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

Public Health Service
Food and Drug Administration
Southwest Region
Denver District Office

 

Bldg 20, Denver Federal Ctr
PO Box 25087
6th Ave & Kipling St
Denver, CO 80225-0087
Telephone: 303-236-3000
FAX: 303-236-3100

May 11, 2000
WARNING LETTER
VIA CERTIFIED MAIL, RETURN RECEIPT REQUESTED

Vincent S. Kandis, CEO
Euthenics International, Inc.
400 Corporate Cir #L
Golden, CO 80401

Ref. No. Ref #: DEN-00-19

Dear Dear Mr Kandis:

This letter is in reference to your firm's marketing and distribution of the products, Testasomal200 and Decasomal200. Labeling for these products contains therapeutic claims, which cause the products to be drugs [Section 201(g) of the Federal Food Drug, and Cosmetic Act (the Act)].

Labeling is not limited to the immediate product containers but includes all promotional literature, which you distribute that accompanies your products. Objectionable claims for Testasomal200 and Decasomal200 include the following:

In addition, these products are transdermal because they are intended to deliver active ingredients "directly through your skin into your bloodstream," and are intended to have a systemic effect on the body. In 1989, the Agency made a determination that transdermal delivery systems are new drugs based on the newness of the delivery system [Title 21, Code of Federal Regulations (21 CFR), Section 310.31. Testasomal200 and Decasomal200 are "new drugs" [Section 201(p) of the Act]. Therefore, they may not be legally marketed in this country without approved New Drug Applications [Section 505(a) of the Act]. This letter is not intended to be an all-inclusive review of all labeling and 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. Further, claims for additional products are included on your firm's Internet web site. Such claims may also cause these products to be misbranded. Products and claims include:
5-HTP
Comparison to the prescription drug Prozac, depression, insomnia, anxiety, headaches.
chitosan
Inhibit bad cholesterol and boost good cholesterol, acts as an antacid and may be beneficial in healing ulcers and lesions, irritable bowel syndrome, antibacterial.
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 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. 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, including 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 directed to the Food and Drug Administration, Attention: Ms Jeannette A Schmieg, Acting Compliance Officer, at the above address.

Sincerely,
/s/
Karen S. Kreuzer
Acting District Director

This page was posted on August 20, 2006.

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