Epilepsy,” and “CBD & Skin Tumors in Dogs EXPLAINED.”

These CBD-containing products 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.1

According to your product labeling, your CBD Pellets for Horses (all flavors), CBD Dog Treats for Anxiety (all strengths), CBD Cat Treats (all flavors), CBD Dog Treats + Joint and Mobility Care (all strengths), CBD Wellness Dog Treats, CBD Calming Chews for Dogs (all strengths), CBD Calming Chews for Cats, and CBD Mobility Chews for Dogs (all strengths) products are animal foods to which CBD has been added. For example, on your website www.holistapet.com, the product page for your CBD Pellets for Horses (all flavors) includes the claim “our pellets are an excellent source of essential nutrients and supplemental protein.” Additionally, the product labeling on your website www.holistapet.com refers to the other CBD products referenced above as “treats.” 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.2

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 CBD Pellets for Horses (all flavors), CBD Dog Treats for Anxiety (all strengths), CBD Cat Treats (all flavors), CBD Dog Treats + Joint and Mobility Care (all strengths), CBD Wellness Dog Treats, CBD Calming Chews for Dogs (all strengths), CBD Calming Chews for Cats, and CBD Mobility Chews for Dogs (all strengths) 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).

Conclusion

This letter is not intended to be an all-inclusive statement of violations that may exist in connection with your products or operations. 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 and FDA’s implementing 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 699082” 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

__________________

1 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.

2 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).

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