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
April 28, 2011
In reply refer to Warning Letter SEA 11-14
Clare Ortwein, Owner
1685 H Street
Blaine, WA 98230
Dear Mr. Ortwein:
This is to advise you that the United States Food and Drug Administration (FDA) and the Federal Trade Commission (FTC) reviewed your websites at the Internet addresses http://www.goodbyeherpes.com and www.everclr3.net in March 2011. FDA has determined that your product EverCLR3 is promoted for conditions that causes it 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 websites 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 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).
On the www.goodbyeherpes.com main webpage, from the EVERCLR3 page:
■ “It is a combination of herbs which restore the body's natural defenses, so that it eliminates the [herpes simplex virus] HSV and its fungal host.”
■ “EverCLR3 . . . energizes your body’s defenses to relentlessly search out HSV1 and HVS2 and eliminate it.”
■ “EverCLR3’s Anti-Viral Herbs take 30 days to 3 months to start to take effect, so you will see fewer and fewer outbreaks until you experience no further outbreaks (usually in about 6 months).”
■ “[E]ffective against Herpes, Genital Herpes, Vaginal Herpes, Cold Sores, Shingles, HSV1, HSV2, Colds and Flu.”
■ “I have battled with chronic herpes cold sores on my lips all of my life. . . . I have been taking EverCLR3 for 6 months and I haven't had a single outbreak since.”
■ “I have suffered from Human Papilloma Virus (HPV) for three years. Since I started taking EverCLR3, I have had no more outbreaks.”
■ “I was diagnosed with genital herpes last year. The outbreaks increased to once a month. After taking EverCLR3, I haven't had one outbreak, or even a cold for that matter.”
On the www.everclr3.net main webpage:
■ “I was plagued several times a month with painful & prolonged herpes outbreaks. The pain was so unbearable. . . . All of this changed thanks to your EverCLR3.”
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 United States 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.
Furthermore, your product is offered for conditions that are not amenable to self-diagnosis and treatment by individuals who are not medical practitioners; therefore adequate directions cannot be written so that a layperson can use this drug safely for its intended purposes. Thus, your product is misbranded within the meaning of section 502(f)(1) of the Act [21 U.S.C. § 352(f)(1)], in that the labeling fails to bear adequate directions for use. 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 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 the FDA Seattle District 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. 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 Lisa Althar, Compliance Officer, U.S. Food and Drug Administration, 22201 23rd Drive SE, Bothell, Washington 98021-4421. If you have any questions regarding any issues in this letter, please contact Ms. Althar at (425) 483-4940.
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 firstname.lastname@example.org, 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
William A. Correll
Office of Compliance
Center for Food Safety
and Applied Nutrition
Food and Drug Administration
Charles M. Breen
Seattle District Office