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

Public Health Service
Food and Drug Administration

 


College Park, MD

JULY 19, 2005

CERTIFIED MAIL
RETURN RECEIPT REQUESTED

Donald Lapre
President/CEO
Torica Productions, Inc.
14809 S 25TH Way.
Phoenix, AZ 85048

Ref. No. CL-05-HFS-810-169

Dear Mr. Lapre:

This is to advise you that the Food and Drug Administration (FDA) has reviewed your web
sites at the following Internet addresses http://www.greatestvitaminintheworld.com and
http://www.thegreatestvitaminintheworld.com and has determined that the product The
Greatest Vitamin in the World is promoted for conditions that cause this product to be a drug
under section 201(g)(1) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C.
§ 321(g)(1)]. The therapeutic claims on your web site establish that this product is a drug
because it is intended for use in the cure, mitigation, treatment, or prevention of disease. The
marketing of the product with these claims violates the Act. Examples of some of the claims
observed on your web sites include:

Blood Sugar Diabetes

“If you have diabetes, please monitor your glucose requirements closely to see what reduction
you have after taking these vitamins. The results may shock you. There are many other
ingredients included in this vitamin supplement that are known to assist the body in areas
which help assist in blood glucose levels."

"If you or someone you know has diabetes or at risk of getting diabetes, spread the word and
make sure they understand the critical importance of protecting their body from this deadly
disease. [N]utritionally support the body with the best absorbed form of nutrients available
with The Greatest Vitamin in The World.”

Stroke

“The Greatest Vitamin in the World only contains these nutrients in the forms proven to
effectively reduce the risk for heart disease and lower cholesterol levels. Additionally, the
nutrients contained in this formula are the most bioavailable forms on the market,…ensuring
that your risk for heart disease and your cholesterol levels are lowered."

Heart Disease Cholesterol

"The Greatest Vitamin in the World only contains these nutrients in the forms proven to
effectively reduce the risk for heart disease and lower cholesterol levels. Additionally, the
nutrients contained in this formula are the most bioavailable forms on the market, … therefore
lowering your risk for heart disease and high cholesterol."

Sleep

“Habitual sleeplessness is classified as insomnia. A sleep disorder known as sleep apnea
affects about 20 million more Americans…. When sleep deprivation robs the body of
nutrients, serious deterioration in performance and the onset of disease ensues….
Supplementation of Magnesium, Zinc, and vitamin B[, ingredients in the product,]
nutritionally help the body to have deeper and more restful sleep. In addition, garlic[, an
ingredient in the product,] has been shown to improve serotonin levels, which are involved in
the regulation of sleep.”

Probiotics

“[Probiotics, an ingredient in the product,] promote health by secreting … antibiotic-like
substances…. These substances… have a wide range of activity against bad bacterial strains
of salmonella, pseudomonas, E. Coli, and other food-borne bacteria."
"As friendly bacteria in the bowel are depleted, the body is subject to numerous diseases,
including colitis, diabetes, meningitis, rheumatoid arthritis, thyroid disease and even bowel
cancer. A deficiency in friendly bacteria can bring on a host of additional problems associated
with bowel toxicity…. What is the answer then, if our lifestyles and environmental factors
are taking away from our supply of friendly bacteria? The Greatest Vitamin in the World
provides a constant supply."

Depression

"Certain nutrients can also greatly benefit those suffering from depression, such as B vitamins
[, an ingredient in the product,] which are the most potent anti-stress vitamin and necessary
for the normal functioning of the brain and nervous system. Folic acid[, an ingredient in the
product,] is particularly found to be deficient in those suffering from depression. Vitamin C [,
an ingredient in the product,] … also aids in preventing depression. Garlic [, an ingredient in
the product,] … maintains balance in the brain, preventing depression.
“The vitamins and minerals contained in The Greatest Vitamin in the World are the highest
quality nutrients found on the market….When taken along with a healthy diet, the symptoms
and triggers of depression will be dramatically reduced.”

Cancer

“Cancer is a terrible disease that many of us are at risk for. The Greatest Vitamin in the World
works to help lower that risk by providing you with 100% of the daily needs of all essential
nutrients along with some of the most researched cancer prevention nutrients known.”

Kidney/Liver

“When toxins build up in the system, the liver and kidneys are unable to function optimally
and the body begins to store toxins in the tissues. As the toxins build up, common symptoms
occur, such as…insomnia, depression, …allergies, …and over time may even lead to chronic
illnesses like cancer, arthritis and Alzheimer’s disease. The Greatest Vitamin in the World
contains several different valuable nutrients, such as milk thistle, which aids in removing
toxins from the body.”

Men’s Health

“It is well established that men have a greater problem with degeneration of discs and joints
due to heavy use. Please be sure to read our section on arthritis/joint pain to see how the
Greatest Vitamin in the World will help you deal with this prevalent issue.”

Arthritis Joint Pain

“Glucosamine[, an ingredient in the product,] works to stimulate joint …repair. It is most
effective in treating osteoarthritis, the most prevalent form of arthritis….

"Both short and long term studies have been performed with a nutrient called Glucosamine
Sulfate. Glucosamine works to stimulate joint … repair. It is most effective in treating
osteoarthritis, the most prevalent form of arthritis. A number of studies over the last 20 years
have shown this to be true. For example, a 1982 clinical study compared usage of the NSAID
ibuprofen with glucosamine sulfate, for osteoarthritis of the knee. The overall results showed
that 44% of the glucosamine group had pain relief compared to 15% for ibuprofen.

A long-term effects study was done with glucosamine and arthritis reported in the Lancet.
The authors concluded that, 'Glucosamine sulfate prevents the progression of osteoarthritis of
the knee, in addition to relieving the symptoms.'
Studies have also been done on discs with Chelated magnesium and new research has shown
promising benefits with essential fatty acids.

The Greatest Vitamin in the World not only contains all of these nutrients, it utilizes the exact
forms that were shown in the studies to be effective."

Furthermore, your product is not generally recognized as safe and effective for the above
referenced conditions and therefore, the product is also a “new drug” 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 new drugs on the basis of scientific data submitted by a drug sponsor to demonstrate
that the drugs are 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 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 requirements 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 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 C.F.R.) 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
Kenneth.Taylor@CFSAN.FDA.GOV, or you may respond in writing to Kenneth M. P.
Taylor, Ph.D., Chemist, 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 Dr. Taylor at (301) 436-1439.

Sincerely,

/s/

Susan J. Walker, M.D.
Director
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 October 3, 2005.

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