Warning Letter to SupraLife International/Mike Lewis

May 4, 2006

Department of Health and Human Services' logo Department of Health and Human Services

Public Health Service
Food and Drug Administration


200 C St SW
Washington, DC 20204

May 7, 2002

Mike Lewis
SupraLife International
9820 Willow Creek Rd, Ste 450
San Diego, CA 92131

Ref. No. CL-02-HFS-810-20

Dear Mr Lewis:

This is to advise you that the Food and Drug Administration (FDA) has reviewed your website at the Internet address: http://www.supralife.com and has determined that the products “Immu-911™,” “Cell Shield™,” “Flex Flow™,” “Sugar-Eze™,” and “Total Toddy™” 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:

Cell Shield™: “…Breakthrough in the fight against premature aging and degenerative disease.” “Some of them are so potent that clinical trials using therapeutic dosages have actually REVERSED devastating diseases like arthritis, asthma, heart disease and even certain cancers!”

Immu-911™: “Colostrum contains antibodies, immunoglobulins and other immune enhancers, which protect against attack from viruses, bacteria, allergens and other environmental toxins.” “Echinacea has historically been used in the treatment and prevention of infections and has a broad spectrum of effects upon the immune system.” “Pau D’Arco is known for its powerful antibiotic, antiviral killing properties.”

Flex Flow™ and Sugar-Eze™: “Flex Flow has helped decrease my arthritis pain so much…Sugar-Eze helps stabilize Jay’s diabetes or rather his blood glucose reading he feels better when on Sugar-Eze.”

Total Toddy™: “I take about an ounce every morning with my juice at breakfast! I had arthritis in most of my major joints, that was increasing every year, prior to starting using Total Toddy! After a few months, I felt much better…” “In 1997 I had to have surgery for colon cancer. The doctor ordered me to take treatment of Chemotherapy. I took 22 treatments and the doctors and nurses were shocked that I never had to take the shots for low blood count. My blood level was always perfect. I told them of the Total Toddy that I was taking…”

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 US 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 APaeng@CFSAN.FDA.GOV, or you may respond in writing to Andrew H. Paeng, 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 Mr Paeng at 301-436-2375 for Food Safety and Applied Nutrition.

Sincerely yours,
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.