Department of Health and Human Services
Public Health Service
5100 Paint Branch Parkway
August 1, 2002
VIA CERTIFIED MAIL, RETURN RECEIPT REQUESTED
5380 W. 34th St, #228
Houston, TX 77092
Ref. No. CL-02-HFS-810-30
Dear Ms Miller:
This is to advise you that the Food and Drug Administration (FDA) has reviewed your website at the Internet address: http://www.behealthy.com and has determined that the products “Bioumune OSF Plus,” “Km by Matol Botanical International,” “Bovine Colostrum,” and “Olive Leaf Extract” being offered are promoted for conditions that cause the products to be drugs under section 201(g)(1) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 USC 321(g)(1)]. The therapeutic claims on your website establish that the products are drugs because they are intended for use in the cure, mitigation, treatment, or prevention of disease. The continued marketing of these products with these claims violates the Act and may subject you or the products to regulatory action without further notice.
Examples of some of the claims observed on your website include:
Bioumune OSF Plus claim located at “products” link: “If You or anyone you know has the following health issues…check this out NOW! AIDS, Allergy Conditions, CFIDS-Severe, Appendix Adenocarcinoma, Arthritis, Auto Immune Disorders, Basal Cell Carcinoma, Bursitis, Cancer-Breast-Bladder-Cervical, etc., Carcinoma, Chronic Infection, Colds and Flu, Colitis, Colon Cancer, Diabetes, Ductal Carcinoma … Fibromyalgia, Gout, Hepatitis C, Herpes Stomatitis-Severe, High Cholesterol, Hypoglycemia, … Leukemia-Lymphocytic-B cell, Lung Cancer, Lupus, Lyme Disease, Lymphoma, Mononeucleosis [sic]-Acute, Multiple Sclerosis, Myelodysplasia, … Osteoporosis, Ovarian Cancer, Pneumonia, Prostate Cancer, Psoriasis, Schleroderma [sic], Sinus and Coughing, Sinusitis, Sore Throat, Staph, Thyroiditis, Tumors, Biomune OSF Express (used for Sinus, Sore Throat, Ears … GREAT FOR CHILDREN, etc.)”
Km by Matol Botanical International claim located at “product” link: “If You or anyone you know has the following health issues… Check this out NOW! Allergy Conditions-Severe, Arthritis, Bursitis, Candida, Chronic Fatigue, Colitis, Diabetes … Gout, High Blood Pressure, High Cholesterol, Hypoglycemia, Lupus, Lyme Disease, Psoriasis, Sinus and Coughing, Sinusitis, Thyroiditis.”
Bovine Colostrum claim located at “products” link: “Success Stories of Colostrum have been seen in the following conditions: allergy conditions, sinus and coughing, bursitis, high cholesterol, after surgery, after accidents, colds and flu, auto-immune disorders, multiple sclerosis, asthma, cuts, hypoglycemia, tumors, diabetes, hemorrhaging, arthritis, rheumatoid arthritis, osteoporosis, burns, gingivitis … balance and regulate blood sugar, irregular bowel, chronic fatigue, scleroderma, … epstein barr virus, depression.”
“‘I have been in a research program for Osteoporsis [sic] and put on medication. The side effect from the pain medication caused sever [sic] stomack [sic] problems and swelling of the hands. After taking 3 Colostrum per day for two days, the next morning my hands were not swollen and the pain was gone.'”
Olive Leaf Extract (claim located at “products” link): “A Natural Approach to: Viruses — Epstein-Barr, HIV, etc., Yeast — Candidiosis [sic], Fungi, Cholesterol Problems, Chronic Fatigue Syndrome,Colds & Flu, Cold Sores, Diabetes, E. Coli, Ear Infections, Eczema, Epstein-Barr, Fibromyalgia, Parasites and Worms, Common Cold and Flu, Vital Infections, Bacterial Infections, Arthritis, Skin Disease, Heart Problems, High Blood Pressure, Hardening of Arteries, Herpes, Hiatal Hernias, High Cholesterol, Hypertension, Gulf War Syndrome, Parasites, Pneumonia, Psoriasis, Rabies, Rheumatoid Arthritis, Roundworm, Rubella, Hepatitis, Salmonella, Skin Conditions and Diseases, Staphylococcus, Streptococcus, Ulcers, Yeast Infections.”
Furthermore, FDA has no information that your products are generally recognized as safe and effective for the above referenced conditions and therefore, the products may also be “new drugs” under section 201(p) of the Act [21 USC 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 USC 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.
FDA is aware that Internet distributors may not know that the products they offer are regulated as drugs or that these drugs are not in compliance with the law. Many of these products may be legally marketed as dietary supplements or as cosmetics if therapeutic claims are removed from the promotional materials and the products otherwise comply with all applicable provisions of the Act and FDA regulations.
Under the Act, as amended by the Dietary Supplement Health and Education Act (DSHEA), dietary supplements may be legally marketed with truthful and non-misleading claims to affect the structure or function of the body (structure/function claims), if certain conditions are met. However, claims that dietary supplements are intended to prevent, diagnose, mitigate, treat, or cure disease (disease claims), excepting health claims authorized for use by FDA, cause the products to be drugs. The intended use of a product may be established through product labels and labeling, catalogs, brochures, audio and videotapes, Internet sites, or other circumstances surrounding the distribution of the product. FDA has published a final rule intended to clarify the distinction between structure/function claims and disease claims. This document is available on the Internet at http://vm.cfsan.fda.gov/~lrd/fr000106.html (codified at 21 CFR 101.93(g)).
In addition, only products that are intended for ingestion may be lawfully marketed as dietary supplements. Topical products and products intended to enter into the body directly through the skin or mucosal tissues, such as transdermal or sublingual products, are not dietary supplements. For these products, both disease and structure/function claims may cause them to be new drugs.
Certain over-the-counter drugs are not new drugs and may be legally marketed without prior approval from FDA. Additional information is available in Title 21 of the Code of Federal Regulations (21 CFR) Parts 310 and 330-358, which contain FDA’s regulations on over-the-counter drugs.
This letter is not intended to be an all-inclusive review of your website 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.
If you need additional information or have questions concerning any products distributed through your website, please contact FDA. You may reach FDA electronically (e-mail) at APope@CFSAN.FDA.GOV, or you may respond in writing to Angela F. Pope, Compliance Officer, Food and Drug Administration, Division of Compliance and Enforcement, 5100 Paint Branch Pkwy, College Park, MD 20740-3835. If you have any questions concerning any issue in this letter, please contact Ms Pope at 301-436-2375.
John B. Foret
Division of Compliance and Enforcement
Office of Nutritional Products, Labeling and Dietary Supplements
Center for Food Safety and Applied Nutrition
This page was posted on May 4, 2006.