WARNING LETTER

November 12, 2024

Re: 696281

Dear William and Susanne Beckett:

This letter concerns your firm’s marketing of unapproved new animal drugs, including SeizureGuard Plus and Life Span Arthritis & Mobility Advanced Enzyme Therapy 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) reviewed your website, evolutionpets.com, and your Amazon store webpages www.amazon.com/SeizureGuard-Epilepsy-Supplement-Supplement-medication/dp/B00HKYSXBC and www.amazon.com/LifeSpan-Systemic-Enzymes-Arthritis-Mobility/dp/B00A0Q0DN8 from October to November 2024, where you offer these products for sale in the United States.

Based on our review, the claims on your website and product labeling establish that your SeizureGuard Plus and Life Span Arthritis & Mobility Advanced Enzyme Therapy 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 to affect the structure or function of the body of animals.

Your product’s names, such as SeizureGuard Plus and Life Span Arthritis & Mobility Advanced Enzyme Therapy, indicate they are intended for use in treating animals with disease conditions and/or to affect the structure or function of the body of animals.

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 product labeling and product listing webpages that show the intended use of your products include, but are not limited to, the following:

SeizureGuard Plus
• On your webpage titled “Dog Seizure Treatment | #1 Rated Dog Seizure Medication for Epilepsy in Dog” at the URL https://evolutionpets.com/pages/dog-seizure-prevention:
  o “Need help preventing Dog Seizures? SeizureGuard PLUS can help.”
  o “Epilepsy in dogs can shorten your pet's life significantly. Luckily SeizureGuard dog seizure medication has been shown to improve a dog's ability to guard against seizures and their damaging after affects. SeizureGuard builds up essential immune and neurological systems to protect vital organs from damage. As a result your dog will be less likely to experience a seizure. If a seizure does occur chances are good that it will last shorter and cause less damage.”
  o “All Natural, safe and proven effective.”
  o “Proven effective remedy to fight the damaging effects of canine seizures. Can be used alone or in combination with prescription medications such as phenobarbital.”

• On your product webpage at the URL https://evolutionpets.com/products/seizureguard-plus?variant=44146971443487:
  o “SeizureGuard rebalances and increases your dog's immune, neurological, kidney, circulatory, and defensive systems up to optimal performance. As a result your dog will be less likely to experience a seizure, and when a seizure does occur, chances are good that it will last shorter and cause less damage. And perhaps the most critical benefit of SeizureGuard is that, when a seizure does occur, your dog will be able to recover quickly from it. It is in this phase where most permanent damage and life threatening effects occur – when a dog cannot recovery [sic] from an epileptic attack.”
  o “Protease: Protease acts as a catalyst to repair damaged proteins, reduces blood toxins after a canine epileptic attack, rebalances the immune system by modulating protein levels, supports increased blood flow essential after an attack resulting from epilepsy, and speeds tissue and muscle repair.”
  o “Amylase: Amylase is one of the best defensives against many diseases including epilepsy in dogs. After an attack, Amylase successfully works in muscle building and improving immune system in order to burn the calories and fight against those chronic diseases. Lastly it has great calming benefits that will help your pet to stop shaking during seizures in dogs.”

• On your webpage titled “About Us” at the URL https://evolutionpets.com/pages/about-us:
  o “SeizureGuard Plus is an all-natural dog seizure medication that can be used alone or in combination with veterinarian prescribed medications. SeizureGuard not only helps to reduce the frequency of epileptic attacks but also aids in quick recovery of seizures. We also have older dogs covered.”

• On your blog post titled “How to Treat Dog Seizures with Natural Supplements” at the URL https://evolutionpets.com/blogs/news/first-time-dog-owners-need-to-know-these-things:
  o “SeizureGuard is highly recommended as a natural dog seizure medication and has helped thousands of dog owners better manage the symptoms and effects of epilepsy in dogs.”
  o “Giving your dog a natural dog seizure medication can have a noticeable impact on their quality of life. That’s because some naturally-derived supplements can improve the severity and frequency of dog seizures. They amy [sic] even help control epilepsy in dogs well enough that they can be weaned off of side-effect-causing pharmaceuticals.”
  o “SeizureGuard is the top rated veterinarian recommended natural dog seizure medication, mainly because it contains all these supplements, plus many others that help dogs feel better between seizures.”

• On your Amazon store webpage at the URL https://www.amazon.com/SeizureGuard-Epilepsy-Supplement-Supplement-medication/dp/B00HKYSXBC:
  o “Builds a strong immune system to limit damage caused by epileptic attacks in dogs. Amazing supplement for dogs with seizures. Works Great!”
  o “Safe and Effective to help prevent dog seizures | All natural remedy and best dog seizures treatment for canine seizures and epilepsy. Top RATED dog seizure medication.”
  o “All natural remedy to help control and seziures in dogs. Can be used along with other medicine for canine eplipesy & seizures”
  o #1 RATED Seizure Medication for Dogs. GUARANTEED or our [sic] your money back”

Life Span Arthritis & Mobility Advanced Enzyme Therapy

• On your product webpage at the URL https://evolutionpets.com/products/lifespan-arthritis-mobility-systemic-enzymes?variant=44174415659295:
  o “Dog Arthritis, Hip Dysplasia, and a lack of mobility will continue to worsen as inflammation and fibrin deposits around your dog's joints continue to increase. Systemic Enzymes are the latest proven choice to end pain, reduce swelling and increase mobility by breaking up the fibrin deposits around dog's joints and muscles. At the same time they help to rebalance the production of Synovial Fluid which is vital for the lubrication of joints.”
  o “LifeSpan also helps counter degeneration of cartridge and slow down the normal aging process with the same Living Enzymes currently produced in a dog's body.”
  o “Enzymes have helped tens of thousands of pets (and humans) with pain, arthritis, and hip dysplasia. In fact it is the most successful alternate remedy to prescription drugs.”

• On your Amazon store webpage at the URL https://www.amazon.com/LifeSpan-Systemic-Enzymes-Arthritis-Mobility/dp/B00A0Q0DN8:
  o “Systematic Enzymes significantly help control Dog Arthritis, Hip Dysplasia. Increases mobility by breaking up the fibrin deposits around dog's joints and muscles.”
  o “Effective against inflammation and fibrin deposits around your dog's joints. Proven to reduce pain”
  o “LifeSpan also helps counter degeneration of cartridge and slow down the normal aging process with the same Living Enzymes currently produced in a dog's body. Great for working dogs & older dogs”
  o “Has helped tens of thousands of pets with pain, arthritis, and hip dysplasia.”

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, new animal drugs must have an approved new animal drug application, conditionally approved new animal drug application, or index listing under section 512, 571, or 572 of the FD&C Act, 21 U.S.C. § 360b, 360ccc, or 360ccc-1, respectively. These products are not the subject of an approved new animal drug application, conditionally approved new animal drug application, or index listing by the FDA, and therefore are 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). 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)].

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 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 the 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 696281” 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