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

Public Health Service
Food and Drug Administration

 

Los Angeles District
19701 Fairchild
Irvine, California 92612-2506
Telephone (949) 608-2900

WARNING LETTER

VIA FEDERAL EXPRESS

January 22, 2004

W/L: 21-04

Raymond J. Francis
President & CEO
University Medical Products USA, Inc.
16912 Von Karman Avenue
Irvine, CA 92606

Dear Mr. Francis:

This letter is in reference to your firm's marketing and distribution of FACE LIFT Collagen 5 products, including Cell Regeneration Cream, Intensive Wrinkle Reducing Cream, and Intensive Lifting Complex; FACE LIFT Daytime Advanced Retinol-A, Nighttime Advanced Retinol-A, Advanced Under Eye Therapy, Vitamin C Anti-Wrinkle Patch, and Overnight Moisturizer; and BODY LIFT Anti-Cellulite Thigh Cream, Weight Reducing Cream, and Anti-Water Retention Lotion. Labeling for these products includes claims that establish their intended use to affect the structure or function of the body, which causes the products to be drugs, as defined in Section 201 (g)(1)(C) of the Federal Food, Drug and Cosmetic Act (the Act).

Objectionable claims that appear on the package labels for the three FACE LIFT Collagen 5 products listed above include the following:

Objectionable claims by product include:

Cell Regeneration Cream

Intensive Wrinkle Reducing Cream

Intensive Lifting Complex

In addition, the product names "Cell Regeneration Cream" and "Intensive Wrinkle Reducing Cream" imply an effect on the structure or function of the body.

Objectionable claims that appear on the package labels for the BODY LIFT products include the following:

Anti-Cellulite Thigh Cream

Weight Reducing Cream

Anti-Water Retention Lotion

In addition, the product names "Weight Reducing Cream" and "Anti-Water Retention Lotion" imply an effect on the structure or function of the body.

Your Internet web site, www.universitymedical.com, also includes claims about the FACE LIFT Collagen 5 products and other products you market that similarly establish the intended use of these products as drugs. Objectionable claims on your website include the following:

FACE LIFT Collagen 5 Products (listed on website as "Collagen 5 for Deep Wrinkles)

Daytime Advanced Retinol-A™ and Nighttime Advanced Retinol-A™

Advanced Under Eye Therapy™

Vitamin C Anti-Wrinkle Patch™

Overnight Moisturizer™

Because these drugs are not generally recognized as safe and effective when used as labeled, they are new drugs under section 201(p) of the Act. A new drug may not be legally marketed in this country without an approved New Drug Application (NDA) [Section 505(a) of the Act].

This letter is not intended to be an all inclusive review of the labeling for all products your firm may market. 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 these violations may result in enforcement action being initiated by the Food and Drug Administration without further notice. The Act provides for the seizure of illegal products and for injunction against the manufacturer and/or distributor of illegal products.

Please notify 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 stated violations, including an explanation of each step being taken to assure that similar violations will not recur. If the
corrective action cannot be completed within 15 working days, state the reason for the delay and the time frame within which the corrections will be implemented.

Your reply should be sent to the Food and Drug Administration, Los Angeles District Office, 19701 Fairchild Street, Irvine, CA 92612. If you have any questions relating to this letter, please contact Barbara Rincon, Compliance Officer at (949) 608-4439.

Sincerely,

/S/

Alonza E. Cruse
Director, Los Angeles District

This page was posted on November 27, 2004.

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