| Public Health Service Food and Drug Administration |
| 5100 Paint Branch Parkway College Park, MD 20740 |
Department of Health and Human Services
SEP 9, 2010
WARNING LETTER
CERTIFIED MAIL
RETURN RECEIPT REQUESTED
Ronald K. Schneider
Enriching Gifts International
915 South Lake
Miles City, MT 59301
Re: CFSAN-OC-10-27
Dear Mr. Schneider:
This is to advise you that the Food and Drug Administration (FDA) reviewed your web site at the Internet address www.enrichinggifts.com and www.enzymesfordigestion.com, an associated site in July 2010 and has determined that the products Plant Enzymes, Sterol Max, Pro Biotic with FOS™, Metabolic Complete™, Heart Algae™, Lightning Colloidal Silver™, and Aloe Ace Max™ are promoted for conditions that cause the products to be drugs under section 201(g)(1)(B) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 321(g)(1)(B)]. The therapeutic claims on these web sites establish that the products are drugs because they are intended for use in the cure, mitigation, treatment, or prevention of disease. The marketing of these products with these claims violates the Act. You may find the Act and the FDA's regulations through links at FDA's home page at http://www.fda.gov
Examples of some of the claims observed on your www.enrichinggifts.com web site include the following:
Plant Enzymes
From the PDF file accessed by clicking on "about plant enzymes" on the web page entitled "enriching gifts international's core product is its exclusive plant enzyme formula":
• "BROMELAIN [ingredient in product] ... • fights arthritis ... • fights cardiovascular problems, such as blood platelet aggregation, phlebitis, varicose ulcers, peripheral venous disease, blood clots, and heart attacks ... • fights viruses and bacteria ... • fights cancer and activates a tumor-fighting substance in the body called tumor necrosis factor (TNF)"
• "The enzyme amylase helps the storage and utilization of sugar in the blood. It has been used to help diabetics ... for over 60 years. Amylase is in Plant Enzymes™.''
• "A digestive enzyme product, like Plant Enzymes™, is recommended by Dr. Anthony Cichoke for treatment of both Type I and Type II diabetes ...."
From the web page entitled "working with A.I.D.S":
• "Enriching Gifts International has now received ... approval ... to import and supply the plant enzymes at a very low cost to people in Nigeria and all of Africa for use against H.I.V. and A.I.D.S."
Sterol-Max
From the PDF file accessed by clicking on "about sterol max" on the web page entitled "enriching gifts international's core product is its exclusive plant enzyme formula":
• "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, BPH, (enlarged prostate) Lupus, Allergies, Psoriasis, MS, Chronic Fatigue Syndrome, Bronchitis, Fibromyalgia, Ankylosing Spondylitis and Hashimoto's Disease."
• "This combination of sterols and sterolins [ingredients in the product] has been shown to have powerful healing effects on cancer, AIDS, tuberculosis ...."
• "Sterols and sterolins [ingredients in the product] have also been proven helpful through extensive research for allergies, allergic rhinitis, asthma, benign prostatic hypertrophy (BPH), cancer, cold virus, fibromyalgia, chronic fatigue syndrome (CFIDS), hepatitis, HIV, AIDS, tuberculosis, and urticaria."
• "The study concluded that Sterol-Max™ would be effective in case of chronic viral infections (like AIDS or herpes), tuberculosis, rheumatoid arthritis, allergies, cancer ..
• "AIDS AND HIV A study of 323 HIV-infected patients, begun in 1993, used the combination of herbs [in the product] in of 323 HIV-infected patients to treat half of the people in the study. The other half was the control group, and did not receive treatment. After six months, the treatment group had no drop in T-cells, whereas the control group did. . .. The difference in the health of the two groups was so dramatic
that the study was stopped, and the control group was given the treatment to decrease their risk of death."
Aloe Ace-Max™
From the PDF file accessed by clicking on "about aloe ace-max" on the web page entitled "enriching gifts international's core product is its exclusive plant enzyme formula":
• "ALOE ACE-MAX™ ... • Reduces inflammation - involved in ulcerative colitis, arthritis, and gastric reflux. . .. • Helps with the reduction of blood sugar with both Type I and Type II diabetes. . .. • Important in preventing and treating arteriosclerosis, heart disease, and Parkinson's disease ... • Direct anti-bacterial and anti-viral effect. .. • Powerful healing effect on AIDS, cancer ... • Causes the body to produce a natural chemical (tumor necrosis factor) that functions to shut off the blood supply to tumors"
• "Cancer Research ... • All of the immune modulating effects from Aloe [ingredient in product] contribute greatly to the prevention and healing of malignant cells. (Ian Tizard, Ph.D. and Maurice Kemp, Ph.D., Texas A&M)"
• "Benefits Lung Cancer ... • Aloe [ingredient in product] was the only of the plant foods that was protective against cancer. "The results of plant epidemiology suggest that aloe prevents human pulmonary carciogenesis (lung cancer)", and aloe is "widely preventive or suppressive against various human cancers." (Japanese Journal of Cancer Research)"
• "AIDS Research ... • In many of the studies [of the ingredient aloe] there was an average of 70% improvement in symptoms and laboratory criteria within 3 to 4 months. (Terry Pulse, M.D., Reg McDaniel, MD., Terry Watson, D.O., Dr. Clumeck). .. • Many patients stated that opportunistic infections had stopped and they were able to return to normal activity.... • Lab studies showed that helper lymphocytes rose to
three times the pre-treatment level. HIV-1 virus could no longer be cultures. P-24 antigen levels for the virus dropped or became negative.... • Researchers discovered that Aloe mucilaginous polysaccharides alter synthesis and thus the structure of the AIDS virus envelope necessary for infecting lymphocytes. (Vanderbilt Medical Center. Nashville, Tennessee)"
• "Eases Intestinal Problems ... • Aloe [ingredient in the product] can be effective for treating inflammatory bowel disease. (Journal of Alternative Medicine) ... • Other studies have shown that aloe helps ... relieve constipation and gastric ulcers." • "Reduces Blood Sugar in Diabetes ...• Aloe [ingredient in the product] reduced the blood sugar levels in diabetes. (Hormone Research) "
Your www.enrichinggifts.com website also contains disease claims in the form of personal testimonials, including:
"I now add the Colloidal Silver throughout the so-called Cold and Flu season, and I haven't been sick in the last 3 years."
Your www.enrichinggifts.com website links directly to www.enzymesfordigestion.com which is operated by Thomas Brewer, Ph.D. On your webpage entitled "about Thomas Brewer, Ph.D.", Dr. Brewer is identified as "a darkfield microscopist, speaker, and consultant with
Enriching Gifts International ...." An online store on the www.enzymesfordigestion.com website can be accessed by clicking on "CLICK HERE TO ACCESS OUR STORE" on the www.enrichinggifts.com website.
Examples of some of the claims observed on the www.enzymesfordigestion.com web site include the following:
Sterol-Max
• "Some of the symptoms and conditions known to respond well to sterol [ingredient in product] supplementations are: Cancer (breast, colon, prostate) Rheumatoid Arthritis ... Hepatitis C ... HIV... BPH (enlarged prostate) Lupus ... Allergies. . . Psoriasis ... MS ... Chronic Fatigue Syndrome ... Bronchitis ... Fibromyalgia. .. Ankylosing Spondylitis ... Hashimoto's Disease."
Pro-Biotic with FOS™
• "Enriching Gifts Pro-Biotics kill parasitic bacteria just like antibiotics. . . . Enriching Gifts Pro-Biotics specialize in destroying anaerobic, i.e. parasitic bacteria. They destroy the' bad' bacteria ...."
• "Key Benefits: ... WARDS off disease by suppressing harmful bacterial growth..."
Metabolic Complete™
• "Metabolic Completes' primary use is for the protection of the body against the development of Cancer and Heart Disease:"
• "Other significant ingredients are: ... Shark Cartilage, proven to be effective against cancer and high in ... analgesic properties."
Heart Algae
• "(Antioxidants [derived from Red Heart Algae, an ingredient in product] have been proven to help deter the collection of plaque on arterial walls along with helping to slow or even prevent the development of arterial blockages.)"
• "Key Benefits: . .. Helps prevent and reduce oxidation and formation of plaque and uric acid that can potentially build up in blood stream ... May significantly reduce your risk of developing Heart Disease and many forms of cancer ... Antioxidants help reduce the risk of acquiring arterial sclerosis (hardening of the arteries)"
Lightning Colloidal Silver™
• "LIGHTNING COLLOIDAL SILVER™ ANTI-BACTERIAL ...."
• "Naturally Anti-Bacterial, Anti-viral, Anti-Germicidal, and Anti-Fungal, Enriching Gifts International's Lightening Colloidal Silver ..."
• "One ounce of Lightning Colloidal Silver contains over nine billion electrically charged positive ions of Pure Silver material which attach to bacteria, virus, fungus and germs in your body and neutralize them."
Aloe Ace-Max™
• "Aloe Vera[ingredient in the product] ... has been proven for thousands of years to be one [sic] the most effective healing agents available for wounds and also when ingested into the body for healing."
• "Aloe Vera [ingredient in product] Benefits: Anesthetic-Relieves itching, swelling and pain ... Anti-Allergenic ... Antibiotic Action ... Anti-Fungal Activity ... Anti-Inflammatory ... Arthritis-Helps reduce Arthritis symptoms by reducing inflammation in joints already afflicted by arthritis Bowel - Detoxifies bowel - Effective for treating inflammatory bowel disease Diabetes-Reduces Blood Sugar level in Diabetics ... Digestive Stimulant-Neutralizes stomach acidity, Relieves constipation and gastric ulcers ... Healing Action-Heals burns, Decreases surgical recovery time, Speeds wound healing ... "
Furthermore, these claims are supplemented by the metatags used to bring consumers to the www.enzymesfordigestion.com website through Internet searches. These metatags include the following:
• Enriching Gifts Pro-Biotics kill parasitic bacteria just like antibiotics, ANTIBACTERIAL, Naturally Anti-Bacterial, Anti-viral, Anti-Germicidal, and Anti-Fungal, anti-bacteriaL, germicidal
Your products are not generally recognized as safe and effective for the above referenced uses and, therefore, the products are "new drugs" under section 201(p) of the Act [21 U.S.C. § 321(p)]. New drugs may not be legally marketed in the U.S. without prior approval from FDA as described in section 505(a) of the Act [21 U.S.C. § 355(a)]. FDA approves a new drug on the basis of scientific data submitted by a drug sponsor to demonstrate that the drug is safe and effective. Your products are also misbranded under section 502(f)(1) of the Act, in that labeling for these drugs fails to bear adequate directions for use [21 U.S.C. § 352(f)(1)].
The above violations are not meant to be an all-inclusive list of deficiencies in your products or their labeling. It is your responsibility to ensure that all of your products are in compliance with the laws and regulations enforced by FDA. You should take prompt action to correct the violations. Failure to promptly correct these violations may result in regulatory actions without further notice. such as seizure and/or injunction.
Please notify this office, in writing, within fifteen (15) working days of the receipt of this letter, as to the specific steps you have taken to correct the violations noted above and to assure that similar violations do not occur. Include any documentation necessary to show that correction has been achieved. If corrective actions cannot be completed within fifteen working days, state the reason for the delay and the time within which the corrections will be completed.
You should direct your written reply to Seyra Hammond, Compliance Officer, Food and Drug Administration, Office of Compliance, Division of Enforcement, Labeling Compliance Team (HFS-608), 5100 Paint Branch Parkway, College Park, Maryland 20740-3835, (301) 436-3064.
Sincerely,
/s/
Jennifer Thomas
Acting Director
Office of Compliance
Center for Food Safety and Applied Nutrition
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