Source: https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/anicell-biotech-558559-07032018
Timestamp: 2019-09-21 23:59:30
Document Index: 134978670

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

AniCell Biotech - 558559 - 07/03/2018 | FDA
AniCell Biotech - 558559 - 07/03/2018
AniCell Biotech MARCS-CMS 558559 — July 03, 2018
Mr. Brandon T. Ames
145 S 79th St.
The U.S. Food and Drug Administration (FDA) inspected your facility located at 145 S 79th St. Chandler, AZ, from September 11, 2017 through September 13, 2017. After a review of the establishment inspection report, and a subsequent review of information provided on your website at the internet address: www.anicellbiotech.com, we have determined that you are marketing unapproved new animal drugs. All of the cell-based, regenerative therapy products that AniCell Biotech markets are intended for use in the mitigation, treatment, or prevention of disease 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, your 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:
“CanisCell Treatments for Dogs”
o “CanisCell AniMatrix™ is an acellular implantable amniotic allograft used as a bioscaffold which provides a matrix for wound management of joints and other tissue damage such as orthopedic, bone, muscle, ligament and tendons.”
“About AniCell Biotech”
o “. . . They found that these regenerative treatments can be used the same day as the injury, are able to be used in the field, are more efficacious and safer to use and best of all, less expensive than similar treatments.”
o “. . . This technology is provisionally patented for use in horses and dogs to treat tendons, ligament, hard-to-heal wounds and eyes.”
“Frequently Asked Questions (FAQ)”
o “. . . What can these treatments be used on? These ‘Human Tested, Animal Approved’ products can be used on a host of ailments such as superficial wounds, orthopedic injuries, eye issues such as corneal ulcers and other debilitating joint issues.”
“CanisCell StemWrap™”
o “. . . Due to its natural anti-inflammatory, anti-microbial and anti-adhesion properties, this product reduces the number of dressing changes needed. The amniotic material is placed on the wound and it contains many of the concentrated proteins and collagens needed to accelerate growth and healing.”
Because AniCell Biotech 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, your 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. Your products 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 501(a)(5) of the FD&C Act [21 U.S.C. § 351(a)(5)].
Your written response should refer to the Warning Letter Number above (558559). Please address your reply to:
If you have any questions about the content of this letter, please contact Jessica Mu, Compliance Officer, at 949-608-4477 and reference unique identifier CMS 558559 on all correspondence.