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WARNING LETTER
•Groupe Cyrenne Inc. dba HomeoAnimal•March 31, 2021

Groupe Cyrenne Inc. dba HomeoAnimal – FDA Warning Letter, Mar 31, 2021

Record Details

The FDA issued a Warning Letter to HomeoAnimal on April 8, 2021, following a review of their websites (www.homeoanimal.com and www.facebook.com/homeoanimal) from December 2020 to March 2021. The FDA determined that HomeoAnimal sells multiple animal products, including Alterra Sili-Mer G5, Anemia, Cancer (Piptopet), Cancer (Specific Remedy), Cataract-L, Fracture, Heart, Heart Murmur, Heartworm, Hip Dysplasia, Parvopet, Seizurepet, Thyroidpet, Virus Defense Kit (Immunopet, Silverpet, Cordyceps), and White Blood Cells, which are marketed with claims indicating their use for the cure, mitigation, treatment, or prevention of disease in animals.

These claims, such as "fights cancer," "dissolving stones," "relieves pain," and "treats heart conditions," classify the products as "drugs" under section 201(g)(1)(B) of the FD&C Act. Furthermore, the products are deemed "new animal drugs" under section 201(v) because they lack general recognition among experts for safety and effectiveness. The Virus Defense Kit is specifically cited for claims related to mitigating, preventing, treating, diagnosing, or curing COVID-19 in animals.

Since these products lack an approved new animal drug application

Company
Groupe Cyrenne Inc. dba HomeoAnimal
Inspection date
March 31, 2021
Product type
Veterinary
Office
Center for Veterinary Medicine
Person
  • Eric M. Nelson (Director - Division of Compliance)
View Company Profile

ID · bb80b099-dfb5-4a76-b814-7a312cf23513

Violation Codes8
21 U.S.C. 321(g)(1)(B)21 U.S.C. 321(v)21 U.S.C. 360b21 U.S.C. 360ccc21 U.S.C. 360ccc-121 U.S.C. 360b(a)21 U.S.C. 351(a)(5)21 U.S.C. 331(a)

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