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

Public Health Service
Food and Drug Administration
Atlanta District Office

 

60 8th St NE
Atlanta, GA 30309
Telephone: 404-253-l 61
FAX: 404-253-1202

August 18, 2000
WARNING LETTER
VIA FEDERAL EXPRESS

Jack L. Davis, President
Jack Davis & Associates, Inc.
d/b/a Davis Vitamin Co.
2925-4 Ledo Rd
Albany, GA 31701

Ref. No. 00-ATL-60

Dear Mr Davis:

This letter is in reference to your firm's marketing and distribution of the Product "Noni Tahiti." Labeling for the produqt (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) of the 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 further 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].

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. Furthermore, we are aware that your firm also promotes additional products via a catalog and other promotional material. Examples of such products include:

These products are drugs based upon their claims. They may also be new drugs and misbranded drugs.

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 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 US Food and Drug Administration, Atlanta District Office, 60 8th St NE, Atlanta, GA 30309, Attention: Karen Y. Dodson, Compliance Officer.

Sincerely,
/s/
Ballard H. Graham
District Director

Enclosure

This page was posted on August 20, 2006.

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