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

Public Health Service
Food and Drug Administration
Los Angeles District Office

 

19900 MacArthur Blvd #300
Irvine, CA 92612-2445
Telephone: 949-798-7600

June 22, 2000
WARNING LETTER
VIA CERTIFIED MAIL, RETURN RECEIPT REQUESTED

Marysa Benjamin
Tahiti Naturel USA, lnc
25546 Spinnaker Dr
San Juan Capistrano, CA 92675

Ref. No. W/L 65-00

Dear Ms Benjamin:

This letter is in reference to your firm's marketing and distribution of the product "Noni Tahiti."

Labeling for the product (promotional materials) contains drug claims for the treatment and prevention of various diseases. Examples include:

"Noni Tahiti" is a drug [section 201(g) of the Federal Food, Drug, and Cosmetic Act (the Act)] and a "new drug" [section 201(p) oft he Act ]. This product may not be marketed in the United States without an approved new drug application [section 505(a) of the Act].

This drug is also misbranded [section 502(f)(1) of the Act] because the labeling fails to bear adequate directions for use, This drug is also misbranded because the labeling is false and misleading as it suggests that the product is safe and effective for its intended use when, in fact, this has not been established [section 502(a) of the Act].

In addition, your Internet website contains claims which may cause your product(s) to be misbranded by establishing intended use for the product(s).

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 comections 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 sent to Director, Compliance Branch, US Food and Drug Administration, 19900 MacArthur Blvd #300, Irvine, CA 92612-2445.

Sincerely,
/s/
Thomas L. Sawyer
Acting District Director

cc:
[redacted]

This page was posted on August 20, 2006.

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