| 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 |
CERTIFIED MAIL
RETURN RECEIPT REQUESTED
WARNING LETTER
Mr. Jim Hill
Viruxo LLC
6470 NW 135 Ave
Morriston, Florida 32668
Dear Mr. Hill:
This is to advise you that the Food and Drug Administration (FDA) and the Federal Trade Commission (FTC) reviewed your website at the Internet address www.viruxo.com in April 2011. FDA has determined that the product “Viruxo Anti-Viral Support” 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. Furthermore, your product’s labeling fails to bear adequate directions for its intended use, causing the product 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).
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 website www.viruxo.com include:
On the main webpage:
- A headline banner statement: “New Herpes Treatment! Cure for Herpes Outbreaks.”
- “Viruxo Anti-Viral Support … Never Have A Herpes Outbreak Again!”
- “Viruxo is currently available without a prescription consisting of 14 synergistic ingredients providing your body the ultimate defense against herpes outbreaks.”
- “America’s #1 Herpes Outbreak Eliminator!”
- “[Viruxo] starves the viruses by cutting off its nourishment, blocks the virus from replicating….”
Through links from the main webpage, at the Viruxo FAQ page:
“What is Viruxo?”
- “Viruxo is the most powerful, no side effect Anti-Viral Immune Support Supplement available without a prescription.”
“Is Daily Suppression better than a Topical Herpes Treatment?”
- “VIRUXO helps to prevent the symptoms as well as the outbreak itself.”
“What is in Viruxo?”
- “Viruxo is designed to help suppress Herpes Outbreaks, caused by the HSV1 and HSV2 viruses.”
- “Lysine– has been shown to retard and slow the growth of certain viruses, including the Herpes Simplex 1&2.”
- “Zinc Sulfate … has [been] shown to directly reduce the frequency, intensity and duration of Herpes outbreaks.”
- “PABA – helps … promote full assumption of important compounds that fight the Herpes Virus.”
- “Panthothenic Acid – helps in wound healing at the skin level. Promotes blister healing and prevention.”
- “Thiamin – helps individuals infected with HSV1 and HSV2, maintain adequate Thiamin Levels. Certain viruses deplete Thiamin from the body.”
- “Vitamin B6 – …. Helps maintain a strong immune system, to fight the Herpes Virus.”
From the link, “Find Out More Why Viruxo Works So Well” on the main webpage:
“Zinc-Sulfate Blocks Herpes Replication!”
- “When Specific Zinc ions are delivered to the body, it inhibits the replication of HSV-1 and -2 .... If enough of the virus is inhibited it WILL self destruct.”
”“Multiple Potent Immune System Strengthening Ingredients”
- “Taking Viruxo will boost your immune system giving it the ability to fight off the virus….”
- “Boosting your immune system with Viruxo will power it to keep an outbreak from happening.”
“Build You Skin’s Defenses to Protect Itself!”
- “Viruxo gives your skin more strength to prevent herpes outbreaks and it [sic] one would occur, it will have the tools to defeat it quickly!”
Your website also contains disease claims in the form of Customer Stories. The following are excerpted from the main webpage:
- “I’m a professional trumpet player and have been hampered with Viral sores for most of my life. This made my work painful and also embarrassing. Now, I am free from any more breakouts.”
- “I have been suffering with genital Herpes for over 5 years …. I found your product about one year ago. I have been free from the pain, suffering ....”
The claims quoted above are supplemented by the metatags used to bring consumers to your website through Internet searches. The metatags include “The most powerful herpes treatment available without a prescription”, “Herpes Treatment! Cure For Herpes Outbreaks”, and “Advanced Herpes Treatment”.
The claims and metatags listed above establish that your product is a drug, because it is intended for use in the cure, mitigation, treatment, or prevention of disease. See section 201(g)(1)(B) of the Act [21 U.S.C. § 321(g)(1)(B)]. 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, because this 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 this product safely for its intended uses. Thus, your product’s 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 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 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 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 this office, in writing, within fifteen (15) working days from your 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. Your response should include any documentation necessary to show that correction has been achieved. If you cannot complete all corrections within fifteen working days, please explain the reason for the delay and the date by which the corrections will be completed.
Your response should be directed to Mr. Winston R. Alejo, Compliance Officer, U.S. Food and Drug Administration, Florida District Office, 555 Winderley Place Suite 200, Maitland, FL 32751. If you have any questions regarding any issues in this letter, please contact Mr. Alejo at (407) 475-4731.
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.
Sincerely,
/S/
Mary K. Engle
Associate Director
Division of Advertising Practices
Federal Trade Commission
/S/
William A. Correll
Acting Director
Office of Compliance
Center for Food Safety
and Applied Nutrition
Food and Drug Administration
/S/
Emma R. Singleton
Florida District Director
Food and Drug Administration
cc:
6 Lookout Lane
Ocala, Fl. 34482
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