FDA WARNING_LETTER - Enriching Gifts International

The FDA reviewed Enriching Gifts International's websites, www.enrichinggifts.com and www.enzymesfordigestion.com, in July 2010 and determined that products including Plant Enzymes, Sterol Max, Pro Biotic with FOS, Metabolic Complete, Heart Algae, Lightning Colloidal Silver, and Aloe Ace Max are promoted for conditions that classify them as drugs under section 201(g)(1)(B) of the Federal Food, Drug, and Cosmetic Act (the Act). The websites make therapeutic claims for these products, indicating their intent for use in the cure, mitigation, treatment, or prevention of disease, which violates the Act.

Specific examples of claims cited include Plant Enzymes for arthritis, cardiovascular problems, viruses, bacteria, cancer, and diabetes; Sterol-Max for cancer, rheumatoid arthritis, hepatitis C, HIV, BPH, lupus, allergies, psoriasis, MS, chronic fatigue syndrome, bronchitis, fibromyalgia, ankylosing spondylitis, and Hashimoto's Disease; and Aloe Ace-Max for reducing inflammation, blood sugar in diabetes, preventing arteriosclerosis, heart disease, Parkinson's disease, anti-bacterial/viral effects, healing AIDS and cancer, and easing intestinal problems. Testimonials and metatags also contributed to these drug claims.

Because these products are not generally recognized as safe and effective for their promoted uses, they are considered "new drugs" under section 201(p)