WARNING LETTER
Intermarket Industries Inc. dba Doc Ackerman Pet Products
MARCS-CMS 696352 —
November 12, 2024
Delivery Method:
Via Email
Product:
Animal & Veterinary
Drugs
Recipient:
Recipient Name
Greg Mongrain
Recipient Title
Vice President
Intermarket Industries Inc. dba Doc Ackerman Pet Products
1131 Industrial Ave
Oxnard
,
CA
93030
United States
gmongrain@juno.com
Issuing Office:
Center for Veterinary Medicine
United States
WARNING LETTER
November 12, 2024
Re: 696352
Dear Greg Mongrain:
This letter concerns your firm’s marketing of an unapproved new animal drug Doc Ackerman's - Epilepsy & Seizure Formula, for the treatment of diseases in animals, in violation of the Federal Food Drug and Cosmetic Act (FD&C Act). The United States Food and Drug Administration (FDA) has reviewed your firm’s Facebook account in October and November 2024 where you direct customers to your product on Amazon and Only Natural Pet Store and has determined that you offer your product for sale there.
Based on our review of your Facebook account and third-party webpages, your product is a drug under section 201(g)(1) of the Federal Food Drug and Cosmetic Act (FD&C Act) [21 U.S.C. 321(g)(1)], because it is 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. This product is an unapproved new animal drug and introducing or delivering this product 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.
The intended use of your “Seizures” product is indicated by its name and is also shown by the claims you make for it. Examples of claims FDA observed on your product labelling, Facebook account and third-party webpages to which you direct your customers that show the intended use of your product include the following:
From your Facebook post titled “
Doc Ackerman's Pet Products
” at the URL https://www.facebook.com/p/Doc-Ackermans-Pet-Products-100057232281085/?_rdr dated April 14:
• “Epilepsy & Seizure Formula… Remedies for Dogs and Cats”
• “… The Epilepsy and Seizure formula will be available at the end of April on Amazon and at Only Natural Pet Store.”
From your product webpage “
Doc Ackerman's - Epilepsy & Seizure Formula
” on Amazon at the URL https://www.amazon.com/Doc-Ackermans-Epilepsy-Seizure-Formula/dp/B0002CGUP0:
• “Epilepsy & Seizure Formula… Remedies for Dogs and Cats”
• “EPILEPSY AND SEIZURE FORMULA for dogs and cats works as a calmative to help lessen the effects of nervous conditions.”
• “…is an anti convulsant [sic] & antispasmodic herb … specifically for Epilepsy.”
• “… help lessen the effects of nervous conditions while acting as a natural tranquilizer,…”
• “… Safe for your pet …”
From your product webpage “
DOC ACKERMAN'S EPILEPSY & SEIZURE FORMULA HERBAL REMEDY POWDER FOR DOGS & CATS - 10 OZ
” on onlynaturalpet.com at the URL https://www.onlynaturalpet.com/products/doc-ackermans-epilepsy-seizure-formula-herbal-remedy-powder-for-dogs-cats:
• “Epilepsy & Seizure Formula… Remedies for Dogs and Cats”
• “… Epilepsy & Seizure Formula
• “…
CAT AND DOG SEIZURE TREATMENT HOME REMEDY
…”
• “… Epilepsy and Seizure Formula… provides dogs and cats relief from the effects of epilepsy...”
• “… natural remedy for dog seizures… to treat epilepsy….”
• “... natural remedy for dog seizures… safe for your pet and for the environment….”
• “… seizure remedy comes in a convenient powder form…”
This product is a new animal drug under section 201(v) of the FD&C Act, [21 U.S.C. 321(v)], because it is 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]. This product is 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 is not intended to be an all-inclusive statement of violations that may exist in connection with your product. 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 the requirements of federal law, including FDA regulations.
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.
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 696352” 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: grgmeister@aol.com
Content current as of:
01/07/2025
Regulated Product(s)
Animal & Veterinary
Drugs