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	Division of Pharmaceutical Quality Operations I 10 Waterview Blvd, 3rd FL Parsippany, NJ 07054 Telephone: (973) 331-4900 FAX: (973) 331-4969

Via UPS

WARNING LETTER

CMS # 537739

October 4, 2017

Mr. Mark Capone
Vet Cellect LLC
400 Madison Ave.
Manalapan, NJ 07726

Dear Mr. 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.

Statements on your website that show these intended uses of your products include, but are not limited to, the following:

 “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)].

This letter is not intended to be an all-inclusive review of your products. It is your responsibility to ensure that all of your products are in compliance with the Act and its implementing regulations. Failure to promptly correct the violations specified above may result in enforcement action without further notice. Enforcement action may include seizure of violative products and/or injunction against the manufacturers and distributors of violative products.

You should notify this office, in writing, within fifteen (15) working days of the receipt of this letter of the steps you have taken to bring your firm into compliance with the law. Your response should include any documentation necessary to show that correction has been achieved. If corrective action cannot be completed within fifteen (15) working days, state the reason for the delay and the date by which the corrections will be completed. Include copies of any available documentation demonstrating that corrections have been made.

Your written notification should refer to the Warning Letter Number above (537739). Please address your reply to:

Ernest F. Bizjak
Compliance Officer, DPQ Div. 1 FDA
11919 Rockville Pike
Rockville, MD 20852

If you have questions regarding the contents of this letter, please contact Ernest Bizjak, Compliance Officer, at 301 796-4081, or by email at [email protected].

Sincerely,
/S/
Diana Amador Toro
Division Director/OPQ Division 1
New Jersey District Office