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

Public Health Service
Food and Drug Administration

 

Minneapolis District Office
Central Region
212 Third Avenue South
Minneapolis, MN 55401
7etephone: (612) 758-7132
FAX: (612) 334-4142


February 15, 2007

WARNING LETTER

Refer to MIN-07-12

CERTIFIED MAIL
RETURN RECEIPT REOUESTED

Steve Basta
President and Chief Executive Officer
BioForm Medical, Inc.
1875 South Grant Street, Suite # 110
San Mateo, California 94402

Dear Mr. Basta:

The Food and Drug Administration (FDA). conducted an inspection of your facility at 4133 Courtney Road, Suite 10, Franksville,WI, from October 2-18, 2006. During that inspection, the investigator collected labels and product inserts for your Cutanix Dramatic Relief for Oily and Acne Prone Skin, Cutanix Dramatic Relief for Normal to.Dry Skin, Cutanix Dramatic Relief for Sensitive Skin, and Cutanix Dramatic Relief Extra Strength products. In addition, the FDA reviewed your web sites at www.bioformmedical.com, wwwtvdepot.com/getridoflhered/ and www.cutttnix.com.

The review of this labeling found the products being offered are promoted for conditio.ns that-cause..them to be drugs under sections 201(g)(1)(B) and 201(g)(1)(C) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. 321(g)(1)(B) and 321(g)(1)(C)]. Claims in your labeling, including your web sites, establish that these products are drugs because they are intended for use in the cure, mitigation, treatment, or prevention of disease and are intended to affect the structure or function of the body. You can find the Act and FDA's regulations through links on FDA's Internet home page, http://www.fda.gov.

Examples of some of the claims observed for these products include:

Claims on the boxes for each of your Cutanix products:

Claims on the Cutanix Dramatic Relief for Oily and Acne Prone Skin box:

Claims on the Cutanix Dramatic Relief for Normal To Dry Skin box:

Claims on the Cutanix Dramatic Relief for Sensitive Skin box

Claims on the Cutariix Dramatic Relief Extra Strength box"

Additional claims on the package insert that accompanies each of your Cutanix products:

"[S]oothing, healing effect on dry, inflamed skin."

Additional claims observed on your web sites www.tvdepot.com and www.cutanix.com (which automatically sends visitors to your www.tvdepot.com web site):

These claims on your product labeling cause your products to be drugs, as defined in sections 201(g)(1)(B) and 201(g)(1)(C) of the Act [21 U.S.C. 321(g)(1)(B) and 321(g)(1)(C)]. Because these drugs 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 [21 U.S.C. 321(p)]. Under section 505(a) of the Act [21 U.S.C. 355(a)], a new drug may not be legally marketed in the United States without an approved New Drug Application (NDA). FDA approves a new drug on the basis of scientific data submitted by a drug sponsor to demonstrate that the drug is safe and effective.

This letter is not intended, to be an all-inclusive review of deficiencies in your products and their labeling, including any brochures that accompany the products. You are responsible for ensuring that products marketed by your firm are in compliance with the Act and its implementing regulations

We may take further action without notice if you do not promptly correct these violations. For instance, we may take further action to seize your products and/or enjoin your firm from operating.

Please notify this office in writing within 15 working days of receipt of this letter of the specific actions you are taking to correct these violations and to prevent the recurrence of similar violations. You should include in your response documentation such as revised labels, or other useful information that would assist us in evaluating your corrections. If you cannot complete all corrections before you respond, we expect that you will explain the reason for the delay and state when you will correct any remaining violations.

Your written response should be sent to Brian D. Garthwaite, Ph.D., Compliance Officer, at the address located on the letterhead. If you have any questions about this letter, please contact Dr. Garthwaite at (612) 758-7132.

Sincerely,

/S/

W. Charles Becoat
Director
Minneapolis District

BDG/ccl

xc: Dean Erickson
Vice President and General Manager, Wisconsin Operations
BioForm Medical, Inc.
4133 Courtney Road Ste 10
Franksville, Wisconsin 53126-9127

This page was posted on March 27, 2019.

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