Inspections, Compliance, Enforcement, and Criminal Investigations
|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
COLLEGE PARK, MD 20740
VIA UNITED PARCEL SERVICE
April 28, 2011
P.O. Box 61359
Sunnyvale, CA 94088-1359
Dear Mr. Sandberg:
This is to advise you that the Food and Drug Administration (FDA) reviewed your web site at the Internet address www.chlamydia-clinic.com in December 2010 and has determined that the product C-Cure is promoted for conditions that cause the product to be a drug under section 201(g)(1) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C § 321(g)(1)]. The therapeutic claims on your web site establish that the product is a drug, because it is intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease. The marketing of this product 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), aff’d, 624 F.3d 1 (1st Cir. 2010); FTC v. Nat'l Urological Group, Inc., 645 F. Supp. 2d 1167, 1190, 1202 (N.D. Ga. 2008), aff’d, 356 Fed. Appx. 358 (11th Cir. 2009); FTC v. Natural Solution, Inc., No. CV 06-6112-JFW, 2007-2 Trade Cas. (CCH) P75,866, 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), pet. for review den., 2010 WL 5108600 (D.C. Cir. Dec. 10, 2010).
Examples of some of the claims observed on your web site include:
On the “Home” page, http://www.chlamydia-clinic.com, under the heading “Chlamydia”:
• “Chlamydia is one of the most commonly sexually transmitted diseases . . . . I have discovered a natural supplement that ease[ ] the pain, cure[ ] the illness . . . . When you finish the C-Cure treatment you will be okay and you can feel a great relief.”
Under the subheading “How Do I Know if I Have Chlamydia?”:
• “She did not believe me that she had PID (Pelvic Inflammatory Disease - in fact she was in denial of having Chlamydia . . . . [S]he found a way to battle her illness and today she is 100% rehabilitated. Any female that wants to know how can request the info for free by e-mail to firstname.lastname@example.org[.] We are both free of the infection now . . . .”
• “What if testing for Chlamydia trachomatis could be abandoned? With C-Cure one can go through treatment once or twice per year and not have to worry about laborious and embarrassing testing.”
• “It is traumatic to acquire Chlamydia for most people, but far worse for teenagers. Therefore, we are considering setting up a service to give C-Cure treatment to young people that cannot afford it.”
Under the heading “C-Cure”:
• “Natural supplement to abate pain caused by the Chlamydia parasite”
The claims quoted above are supplemented by metatags, which are used to bring consumers to your website through Internet searches. The metatags include:
• "Chlamydia Cure”
• “Sexually Transmitted Disease”
• “Chlamydia Symptoms”
• “Non-Antibiotic Chlamydia Treatment”
• “Cure without Antibiotics”
• “Natural Cure for Chlamydia”
• “Natural Supplement for Curing Chlamydia”
• “Pelvic Inflamatory Disease”
In addition, the name of the web site, “chlamydia-clinic.com,” the e-mail contact, “chlamydia-Cure@cox.net,” and the name of the product, “C-Cure” are implied disease claims for Chlamydia.
Furthermore, your product, C-Cure, is not generally recognized as safe and effective for the above referenced uses and, therefore, the product is a “new drug” 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 product, C-Cure, is also misbranded within the meaning of 502(f)(1) of the Act [21 U.S.C § 352(f)(1)], in that the labeling for this drug fails to bear adequate directions for use. Because C-Cure 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 layperson can use the product safely for its intended uses. Thus, its labeling fails to bear adequate directions for its intended uses, causing it to be misbranded under section 502(f)(1) of the Act [21 U.S.C. § 352(f)(1)].
The above violations are not meant to be an all-inclusive list of deficiencies in your product and its labeling. It is a manufacturer’s responsibility to ensure that the products it markets are in compliance with the Act and all of its implementing regulations. We advise you to review your website, product labels, and any 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 and prevent their recurrence. 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 this office, 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 assure that similar violations do not occur in the future. 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.
Your response should be directed to Carl Lee Compliance Officer, U.S. Food and Drug Administration, San Francisco District, 1431 Harbor Bay Parkway, Alameda, CA 94502. If you have any questions regarding any issues in this letter, please contact Carl Lee at 510-337-6737.
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 email@example.com, 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.
Mary K. Engle
Division of Advertising Practices
Federal Trade Commission
Office of Compliance
Center for Food Safety and Applied Nutrition
Food and Drug Administration
San Francisco District Office
Food and Drug Administration