Department of Health and Human Services' logo Department of Health and Human Services

Public Health Service
Food and Drug Administration
New Orleans District
Nashville Branch

 

297 Plus Park Blvd
Nashville, TN 37217

May 12, 2000
WARNING LETTER
VIA CERTIFIED MAIL, RETURN RECEIPT REQUESTED

Mr. Donald Lowery
Health Resources
130-132 Pine Crest Rd
Hueytown, AL 35023-1321

Ref. No. 00-NSV-17

Dear Mr Lowery:

This letter is in reference to your firm's marketing and distribution of various Health Resources products. Labeling for these products contains therapeutic claims which cause the products to be drugs [section 201(g) of the Federal Food Drug, and Cosmetic Act (the Act)]. Labeling is not limited to the immediate product containers but includes Internet web sites, all promotional literature and audiotapes which you distribute in connection with your products. Objectionable products and claims include the following:

bCalm’d™
high blood pressure, ulcers, migraine, strokes, alcoholism, heart disease, cancer; drug and alcohol rehab, "A safe natural alternative to drugs," Ritalin Attention Deficit Disorder, ADHD, depression, "works as well as … Ritalin." obesity, anxiety, panic attacks, and alcohol addiction, drug abuse, learning disability.
Earthwise
antibiotic, broad spectrum germ fighter and disinfectant, flu, fevers, herpes, hepatitis, Epstein Barr, bronchitis, pneumonia, yeast or vaginal infections, external infections such as? eyes? ears~ sore throat, dental abscesses, nasal or sinus, poison oak, rashes, burns, cuts, bites, fungus, parasites, viruses, comparisons to prescription antibiotics, growth stimulation of the tissues in a wound.
AloeGold
sunburn and frostbite relief, anti-inflammatory, antiviral, anti-fungal; X-ray burns, antibacterial, wound healing, "promote only healthy cell growth; if a cell is cancerous, growth is not stimulated," cancer, AIDS, malignant liver tumors, Kaposi's Sarcoma leukemia, diphtheria, Candida, Epstein-Barr, Herpes, malignant brain tumor.
Para 90
parasites, hookworm, roundworm, pinworm, protozoa (amoebas, giardia), nematode, cestode (tapeworms), trematode (flukes), bacteria, diarrhea, irritable bowel syndrome, joint and muscle aches and pains, sleep disturbances, teeth grinding, chronic fatigue, skin problems, hypoglycemia, arthritis ache, obesity, depression, depress immune system function, nutrient malabsorption.
Maxi-Chel
heart disease, arthritis diabetes, Parkinson's, Alzheimer's, porphyria, scleroderma, Peyronie's disease, remove abnormal calcium deposits, [remove] mercury, and lead, blood vessel disease, heart-related death, cleans plaque from arteries and veins, regulate cholesterol, all types of aches and pains, normalizes blood pressure, increases resistance to infection, removes toxicity by removing metallic ions that cause degenerative diseases, [prevent] by-pass surgery, clogged coronary arteries.
Enhance Plus
all types of aches and pains, arthritis~ normalizes blood pressure, increases resistance to infection.
SuperBP
for blood pressure, normalizing blood pressure, high blood pressure.
Triomin
heavy metal poisoning, cancer of breast, colon, lung and prostate, osteoporosis [prevented or treated by Boron], arthritis, aches and pains, anxiety~ chronic pain, cataracts, learning handicap with trouble focusing.
Perform
increases resistance to disease, relieve high blood pressure, relieve congestion, erectile dysfunction.
Composure
cardiovascular disease, digestive diseases (ulcers, ulcerative colitis), mental disorders, injury, nervous system and sensory-organ disease, musculoskeletal disease, cancer, endocrine and metabolic disease, skin disorders, and infectious ailments, [reduced immunity due to reduced] efficacy of your T cells, [help produce] the T cells that fight disease, development and control of allergies, high blood cholesterol.
Just Carrots
degenerative disease, tumor growth, neuroblastoma, cancer, chronic diseases, breast cancer, eliminate carcinogenic, prostate cancer, heart disease.
Herbal Fiberblend
lowered cholesterol, diverticulitis, colon cancer, appendicitis~ heart attacks, cancer, diabetes, death, colon cancer, hiatal hernia, varicose veins, diabetes, obesity, diarrhea, cold, flu, pneumonia bladder infections, thyroid dysfunction, hemorrhoids, lesions on the tongue, easy bruising, nose bleeds, Candida, congestive heart failure, colitis, parasites.

These products are "new drugs" [section 201(p) of the Act]. Therefore, they may not be legally marketed in this country without approved New Drug Applications [section 505(a) of the Act].

These drugs are also misbranded because their labeling fails to bear adequate directions for the conditions for which they are offered [section 502(f)(1) of the Act] and their labeling is false and misleading because it suggests that these products are safe and effective for their intended use, when in fact, this has not been established [section 502(a) of the Act].

Further, labeling for Earthwise includes statements that FDA allows colloidal silver to be marketed as an antibiotic because it is a pre-1938 drug and is "grandfathered" and that FDA has no jurisdiction over a mineral element. These statements are incorrect. FDA published a Final Rule on Over-the-counter (OTC) Drug Products Containing Silver Salts on August 17, 1999. This rule includes a finding that OTC colloidal silver drug products do not qualify for the grandfather exemption and that they are new drugs. In addition, FDA has jurisdiction over any product that meets the definition of a drug including mineral elements.

This letter is not intended to be an all inclusive review of all labeling and products your firm may market. It is your responsibility to ensure that all products marketed by your firm are in compliance with the Act and its implementing regulations. Federal agencies are advised on the issuance of all Warning Letters about drugs and devices so that they may take this information into account when considering the award of contracts.

In addition, we are aware that your catalog includes therapeutic claims for additional products and that your firm's Internet web site includes therapeutic claims for these and additional products. Such claims may also cause your products to be misbranded drugs.

We request that you take prompt action to correct these violations. Failure to promptly correct these violations may result in enforcement action being initiated by the Food and Drug Administration without further notice. The Federal Food, Drug, and Cosmetic Act provides for the seizure of illegal products and for injunction against the manufacturer and/or distributor of illegal products.

Please notify this office in writing within fifteen (15) working days of receipt of this letter as to the specific steps you have taken to correct the stated violations, including an explanation of each step being taken to identify and make corrections to assure that similar violations will not recur. If corrective action cannot be completed within fifteen (15) working days, state the reason for the delay and the time within which the corrections will be implemented.

Your reply should be sent to the attention of Joseph E. Hayes, Compliance Officer, Food and Drug Administration, 297 Plus Park Blvd, Nashville, TN 37217.

Sincerely,
/s/
Carl E. Draper
District Director

This page was posted on August 20, 2006.

Links to Recommended Companies