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WARNING LETTER

VetraGenics MARCS-CMS 485675 — Aug 09, 2016

VetraGenics - 485675 - 08/09/2016

Product:
Animal & Veterinary

Recipient:
VetraGenics


United States

Issuing Office:
Atlanta District Office

United States


   

Department of Health and Human Services logoDepartment of Health and Human Services

Public Health Service
Food and Drug Administration
  Atlanta District Office
60 Eighth Street N.E.
Atlanta, GA 30309 

August 9, 2016
 

VIA UNITED PARCEL SERVICE

WARNING LETTER

(16-ATL-16)

Mr. Brandon Hoats
VetraGenics, LLC
229 Peachtree Street NE
Suite 675
Atlanta, GA 30303
 

Dear Mr. Hoats:
 

This letter concerns your firm's marketing of injectable cell-based, regenerative therapy products for animals, including but not limited to, VetraRenew™, VetraGen™, VetraSight™, VetraWound™, VetraShield™ and VetraShield™/Dry. The U.S. Food and Drug Administration (FDA) has reviewed your website at the internet address www.vetragenics.com, where you promote and sell these products. We have determined that these products are intended for use in the mitigation, treatment, or prevention of diseases in animals, which makes them drugs 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, these products are unapproved new animal drugs and your marketing of them 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:

• "VetraRenew was developed specifically to treat soft tissue injuries and conditions, to support repair and promote reconstruction."
 
• "VetraRenew is most commonly used to treat:
 
o Osteoarthritis (djd- degenerative joint disease)
o Tendinitis
o Lameness
o Soft tissue (such as muscle) tears
o Areas of inflammation
o Repetitive motion injuries"
 
• "VetraGen™ is a liquid graft derived from amniotic fluid and tissue. It does not contain morselized bits of tissue and is used as an injection to treat localized hard tissue (primarily bone) and ligament injuries and conditions, and in other treatments for which the presence of morselized bits of tissue is not conducive."
 
• "Our products work with healing assistance in a wide range of injury and disease, ranging from soft tissue, bone, arthritis, eye issues, wound care, and organ failure, just to name a few."
 
• "The products offered by VetraGenics have been used to treat humans in over 40,000 procedures for osteoarthritis, ligament and tendon repair, fractures, wound care, corneal damage, and many other conditions, injuries and ailments."
 
• "VetraGenics™ products are safe, effective, and reliable to use for treatment with dogs, cats, horses and many other pets."
 
• "Our membrane products contain the most robust extracellular matrix found anywhere - the one that is used at the outset of life to build every tissue in the body. They also contain a broad array of growth factors and cytokines, those used by the body in the early healing process for every tissue to attract cells and induce them to take action, and to coordinate cellular communication."
 
• "VetraSight™ is pre-cut into disc form for direct application to the eye, and used for ocular repair and regeneration in a variety of applications and procedures."
 
• "Vetra Wound™ is applied directly to the skin and used to treat burns, chronic wounds and acute (traumatic and surgical) wounds."
 
• "VetraShield™ is available in dry and hydrated form, and is used as an adhesion barrier to reduce scar tissue formation on underlying tissue post-surgery."
 
Because your products are intended to prevent, mitigate or treat diseases 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, as defined by 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. They are 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, the 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 50l(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.
 
Please direct your response to the U.S. Food and Drug Administration, 60 Eighth Street, Atlanta, GA 30309, to the attention Derek Price, Director of Compliance, Atlanta District. If you have questions about this letter, please contact Mr. Price at (404) 253-2277.
 
Sincerely,
/S/
Ingrid A. Zambrana
Director
Atlanta District