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

Public Health Service
Food and Drug Administration
Central Region
Minneapolis District

 

212 3rd Ave S
Minneapolis, MN 55401
Telephone: (612) 758-7114
FAX: (612) 334-4142

March 31, 2005
WARNING LETTER
VIA CERTIFIED MAIL, RETURN RECEIPT REQUESTED

Tropical Traditions, Inc.
823 S Main St
PMB #219
West Bend, WI 53095

Ref. No. MIN-05-11

Dear Sir or Madam:

This is to advise you that the Food and Drug Administration (FDA) has reviewed your website at the Internet address www.tropicaltraditions.com and has determined that your products "Organic Virgin Coconut Oil," "Ampalaya," "Banaba," "Banaba P1us™," and "Sambong" are promoted for conditions that cause the products to be drugs under section 201(g)(1)(B) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 USC 321(g)(1)(B)]. The therapeutic claims on your website establish that the products are drugs because they are intended for use in the cure, mitigation, treatment, or prevention of disease. The marketing of these products with these claims violates the Act.

Examples of some of the claims observed on your website include:

Furthermore, your products are not generally recognized as safe and effective for the above referenced conditions and therefore, the products are also "new drugs" under section 201(p) of the Act [21 USC 321(p)]. New drugs may not be legally marketed in the US without prior approval from FDA as described in section 505(a) of the Act [21 USC 355(a)]. FDA approves a new drug on the basis of scientific data submitted by a drug sponsor to demonstrate that the drug is safe and effective. Your products are also misbranded within the meaning of section 502(f)(1) of the Act, in that the labeling for these drugs fails to bear adequate directions for use [21 USC 352(f)(1)].

This letter is not intended to be an all-inclusive review of your website and products your firm markets. It is your responsibility to ensure that all products marketed by your firm comply with the Act and its implementing regulations.

Failure to promptly correct the violations described above may result in enforcement action without further notice. The Act authorizes the seizure of violative products, and manufacturers and distributors of such products are subject to injunction and criminal prosecution.

Please advise this office, in writing and within fifteen (15) working days of the receipt of this letter, as to the specific steps you have taken to correct the violations noted above and to assure that similar violations do not occur. If corrective actions cannot be completed within fifteen working days, state the reason for the delay and the time within which the corrections will be completed.

Your reply should be sent to Compliance Officer Tyra S. Wisecup at the address in the letterhead.

Sincerely,
/s/
W. Charles Becoat
District Director

This page was posted on March 28, 2006.

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