- Delivery Method:
- Via Email
- Animal & Veterinary
Recipient NameDerrick Cooke
- Equine Podiatry Solutions, LLC
105 Burkhalter Road
Claxton, GA 30417
- Issuing Office:
- Center for Veterinary Medicine
May 16, 2022
Dear Derrick Cooke:
This letter concerns your firm’s marketing of unapproved veterinary products for the treatment of disease in animals, including but not limited to, Desmosphyrine. The U.S. Food and Drug Administration (FDA) has reviewed your website at the Internet address www.beatlaminitis.com in October 2021, November 2021, and March 2022 and has determined that you distribute this product there. We have also reviewed your social media websites at www.facebook.com/equine-podiatry-solutions-llc and https://www.youtube.com/channel/UCR9waBp-xd02qG5ugsHJ-oQ where you direct consumers to your website at www.beatlaminitis.com to purchase products. The claims on your website and social media websites establish that your “Desmosphyrine” product is a drug under section 201(g)(1)(B) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) [21 U.S.C. § 321(g)(1)(B)] because it is intended for the use in the diagnosis, cure, mitigation, treatment, or prevention of disease in animals. As explained further below, this product is an unapproved new animal drug and introducing or delivering this product 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 homepage at www.fda.gov.
Examples of claims FDA observed on your website and social media that show the intended uses of your “Desmosphyrine” product includes, but may not be limited to, the following:
From your website www.beatlaminitis.com: Webpage titled – “Guide to Laminitis: Treatment Solutions for Horses”
- “Desmosphyrine is the first product that effectively treats acute laminitis before it becomes chronic.”
- “Desmosphyrine is the only treatment available that directly addresses the underlying cause of laminitis and stops the matrix metalloproteinase from digesting collagen. This treatment has been successful in clinical trials at treating acute laminitis when applied early.”
- “Desmosphyrine is a new method of treatment that helps prevent MMP from activating and digesting the collagen of a hoof.”
From your website www.beatlaminitis.com: Webpage titled – “How Important Time Is To Preventing Chronic Laminitis”
- “Desmosphyrine is the first effective product for treating acute laminitis…”
- Radiographs labeled as “BEFORE” and “AFTER” with the accompanying statement, “Evidence of effectiveness of product as shown through before and after radiographs.”
From your website www.beatlaminitis.com: Webpage titled – “(b)(6) Success with Beating Laminitis – Equine Podiatry Solutions”:
- Under a header “DESMOSPHYRINE”, your website states “A man named Derrick from Equine Podiatry Solutions LLC reached out to (b)(6) and her owner with a donation of Desmosphyrine that was meant to help treat (b)(6) acute laminitis. Fortunately, after the application of treatment, …, she began to improve."
From your website www.beatlaminitis.com: Webpage titled – “Client Reviews”:
- “(b)(6) was treated with Desmosphyrine on November 5, 6, and 7. He was back under the saddle on December 28, 2015.”
- “Desmosphyrine is the first effective product for treating Acute Laminitis…”
From your social media website www.facebook.com/BeatLaminitis: Webpage titled – “Equine Podiatry Solutions LLC – Home | Facebook”:
- On your February 10, 2022 post: “We are committed to preventing permanent damage to horses after Acute laminitis & stopping euthanasia from the disease. We are proud to be the industry leader and standard for treating acute laminitis. At Equine Podiatry Solutions, our passion for seeing horses healthy and at peak performance drives our mission to provide healing.”
- On your March 10, 2022 post: “In order for this treatment to be effective, it must be applied as soon as signs of acute laminitis are present!"
- On your February 2, 2022 post: “Join the growing number of clinics using Desmosphyrine to treat laminitis, and engage with the community making a difference in the second leading killer of horses.”
- On your February 18, 2022 post that has a link to a youtube.com video titled “Springtime Laminitis”: “We are proud to be the industry leader and standard for treating acute laminitis.”
From your Equine Podiatry Solutions, LLC YouTube channel, https://www.youtube.com/channel/UCR9waBp-xd02qG5ugsHJ-oQ:
- March 15, 2021 YouTube video titled “Springtime Laminitis”, posted on the webpage: https://www.youtube.com/watch?v=gG2WBcNG474]
o “We hope you don’t have to use our product, Desmosphyrine. Our product is now available… We are pretty excited about this product. It helps these horses that undergo the acute phase of laminitis.” [from 01:01 – 01:27]
o “We are glad that this product not only helps them survive the acute phase of laminitis with their life, but they’re actually able to go back to work in a relatively short period, most of the time it’s about two months.” [from 01:58 - 02:13]
This product is a new animal drug, as defined by section 201(v) of the FD&C Act, [21 U.S.C. § 321(v)], because it is 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]. This product is not approved or index listed by FDA, and therefore, the product is 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 into interstate commerce of an adulterated drug 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 product. 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 the 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/or injunction.
Please notify this office, in writing, within fifteen (15) working days of the receipt of this letter of the 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 the corrective actions 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 product is not in violation of the FD&C Act, include your reasoning and any supporting information for our consideration.
Your response should be sent via e-mail to Dr. Vic Boddie at CVMUnapprovedDrugs@fda.hhs.gov. If you have any questions about this letter, please contact Dr. Boddie at that address.
Neal Bataller, ME, DVM
Director, Division of Drug Compliance
Office of Surveillance & Compliance
Center for Veterinary Medicine