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  1. Warning Letters

WARNING LETTER

Natural Wonder Products Corp MARCS-CMS 592699 —


Delivery Method:
SIGNATURE CONFIRMED DELIVERY
Product:
Animal & Veterinary
Drugs

Recipient:
Recipient Name
Gary Le Mon
Recipient Title
Chairman of the Board of Directors
Natural Wonder Products Corp

Green Valley, AZ 85622
United States

Issuing Office:
Division of Pharmaceutical Quality Operations IV

19701 Fairchild Road
Irvine, CA 92612-2506
United States


September 23, 2019

 

Dear Mr. Le Mon:

This letter concerns your firm’s marketing of products for the treatment of disease in pets, including but not limited to, Daily Sure Multi-Herbal, Denta Sure, Adadren, Arthridia, C-Care, Cataractin, CortiQuel, Detox, Blood-Sugar Balance, Number 2, Ear Mist,  Heart Hardy, SoothAway, Immune, KC Cat Cough, KC for Kennel Cough, K9 Calm, PV for Canine Parvovirus, Tidy Tears, ThyroPaws, TSH, Number 1, FourGuard, and FlexaSure.  The U.S. Food and Drug Administration (FDA) has reviewed your websites at various internet addresses where you promote and sell these products.  These internet addresses include, but are not limited to:  www.natural-wonder-pets.com and www.natural-wonder-remedies.com.  We have determined that these products are intended for use in the mitigation, treatment, or prevention of diseases in animals, which makes them drugs under section 201(g)(1)(B) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) [21 U.S.C. § 321(g)(1)(B)].  Further, as discussed below, these products are unapproved new animal drugs and your marketing of them violates the FD&C Act.

Statements on your website that show these intended uses of your products include, but are not limited to, the following:

Daily Sure Multi-Herbal

  • “…helps prevent disease.”
  • “Tumeric Root…Prevents and shrinks cancerous tumors…Prevents or reduces pain associated with arthritis, bursitis, and tendonitis”
  • “Wheatgrass…Is scientifically proven to prevent cataracts in aging dogs”

Denta Sure

  • “…prevent future dental disease”
  • “Grapefruit seed extract is effective in curing oral infections…”
  • “Grapeseed extract…This powerful ingredient can heal teeth and gums as well as strengthen blood vessels, aid in circulation, and reduce risks of cancer.”

Primalix Adadren

  • “Ginger…It soothes the intestinal issues that come up with Addison’s, reducing painful symptoms and treating the disease at the same time.”
  • “Manages symptoms of Addison's on its own and/or works as an adjunct with conventional medications.”
  • “Gentian Root…It also has germicidal properties, making it very useful when treating Addison's.”

Arthridia

  • “Ingredients clinically proven to reduce cat and dog arthritis pain and inflammation as effectively or more effectively than non-steroidal anti-inflammatory drugs (NSAIDs).”
  • “Effective treatment for swollen joints and aching muscles.”
  • “Rehmannia stimulates the production of adrenal cortical hormones, which rapidly reduce pain and inflammation.”

C-Care

  • “Ingredients are proven scientifically in clinical studies as well as having long traditions of being used successfully to fight cancer.”
  • “Customer recommended to be safe and effective in the treatment of cat and dog cancer.”
  • “Turkish (Indian) Rhubarb Root (Rheum palmatum) can regenerate healthy cells to fight the growth of cancer cells as well as cleanse and detoxify the body due to its antioxidant properties.”

Cataractin

  • “Use the power of antioxidants in proven ingredients like Bilberry Berries, Wheatgrass Extract, and Dandelion Root to attack the free radicals that oxidize the lens and cause cataracts.”
  • “…wheatgrass…maintains eye health and reverses cataracts in dogs and cats.”
  • “Dandelion root…beneficial uses including being effective against cataracts.”

CortiQuel

  • “…alleviates symptoms associated with Cushing's.”
  • “Effective against Cushing's in dogs to restore homeostasis.”
  • “Alfalfa reduces some of the symptoms that occur in dogs with Cushing's, such as joint and muscle pain and fatigue.”

Detox

  • “Fights off common viruses (Blocks viral replication, effective against the common cold and dog flu.)”
  • “Black Walnut Hull…has been used for centuries by Native Americans as an anti-parasite, anti-bacterial, anti-viral and anti-fungal herbal remedy.”
  • “Oregano is anti-viral; it detoxifies the lungs and protects against colds, dog flu, and other viral infections.”

Blood-Sugar Balance

  • “Proven to not only prevent and stop the progress of cat and dog diabetes but reverse damage caused by diabetes.”
  • “Lowers blood glucose levels, stimulates natural insulin production, and reverses insulin resistance naturally.”
  • “Not only reverses diabetic disease but can also help reverse damage caused by diabetes, such as incurable diabetic wounds and neuropathy.”

Number 2

  • “We’ve included herbs that have anti-inflammatory action…”
  • “In Indian medicine dried Barberry root bark is used to treat diarrhea as well as reduce fever, soothe upset stomach, stimulate appetite and promote an overall sense of wellbeing.”
  • “It contains a blend of natural medicines that disinfect your pet’s digestive system of the harmful bacteria that cause diarrhea including diarrhea with blood.”

Ear Mist

  • “…is a potent herbal formula that TARGETS three infectious organisms. Bacteria, fungi (yeast) and parasites (mites).”
  • “…contains a natural botanical medicine that SOOTHES your dog or cat’s itchy, irritated ears and helps promote rapid healing.”

Heart Hardy

  • “Acts as a mild diuretic to reduce excess fluid retention.”
  • “Heart Hardy helps reverse symptoms and effects of heart disease and CHF in dogs and cats.”
  •  “Use for congestive heart failure in dogs and cats, hypertension (high blood pressure) and edema (fluid retention).”
  • “Motherwort prevents the formation of blood clots, reducing the risk of heart attack, stroke, and other diseases, and is good for hypertension because it relaxes blood vessels and calms nerves.”

SoothAway

  • “Soothes away the ITCH of flea-allergic dermatitis…”
  • “Disinfects viral, fungal, bacterial, and parasitic infections including scabies mites (Sarcoptis scabiei), ear mites, lice, and ringworm.”
  • “Reduces pain and inflammation, and promotes rapid healing of skin cell tissue.”
  • “Tea tree oil is a natural antifungal, antibacterial, antiviral, anti-infection oil. It can be used to cure and heal a long list of ailments and conditions from flea bites to ear mites.”

Immune

  • “Astragalus…has valuable anticancer, anti-aging and life span extending properties.”
  • “The National Cancer Institute found in clinical studies that the primary antioxidant in licorice root may inhibit the growth of cancer cells and cause cancer cell death.”

KC Cat Cough

  • “Target and destroy invading pathogens at the root of the problem…”
  • “…Coltsfoot has been used worldwide for thousands of years to ease racking, dry coughs and chronic or acute bronchitis.”
  • “Mullein flower (Verbascum thapsus) is frequently combined with other herbs in mixtures for treating cat cough.”

KC for Kennel Cough

  • “Cure kennel cough in dogs - without drugs, chemicals or side effects - in your home, safely and effectively, with the cure Nature engineered eons ago.”
  • “Our proprietary blend of specific herbs can give your dog fast, natural relief from kennel cough without worry of building resistance to bacteria or viruses.”
  • “Primalix KC is a safe and effective natural treatment for kennel cough in all dog breeds.”

K9 Calm

  • “The Time-Honored Blend of ‘Most-Recommended’ Naturally Potent Herbs For Calming Jittery Nerves, Relieving Panic Triggers and Curing Your Dog of Separation Anxiety”

PV for Canine Parvovirus

  • “Increases protein and the production of blood cells to counteract damaging effects of canine parvovirus”
  • “Increases immunity so that dogs can fight off viruses more effectively”
  • “Antidiuretic effects protect your dog from dangerous dehydration due to diarrhea”
  • “Dandelion Root…Since the dehydration caused by chronic diarrhea during a parvovirus infection is one of the leading causes of death, this herb’s power to reduce diarrhea is essential to holistic healing.”

Tidy Tears

  • “First, it disinfects the microbial breeding ground at the root of the problem by killing the bacteria that, when interacting with yeast in the affected areas, cause the formation of pigment and subsequent staining.”
  • “Grapefruit seed extract…broad spectrum destroyer of bacterial, viral and fungal infections, plus Gram positive organisms, the specific bacteria at the source of the cat and dog tear stains.”

ThyroPaws

  • “Reduces thyroid hormone production”
  • “Motherwort calms rapid heartbeat and helps an overactive thyroid without altering normal thyroid function.”
  • “Herbal Medicine for Hyperthyroidism in Cats”

TSH

  • “Thyroid stimulating herbs”
  • “Primalix TSH - Thyroid Stimulating Herbs for Dogs with Hypothyroidism provides natural thyroid stimulation”

Number 1

  • “Treat Dog Urinary Tract Infection and Cat UTI with Safe Herbal Remedy.”
  • “Eases the symptoms of UTI to make your pet comfortable while healing”
  • “Prevent urinary tract infection, bladder stones, and kidney stones without harmful side effects”
  • “Treats and prevents UTIs without building up bacterial resistance, making it safe even for chronic UTIs”

FourGuard

  • “Symptoms of dog worms and cat worms disappear after treating with unique, ancient herbal remedy.”
  • “Works together with TripleSure Natural Flea and Tick Spray to eliminate the vicious cycle of flea and worm infestation”
  • “Effective against infestations and is safe to use for maintenance throughout your pet’s lifetime”
  • “Works on heartworm plus the negative symptoms of dog worms and cat worms by natural extermination”
  • “Works on a wide range of intestinal parasites including roundworms, hookworms, pinworms, tapeworms, and whipworms”
  • “Cloves have been used to alleviate pain, prevent and treat bacterial infections, relieve congestion, and treat worms, symptoms of dog worms, and internal parasites.”

FlexaSure

  • “Natural arthritis therapy”
  • “…works on the cellular level to cleanse, rehydrate, and fortify damaged tissue.”
  • “…reduces pain and inflammation but actively helps stop the degeneration of connective tissue that leads to arthritis pain.”
  • “…stop the progression of arthritis but also help reverse damage.”

Because your products are intended to prevent, mitigate or treat diseases in animals, they are drugs within the meaning of section 201(g)(1)(B) of the FD&C Act, [21 U.S.C. § 321 (g)(1)(B)].  Moreover, 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)]. 

This letter is not intended to be an all-inclusive review of your products.  It is your responsibility to ensure that all of your products are in compliance with the Act and its implementing regulations.  Failure to promptly correct the violations specified above may result in enforcement action without further notice. Enforcement action may include seizure of violative products and/or injunction against the manufacturers and distributors of violative products. 

You should notify this office, in writing, within fifteen (15) working days of the receipt of this letter of the steps you have taken to bring your firm into compliance with the law.  Your response should include any documentation necessary to show that correction has been achieved.  If corrective action cannot be completed within fifteen (15) working days, state the reason for the delay and the date by which the corrections will be completed.  Include copies of any available documentation demonstrating that corrections have been made. 

Please send your electronic reply to ORAPHARM4_RESPONSES@FDA.HHS.GOV or mail your reply to:

CDR Steven E. Porter, Jr.
Director, Division of Pharmaceutical Quality Operations IV
U.S. Food & Drug Administration
19701 Fairchild Road
Irvine, CA 92612

Please identify your response with the unique identifier: CMS 592699.

If you have any questions regarding the content of this letter, please contact William V. Millar, Compliance Officer via email at william.millar@fda.hhs.gov or by phone at (503) 671-9711 Extension 30.

Sincerely,
/S/
CDR Steven E. Porter, Jr.
Director, Division of Pharmaceutical Quality Operations IV