Natural Remedies For Your Prostate Health

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The following is a letter sent to 4life:

NOV 1 2004

CERTIFIED MAIL
RETURN RECEIPT REQUESTED
David Lisonbee
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”
BioGenistein Plus
“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 ociated 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.

Read the rest at the link below:

www.casewatch.org/fdawarning/prod/2004/4life.shtml

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