Department of Health and Human Services
Public Health Service
850 3rd Ave
January 8, 1997
VIA CERTIFIED MAIL, RETURN RECEIPT REQUESTED
Daniel Farrington, President
39 Locust Ave
East Moriches, NY 11940
Ref. No. 26-NYK-97
Dear Mr Farrington:
This letter is in reference to the folIowing veterinary homeopathic products which are distributed by your firm. These products make claims for their use in the treatment of various conditions. The product claims and indications are as follows:
- HOMEOPET MILIARY ECZEMA
Remedy to provide relief from Milary Eczema(Female).
Indications for use: Milary eczema, eosinophilic plaques, itching/violent itching, changes post spaying, hair loss due to spaying.
- HOMEOPET MILIARY ECZEMA
Remedy to provide relief from Milary Eczema (Male)
Milary eczema, eosinophilic plaques, itching/violent itching, changes post castration, hair loss due to castration.
- HOMEOPET SKIN AND SEBORRHEA
Remedy to provide relief from Skin Seborrhea Condition.
Indications for use: Seborrhea, hot dog syndrome, allergic dermatitis, itching, some eczemas, rough dry scaly skin aggravated by heat or cold.
- HOMEOPET SINUSITIS
Remedy to provide relief from Sinusitis.
Indications for use: Sneezing, feline upper respiratory infections, nasal discharges—light or heavy, obstruction of nasal passages due to foreign bodies, scabs on nose due to blockage or infection, dry nose, loss of taste, loss of smell.
- HOMEOPET TRAUMA
Remedy to protide relief from Trauma.
Indications for use: Bite wounds, cuts, bruising, sprains, teething, fever, bone fractures, bleeding into eye, assisting in reduction bleeding, extractions.
- HOMEOPET URINARY INCONTINENCE
Remedy to provide relief from Urinary Incontinence.
Indications for use: Old age incontinence, leakage during sleep, changes post-neutering, profuse clear watery flow in frequent but small amounts, incontinence associated with sleep, excitement or surgery.
- HOMEOPET ANXIETY
Remedy to provide relief from anxiety.
Indications for use: Separation from owner, separation from mother, left at kennel. Pet doesn’t eat while owner is away, fretting, fear, hysteria (especially thunderstorms, fireworks, gunshots), travel sickness, stress licking.
- HOMEOPET ARTHRITIS
Remedy to provide relief from Arthritis,
Indications for use: Lameness, stiffness, pain on movement, difficulty rising after rest, rheumatic pains, inflamation of joints, cracking of joints, sore joints, back pain crossing over gait, destructive chewing, chronic sprain, bone deformity, degenerative reticula myelopathy, leg perthes, hip displasia.
- HOMEOPET COUGH
Remedy to provide relief from Cough.
Indications for use: Kernel cough, asthmatic cough, geriatric cough, croupy cough, wet heart cough, dry cough, deep cough, hysteria associated cough, difficulty swallowing, swollen glands.
- HOMEOPET FLEAS
Remedy to provide relief from Fleas.
Indications for use: Reaction to flea bites, allergic dermatitis
- thick scabs
- small blisters
- prickly itching
- smelly skin
- HOMEOPET HOT SPOTS
Remedy to provide relief from Hot Spots.
Indications for use: All forms of eczema, wet eczema on skin, ears, paws between, toes, inside joints, sore infected eczema, pruritic skin rash, hot smelly skin, vaginal eczema, scrotal eczema.
- HOMEOPET GASTROENTERITIS
Remedy to provide relief from Gastroenteritis.
Indications for use: Vomiting, food regurgitation, diarrhea, colic, flatulence, bloat due to retained gas, poor appetite, loss of appetite.
- EquioPathics ASTHMA& ALLERGY
Remedy to provide reliefhorn Asthma& AIIergy.
Indications for use: Coughing, sinusitis conditions, hysteria associated coughing, dyspnea (respiratory distress), asthmatic conditions (canhelp in emphysema), hay dust allergy, hay fever.
- EquioPathics WORMS
Remedy to provide relief from worms.
Indications for use: Roundworm, tapeworm or hookworm infestation, deb~tation (where animal’s life is in immediate danger due to a massive worm infestation veterinary advice should be immediately sought).
- EquioPathics GASTROENTERIC-COLIC
Remedy to provide relief from Gastrocnteric-Colic.
Indications for use: Diarrhea inappetencc, colic (where shock is present, seek immediate veterinary care), flatulence, irritability, dysentery.
- EquioPathics HOOF
Remedy to provide relief from Hoof
Indications for use: Cracked hooves, poor hoof growth, dry hooves, sand cracks, weak white hooves and damage to hooves, eczema, laminitis, arthritis, warts and skin growths, vaccinosis, increases ability to absorb impacts.
- EquioPathics MUSCULO-SKELETAL
Remedy to provide relief from Musculo-Skeletal.
Indications for use: Muscular injury, lameness, sprains, tendon injuries, laminitis, navicular stiffness, pain on movement, arthritic conditions, laminitis (founder), bruised sole and bruising, spavins, splints, curb and windgall.
- EquioPathics NOSE& SINUS
Remedy to provide relief from Nose& Sinus.
Indications for use: Sinusitis, nasal discharge, sneezing, nasal blockage, inflammation of frontal sinuses.
- EquioPathics URINARY DISFUNCTION
Remedy to provide relief from Urinary Disfunction.
Indications for use: Fluid retention, urinary tract infection, jealousy, swelling and puffed up with fluid, suppressed urination due to anxiety and fear.
- EquioPathics TRAVEL ANXIETY
Remedy to provide relief from Travel Anxiety,
Indications for use: Fractious animals, psychosomatic disorders, post-travel scour, hysterical response to being loaded or while being transported, trembling from fear, itching and fidgety feet when boxed for travel, terrified reactions to entering darkness.
- EquioPathics PRE-PERFORMANCE STRESS
Remedy to provide relief from Pre-Performance Stress.
Indications for use: Fractious animals, psychosomatic disorders, teething scour, oversensitive young animals, especially impatient, intolerant whining, restlessness, colicky individuals, highly emotional animals, anxiety with palpitation.
Use of these products by animal owners for the labeled claims could potentially endanger the health of the animal by delaying timely, appropriatetreatment by a licensed veterinary practitioner.
All of the above listed products constitute both drugs as defined under Section 201(g) of the Federal Food, Drug, and Cosmetic Act (the Act) and “new animal drugs” as defined under Section 201(w) of the Act in that they are not generally recognized as being safe and effective for use under the conditions prescribed, recommended or suggested in the labeling, As such these products are considered adulterated under Section 501(a)(5) of the Act.
The above is not intended to be an all inclusive review of all drug products marketed by your firm. It is your responsibility to ensure that all requirements of the Act and requirements of the implementing regulations promulgated thereunder are being met for all your products, Federal agencies are advised of the issuance of all Warning Letters about drugs so that they may take this itiormation into account when considering the award of contracts.
You should take prompt action to correct these deviations. Failure to promptly correct these deviations may result in regulatory action without further notice. This includes seizure and/or injunction.
You should notify this office in writing within fifteen (15) working days of receipt of this letter, of the specific steps you have taken to correct the noted violations. If corrective action cannot be completed within the fifteen working days, state the reason for the delay and the time within which the corrections will be completed. Your reply should be sent to the Food and Drug Administration, 850 3rd Ave, Brooklyn, NY 11232, Attention: Fabio L. Mattiasich, Compliance Officer.
David G. Field
Acting District Director
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