Source: https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2017/ucm579090.htm
Timestamp: 2019-01-22 11:06:28
Document Index: 718686899

Matched Legal Cases: ['§ 321', '§ 321', '§ 321', '§ 360', '§ 360', '§ 351']

Vet Cellect Bio Products, LLC 10/4/17
CMS # 537739
Mr. Mark Capone
This letter concerns your firm’s marketing of your cell-based, regenerative therapy product ExCellR8™. The U.S. Food and Drug Administration (FDA) has reviewed your website at the internet address www.vetcellect.com, where you promote and sell the product ExCellR8™. We have determined that ExCellR8™ is intended for use in the mitigation, treatment, or prevention of diseases in animals, which makes it 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)]. Further, as discussed below, ExCellR8™ is an unapproved new animal drug and your marketing of ExCellR8™ violates the FD&C Act.
 “ExCellR8™ Equine Topical Cream is indicated for the control of irritation and inflammation associated with over exertion, injury or osteoarthritis in tarsal, carpal, metacarpophalangeal, metatarsophalangeal and proximal interphalangeal (hock, knee, fetlock and pastern) joints in horses.”
 “Given the inherent anti-inflammatory and all-natural properties of its acellular derivatives, ExCellR8™ can promote natural equine health through regimented daily maintenance applications.”
 “At Vet Cellect, our focus is on a new strategy for treatment, involving non-invasive products that may help support healthy joint and cartilage function.”
 “Stem cells are a powerful tools for treating common injuries that result from athletic endeavor, resulting in high morbidity and often compromising an equine athlete’s performance.”
 “At Vet Cellect, we believe in providing practical products and services based on the transformative potential of regenerative stem cell treatments and medicines.”
 “We’re not only in the business of treating horses, we are also involved in the everyday care of these incredible animals.”
Because ExCellR8™ is intended to prevent, mitigate or treat diseases in animals, ExCellR8™ is a drug within the meaning of section 201(g)(1)(B) of the FD&C Act, [21 U.S.C. § 321 (g)(1)(B)]. Moreover, ExCellR8™ is a new animal drug, as defined by section 201(v) of the FD&C Act, [21 U.S.C. § 321(v)], because ExCellR8™ 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. ExCellR8™ is not the subject of 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]. Therefore, ExCellR8™ 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)].
Your written notification should refer to the Warning Letter Number above (537739). Please address your reply to:
Compliance Officer, DPQ Div. 1 FDA
If you have questions regarding the contents of this letter, please contact Ernest Bizjak, Compliance Officer, at 301 796-4081, or by email at Ernest.Bizjak@fda.hhs.gov.