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

Public Health Service
Food and Drug Administration
Los Angeles District Office

 

19900 MacArthur Blvd #300
Irvine, CA 92612-2445
Telephone: 949-798-7600

February 10, 1998
WARNING LETTER
VIA CERTIFIED MAIL, RETURN RECEIPT REQUESTED

Real Health Laboratories
2121 El Cajon Blvd
San Diego, CA 92104-1101

Ref. No. W/L 17-8

Dear Dr Gilette:

This letter is in reference to your firm's marketing, and distribution of your product "The Prostate Supplement".

Labeling for the product (promotional materials) contains drug claims for the treatment and prevention of Benign Prostatic Hypertrophy (BPH). These claims include "prostate dysfimction", "the prevention of BPH and relief of its symptoms," "antiproliferative effect on prostate cancer cells", "reductions in prostate size and symptoms of BPH", and "certain natural ingredients can produce results similar to the leading prostate drugs". Claims associated with symptoms of BPH such as "the constant need to urinate, day or night; difficulty in starting or restricting urination; inability to fully empty bladder; inability to urinate; weak urine stream; incontinence; pain while urinating; painful ejaculation" are also made.

A Federal Register notice dated February 27, 1990, titled "Benign Prostatic Hypertrophy Drug Products for Over-the-Counter Human Use" established that no drug product offered for over-the counter (OTC) human use for Benign Prostatic Hypertrophy is generally recognized as safe and effective and therefore, the product would be misbranded.

"The Prostate Supplement" is a drug [section 201(g) of the Federal Food, Drug, and Cosmetic Act (the Act)] and a "new drug" [section 201(p) of the Act]. This product may not be marketed in the United States without an approved new drug application [section 505(a) of the Act].

This drug is also misbranded [section 502(f)(1) of the Act] because the labeling fails to bear adequate directions for use and because the labeling is false and misleading as it suggests that the product is safe and effective for its intended use when, in fact, this has not been established [section 502(a) of the Act].

This letter is not intended to be an all inclusive review of all labeling and products your firm markets. It is your responsibility to ensure that all products marketed by your firm are in compliance with the Act and its implementing regulations.

We request that you take prompt action to correct these violations. Failure to promptly correct violations may result in etiorcement action being initiated by the Food and Drug Administration without further notice. The Federal Food, Drug and Cosmetic Act provides for the seizure of illegal products and for injunction against the manufacturer and/or distributor of illegal products. Your promotional material claims that the product "is mardactured in the United States in a licensed pharmaceutical facility to the exacting standards of the US Food and Drug Administration (FDA)." Involving the name "FDA" implies approval of the product or its manufacture when, in fact, this is not the case.

Please notify this office in writing within fifteen (15) working days of receipt of this letter as to the specific steps you have taken to correct the stated violations. You should also include an explanation of each step being taken to identify and make corrections to assure that similar violations will not recur. If corrective action cannot be completed within 15 working days, state the reason for the delay and the time within which the corrections will be implemented.

Your reply should be sent to:

John A. Nicholson, Investigator
US Food and Drug Administration
Phoenix Resident Post
4615 E Elwood St #200
Phoenix, AZ 85040

Sincerely yours,
/s/
Elaine C. Messa
District Director

This page was posted on August 20, 2006.

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