Groupe Cyrenne Inc. dba HomeoAnimal

WARNING LETTER Groupe Cyrenne Inc. dba HomeoAnimal MARCS-CMS 613008 — April 08, 2021 More Warning Letters Warning Letters About Warning and Close-Out Letters Product: Animal & Veterinary Recipient: Recipient Name Suzie Cyrenne & Mathieu Lessard Groupe Cyrenne Inc. dba HomeoAnimal 1205 Des Chataigniers Quebec QC G3G 3C4 Canada support@homeoanimal.com Issuing Office: Center for Veterinary Medicine United States WARNING LETTER Date: April 8, 2021 RE: [613008] This is to advise you that the United States Food and Drug Administration (FDA) reviewed your website at the Internet address www.homeoanimal.com in December 2020 through March 2021, and has determined that you take orders there for 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, which includes your Immunopet, Silverpet, and Cordyceps; and White Blood Cells. We have also reviewed your social media website at www.facebook.com/homeoanimal where you direct consumers to your website www.homeoanimal.com, to purchase your products. In addition, FDA has observed that the product Virus Defense Kit is intended to mitigate, prevent, treat, diagnose or cure COVID-19 1 in animals. The claims on your website establish that the 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, which includes your Immunopet, Silverpet, and Cordyceps; and White Blood Cells are intended for use in the cure, 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, these products are unapproved new animal drugs and introducing or delivering these products for introduction into interstate commerce violates section 301(a) of the FD&C Act [21 U.S.C. § 331(a)]. You can find the Act and FDA regulations through links on FDA's homepage at www.fda.gov. Examples of claims on your website www.homeoanimal.com that show the intended uses of your products include, but are not limited to, the following: • Alterra Sili-Mer G5 o “SILI-MER G5 remedy has also proven its effectiveness in cases of urinary kidney stones.” o “…is excellent for dissolving stones and preventing their appearance.” o “Who is this remedy suitable for? Animals suffering from arthritis or joint inflammation, showing signs of kidney stones, or suffering from dermatological problems.” • Anemia o “Effectively alleviate your animal’s anemia (dog, cat, horse & pets).” o “This remedy supports a healthy level of hemoglobin while increasing the number of red blood cells and improving blood quality.” • Cancer (Piptopet) o “Piptopet's active ingredient…helps fight cancer in dogs, cats and other animals. This broadband antiviral and antibiotic mother tincture has undeniable anti-inflammatory and anti-tumour properties that attack unhealthy cells, but leaves healthy ones intact.” • Cancer (Specific Remedy) o “These are made to target DIAGNOSED cancers either in the brain, lungs, liver or stomach, or also for Osteosarcoma, Hodgkin, mammary or Melanoma cancers!” o “We will specially make it to help slow the growth of cancer cells and shrink tumors that have already formed…” • Cataract-L o “Effectively relieve your animal’s cataracts (dog, cat, horse & pets).” o “Slows the development of cataracts” • Fracture o “Effectively treats your animal’s fracture (dog, cat, horse & pets).” o “…relieves pain and reduces swelling after a fracture or sprain.” • Heart o “This remedy strengthens your pet's heart muscle and helps to treat various heart conditions such as heart failure. It can also be used to control cardiac health.” • Heart Murmur o “Effectively relieves conditions that cause heart murmurs.” • Heartworm o “In heartworm-positive pets, HEARTWORM helps prevent the infection from progressing by destroying and expelling internal parasites.” o “It can also provide relief for common heartworm syndrome by: Increasing energy (thus counteracting fatigue and exercise intolerance), Easing coughing fits, Improving appetite, Maintaining weight (and preventing weight loss)” • Hip Dysplasia o “Effectively relieves your animal’s hip dysplasia” o “…reducing pain and tension in the joint area of the hip” o “…relieves your pet’s joint and muscle pain, repairs tendons and ligaments, and relieves painful, swollen and stiff joints.” • Parvopet o “This formula can aid in the treatment of parvovirus (parvo for short) in pets, which is an infection that affects the gastrointestinal tract…” • Seizurepet o “Effectively relieve seizures and epilepsy in animals” o “…designed to decrease the frequency and intensity and seizures…” [sic] • Thyroidpet o “Effectively relieve thyroid diseases in pets.” o “Helps correct thyroid imbalances for pets suffering from hypothyroidism or hyperthyroidism…” • Virus Defense Kit • On your Blog post titled “Everything You Need to Know About Coronavirus in Dogs”: o The following claims have embedded links to your “Virus Defense Kit” product page:  “This set of remedies is the ultimate tool for fighting a virus, no matter its nature. It’s made up of IMMUNOPET, SILVERPET and CORDYCEPS which are some of our best allies in strengthening the immune system.” • Your website metadata, which you use for searches on your website, contains the following tags for the “Virus Defense Kit”: “coronavirus,” “covid,” and “covid-19.” • White Blood Cells o “This remedy can be used for prevention or in support of traditional treatments. It is highly recommended in cases of leukopenia (low white blood cell or leukocyte count) and cancer, to fight the disease itself or to better deal with treatments such as chemotherapy or radiotherapy.” Examples of claims on your social media site www.facebook.com/homeoanimal that show the intended uses of your products include, but are not limited to, the following: • On a January 6, 2021 Facebook post with a video: “Pet parent Christopher loves that HomeoAnimal's PiptoPet (Cancer) remedy contains a potent, medicinal mushroom that helps fight the disease.” These products are "new animal drugs" under 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. To be legally marketed, a new animal drug must have 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]. These products are not approved or index listed by the FDA, and therefore these products are unsafe under 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)]. The introduction or delivery for introduction of these products into interstate commerce is prohibited under section 301(a) of the FD&C Act [21 U.S.C. § 331(a)]. Conclusion This letter is not intended to be an all-inclusive statement of violations that may exist in connection with your products. You are responsible for investigating and determining the causes of any violations and for preventing their recurrence or the occurrence of other violations. It is your responsibility to ensure that your firm complies with all requirements of federal law, including FDA regulations. This letter notifies you of our concerns and provides you an opportunity to address them. Failure to adequately address this matter may result in legal action including, without limitation, seizure and injunction. Please notify FDA in writing, within 15 working days of receipt of this letter, of the specific steps you have taken to address any violations. Include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation. If you cannot complete corrective actions within 15 working days, state the reason for the delay and the time within which you will do so. If you believe that your products are not in violation of FD&C Act include your reasoning and any supporting information for our consideration. Your response should be sent to Dr. Vic Boddie, United States Food and Drug Administration, Center for Veterinary Medicine, Office of Surveillance and Compliance, Division of Compliance by e-mail to Vic.Boddie@fda.hhs.gov. Sincerely, /S/ Eric M. Nelson Director Division of Compliance Center for Veterinary Medicine Food and Drug Administration __________________________________ 1 There is currently a global outbreak of respiratory disease in humans caused by a novel coronavirus that has been named “severe acute respiratory syndrome coronavirus 2” (SARS-CoV-2). The disease caused by the virus has been named “Coronavirus Disease 2019” (COVID-19). On January 31, 2020, the Department of Health and Human Services (HHS) issued a declaration of a public health emergency related to COVID-19 and mobilized the Operating Divisions of HHS. In addition, on March 13, 2020, there was a Presidential declaration of a national emergency in response to COVID-19. Therefore, FDA is taking urgent measures to protect consumers from certain products that, without approval or authorization by FDA, claim to mitigate, prevent, treat, diagnose, or cure COVID-19. As described below, you sell a product that is intended to mitigate, prevent, treat, diagnose, or cure COVID-19 in animals. We request that you take immediate action to cease the sale of any unapproved and unauthorized products for the mitigation, prevention, treatment, diagnosis, or cure of COVID-19. Content current as of: 04/27/2021 Regulated Product(s) Animal & Veterinary