Department of Health and Human Services
Public Health Service
College Park, Maryland 20740
NOV 1 2004
RETURN RECEIPT REQUESTED
4 Life Research
9850 South 300 West
Sandy, Utah 84070
Ref. No. CL-04-HFS-810-108
Dear Mr. Lisonbee:
This is to advise you that the Food and Drug Administration (FDA) has reviewed your web site at the
Internet address http://www.my4Iife.com/transferfactorplus and has determined that the products "4Life Transfer Factor GluCoach," "BioGenistein Plus," and "Transfer Factor ReCall" 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 web site 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.
Examples of some of the claims observed on your web site include:
4Life Transfer Factor GluCoach
- "It's an even more important aspect of good health for people afflicted with metabolic and endocrine disorders.
- "[H]elps combat infection-causing inflammation directly linked to metabolic and endocrine disorders"
"Prostate cancer, breast cancer. .. have been found to be ... almost unknown in many Eastern cultures. [S]cientists have found a link-the consumption of soy-rich foods! Soy is rich in several phytoestrogens, including genistein and genistin. . . . BioGenistein Plus contains the soy isoflavones genistein and genistin."
Fibro AMJ System (including Fibro AMJ® Day-time and Night-time Formulas)
"The Fibro AM] System offers complete support for the pains, aches and inflammation associated with fibromyalgia. Since fibromyalgia offers different obstacles at different times of the day, 4Life provides the day and nighttime formulas in the Fibro AM] System."
"Fibro AMJ Day-Time Formula is the most scientifically advanced and complete formula ever developed for the fight against fibromyalgia."
"Fibro AMJ Night-Time Formula is a revolutionary product that works in conjunction with the Fibro AMJ Day-Time Formula in the fight against fibromyalgia."
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 if claims about diagnosis, cure, mitigation, treatment, or prevention of disease 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, 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 C.F.R. 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 trans dermal 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 web site and products your firm markets. It is your responsibility to ensure that all products marketed by your firm comply with the Act and its implementing regulations.
If you need additional information or have questions concerning any products distributed through your web site, please contact FDA. You may reach FDA electronically (e-mail) at Linda.Webb@FDA.GOV, or you may respond in writing to Linda J. Webb, Compliance Officer, Food and Drug Administration, Division of Dietary Supplement Programs, 5100 Paint Branch Parkway, College Park, Maryland 20740-3835. If you have any questions concerning this letter, please contact Ms. Webb at (301) 436-2375.
Susan J. Walker, M.D.,
Division of Dietary Supplement Programs
Office of Nutritional Products, Labeling and Dietary Supplements
Center for Food Safety and Applied Nutrition
This page was posted on November 28, 2004.