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WARNING LETTER

Date: August 25, 2020

CC: perthoffice@hampl.com.au

RE: Unapproved New Animal Drug Products

RE: [610273]

Dear (b)(6):

This is to advise you that in July and August 2020, the United States Food and Drug Administration (FDA) reviewed your website at the Internet address www.holistichealthypet.com where you take orders for the following products: Doctor’s Best for Your Pets - Bee Propolis, Savvy Hlistic Health Pet Essences - Calming Comfort, Holistic Animal Remedies (HAMPL)/ HAMPL Pet Formulas (AN008, AN013(A), AN013(D), AN165, AN167, AN169, AN177, AN183(A), AN206, AN231, AN287, and AN312), Calm My Pet - Calming Essence: Calm My Arthritis, and Glacier Peak Holistics - Inflapotion Capsules products. The claims on your website establish that your products are drugs under section 201(g)(1)(B) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) because they are intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease. Based on our review, your products are unapproved new animal drugs. As discussed below, marketing of unapproved new animal drugs violates the FD&C Act.

Examples of claims observed on your website (www.holistichealthypet.com) that establish the intended use of your products as drugs include, but may not be limited to, the following:

Doctor’s Best for Your Pets
• Bee Propolis
“…propolis which essentially acts as an antibiotic that stops bacteria in its tracks.”
“…propolis, the natural beeswax additive that acts like an antibiotic.”

Savvy Holistic Health Pet Essences
• Calming Comfort
“Use in new situations, on trips, or when your pet can’t relax. Also if angry, out of control, vicious, high strung, overly possessive, demanding, mischievous, wants too much attention or can’t seem to calm down easily.”

Holistic Animal Remedies (HAMPL)/ HAMPL Pet Formulas
• AN008 – Seizure – Feline Cat or Kitten
“often seen after using insecticide drugs – worming, flea, tick EG Trifexis (Spinosad + milbemycin oxime).”
“Seizures – neurological brain stem region”

• AN013(A) – Cancer-Oral
“oral tumor growths,”
“gingival squamous cell carcinoma in pets,”
“tumors grow rapidly and typically invade nearby bone and tissue”.

• AN013(D) – Cancer-Brain Tumor
“Detox support from past or present toxins,”
“Herbal &immune and detox,”
“Cancerous Pituitary or Benign Tumors.”

• AN165 – Canine Distemper Virus
“…effective solution for acute virus symptoms.”
“Support from pain, inflammation, and other symptoms”
“One “set of the Distemper formulas” will help several puppies and dogs get their health back – prevention.”

• AN167 – Performance Racing Industry
“Pulmonary bleeds, racing industry.”
“Injury strains and bruising.”
“Nerves, bleeding, bruising from knocks, lameness, etc.”

• AN169 – Severe Acute Injury
“Bladder, intestinal, or rectum prolapse, paralysis, etc.”
“Bone, dislocation, disc, spine, hip, concussion, shock.”
“Nerve repair, shock, pain relief, infection, bleeds”

• AN177 – Canine Heartworm
“EFFECTIVE AND PROVEN POTENT (HERBAL MEDICINES) NATURAL SOLUTION & PREVENTION…”
“PREVENTION…Give a herbal dose once a day, during high mosquito season of the year.”
“You can the drops twice daily…for 6 weeks to kill the worm.”

• AN183(A) – FIP ‘WET’ (FELINE INFECTIOUS PERITONITIS)
“Feline infectious peritonitis”
“Neuro FIP (nerve, spasms, paralysis, weakness, seizure.”

• AN206 – CANCER – BONE CANCER (OSTEOSARCOMA) SPINDLE CELL TUMORS IN PETS
“Draws out toxic cells from the site, naturally.”
“Liver detox and liver regenerative of cells.”
“…amputation is not needed when we use herbal and homeopathic support.”

• AN231 – BEHAVIOR – CHEWING OR CHASING TAIL, LEG OR BACKEND
“Emotional support formula that helps the anxiety issues.”
“Injuries to the Brain and Spinal Cord”

• AN287 – RABIES VIRUS HOMEOPATHIC PROPHYLACTIC (LYSSIN ORAL NOSODE)
“A homeoprophylaxis will help maintain a pets immunity against infection”
“One bottle will treat several dogs, puppies, cats and kittens and any other species for many years.”

• AN312 – CANINE PARVO VIRUS PROTECTION
“Oral nosodes prophylactic”

Calm My Pet
• Calming Essence: Calm My Arthritis
“This spray is recommended for arthritis, discomfort, muscle/joint soreness and overuse.”
“Daily misting of Calm My Arthritis will ease discomfort, muscle joint soreness and overuse.”

Glacier Peak Holistics
• Inflapotion Capsules
“Inflammation and Tissue support”
From the product information page:
“Traditionally used to relieve everyday aches and pains.”
“…general age-related stiffness and discomfort, large breed puppy ‘growing pains,’ minor injuries, minor injuries, overexertion associated with working dogs and hospice care.”

Based on our review, 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. 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]. New animal drugs that are not the subject of an approved new animal drug application, conditionally approved new animal drug application, or index listing are 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 injunction.

This letter and FDA’s April 7, 2020, Warning Letter are 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.

Your response should be sent to Dr. Vic Boddie, United States Food and Drug Administration, Center for Veterinary Medicine, Office of Surveillance and Compliance, Division of Compliance by e-mail to Vic.Boddie@fda.hhs.gov.

Sincerely,
/S/

Dr. Amber McCoig
Deputy Director, Division of Compliance
Center for Veterinary Medicine
Food and Drug Administration