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June 22, 2023

Re: 661290

Dear Amanda A. Banting:

This letter concerns your firm's marketing of unapproved new animal drug products for the treatment of disease in animals, including but not limited to, "Canine Heart Tonic, Hawthorne Tincture, Hepara-Cleanse, and Rena-Cleanse". The U.S. Food and Drug Administration (FDA) has reviewed your websites at the internet addresses www.caninehearthealth.com, www.caninekidneyhealth.com, www.canineliverhealth.com, and www.fiveleafpetbotanicals.com in March, April, and May 2023 and has determined that you distribute these products there.

Based on our review of your websites, your "Canine Heart Tonic, Hawthorne Tincture, HeparaCleanse, and Rena-Cleanse" products are drugs under section 201 (g)(1 )(B) and (C) of the Federal Food Drug and Cosmetic Act (FD&C Act) [21 U.S.C. 321 (g)(1 )(B) and (C)], because these products are intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease and/or intended to affect the structure or function of the body of animals. As explained further below, 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)]. These products are also sold as part of packages which include, but may not be limited to, "Canine Heart Health Packages (One, Two, Three, and Four), Canine Heart Health Packages + Kidney & Liver (One, Two, Three and Four), Hawthorne Tincture, Hepara-Cleanse + Blood Cleansing Tonic, and Rena-Cleanse+ Blood Cleansing Tonic."

You can find the FD&C Act and FDA regulations through links on FDA's homepage at www.fda.gov.

1. Some examples of claims observed on your www.caninehearthealth.com website that show the intended uses of your "Canine Heart Health" products include, but may not be limited to, the following:

On your website www.caninehearthealth.com:

• "We have helped many people support canine health during:

    o CHF Canine Congestive Heart Failure
    o Valvular Disease
    o DCM Dilated Cardiomyopathy
    o Canine Heart Murmurs”

• “The second step is to give your dog a powerful heart tonic that will help pump his heart NATURALLY…”
• “Almost two years ago my 13 year old [sic] Yorkie, (b)(6), was rushed to the hospital with pancreatitis. While he was there, he was diagnosed with Congestive Heart Failure...My Vet called and suggested that I check out your web site… And I attribute your Canine Heart Health Program with his recovery…”

On your website https://caninehearthealth.com/ingredients.html:

• “Canine Heart Tonic”
• “HAWTHORNE (berry, flower and leaf)”:

    o “Hawthorne contains potent phytochemicals which have been found in medical studies to:
       Increase the contractions of the heart muscle
       Improve left ventricle ejection fraction
       Reduce peripheral vascular resistance by dilating the blood vessels
       Be a mild diuretic
       Powerful antioxidant”
    o “Overall Hawthorne helps the heart pump more easily, but with more force and protects the heart from any future damage.”
    o “This herb is considered to be the user friendly Digitalis”

• “Hawthorne Tincture”

    o “Hawthorne … has been proven to be effective for high blood pressure, angina, cholesterol, arrhythmias, atherosclerosis, and congestive heart failure.”

• “Rena-Cleanse”

    o “Our formula contains herbs that will kill ANY urinary infections, clean and repair the kidneys and it is also a diuretic.”

• “Hepara-Cleanse”

    o “Hepara-Cleanse also removes parasites and intestinal worms.”
    o We have seen dogs with sinus infections, skin infections and ear infections that recovered after ONLY one month of kidney and liver flush programs.

From your website https://caninehearthealth.com/program-reviews.html:

• “My 10 year old [sic] beagle mix (b)(6) was diagnosed with heart disease last summer with a grade 4 heart murmur…our rescue group was allowed into a shelter to pull a tiny Pommie the shelter thought was dying. Aside from being emaciated and dehydrated, the vets also told us he suffered from grade 5/6 CHF. We were told he only had 6-12 months left. A good friend, who is also a pediatric neurologist suggested 5 Leaf Heart Tonic.”
• “…we came across Amanda’s Canine Heart Health website!! With this, we ordered the 40 lb canine heart health package and started her on the heart disease dose, as well as hydrotherapy, twice a day for 10 minutes at a time, and alternated between one week of liver cleanse and one week of kidney cleanse. We were not aware of any kidney or liver issues at this time and figured this would suffice.”
• “Today, (November 3, 2016) we took (b)(6) into the vet, to have an Echocardiogram done. The cardiologist said she only had a grade 1-2 heart murmur with zero wall thickening and zero chamber enlargement! (b)(6) is still on all of the supplements listed above except for… (as she is already getting hawthorn in Amanda’s program). We plan to transition back to the heart disease dosage of Amanda’s Canine Heart Health program…”

2. Some examples of claims observed on your www.canineliverhealth.com website that show the intended uses of your “Canine Liver Health” products include, but may not be limited to, the following:

From your website https://canineliverhealth.com/ingredients.html:

• “Our liver flush cleans and protects the liver and is a life saver for dogs with serious liver disease.”
• “Hepara-Cleanse also removes parasites and intestinal worms.”
• “We have seen dogs with sinus infections, skin infections and ear infections that recovered after ONLY one month of kidney and liver flush programs.”
• “Our formula contains herbs that kill most urinary infections, clean and repair the kidneys and it is also a diuretic.”

From your website https://canineliverhealth.com/program-reviews.html:

• “I have been treating my dog, (b)(6) for Valley Fever for the past five years…for Valley Fever and in the meantime do the liver and kidney cleanse with your products. When I began (6 wks. ago) her liver count was 269 and going up.”
• “The first site that caught my interest was the canine liver health site. I felt so strongly about it and it was really my only chance so I wrote to Amanda and related my story. She suggested I start the programme [sic] and change her diet immediately…I started on the five leaf liver programme [sic] in January and all I can say is that (b)(6) is a miracle since starting the programme [sic]...In the year that she has been on the five leaf meds she has been more active...”

3. Some examples of claims observed on your http://www.caninekidneyhealth.com website that show the intended uses of your “Canine Kidney Health” products include, but may not be limited to, the following:

From your website https://caninekidneyhealth.com/program-reviews.html:

• “(b)(6) is a 3 year old [sic] German shepherd dual purpose Police K9. He went into kidney failure in May and has been back and forth to the vet with his creatinine level, BUN level, and phosphorus level so that that he shouldn’t have even been alive. Creatinine alone was at 9.3.

I began this kidney health program with just hopes that something would save him. Today after three months all of his kidney levels were completely normal and he been taken off all medication and fluids.”

• “(b)(6) was diagnosed on 3/22/19 with kidney/renal neoplasia… researched and found FIVE LEAF PET! We started her on the program through 3 cycles (9 weeks) and had her blood tests re-evaluated and her kidney values…”

These products are new animal drugs, as defined by 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. They are not the subject of 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]. Therefore, the products are 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)].

Conclusion

This letter is not intended to be an all-inclusive statement of violations that may exist in connection with your products. 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 you comply with all requirements of federal law and FDA regulations.

This letter notifies you of our concerns and provides you an opportunity to address them. You should take prompt action to correct any violations. Failure to adequately address this matter may lead to legal or regulatory action, including without limitation, seizure and injunction.

Within fifteen (15) working days of the receipt of this letter, please notify this office in writing of the steps that 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 actions 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.

Your response should be sent via e-mail to Dr. Vic Boddie at CVMUnapprovedDrugs@fda.hhs.gov. If you have any questions or comments, please contact Dr. Boddie.

Sincerely,
/S/

Neal Bataller, ME, DVM, Director
Division of Drug Compliance
Office of Surveillance & Compliance
Center for Veterinary Medicine