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

Public Health Service
Food and Drug Administration

 

Dallas District 4040 N. Central Expressway Dallas, TX 75204-3145

July 24, 2002
WARNING LETTER
VIA CERTIFIED MAIL, RETURN RECEIPT REQUESTED

Mr. Farouk M. Shami
President & CEO,
Farouk Systems, Inc
250 Pennbright
Houston, TX 77090

Ref. No. 2002-DAL-WL-18

Dear Mr Shami:

This letter is in reference to your firm's marketing of the "POWER PLUS" Hair Loss Prevention System and "BIOSILK" Dandruff Control products. A FDA investigator inspected your manufacturing and distribution facility for these products on May 29, May 30 and June 4, 2001. A follow-up inspection was conducted on May 28, 2002.

"POWER PLUS" Hair Loss Prevention System:

During the inspections, the FDA investigator determined that your firm manufactures, promotes, and distributes the hair loss prevention system in kits, made up of shampoos, conditioners, and hair supplements. The ingredients of these products are declared as Stinging Nettle and other herbs, vitamins, and minerals. The products are marketed as a natural non-chemical alternative to chemical hair treatments, in kits intended for normal hair and chemically treated hair. Components of the kits are also marketed separately, and a Root Booster product is marketed separately from the kits and as a component of the "POWER PLUS" Hair-Loss Prevention System.

Labeling of the "POWER PLUS" Hair Loss Prevention System includes a four-fold brochure which makes the following claims:

"POWER PLUS"

Carton labeling for the "POWER PLUS" Hair Loss Prevention System kit intended for normal hair makes the following claims:

"POWER PLUS"

Carton labeling for the "POWER PLUS" Hair Loss Prevention System kit intended for chemically treated hair makes the following claims:

"POWER PLUS"

Container Labeling of the components of the "POWER PLUS" Hair Loss Prevention System makes the following claims:

"POWER PLUS"

"POWER PLUS"

"POWER PLUS"

"POWER PLUS"

"POWER PLUS"

"POWER PLUS"

Additionally, the "POWER PLUS" Hair Loss Prevention System is marketed on your Internet website (http://www.farouk.com) which makes the same claims as those indicated in labeling of kits and components.

Based on the intended uses described above, these products are drugs under section 201(g) of the Federal Food, Drug, and Cosmetic Act (the Act). These drugs are subject to the final rule covering Hair Grower and Hair Loss Prevention Drug Products for Over-the-Counter (OTC) Human Use, Title 21, Code of Federal Regulations (21 CFR), Part 310.527. Under this rule, no ingredients are generally recognized as safe and effective to grow hair or prevent hair loss. Therefore, your "POWER PLUS" products are "new drugs" under section 201(p) of the Act. Under section 505(a) of the Act, a new drug may not be marketed in the US without an approved new drug application (NDA). Additionally, labeling indicates these products are "FDA Approved". This statement is false and misleading in violation of section 502(a) of the Act because no such approval exists for these products.

"BIOSILK" Dandruff Control products:
In addition, the FDA investigator determined that your firm manufactures, promotes, and distributes "BIOSILK" Dandruff Control Shampoo and Dandruff Control Conditioner for the treatment of dandruff as evidenced by the labeling for these products, which establishes their intended use as drugs for the treatment of dandruff. These products are subject to the final rule covering Over-the-Counter Drug Products for the Control of Dandruff, Seborrheic Dermatitis, and Psoriasis, Title 21, Code of Federal Regulations (CFR), Part 358.701. Specifically, neither product bears the required indications, warning statements and directions set forth in 21 CFR 358.750(b), (c) and (d).

Additionally, the Batch Master record for Dandruff Control Conditioner indicates this product is not formulated to contain an active ingredient at a concentration specified under the final rule. Therefore, these products are also "new drugs" under section 201(p) of the Act. Under section 505(a) of the Act, a "new drug" may not be marketed in the United States without an approved NDA.

In addition, all of the drug products mentioned above are misbranded because the labeling for your drug products fails to list active ingredients as required by section 502(e)(l)(A)(ii) of the Act. Furthermore, your drug products are misbranded under section 502(o) of the Act, because they have been manufactured in an establishment that has not been duly registered under section 510 of the Act, and the products have not been listed as required by section 510(j).

The violations cited in this letter are not intended be a statement of all the violations that may exist for products marketed by your firm. It is your responsibility to assure that all your products are in compliance with federal laws and regulations. Failure to promptly correct these violations may result in enforcement action being initiated without further notice. Possible actions include seizure and/or injunction.

The FDA follow-up inspection conducted at your facility on May 28, 2002 found your marketing activities for the above products to be virtually unchanged. You should notify this office in writing, within 15 working days of receipt of this letter, of the specific steps you have taken to correct the noted violations, including an explanation of each step being taken to prevent the recurrence of similar violations. If corrective actions cannot be completed within 15 working days, state the reason for the delay and the time frame within which corrections will be completed. Please direct your response to James R. Lahar, Compliance Officer, at the above address.

Sincerely
/s/
Michael A. Chappell
District Director

This page was posted on May 4, 2006.

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