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FDA Issues Warning to Enriching Gifts
September 28, 2010
2 Min Read
MILES CITY, Mont.Enriching Gifts International received a not-so-welcome gift from FDA in early September in the form of a warning letter, notifying the company that the agency had serious concerns with the marketing of several of its dietary supplement products. FDAs Sept. 8 warning letter noted it had reviewed the companys websites and determined the way several products are promoted positions them as drugs, as they appear to be positioned to cure, mitigate, treat or prevent diseases. Specific products were promoted in marketing files on the Enriching Gifts website, and on the on the EnzymesForDigestion.com website, an online store affiliated with the company, using claims including:
Plant Enzymes: "treatment of both Type I and Type II diabetes," "fights cardiovascular problems," "fights cancer," and "for use against H.I.V. and A.I.D.S."
Sterol Max: "has been shown to have powerful healing effects on cancer, AIDS, tuberculosis" and "Some of the symptoms known to respond well to sterol [ingredient in the product] supplementations are: Cancer (breast, colon, prostate), Rheumatoid Arthritis, Hepatitis C, HIV"
Aloe Ace-Max: "important in preventing and treating arteriosclerosis, heart disease and Parkinsons disease," "direct anti-bacterial and anti-viral effect," and "powerful healing effect on AIDS, cancer."
Pro Biotic with FOS: "kill parasitic bacteria just like antibiotics."
Metabolic Complete: "protection of the body against the development of cancer and heart disease."
Heart Algae: "may significantly reduce your risk of developing heart disease and many forms of cancer."
Lightning Colloidal Silver: "naturally anti-bacterial, anti-viral, anti-germicidal and anti-fungal."
As the products have not been recognized as safe and effective for the prevention and treatment of diseases, they are therefore positioned as "new drugs" in the eyes of FDA, which may not be marketed without prior agency approval. FDAs warning letter noted the items are also misbranded, as the labeling fails to bear adequate directions for use.
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