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

Public Health Service
Food and Drug Administration
Central Region
New Jersey District Office

 

Waterview Corporate Ctr
10 Waterview Blvd, 3rd Fl
Telephone: 973-331-2909
Parsippany, NJ 07054

April 14, 1998
WARNING LETTER
VIA CERTIFIED MAIL, RETURN RECEIPT REQUESTED

Philip Chen, President
Takao, Inc.
1037 Rt 46 E #C-233
Clifton, NJ 07013

Ref. No. 98-NWJ-21

Dear Mr Chen:

This letter is in reference to the promotion, marketing and distribution of the products "Bidara", "Kitara", "Milk Thistle", and "H&V Natural Herb Formula."

Promotional literature far your products makes the following claims:

Based on the claims made for these products and their intended uses, these products are drugs [Section 201(g) of the Food, Drug, and Cosmetics Act (the Act)]. They are new drugs [Section 201(p) of the Act] and may not be legally marketed in the United States without approved New Drug Applications (Section 505).

These drugs are also misbranded [Section 502(f)(1)] because the labeling fails to bear adequate directions for use and is false and misleading as it suggests that the products are safe and effective for their intended uses when this has not been established [Section 502(a)].

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 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. You should also include an explanation of each step being taken to identify and make corrections to assure than 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 the Food and Drug Administration, New Jersey District Office, 10 Waterview Bldg, 3rd Fl, Parsippany, NJ 07054, Attention: Mercedes B. Mota, Compliance Officer.

Sincerely,
/s/
Edward H. Wilkins for
Douglas I. Ellsworth
District Director

This page was posted on August 20, 2006.

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