Maybe Old News - But FDA Letter to Garden Of Life

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Department of Health and Human Services Public Health Service

Food and Drug Administration

 

555 Winderley Pl., Ste. 200

Maitland, FL 32751

 

 

 

 

CERTIFIED MAIL

RETURN RECEIPT REQUESTED

 

WARNING LETTER

 

FLA-04-31

 

May 11, 2004

 

Robert U. Craven, CEO

Garden of Life inc.

5500 North Village Blvd.

Suite 202

West Palm Beach, Florida 33407-1901

 

Dear Mr. Craven:

 

From January 8 to January 23, 2004, the Food and Drug Administration

inspected your firm at 1449 Jupiter Park Drive, Jupiter, Florida.

During this inspection, the investigator collected copies of product

labels, brochures, advertising materials, and other documents. Our

review of these materials finds that your products are in violation

of the Federal Food, Drug, and Cosmetic Act (the Act). You can find

the Act and implementing regulations on our Internet web site at

www.fda.gov.

 

 

Products Labeled as Dietary Supplements

 

 

Under the Act, articles intended for use in the diagnosis, cure,

mitigation, treatment, or prevention of disease in man are drugs

[section 201(g)(1)(B) of the Act]. We have reviewed labeling

(including promotional materials) for a number of your products and

have found the labeling to include disease claims that cause your

products to be drugs as defined in section 201 (g)(1)(B) of the Act.

These claims include:

 

Q-Zyme (OmegaZyme):

 

Brochure:

 

Amylase - " Acts in association with lipase to digest fragments of

viruses and reduce inflammation and infections. "

 

Lactase - " May be beneficial for those suffering from irritable bowel

syndrome.. . . "

 

Papain - " Used to treat chronic diarrhea and celiac disease. Treats

gastrointestinal discomfort due to intestinal parasites. "

 

Poten-Zyme Cat's Claw Extract - " Cat's claw has been used . . . as a

treatment for . . . urinary track infections and arthritis. "

 

The product brochure also contains claims that imply that this

product is useful for the treatment or prevention of numerous

diseases, including colon cancer and arthritis.

 

Primal Defense:

 

Trifold:

 

Testimonial: " this product is the primary therapy I employ on a

routine basis, especially as a treatment for patients suffering from

inflammatory bowel disease. "

 

Testimonial: " I am enthusiastic about Primal Defense as a treatment

for Autism. . . . "

 

" [been shown to drastically reduce populations of yeast, parasites

and bad bacteria in the intestines. "

 

Fungal Defense:

 

Trifold:

 

" Powerful Anti-Candida Formula "

 

" Contains Potent Anti-Yeast and Anti-Fungal Compounds. . . [Certain

conditions can cause fungi to multiply, weakening the immune system

and causing infection. . . Fungal Defense delivers nature's most

effective anti-yeast and anti-fungal compounds to actively help

eliminate Candida from your body.. . .Fungal Defense contains the

most powerful anti-fungal substances found in nature. Wild Oregano

and Olive Leaf Extracts are recognized for their potent anti-fungal,

anti-bacterial, anti-viral, and anti-parasitic properties. "

 

Taken together, statements in this document imply that the product

will treat Attention Deficit Disorder (ADD) and Attention Deficit

Hyperactivity Disorder (ADHD). For example, the section titled, `What

is Candida " states " [yeast overgrowth.. .is especially prevalent in

hyperactive children and those with ADD and ADHD, " and the section

titled, " A Word on Diet " states that " [t]he powerful ingredients in

Fungal Defense are specifically targeted to destroy yeast.. . "

 

Extra Virgin Coconut Oil:

 

Trifold:

 

" Contains Antibacterial, Antiviral, Anti-fungal Properties "

 

" Helps to improve HDL and LDL Cholesterol Ratios "

 

" Coconut oil has been shown to . . . help prevent bacterial, viral

and fungal infections. "

 

Fruits of Life:

 

Product information sheet

 

" Research has shown that rheumatoid arthritis, chronic fatigue and

even certain types of cancer are the direct result of free radical

damage. The destruction of healthy cells may be avoided by simply

adding.. . Fruits of Life to your daily diet. "

 

Raisin: " contain . . . a phytonutrient shown to have cancer-

prevention effects. " " Raisins are a rich sources of polyphenols and

proanthocyanidins, which are recommended in prevention and treatment

protocols for cardiovascular disease, cancer.. . asthma, diabetes,

liver disease, cataracts, and macular degeneration. "

 

Flavonoids: " Flavonoids contain antibacterial and antiviral

properties.. . . " " The flavonoids present in Fruits of

Life . ..strengthen and repair . . . cardiac irregularities arising

from a decrease in blood flow and arterial blockage. "

 

Ellagic Acid: " Ellagic acid helps inhibit four different types of

cancer causing agents.. . " " ellagic acid reduces the incidence of

birth defects, promotes wound healing, reduces and reverses

chemically induced liver fibrosis, and is helpful in the fight

against heart disease. "

 

Lists the following diseases and implies the product is useful in

preventing or treating them: cancer, arteriosclerosis, high blood

pressure, diabetes, arthritis, gout, kidney disease, chronic fatigue,

osteoporosis, asthma, allergies, obesity, and tooth and gum diseases.

 

FYI - For Your Inflammation:

 

Tri-fold:

 

" FYI consists of cartilage building proteins and

mucopolysaccharides.. ., systemic enzymes, and specific whole foods

and herbs . . . . These compounds contain powerful anti-bacterial and

antiviral properties.. "

 

Taken together, claims in this document imply that the product will

treat disease such as arthritis. Examples of these claims include the

following: " Components of FYI have been Clinically Proven to Reduce

Effects of Inflammation; " and " Contains Herbs that may Inhibit the

COX-2 Inflammation process. "

 

Product information sheet

 

Lists the following disease claims and implies the product treats or

prevents them: fibromyalgia, osteoarthritis, rheumatoid arthritis,

bursitis, scleroderma, asthma, allergies, lupus, Chrons' and colitis.

 

Papain - " Papain is valuable as an anti-inflammatory agent as well as

the ability to reduce the tissue irritation and joint inflammation in

rheumatoid arthritis. "

 

Chicken Collagen Type II - " contains anti-inflammatory properties and

has been clinically demonstrated to decrease pain and discomfort

stemming from joint disorders. "

 

Poten-Zyme Cat's Claw Extract - " has been extensively used to treat a

wide range of illnesses including asthma, urinary tract inflammation,

inflammatory bowel disease, arthritis, rheumatism.. .. "

 

RM-10:

 

Trifold:

 

" Potent Anti-Viral, Anti-Bacterial, and Anti-Fungal properties "

 

Testimonial: " It is effective in all degenerative autoimmune

conditions "

 

" Surviving Cancer at 80 "

 

Product catalog

 

Lists the following diseases and implies the product is useful in

treating or preventing them: hepatitis, cancer, diabetes, AIDS,

rheumatoid arthritis, Lupus

 

RevivAlI Classic:

 

Product information sheet

 

" Plant fats (phytosterols and sterolins) have been found to be

effective in balancing immune response and useful in the treatment of

autoimmune diseases like lupus and multiple sclerosis, as well as

infectious diseases such as HIV, tuberculosis, and hepatitis C "

 

" Malignancies: Phytosterols and sterolins may block the development

of tumors in the colon, breast, and prostate glands... "

 

In addition, the book, PATIENT Heal Thyself, references a number of

diseases and states, " make these health supplements to alleviate

symptoms and get well. " For example, your product, Primal Defense, is

promoted for the treatment of autoimmune diseases such as Diabetes

Type I, Grave's Disease, Lupus, Multiple Sclerosis, Myasthenia

Gravis, Rheumatoid Arthritis, and Scleroderma, and " Brain Health "

diseases such as Alzheimer's Disease and Parkinson's. Your product,

Zero Gravity, is promoted for the treatment of obesity and obesity-

related diseases, such as cancer, diabetes, and heart disease. The

book is considered labeling for your products, as it accompanies the

products.

 

 

Based on the claims noted above, these products are drugs under the

Act, since they are intended for use in the diagnosis, cure,

mitigation, treatment or prevention of disease in man [section 201 (g)

(1)(B) of the Act]. Because the products are not generally recognized

as safe and effective when used as labeled, they are also new drugs

as defined in section 201 (p) of the Act. Under section 505 of the

Act, a new drug may not be legally marketed in the United States

without an approved New Drug Application (NDA).

 

 

Under the Act, as amended by the Dietary Supplement Health and

Education Act, dietary supplements may be legally marketed with

claims to affect the structure or function of the body

(structure/function claims), if certain requirements are met. 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)). The manufacturer of a dietary supplement containing

a " structure/function " claim in the product's labeling must have

substantiation that the claim is truthful and not misleading [21

U.S.C. § 343®(6)(B)]

 

Medical Foods

 

 

During the inspection, the investigator also collected copies of

labels for your products labeled as medical foods, RM-10 OM, Primal

Defense OM, Perfect Food OM, and Living Multi OM. These products do

not meet the definition of medical food in 21 USC 360ee(b)(3), which

defines a medical food as a food which is formulated to be consumed

or administered enterally under the supervision of a physician and

which is intended for the specific dietary management of a disease or

condition for which distinctive nutritional requirements, based on

recognized scientific principles, are established by medical

evaluation. The regulations further define a medical food as one that

is intended for the dietary management of a patient who has special

medically determined nutrient requirements, the dietary management of

which cannot be achieved by the modification of the diet alone [21

CFR 101.9(j)(8)(ii)]. Your products RM-10 OM, Primal Defense OM,

Perfect Food OM, and Living Multi OM are not medical foods because

the product labels do not indicate that the products are intended for

the specific dietary management of a disease or conditions for which

distinctive nutritional requirements are established. Further, the

diseases and conditions described in the product labeling do not have

distinctive nutritional requirements and the products do not have any

unique impact on the dietary management of those diseases and

conditions beyond that which could be achieved by modification of the

normal diet alone.

 

Because these products do not meet the definition of a medical food,

they are not subject to the exemption from nutrition labeling

afforded medical foods. Therefore, your products RM-10 OM, Primal

Defense OM, Perfect Food OM, and Living Multi OM are misbranded

within the meaning of section 403(q)(1) of the Act because the labels

do not bear nutrition labeling in the appropriate format as

prescribed in 21 CFR 101.9.

 

In addition, the labeling for the products RM-10 OM and FYI OM bears

claims that indicate they are intended for the diagnosis, cure,

mitigation, treatment, or prevention of disease in man. Examples of

these claims include the following:

 

Original Medicine Wholefood Nutrition brochure:

 

RM-10 OM

 

" RM-10 OM....is known to improve the immunity of patients suffering

from different conditions. An abnormally functioning immune system

exposes you to many conditions such as; AIDS, Cancer, Allergies, M.S,

Fibromyalgia, Diabetes, Syndrome X, Hepatitis, Rheumatoid Arthritis "

 

" Mushrooms and other foods have been used for centuries to defend

against disease. "

 

FYI OM

 

" The following diseases, among others, produce inflammation:

Alzheimers, Artherosclerosis, Cancer, Cardiovascular Disease,

Osteoporosis, Arthritis, Stroke. FYI-OM's blend of foods has shown

moderation of inflammation.. . "

 

 

These claims are evidence that the products are intended for use as

drugs within the meaning of Section 201(g)(1)(B) of the Act. These

products are new drugs under section 201 (p) of the Act because there

is no evidence that these products are generally recognized as safe

and effective for their intended uses. Therefore, they may not be

legally marketed in the United States without approved new drug

applications (section 505 of the Act).

 

The above violations are not meant to be an all-inclusive list of

deficiencies in your products and their labeling. It is your

responsibility to ensure that products marketed by your firm and all

labeling for such products comply with the Act and its implementing

regulations. Labeling may include your websites

www.gardenoflifeusa.com and www.silverspringsupplements.com , flyers,

trifolds, product catalogs, books promoting your products, compact

disks, training materials, and other sources.

 

The Act authorizes the seizure of illegal products and injunctions

against manufacturers and distributors of those products. You should

take prompt action to correct these deviations and prevent their

future recurrence. Failure to do so may result in enforcement action

without further notice.

 

Please advise this office, in writing within fifteen (15) working

days of the receipt of this letter, as to the specific steps you have

taken to correct the violations noted above and to assure that

similar violations do not occur. If corrective actions cannot be

completed within fifteen working days, state the reason for the delay

and the time within which the corrections will be completed.

 

We note that in your January 30, 2004 letter to Ms. Susan Corrales,

you indicated that the medical food products are no longer being

sold; however, they are still shown on your Internet web site. In

addition, your letter states that the product materials are being

revised and that the book PATIENT Heal Thyself will no longer be made

available. Please provide the final version of any product brochures

or accompanying materials that will be used.

 

Your reply should be addressed to Shari H. Shambaugh, Compliance

Officer, U.S. Food and Drug Administration, 555 Winderley Place,

Suite 200, Maitland, Florida 32751.

 

 

Sincerely,

 

/s/

Emma R. Singleton, Florida District

 

 

 

 

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