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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:

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(r)(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:

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
Director, Florida District

This page was posted on November 21, 2004.

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