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  5. Energetic Essences, LLC dba Pet Essences - 696395 - 11/12/2024
  1. Warning Letters

WARNING LETTER

Energetic Essences, LLC dba Pet Essences MARCS-CMS 696395 —

Delivery Method:
Via Email
Product:
Animal & Veterinary
Drugs
Recipient:
Recipient Name
Polly Fox
Recipient Title
President
Energetic Essences, LLC dba Pet Essences

(b)(6)
United States

help@petessences.com
Issuing Office:
Center for Veterinary Medicine

United States

WARNING LETTER

November 12, 2024

Re: CMS Case # 696395

Dear Polly Fox:

This letter concerns your firm’s marketing of an unapproved new animal drug for the treatment of seizures in animals, in violation of the Federal Food, Drug, and Cosmetic Act (FD&C Act). The United States Food and Drug Administration (FDA) reviewed your website at the Internet address https://petessences.com/ in October to November 2024 and has determined that you offer this product for sale there.

Based on our review of your website at the internet address https://petessences.com/products/seizures, 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, prevention of disease, 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 website and product labeling that show the intended use of your product include, but are not limited to the following:

From your home website titled “Seizures” at the URL https://petessences.com/products/seizures:

• “Our Seizures formula is designed to help reduce the frequency, severity, and duration of seizures in animals.”
• “We recommend administering it to your pet 2 to 4 times a day to help prevent seizures from occurring.”
• “…this formula can also be used to manage seizures as they occur.”
• “…certain physical symptoms like shaking, drooling, and lack of control can be addressed with our formula.”

On your home webpage titled “Formulas” at the URL https://petessences.com/pages/formulas?_pos=2&_sid=9eb800182&_ss=r:

• “At the time of a seizure, use Emergency to help the animal recover. Then use Seizure Prevention to help ease the emotional stress associated with seizures. Use it daily…”
• “Our Seizures formula is designed to help reduce the frequency, severity, and duration of seizures in animals. We recommend administering it to your pet 2 to 4 times a day to help prevent seizures from occurring. However, this formula can also be used to manage seizures as they occur… certain physical symptoms like shaking, drooling, and lack of control can be addressed with our formula….”

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 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 #696395” 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: help@petessences.com

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