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

Public Health Service
Food and Drug Administration
New Orleans District
Nashville Branch

 

297 Plus Park Blvd
Nashville, TN 37217

JuIy 3, 1997
WARNING LETTER
VIA CERTIFIED MAIL, RETURN RECEIPT REQUESTED

Frank Vandersloot, CEO
Melaleuca, Inc.
3910 S Yellowstone Hwy
Idaho Falls, ID 83402

Ref. No. 97-NSV-08

Dear Mr Vandersloot:

This letter is in reference to an inspection of your firm in KnoxvilIe, TN, on February 6, 11, 1997, which revealed the marketing and distribution of "ProVex", "ProVex-Plus", and "Replenex" which are being promoted to treat disease conditions. The promotional material (labeling) makes claims for "ProVex" that include:

Your claims for "ProVex-Plus" include:

The claims made for your product "Replenex" include:

Your promotional brochure (labeling) makes therapeutic claims for these products which cause them to be drugs as defined under Section 201(g) of the Federal Food, Drug, and Cosmetic Act (the Act). These products are also "new drugs" under Section 201(p) of the Act and, therefore, they may not be legally marketed in the United States without approved New Drug Applications as stated in Section 505 of the Act.

These drugs are also misbranded because the labeling fails to bear adequate directions for use as stated in Section 502(f)(1) and because the labeling is false and misleading as it suggests that the products are safe and effective for their intended uses when this has not been established as referenced under 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 Food, Drug and Cosmetic Act and its implementing regulations.

We request that you take prompt action to correct these violations. Failure to promptly correct violations may resuit in enforcement action being initiated by the Food and Drug Administration without further notice. Such actions include, but are not limited to seizure and injunction.

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 these violations. You should also 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, please state the reason for the delay and the time within which the corrections will be implemented.

Your response should be sent to Mr. Joseph E. Hayes, Compliance Officer; Food and Drug Administration; 297 Plus Park Blvd; Nashville, TN 37217.

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This page was posted on August 20, 2006.

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