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

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

Michel Guillemet
Polynesian Natural Health Products, LLC
1030 Cane Cordillera #106
San Clemente, CA 92674

Ref. No. W/L 54-00

Dear Mr Guillemet:

This letter is in reference to your firm's marketing and distribution of the product "Pol’Noni." Labeling for the product contains numerous therapeutic claims that cause the product to be a drug [section 201(g) of the Federal Food, Drug and Cosmetic Act (the Act)]. Labeling includes product labels, brochures, Internet sites, and other promotional literature which you distribute in connection with your products.

Objectionable claims for "Pol’Noni" include the following:

"Pol’Noni" is also a "new drug" [section 201(p) of the Act] which 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 and because the labeling is false and misleading as it suggests that the product is safe for its intended use when, in fact, this has not been established [section 502(a) of the Act].

This letter is not intended to be an all-inclusive review of all labeling and products your firm markets, It is your responsibility to assure that all products marketed by your firm are labeled 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 seizure of illegal products and for injunction against the manufacture and/or distributor of illegal products.

In addition, your website also includes disease claims for your intended product "Tamanu Oil" which include "…healing balm for many skin ailments such as burns … dermatitis, small wounds, eczema … psoriasis and other skin problems" and "…many skin ailments including burns, cuts, wounds, rashes, dermatitis … psoriasis …earaches…" We note that you did not have this product during the inspection (02/08/00). However, if you do have this product the future, such Internet claims may cause the product to be misbranded.

P1ease notify this office in writing, within fifleen (15) working days of receipt of this letter as to the specific steps you have taken to correct the stated violations. You should aIso include 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 sent to Director, Compliance Branch, US Food and Drug Administration, 19900 MacArthur Blvd #300, Irvine, CA 92612-2445.

Sincerely yours,
/s/
Mark S. Roh
Acting District Director

cc:
[redacted]

[redacted]

[redacted]

This page was posted on August 20, 2006.

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