WARNING LETTER
Essential Research, LLC
MARCS-CMS 665098 —
August 16, 2023
Delivery Method:
Via Email
Product:
Animal & Veterinary
Recipient:
Recipient Name
Amadeus Benitez, CEO
Recipient Title
Arek Schmocker, CFO, COO
Essential Research, LLC
(b)(6)
United States
info@essentialresearchllc.com
Issuing Office:
Center for Veterinary Medicine
United States
WARNING LETTER
August 16, 2023
Re: 665098
Dear Amadeus Benitez and Arek Schmocker:
In July 2023, the United States Food and Drug Administration (FDA) reviewed your social media pages and your website, www.chocolaterescuefordogs.com where you offer the product “Chocolate Rescue for Dogs” for sale in the United States. Based on our review, your product is an unapproved new animal drug. As discussed below, marketing an unapproved new animal drug violates the Federal Food, Drug, and Cosmetic Act (FD&C Act).
The claims on your websites establish that your product is a drug under section 201(g)(1) of the 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.
Chocolate contains components that can be poisonous to dogs. Its ingestion by dogs can potentially cause a life-threatening emergency requiring immediate attention by a veterinarian. Your product, which claims to treat this issue, has not been determined by FDA to be safe and effective. Your unproven treatment could cause animal owners to forgo or delay appropriate veterinary care.
Your product’s name “Chocolate Rescue for Dogs” indicates it is for use in treating (“rescuing”) dogs, who may experience serious adverse health events caused by ingesting chocolate.
Additional examples of claims on your websites and social media webpages that establish these intended uses of your product include, but are not limited to, the following:
On your webpage titled “Chocolate Rescue for Dogs” at the URL https://www.chocolaterescuefordogs.com:
• “Chocolate Rescue for Dogs quickly and efficiently encapsulates the toxins in chocolate — the encapsulated toxins safely pass through your dog's digestive system. The active ingredients specifically affect the toxins but remain unreactive to other molecules, so there are few, if any, side effects.”
• “Within seconds, Chocolate Rescue for Dogs will start absorbing and encapsulating the toxins.”
On your Chocolate Rescue for Dogs product webpage at the URL https://www.chocolaterescuefordogs.com/products/chocolate-rescue-for-dogs:
• “…at-home remedy for chocolate ingestion in dogs. The beef soft-chew is safe, effective…”
On your webpage titled “Veterinarians – Chocolate Rescue for Dogs” at the URL https://www.chocolaterescuefordogs.com/pages/for-veterinarians:
• “The active ingredients quickly push away saliva and other non-toxic molecules, targeting only theobromine and caffeine, allowing a much smaller dose to bind the toxins. As a result, there exists no risk of aspirational pneumonia or intestinal blockage. Most notably, dogs will eat the palatable treat willingly, and at only 7 grams, even a dog with a little appetite can easily be given the potentially lifesaving ‘treat.’”
• “Chocolate Rescue is extremely effective in permanently encapsulating caffeine and theobromine. The product uses a specially-formulated combination of ingredients that instantly draws the free toxins out of the chyme before they can be absorbed. Further, there are millions of binding sites in each dose of Chocolate Rescue, meaning that one chew will effectively nullify large quantities of high-concentration chocolate in a dog's stomach.”
On your blog post titled “Goodwill about Chocolate Rescue for Dogs” at the URL https://www.chocolaterescuefordogs.com/blogs/news:
• “We are very excited about our product and possibly the end of chocolate toxicosis in dogs!”
On your social media webpages at the URLs https://www.facebook.com/p/Chocolate-Rescue-for-Dogs-100087135855031/ and https://www.instagram.com/cr4dogs/:
• On your May 24, 2023, Facebook post: “Thanks to
(b)(6)
for eating chocolate, giving us the idea to develop a cure!”
• On your November 29, 2022, Facebook and Instagram posts: “Curious about how Chocolate Rescue for Dogs works?” The post contains an infographic that states: “Chocolate Rescue for Dogs quickly and efficiently encapsulates the toxins in chocolate — the encapsulated toxins safely pass through your dog's digestive system. The active ingredients specifically affect the toxins but remain unreactive to other molecules, so there are few, if any, side effects.”
Your “Chocolate Rescue for Dogs” 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, or 572 of the FD&C Act, 21 U.S.C. § 360b, 360ccc, or 360ccc-1, respectively. Your “Chocolate Rescue for Dogs” product is not the subject of an approved new animal drug application, conditionally approved new animal drug application, or index listed by the FDA, and therefore is considered 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).
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 injunction.
This letter is not intended to be an all-inclusive statement of violations that may exist in connection with your products or operations. 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 correct 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 products are 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 “CMS Case 665098” 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: info@chocolaterescuefordogs.com
Content current as of:
08/29/2023
Regulated Product(s)
Animal & Veterinary