| Public Health Service Food and Drug Administration |
Detroit District |
Department of Health and Human ServicesWARNING LETTER
2012-DET-05
December 6, 2011
VIA UPS
Mr. Brian Kabara
Med-Chem Labs
3390 W. Eight Mile Road, Suite 171
Farmington, MI 48335
Dear Mr. Kabara:
This is to advise you that the Food and Drug Administration (FDA) has reviewed your website at www.lauricidin.com in August 2011 and has determined that “Lauricidin” is promoted for conditions that cause the product to be a drug 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 claims on your website establish that this product is a drug because it is intended for use in the cure, mitigation, treatment, or prevention of disease. The marketing of your product with these claims violates the Act.
On your home page there is a list of hyperlinks which open to pages that include claims about the product “Lauricidin”. Examples of some of the claims observed on your website include:
Under the heading ”Lauricidin Technical Information”:
• “[L]auricidin adversely affects bacteria, yeast, fungi, protozoa, and envelope viruses.”
• “The antiviral action attributed to monolaurin [Lauricidin] is that of fluidizing the structure in the envelope of the virus, causing the disintegration of the microbial membrane.”
“Antiviral Effects”:
• “Some of the viruses inactivated…are the measles virus, herpes simplex virus (HSV-1 and -2), herpes family members (HIV, hepatitis C, vesicular, stomatitis virus (VSV), visna virus, and cytomegalovirus (CMV).”
“Antibacterial Effects”:
• “The potentially pathogenic bacteria inactivated by monolaurin [Lauricidin] include Listeria monocytogenes, Staphylococcus aureus, Streptococcus agalactiae, Groups A, streptococci-gram-positive organisms, and some gram-negative organisms (Vibrio parahaemolyticus and Helicobacter pylori).”
• “A number of fungi, yeast, and protozoa are also inactivated or killed by monolaurin [Lauricidin].”
Under the heading titled “Microorganism Inactivated:”
• “Microorganisms Inactivated Under Laboratory Conditions”
o “Viruses: HIV or HIV-1, 6, Visna virus, Herpes simplex virus-i(HSV-1 & 2), Vascular stomatitis virus (VSV), Measles virus, Rubella virus, Epstein-Barr virus (EBV), Cytomegalovirus (CMV), Influenza virus, Lymphocytic choriomeningitis, Human papilloma virus (HPV), Pneumovirus.”
o “Bacteria: Bacillas anthracis (Anthrax), Chlamydia, pneumonia,…Staphylococcus aureus…Clostridium perfingens,… Neisseria gonorrhoeae (sic).”
o “A number of protozoa like Giardia lamblia are also inactivated or killed by Lauricidin”
Your website also contains disease claims in the form of personal testimonials. The following testimonials are excerpted from the hyperlink titled “Testimonials” with the following sub-headings for the disease states:
“Health Professional Testimonial”
• “[I]n the past year, I discovered a product called Lauricidin, which is a concentrate or pure form of monolaurin…I have been consistently impressed with the ability of Lauricidin to suppress herpes outbreaks not to mention yeast problems like Candida (monolaurin is also a potent anti-fungal agent) and allow people to get off their antifungal drugs…The usual dose to suppress the herpes is about 1/2 to I scoop, one to three times per day.
With this regimen most of my patients have been able to avoid conventional antiviral drugs and the painful symptoms of genital herpes.”
“Hep C Testimonials”
• “[M]y Hep PCR qaunt[sic] is down and [Lauricidin] is in large part responsible for the ever-increasing drop in my viral load. It’s by far the most amazing supplement I’ve ever been on. I believe I have even dissolved nuisance fibroid recently, and I attribute it to the Lauricidin, without a doubt.”
“Herpes Testimonials”
• “[N]ot had one outbreak since taking it…when I feel I may be close to an outbreak, I increase my dosage for a couple days and it goes away.”
• “I was one of those cases who had constant breakouts with miserable pain. I think I now have the best formula for me I take 2 scoops of Laurcidin 3 times a day and now have no outbreaks(I mean none).”
• “I am taking Lauricidin for herpes. Since I have started taking it….I have not had a breakout...”
• “Naturally Reduce The Frequency Of Your Herpes Outbreaks …”
Your product is not generally recognized as safe and effective for the above referenced uses and therefore, the product is “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. The introduction of an unapproved new drug into interstate commerce is a violation of section 301(d) of the Act [21 U.S.C. § 331(d)].
Furthermore, because your product is offered for conditions that are not amenable to self-diagnosis and treatment by individuals who are not medical practitioners, adequate directions cannot be written so that a layman can use the products safely for their intended uses. Thus, their labeling fails to bear adequate directions for their intended uses, causing them to be misbranded under section 502(f)(1)of the Act [21 U.S.C. § 352(f)(1)]. The introduction of a misbranded drug into interstate commerce is a violation of § 301(a) of the Act [21 U.S.C. § 331(a)].
The above violations are not meant to be an all-inclusive list of deficiencies in your products and their labeling. It is your responsibility to ensure that all of your products are in compliance with the laws and regulations enforced by FDA. You should take prompt action to correct the violations described above. Failure to promptly correct these violations may result in regulatory action without further notice, such as seizure and/or injunction.
Please notify FDA in writing, within 15 working days of the receipt of this letter, of the specific steps you have taken to correct the violations noted above and to ensure that similar violations do not occur. Include any documentation necessary to show that correction has been achieved. If corrective actions cannot be completed within 15 working days, state the reason for the delay and the time within which the corrections will be completed.
Your response should be directed to Catherine V. Quinlan, Compliance Officer, Food and Drug Administration, 300 River Place, Suite 5900, Detroit, MI 48207. If you have any questions regarding compliance with the laws and regulations enforced by FDA, please contact her at (313)393-8153.
Sincerely,
/s/
Glenn T. Bass
District Director
Detroit District Office
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