| UNITED STATES OF AMERICA FEDERAL TRADE COMMISSION BUREAU OF CONSUMER PROTECTION WASHINGTON, D.C. 20580 | DEPARTMENT OF HEALTH AND HUMAN SERVICES FOOD AND DRUG ADMINISTRATION WASHINGTON, D.C. 20740 |
SEP 28 2010
CERTIFIED MAIL
RETURN RECEIPT REQUESTED
WARNING LETTER
Apurve Mehra
Telledant LLC
345 W. 37th Street
Miami, Fl 33140
5730 Uplander Way
Suite 110
Culver City, Ca. 90230
CFSAN-OC-10-28
Dear Mr. Mehra:
This is to advise you that the Food and Drug Administration (FDA) and the Federal Trade Commission (FTC) reviewed your websites at the Internet addresses http://www.biogetica.com, www.fixdisease.com, www.guantumcure.com, www.fixherpes.com and www.quantumfix.com in August 2010. FDA has determined that the following Biogetica products, "Deliverance From Herpes Kit," "Herpes Optimal-Kit," "Herpes Essentials-Kit," "Freedom from Herpes Kit," "Epilepsy Essentials-Kit," "C20 Epilepsy Formula," "C55 Neuro Calming Formula," "Freedom from Epilepsy Formula (Epilepsy 1M)," "Diabetes Brittle Essentials-Kit," "Type II Diabetes Essentials-Kit," "Diabetes Insipidus Essentials-Kit," "Type I Diabetes Essentials-Kit," "Pre-Diabetes Essentials Kit," "Freedom from Diabetes Kit," "Deliverance From Gonorrhea," "Gonorrhea Formula," "Syphilis Formula 1," "Syphilis Formula 2," "Syphilis Formula 3," "Deliverance From Chlamydia Kit," and "Chlamydia Venereal Mix Formula," are promoted for conditions that cause them 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 websites 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.
In addition, it is unlawful under the FTC Act, 15 U.S.C. § 41 et seq., to advertise that a product can prevent, treat, or cure human disease unless you possess competent and reliable scientific evidence, including, when appropriate, well-controlled human clinical studies, substantiating that the claims are true at the time they are made. See FTC v. Direct Mktg. Concepts, 569 F. Supp. 2d 285, 300, 303 (D. Mass. 2008); FTC v. Nat'l Urological Group, Inc., No. 1:04-CV-3294-CAP, 2008 U.S. Dist. LEXIS 44145, at *43-44 (N.D. Ga. June 4,2008); FTC v. Natural Solution, Inc., No. CV 06-6112-JFW, 2007 U.S. Dist. LEXIS 60783, at *11-12 (C.D. Cal. Aug. 7, 2007). More generally, to make or exaggerate such claims, whether directly or indirectly, through the use of a product name, website name, metatags, or other means, without rigorous scientific evidence sufficient to substantiate the claims, violates the FTC Act. See In re Daniel Chapter One, No. 9239, slip op. 18-20,2009 WL 516000 (F.T.C.), 17-19 (Dec. 24, 2009) (http://www.ftc.gov/os/adjpro/d9329/091224commissionopinion.pdf.)
Examples of some of the claims observed on your www.fixdisease.com, www.quantumcure.com, www.fixherpes.com and www.quantumfix.com websites include:
Biogetica Deliverance From Herpes Kit, Biogetica Herpes Optimal-Kit, Biogetica Herpes Essentials-Kit, and Biogetica Freedom from Herpes Kit
• "Reclaim Your Freedom with Superior, Natural, Effective Herpes Treatments Biogetica's advanced herpes treatment offers you:
o A choice of cutting edge clinically proven herpes healing kits
o Relief from herpes symptoms
o Reduced herpes outbreaks"
Biogetica Deliverance From Herpes Kit and Biogetica Freedom from Herpes Kit
• "Extracts of Hypericum Mysorense [an ingredient in Hyperisince Tablets, which are a component of your products], supported suppression of HSV [Herpes Simplex Virus] 100% (in-vitro trials)!"
Examples of some of the claims observed on your www.biogetica.com website include:
Biogetica Freedom from Herpes Kit and Biogetica Deliverance From Herpes Kit
• "Hyperisince Mysorense [an ingredient in Hyperisince Tablets, which are a component of both kits], the herpes wonder-herb provides unparalleled immune support against HSV."
• "Visarpa clay [a component of both kits] instantly soothes the site of the outbreaks, reduces pain, eliminates lesions, kills infections and reduces scarring."
• The names of these two products are claims that the products treat and cure herpes.
Biogetica Herpes Optimal-Kit and Biogetica Herpes Essentials-Kit
• "The natural herpes remedies in this kit work specifically by:
• Using nosodes to coax your immune system to create antibodies specific to the herpes virus
• Preventing relapses of herpes."
• The names of these products are implied claims for treatment of herpes.
Biogetica Epilepsy Essentials-Kit
• "Us[es] ingredients that help reduce the duration of a seizure and prevent complications such as neurological deficits."
• The name of this product is an implied claim for treatment of epilepsy.
C20 Epilepsy Formula
• "Reduc[es] your tendency for recurrent seizures, naturally, without harming your nervous system in any way."
• The name of this product is an implied claim for treatment of epilepsy.
C55 Neuro Calming Formula
• "[E]xcellent nerve tonic for the treatment of epilepsy."
• "Tackl[es] physical symptoms related to the nervous state ..."
• "[C]an be used in cases of temporal lobe epilepsy to reduce violence."
Freedom from Epilepsy Formula (Epilepsy 1M)
• "[S]afe and effective alternative medicine for epilepsy treatment."
• "Reliev[es] symptoms associated with convulsions, like muscle contractions, nausea, vomiting, etc."
• The name of this product is a claim that the product treats and cures epilepsy.
Biogetica Diabetes Brittle Essentials-Kit
• "Biogetica Diabetes Brittle Essentials-Kit is an admixture of well-known natural diabetes remedies that not only help in the treatment of brittle diabetes, but also work towards reversing the underlying pathological changes responsible for fluctuations in your blood sugar levels."
• The name of this product is an implied claim for treatment of unstable type 1 diabetes.
Biogetica Type II Diabetes Essentials-Kit
• "[A] brilliant formulation of natural diabetes treatments that together correct glucose metabolism and results [sic] in reduction of blood glucose levels."
• The name of this product is an implied claim for treatment of type 2 diabetes.
Biogetica Diabetes Insipidus Essentials-Kit
• "Biogetica Diabetes Insipidus Essentials-Kit contains effective natural alternative medicines for treating diabetes insipidus. These natural diabetes treatments stimulate your pituitary gland to rectify the deficiency of vasopressin."
• The name of this product is an implied claim for treatment of diabetes insipidus.
Biogetica Type I Diabetes Essentials-Kit
• "[H]elps to ... reduce the need of high doses of external source of insulin ...."
• "The Kit consists of ... 3 products for the treatment of type 1 diabetes."
• The name of this product is an implied claim for diabetes treatment.
Biogetica Pre-Diabetes Essentials-Kit
• "If this therapy is used from the initial appearance of symptoms, it can prevent pre-diabetes from progressing to frank or overt diabetes mellitus."
• The name of this product is an implied claim that the product helps to prevent diabetes in people with elevated blood glucose levels.
Biogetica Freedom from Diabetes Kit
• "One of the products in this kit ... has proven to reduce blood sugar levels and delay the need for insulin therapy for type II diabetes patients in independent clinical trials."
• "A guaranteed safe and natural wise long-term solution for diabetes management..."
• The name of this product is a claim that the product treats and cures diabetes.
Biogetica Deliverance From Gonorrhea
• "Biogetica Deliverance From Gonorrhea is a combination of state-of-the-art natural gonorrhea treatments that represent the creme-de-la-creme of alternative medicine for treating gonorrhea (the Clap)."
• The name of this product is a claim that the product treats and cures gonorrhea.
Biogetica Gonorrhea Formula
• "[K]nown to reduce urethritis and production of gleet. ... [A]lso prevents further progression of the infection into the deeper and more important organs."
• The name of this product is an implied claim for gonorrhea treatment.
Biogetica Syphilis Formula 1
• "Biogetica Syphilis Formula 1 is to be used in the primary stage of syphilis, where there is only genital ulceration. In these cases, our formula not only treats the ulceration but also boosts the immunity so as to combat the infection and prevent further progression."
• The name of this product is an implied claim for syphilis treatment.
Biogetica Syphilis Formula 2
• "Biogetica Syphilis Formula 2 must be used in the secondary stage of syphilis where generalized rash, wart-like lesions and painless punched out ulcers develop in the mouth and genitals, accompanied by fever, malaise, and enlarged lymph nodes."
• The name of this product is an implied claim for syphilis treatment.
Biogetica Syphilis Formula 3
• "Biogetica Syphilis Formula 3 is to be used in the tertiary stage of syphilis when gummata develop, leading to tissue-destruction and sometimes producing neurosyphillis. These remedies try to revert [sic] the changes as far as possible and restrict further progression and damage to a great extent."
• The name of this product is an implied claim for syphilis treatment.
Biogetica Deliverance From Chlamydia Kit
• "This natural Chlamydia treatment offers you freedom from Chlamydia ...."
• The name of this product is a claim that the product treats and cures chlamydia.
Biogetica Chlamydia Venereal Mix Formula
• "Biogetica Chlamydia Venereal Mix Formula is a holistic preparation for the treatment of the common sexually transmitted diseases. This product ... coax[es] the immune system to fight these virulent beings, and heal the body the natural way."
• The name of this product is an implied claim for treatment of chlamydia and other sexually transmitted diseases.
Your website also contains disease claims in the form of personal testimonials found on the www.biogetica.com testimonial page. Examples of these claims include:
• "I had an ache in my lower-back for some time. I did not pay much heed to it. Then I started getting a vaginal discharge. I ran to my doctor who diagnosed it as Gonorrhea. I was prescribed Tetracycline which I took but without much relief. A friend praised your Gonorrhea formula. She said that she had been cured of Chlamydia and Gonorrhea with your treatments. 1 have been taking it for a month and I am absolutely symptom free."
• "I had developed a syphilitic ulcer. I consulted my doctor who confirmed the diagnosis after inspection and some blood tests. ... I was searching for natural treatments when I found your Syphilis formula 1. I took it for 6 weeks and my ulcer has completely healed. There is no scar left as well. Thanks to your products, I have been cured of what could have been a dreadful illness."
• "I had this painful burning sensation whenever I tried to pass urine.... I went to a Urologist and after some tests it was known that I had Chlamydia. . .. Even after taking the antibiotics for the prescribed duration I did not get much relief.... Luckily I zeroed in on Biogetica's Chlamydia formula. Within a few weeks my symptoms started reducing and today I am completely alright. This seems like the best cure for Chlamydia and its [sic] natural!"
Your products are not generally recognized as safe and effective for the above referenced uses and, therefore, the products are "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 Biogetica products "Deliverance From Herpes Kit," "Herpes Optimal-Kit," "Herpes Essentials-Kit," "Freedom from Herpes Kit," "Epilepsy Essentials-Kit," "C20 Epilepsy Formula," "C55 Neuro Calming Formula," "Freedom from Epilepsy Formula (Epilepsy 1M)," "Diabetes Brittle Essentials-Kit," "Type II Diabetes Essentials-Kit," "Diabetes Insipidus Essentials-Kit," "Type I Diabetes Essentials-Kit," "Pre-Diabetes Essentials Kit," "Freedom from Diabetes Kit," "Deliverance From Gonorrhea," "Gonorrhea Formula," "Syphilis Formula 1," "Syphilis Formula 2," "Syphilis Formula 3," "Deliverance From Chlamydia Kit," and "Chlamydia Venereal Mix Formula" are also misbranded within the meaning of section 502(f)(1) of the Act [21 U.S.C. § 352(f)(1)], in that the labeling for these drugs fails to bear adequate directions for use.
The above violations are not meant to be an all-inclusive list of deficiencies in your products or their labeling. While reviewing your website, we noticed that you are promoting other products for disease treatment and/or prevention. The unlawful disease treatment and prevention claims made on your website were too numerous to list in this letter. It is your responsibility to ensure that all products marketed by your firm comply with the Act and its implementing regulations. We advise you to review your website, product labels, and other labeling and promotional materials for your products to ensure that the. claims you make for your products do not cause them to violate the Act.
You should take prompt action to correct the violations described above. Failure to do so may result in enforcement action without further notice. The Act authorizes the seizure of illegal products and injunctions against manufacturers and distributors of those products [21 U.S.C. §§ 332 and 334].
Please notify FDA in writing, 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 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 fifteen working days, state the reason for the delay and the time within which the corrections will be completed.
Please send your reply to Felicia Binion Williams, U.S. Food and Drug Administration, Center for Food Safety and Applied Nutrition, 5100 Paint Branch Parkway, Office of Compliance (HFS-608), Division of Enforcement, College Park, Maryland 20740-3835. If you have any questions, please contact Ms. Williams at 301-436-2566.
In addition, FTC strongly urges you to review all claims for your products and ensure that those claims are supported by competent and reliable scientific evidence. Violations of the FTC Act may result in legal action seeking a Federal District Court injunction or Administrative Cease and Desist Order. An order also may require that you pay back money to consumers. Please notify FTC via electronic mail at healthproducts@ftc.gov, within fifteen (15) working days of receipt of this letter, of the specific actions you have taken to address FTC's concerns. If you have any questions regarding compliance with the FTC Act, please contact Richard Cleland at 202-326-3088.
Very truly yours,
/S/
Mary K. Engle
Associate Director
Division of Advertising Practices
Federal Trade Commission
/S/
Jennifer A. Thomas
Acting Director Office of Compliance
Center for Food Safety and Applied Nutrition
Food and Drug Administration
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