Food and Drug Administration
212 Third Avenue South
Minneapolis, MN 5540'i .
Telephone: (612) 758-7114 - --
Fax: (612) 334-4142
March 31, 2005
WARNING LETTER
Certified Mail
Return -Receipt Requested Refer to MIN 05 -11 -
xxx, Inc.
xxx Main Street
xxx
Dear Sir or Madam:
This is to advise you that the Food and Drug Administration (FDA) has reviewed your website at the Internet address http://www..... and has determined that yourproducts "Organic Virgin Coconut Oil," "xxx" xxx," "xxx," and "xxx" 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 U.S.C. & 321(g)(1)(B)]. The therapeutic claims on your web site 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 web site 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. xxx)
"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 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 Colicitis"
"There is exciting research showing that the MCTs (medium chain triglycerides) in coconut oil act to kill Candida Albicans! These MCTs .. . hold a promise for Chronic Fatigue Syndrome sufferers . . .."
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 U.S .C. & 321(p)]. New drugs may not be legally marketed in the U.S. without prior approval from FDA as described in section 505(a) of the Act [21 U.S.C. & 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 U.S .C. & 352(f)(1)].
This letter is not intended to be an all-inclusive review of your web site 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,
W. Charles Becoat
District Director
Minneapolis District
li, thx banget yah buat link dan commentnya:) *hug*
emang orang yang gak punya hati nurani itu susah bertobat:)
met wiken lili...