Veterinary Select Formula dba Allergic Pet

WARNING LETTER Veterinary Select Formula dba Allergic Pet MARCS-CMS 696354 — November 12, 2024 More Warning Letters Warning Letters About Warning and Close-Out Letters Delivery Method: Via Email Product: Animal & Veterinary Drugs Recipient: Recipient Name Adam Gore Recipient Title Principal Veterinary Select Formula dba Allergic Pet (b)(6) United States info@allergicpet.com Issuing Office: Center for Veterinary Medicine United States WARNING LETTER November 12, 2024 Ref: 696354 Dear Adam Gore: This letter concerns your firm’s marketing of unapproved new animal drugs Vet Select© Nuroplex Capsules and Vet Select Nuroplex© - 2oz homeopathic Spray, in violation of the Federal Food Drug and Cosmetic Act (FD&C Act). The United States Food and Drug Administration (FDA) reviewed your website, https://www.allergicpet.com/, from October to November 2024, and has determined that you offer these products for sale there. Based on our review of your website and social media webpages, your products are drugs under section 201(g)(1) of the Federal Food Drug and Cosmetic Act (FD&C Act) [21 U.S.C. 321(g)(1)], because they are intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in animals and/or intended to affect the structure or any function of the body of an animal. These products are unapproved new animal drugs and introducing or delivering these products for introduction into interstate commerce is prohibited under section 301(a) of the FD&C Act [21 U.S.C. § 331(a)]. You can find the FD&C Act and FDA regulations through links on FDA’s homepage at www.fda.gov. Examples of claims FDA observed on your website and product labeling that show the intended use of your products include the following: From your home website titled “Vet Select© Nuroplex Capsules ” at the URL https://www.allergicpet.com/products/nuro-plex.html: • “Nuroplex herbal supplement capsules help to alleviate the symptoms of chronic seizures and epilepsy (shaking, tremors, loss of body control, etc.) in dogs and cats… ” • “… natural alternative to traditional drug therapy…beneficial for pets with elevated liver enzymes (can be caused by chemical exposure or toxic side effects of some drug therapies).” • “… Helps to alleviate symptoms of seizures in cats and dogs (shaking, tremors, loss of body control, etc.)…” • “… combine with Nuroplex homeopathic spray for more severe or frequent seizures…” • “… Helps to control and reduce quantity, duration, & [sic] severity of chronic seizures & [sic] epilepsy (shaking, tremors, loss of body control, etc.)” From your home website titled “Vet Select© Nuroplex - 2oz homeopathic Spray ” at the URL https://www.allergicpet.com/products/nuroplex-spray.html: • “Nuroplex 2 oz homeopathic spray is a natural and safe alternative to drug therapy… control symptoms of chronic seizures and epilepsy in dogs and cats.” • “… a preventative therapy and/or during or after a seizure to help speed recovery time….” • “… help control and alleviate symptoms of seizures in cats and dogs (shaking, tremors, loss of body control, etc.)” • “For more severe or frequent seizures, combine with Nuroplex capsules - see Nuroplex Full Treatment Pack” • “Can be used daily as a preventative and/or during or immediately after a seizure to help speed recovery” • “… reduce quantity, duration, & [sic] severity of chronic seizures & [sic] epilepsy (shaking, tremors, loss of body control, etc.)” From your home website titled “Vet Select© Nuroplex – Full Treatment Pack ” at the URL https://www.allergicpet.com/products/nuroplex-full-treatment-pack.html: • “Nuroplex Full Treatment Pack helps to control and alleviate the symptoms of chronic seizures and epilepsy in dogs and cats (shaking, tremors, loss of body control, etc.) ..." • “Helps to alleviate symptoms of seizures in cats and dogs (shaking, tremors, loss of body control, etc.)” • “… recommended for more severe or frequent seizures” • “Both products help control seizures in unique and different ways…” • “Helps to reduce quantity, duration, & severity of chronic seizures & epilepsy (shaking, tremors, loss of body control, etc.)” • “Helps lower elevated liver enzymes from toxic drug side effects” From your YouTube webpage “Allergicpet.com” at the URL https://www.youtube.com/@allergicpet3576/videos: • “AllergicPet.com Provides Treatment For Epilepsy In Dogs” • “AllergicPet.com provides the best selection of specialized, all-natural products to treat dog allergies, cat allergies, dog constipation, cat diarrhea, epilepsy in dogs...” 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 FDA, and therefore, the product 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)]. The introduction or delivery for introduction into interstate commerce of an adulterated drug is prohibited under section 301(a) of the FD&C Act [21 U.S.C. § 331(a)]. Conclusion This letter notifies you of our concerns and provides you an opportunity to address them. Failure to address this matter may lead to legal action without further notice, including, without limitation, seizure and/or injunction. This letter is not intended to be an all-inclusive statement of violations that may exist in connection with your products or operations. Our review of your website indicates that you are offering for sale unapproved animal drugs in addition to those listed above. If FDA takes legal action, the action may address all of your unapproved new animal drugs, not just those listed above. It is your responsibility to ensure that your firm complies with all requirements of federal law and FDA’s implementing regulations. Within fifteen (15) working days of receipt of this letter, please notify this office in writing 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 action within fifteen (15) working days, state the reason for the delay and the time within which you will complete the correction. If you believe that your product is not in violation of the FD&C Act, include your reasoning and any supporting information for our consideration. Please direct your response to U.S. Food and Drug Administration, Center for Veterinary Medicine, Office of Surveillance and Compliance, Division of Drug Compliance by email to CVMUnapprovedDrugs@fda.hhs.gov. Please include “Reference 696354 ” in the subject line of your email. Sincerely, /S/ Neal Bataller, ME, DVM Director Division of Drug Compliance Office of Surveillance and Compliance Center for Veterinary Medicine cc: contact@allergicpet.com Content current as of: 01/07/2025 Regulated Product(s) Animal & Veterinary Drugs