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
RETURN RECEIPT REQUESTED
2030 Elmwood Ave.
Rochester, NY 14620
Dear Mr. Davidson:
This is to advise you that the Food and Drug Administration (FDA) and the Federal Trade Commission (FTC) has reviewed your websites at the internet addresses, www.polyDNA.com and www.gene-eden.com in March 2011. FDA has determined that the product “Gene-Eden” 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 therapeutic claims on your website establish that the product is a drug because it is intended for use in the cure, mitigation, treatment, or prevention of disease. The marketing of the 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 www.polyDNA.com website include:
"Gene-Eden … [is] a broad range, all natural, antiviral supplement that targets viruses … these viruses include the flue virus, Epstein-Barr Virus (EBV), Cytomegalovirus (CMV), Herpes Simplex (HSV), Varicella Zoster Virus(VZV), Hepatitis B Virus (HBV), Hepatitis C Virus (HCV), or Human Papillomavirus (HPV), among others.”
Your website www.gene-eden.com also contains disease claims in the form of personal testimonials. Examples of these claims include:
“I was diagnosed with chronic Epstein Barr Virus … I have been taking this [Gene-Eden] supplement for 6 months. I feel so much better. I have energy again, I don’t wake up exhausted, and I feel good.”
“I was suffering from HPV warts since 2006. I am very pleased with the way Gene-Eden cleared all the warts and my face is now free of lesions!”
“This product was a miracle supplement for my daughter! She was diagnosed with a very severe case of mono, which led to viral hepatitis (jaundice, enlarged liver, spleen & gallbladder) … She started taking Gene-Eden about a week after she was released from the hospital and felt much better immediately.”
The claims in the form of personal testimonials quoted above are supplemented by the metatags used to bring consumers to your www.gene-eden.com website through Internet searches. The metatags include “hepatitis,” “HPV,” “papilloma virus,” “human papilloma virus,” “Herpes,” and “Epstein Barr.”
Your product 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 is 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 this product 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. The unlawful disease treatment and prevention claims made on your websites 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 websites, 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 and prevent their future 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 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 Patricia Clark, U.S. Food and Drug Administration, New York District Office Compliance Branch, Buffalo Office, 300 Pearl Street (HFR-NE340), Buffalo, NY 14202. If you have any questions, please contact Ms. Clark at 716-551-4461 ext. 3168.
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
New York District Office
Food and Drug Administration