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WARNING LETTER

Ardent Animal Health, LLC MARCS-CMS 662394 —

Delivery Method:
Via Email
Product:
Animal & Veterinary
Drugs
Recipient:
Recipient Name
Rachel Bahr
Recipient Title
President, CEO
Ardent Animal Health, LLC

220 Bellaire Drive
Nicholasville, KY 40356
United States

info@ardentanimalhealth.com
Issuing Office:
Center for Veterinary Medicine

United States

WARNING LETTER

October 22, 2024

Re: 662394

Dear Rachel Bahr,

The U.S. Food and Drug Administration (FDA) inspected your facility located at 220 Bellaire Drive, Nicholasville, KY 40356 from September 10, 2024, through September 13, 2024. After a review of the inspection report, and a subsequent review of information provided on your website www.ardentanimalhealth.com, your social media webpages www.facebook.com/Ardentanimalhealth and www.instagram.com/ardentanimalhealth, and your Ardent Animal Health phone application, we have determined that you are marketing unapproved new animal drugs. The claims on your website establish that your cell and tissue-based, regenerative therapy products Acti-Stem Therapy and PureVet PRP are drugs under section 201(g)(1) of the Federal Food, Drug, and Cosmetic Act (The FD&C Act) [21 U.S.C. § 321(g)(1)(B)], 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, your products are unapproved new animal drugs. Acti-Stem Therapy consists of stromal vascular fraction with platelet-rich plasma for autologous use in dogs and cats. PureVet PRP consists of platelet-rich plasma for autologous use in dogs and cats. Introducing or delivering these unapproved new animal drugs for introduction into interstate commerce is prohibited under section 301(a) of the FD&C Act [21 U.S.C. § 331(a)].

You can find the FD&C Act and FDA regulations through links on FDA’s homepage at www.fda.gov. You can find specific information about how FDA regulates cell and tissue products for animals at https://www.fda.gov/animal-veterinary/biotechnology-products-cvm-animals-and-animal-food/cell-and-tissue-products-animals.

Examples of claims FDA observed on your website, www.ardentanimalhealth.com, your social media webpages, www.facebook.com/Ardentanimalhealth and www.instagram.com/ardentanimalhealth, and your Ardent Animal Health phone application that show the intended use of your products as drugs include, but are not limited to, the following:

  • Acti-Stem Therapy

o “How Does it Work? This ability arises from repair cells that are found throughout our body. In the case of injury or disease repair cells are mobilized to damaged areas to attempt to fix the problem.
Due to injury and/or age sometimes our own repair abilities can use a jump-start. By using the pet’s own repair cells isolated from fat tissue in the body, this repair ability can be applied to areas of need.”

o At the :41 second mark to the 1:22 minute mark of the “What is ActiStem? Ardent Animal Health” video posted on your https://ardentanimalhealth.com/actistem-therapy/ webpage, it states: “As we age, our stem cells response to injury and ability to repair can decrease or be overwhelmed due to disease. Degenerative disease such as Osteoarthritis can overwhelm your pet’s own natural repair process, leading to pain, inflammation, and limited mobility. Osteoarthritis has a long-term impact on the patient by causing loss of cartilage and accelerated lameness. Acti-Stem Therapy provides an all-natural solution to rebuild and regenerate cartilage as well as repair tissues and processes the way the body intended. This provides a solution to the underlying cause of the disease as opposed to just suppressing the symptoms.”

o “(b)(6) Actistem Story… She went from paralyzed to the wheelchair, to dragging herself out of the chair and trying to stand on her own. In the last 3 years, she progressed to walking which was still ataxic, but she has not regained the ability to urinate on her own… She has received 2 doses of stem cells now on July 2, 2019 and August 10, 2019. She is running, wagging her tail and can support herself on her hind legs. She has much more conscious control of her hind legs. She still is unable to urinate on her own and has to be expressed, but we will see what happens with that as time goes on.”

o “(b)(6) is our rescue boxer mix who was diagnosed with patellar luxation in both back legs and hip dysplasia in both hips. She’s had several knee surgeries (including a torn ACL) …This April, she could no longer stand up from a sitting position or walk. Dr. (b)(6) (and his awesome staff) wanted (b)(6) to be their first stem cell patient… I went to pick her up after her surgery — and she walked to me…”

  • PureVet PRP

o “PRP or Platelet Rich Plasma is a convenient same day treatment that harnesses the healing abilities of the patient’s blood platelets. Veterinarians utilize the treatment in conjunction with common surgeries or as a part of treatment plans to combat injury and disease.”

o “Ardent’s PRP Kit can be used to treat injured joints, tendons, or used in its gel form.”

o “PRP can be used to aid in the treatment of many ailments as seen in the illustration below… canine degenerative joint disease, hip dysplasia, soft tissue injuries… feline degenerative joint disease, wound healing, soft tissue injuries”

o “…I HAVE USED PRP THERAPY IN THE TREATMENT OF OSTEOARTHRITIS, BICEPS TENOSYNOVITIS, AS WELL AS NONSURGICAL MANAGEMENT OF CHRONIC ACHILLES MECHANISM INJURIES…”

o “Case Study… These radiographs were taken from the left hock of a 7 year old FS Mix breed dog that was chronically lame in both hind legs. The ankles were swollen and painful, not responding to any anti-inflammatory medication. The pronounced dystrophic mineralization was present in both hocks, but the response to regenerative medicine was striking on the left side. The owner consented to injections of PRP, or platelet rich plasma, into the gastrocnemius tendon as well as an intravenous application of the autologous fluid. As you can see after a few weeks, the mineralization is less pronounced. There is less soft tissue swelling, and there is a greater degree of joint mobility. Most importantly, the dog is more comfortable and does not require NSAIDs.”

o “Ardent’s PRP Kit can be introduced topically in or around an injured joint, tendon, or used in its gel form to treat large burns or wounds. Ardent’s PRP is not limited to acute injuries, it can also be used for chronic conditions. Here are some of the most common uses for PRP therapy in pets:

 Complimentary to your pet’s next surgery
 Osteoarthritis
 Tenosynovitis
 Wound Care
 General Inflammation
 Corneal Ulcers
 Post Surgical Healing”

o On your September 24, 2024 Facebook and Instagram posts:

 “5 Things Every Pet Owner Should Know About PUREVET PRP Therapy! Did you know PRP therapy can help pets heal naturally? Here’s why you should consider it:
    1. PRP utilizes your pet’s own healing factors. 2. PRP is a nonsurgical form of regenerative medicine therapy. 3. PRP is a same-day procedure. 4. PRP can be a standalone treatment or in conjunction with surgeries. 5. PUREVET PRP can be utilized for a variety of conditions and injuries.”

Because your Acti-Stem Therapy and PureVet PRP products are intended to diagnose, cure, mitigate, treat, or prevent disease in animals, they are drugs within the meaning of section 201(g)(1)(B) of the FD&C Act, [21 U.S.C. § 321 (g)(1)(B)]. Moreover, these 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, new animal drugs 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 FDA, and therefore these products are unsafe within the meaning of 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)].

This letter is not intended to be an all-inclusive statement of violations that may exist in connection with your products or operations. 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 address this matter may lead to legal action without further notice, including, without limitation, seizure and/or injunction.

Within fifteen (15) working days of receipt of this letter, please notify this office in writing of the specific steps you have taken to correct 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 action within fifteen (15) working days, state the reason for the delay and the time within which you will complete the correction. 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.

Please direct your response to the U.S. Food and Drug Administration, Center for Veterinary Medicine, Office of Surveillance and Compliance, Division of Drug Compliance by email to CVMUnapprovedDrugs@fda.hhs.gov. Please include “Reference 662394” in the subject line of your email.

Sincerely,
/S/

Neal Bataller, ME, DVM
Director
Division of Drug Compliance
Office of Surveillance and Compliance
Center for Veterinary Medicine

Cc: Matt Yeich, Operations Manager
matt@ardentanimalhealth.com

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