Warning Letter to Ophthalmic International 1989

Department of Health and Human Services

Public Health Service
Food and Drug Administration

Los Angeles District
1821 West Pico Boulevard
Los Angeles, California 90015-2486
Telephone (714) 798-7600

LA 28-9

SECTION

403(a) (1) and 201(n)
21 CPR 101.9(1)(1)

BRIEF DESCRIPTION

In that the labeling falsely represents, suggests or implies that these foods are adequate or effective In the prevention, cure, mitigation or treatment of the labeled conditions such as:

Green Magma – 

“necessary to activate “immune system cells” (leaflet GPC7) “energizes” (pamphlet Drink Your Salad) “eliminating body diseases, increasing energy, reducing age”; “eliminated constipation, acne, pancreatitis, high blood pressure, diabetes, gastritis, liver disorders, asthma, menstrual cramps, hemorrhoids”; “prevented carcinogenic substances” (reprint Whole Life Times) “detoxify cellular tissue and slow down “cellular oxidation (aging)”; used as a medicine for reducing overweight conditions or for dissolving Intestinal or liver hardenings; “for reversing the development of tumors and other swellings”; “reduced appetite”; “less fatigue”; “less need for sleep (Reprint East West Journal).

Sodex –

“to act as a deterent to DNA damage, radiation, poisoning, and the aging process” (reprint Whole Life Times) “Incredible healing effect”; “anti-aging agent; “a cell protector and may slow down the aging process”; “lessens the effects of radiation”; “acts as an anti-inflammatory compound”; “May prevent the Irreversibility of cell damage following a heart attack” (reprint East West Journal)

In that the labeling falsely represents, suggests or implies these foods have nutritional properties when such properties are of no significant value or need In human nutrition such as:

Green Magma –

“health food” (label and package) “maximize potency”; “more complete food”; “40-60′ light weight protein”; “highest potassium of most vegetables”; “highest chlorophyll of grasses”; “high in carotene” (leaflet GPC 7) “balanced vegetable nutrition”; “energizes”; “nutritional food”’; “the highest quality naturally potent and balanced green food available to human kind today”; maximum amount of nutritional essence”; “protects the enzymes, proteins, vitamins and other active nutrients”; “high content of chlorophyll”; “Vitamins: 25 different natural vitamins, Including beta carotene (A), B complex family, C, and many others. Minerals: Potassium, calcium., phosphorus, iron, magnesium, manganese, zinc, copper and many trace elements. Amino Acids: 19 different amino acids including all 8 essential amino acids.” (pamphlet Drink Your Salad!)

“highly balanced In protein, mineral, vitamin xx content”; “three times more vitamin C than oranges, ten times more calcium than cow’s milk, five times more iron than spinach, two times the amount of copper, selenium and manganese than nutritional yeast” (reprint Whole Life Times).

“Most balanced concentration of vitamins, minerals, proteins”; “best source of these nutrients”; “high concentrations of magnesium and iron”; “four times. the vitamin B in whole wheat flour” (East West Journal).

Sodex –

“2000 units per 4 tablets; each tablet contains Superoxide Dismutase 500 mite Catalase. 125 units (label and pkg.); “help In digesting and absorbing other nutrients” (East West Journal).

SECTION

402(a)(2)(C)

BRIEF DESCRIPTION

The product, Sodex, containing Superoxide Dismutase, is adulterated within the meaning of section 402(a)(2)(C) in that it is a food additive which is unsafe within the meaning of section 409 (a), since its use and Intended use is not In conformity with a regulation or exemption in effect pursuant to section 409.