Department of Health and Human Services
Public Health Service
212 3rd Ave S
March 31, 2005
VIA CERTIFIED MAIL, RETURN RECEIPT REQUESTED
Tropical Traditions, Inc.
823 S Main St
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:
Organic Virgin Coconut Oil
- "Initial trials have confirmed that coconut oil does have an anti-viral effect and can beneficially reduce the viral load of HIV patients. …" (quoting Dr Conrato S. Dayrit)
- "To read more about fungal infections like Candida, and how coconut oil can help.…"
- "[C]oconut oil is converted by the body into "Monolaurin" a fatty acid with anti-viral properties that might be useful in the treatment of AIDS:"
- "The antiviral, antibacterial, and antifungal properties of the medium chain fatty acids/triglycerides (MCTs) found in coconut oil have been known to researchers since the 1960s."
- "Much of the recent research done on coconut oil and lauric acid, the most predominant fatty acid chain found in coconut oil, has centered around the antimicrobial and anti-viral properties of this unique fatty acid. … When lauric acid is consumed in the diet, … lauric acid forms a monoglyceride called monolaurin, which has been shown to destroy several bacteria and viruses, including listeria monocytogenes and helicobacter pylori, and protozoa such as giardia lamblia. Some of the viruses that have been destroyed by monolaurin include HIV, measles, herpes simplex virus-1, vesicular stomatitis virus, influenza and cytomegalovirus."
- "Virgin Coconut Oil offers great hope for those suffering from hypothyroidism (low thyroid function) today." (testimonial)
- "Virgin Coconut oil is rich in lauric acid, a proven antiviral and antibacterial agent. It is currently being used in treating AIDS."
- "Virgin Coconut Oil is also great for digestive disorders such as Crohn's disease, IBS, and Colits [sic]."
- "[T]here is exciting research showing that the MCTs (medium chain triglycerides) in coconut oil act to kill Candida Albicans! These MCTs … hold promise for Chronic Fatigue Syndrome sufferers. …"
- "Purchase Ampalaya (Momordica Charantia — bitter melon) … There has been much research done on the effectiveness of using Momordica Charantia in the treatment of diabetes."
- "It has been recommended by the Department of Health of the Philippines, as one of the best herbal medicines for it's [sic] ability to help with liver problems, diabetes and HIV."
- "It is also used in the treatment of skin diseases, sterility in women, as a parasiticide, as an antipyretic,…"
- Banaba and Banaba PIus™
- "In the Philippines, Banaba is a popular medicine plant and is used in treatment of diabetes mellitus. It is considered a natural plant insulin, can be taken orally, and has no side effects, according to Japanese research."
- "A study published in 2001 by Edison Biotechnology Institute … concluded that the whole herb had a glucose lowering effect and could be used to fight diabetes and obesity."
- "Sambong is a remarkable medicinal plant … commonly used in the treatment of kidney disorders."
- "Sambong is also known as a diuretic, and is used in cases of hypertension and mild to moderate congestive heart failure."
- "Clinical studies, including double blind/placebo randomized studies, have shown Sambong to be both safe and effective in the cases of kidney stones and hypertension."
- "The leaves of Sambong are also used … as a cure for colds. It is said to have antidiarrhetic and antigastralgic properties. … It is given for worms and dysentery."
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.
W. Charles Becoat
This page was posted on March 28, 2006.