| 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 |
April 28, 2011
WARNING LETTER
Ms. Stacy Lyles
Medavir Medical Advances, Inc.
PO Box 174
Windermere, FL 34786
502 N Division St
Carson City, NV 89703
Dear Ms. Lyles:
This letter is to advise you that the United States Food and Drug Administration (FDA) and the United States Federal Trade Commission (FTC) have reviewed your websites at the Internet addresses www.medavir.com, www.medavir.net, and www.taghealth.com. The FDA has determined your firm’s marketing of the products Medavir, ViraBalm, and Vyristic Immune Support, which are offered for sale on your website, violates the Federal Food, Drug, and Cosmetic Act (the Act). As described in more detail below, these products are unapproved new drugs in violation of sections 301(d) and 505(a) of the Act [21 U.S.C. §§ 331(d) and 355(a)] and are misbranded under sections 502 and 502(f)(1) of the Act [21 U.S.C §§ 352 and 352(f)(1)]. Your products are further misbranded under section 502(j) of the Act [21 U.S.C. § 352(j)] in that they are dangerous to health when used in the manner recommended or suggested in their labeling.
Labeling statements on your website include, but are not limited to, the following:
Medavir (topical)
- “MedaVirTM is the #1 rated non prescription herpes treatment because it is proven effective and prevents 98% of all outbreaks (safe topical gel, no pills or side effects).”
- “Apply MedaVirTMjust before the outbreak (burning, itching prodromal phase) and sores never break thru skin”
- “Any sores that do occur heal 50% faster and are much less severe, results are dramatic.”
- “Most who use MedaVirTM report future outbreaks stop after just a few treatments, outbreak free for months and even years.”
- “MedaVirTM is the only treatment that works. That is why I continue to recommend it to all of my patients with herpes. Most report all outbreaks stop after a few treatment cycles.”
- “MedaVirTM is a safe topical antiviral medication applied directly to the site of infection before and during a herpes simplex outbreak.”
- “MedaVirTM . . . prevents outbreaks and lessens the amount of virus in the body with each successive treatment.”
- “Medavir is proposed to help users to become ‘asymptomatic’ to (sic) in that Medavir can eliminate virus on and just below the skin during an outbreak.”
- “MedaVirTM is clinically proven to reduce healing time on active sores to about 72 hours instead of several weeks. Once active sores are treated the future recurrence becomes less severe and frequent. MedaVirTM also provides instant pain relief from sores. Most users report outbreaks stop completely after 2-3 treated outbreaks.”
- “This is a great time to order MedaVirTM since outbreaks can be completely prevented when this product is applied during the burning, itching prodromal phase. Over 90% of outbreaks do not occur when you apply MedaVirTM at first signs of outbreak.”
- “MedaVirTM is a special patented formulation of Stannous Fluoride (tin bifluoride) manufactured . . . to give our product its effectiveness against Herpes Simplex.”
- “MedaVirTM works using a new proposed mechanism of action to attach and kill the live virus exposed in the skin, so less virus replicates and retreats back into the body for future outbreaks.”
- “The ingredients in Medavir were successfully tested in clinical studies proving it is effective against Herpes Simplex.”
- “Just read the independent research below that proves Medavir kills and stops the herpes virus.”
- “Clinically proven topical herpes treatment for multiple sore outbreaks”
- “Stop Future Outbreaks”
- “Heal Sores in Hours”
- “Stop herpes simplex outbreaks forever!”
ViraBalm (topical)
- “ViraBalm Extra Strength . . . is a 100% organic essential oils herpes treatment used as a suppressive therapy. ViraBalm is made from antiviral plant constituents demonstrated effective to inactivate the herpes virus . . . Evidence shows topical application of these products may assist in reduction of viral count.”
Vyristic (oral)
- “Vyristic Immune System Support Supplement capsule is the most complete and effective daily Herpes supplement ever developed!”
- “ . . . [F]ound to increase the body’s immune response against herpes viruses, prevent future outbreaks, and provide some resistance to infection.”
- “Taking one Vyristic capsule daily can be a safe and easy way to help manage outbreaks, without the risk of side effects associated with prescription medication.”
Medavir H-Elimination Kit (contains Medavir, ViraBalm, and Vyristic):
- “Herpes Elimination Kit“
- [T]he best combination of . . . Medical Herpes Treatments ever assembled.”
These claims are supplemented by the metatags that you use to bring consumers to your website. These include “[h]erpes,” “herpes simplex,” “genital herpes,” “herpes sores,” “herpes cure,” and “cure for herpes.”
Based on these claims, your products are drugs as defined by section 201(g)(1)(B) and (C) of the Act [21 U.S.C. § 321(g)(1)(B) and (C)] because they are intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease, or to affect the structure or function of the body of man. Furthermore, these products are “new drugs,” as defined by section 201(p) of the Act [21 U.S.C. § 321(p)], because they are not generally recognized as safe and effective for their labeled uses. Under sections 301(d) and 505(a) of the Act, a new drug may not be introduced into interstate commerce unless an FDA-approved new drug application (NDA) is in effect for it. Your sale of Medavir, ViraBalm, and Vyristic without approved NDAs violates these provisions of the Act.
Genital herpes is not amenable to self‑diagnosis and treatment by individuals who are not medical practitioners. “Adequate directions for use” is defined in 21 CFR § 201.5 as “directions under which the layman can use a drug safely and for the purposes for which it is intended.” Because this condition requires the supervision of a practitioner licensed to prescribe drugs, adequate directions cannot be written for them so that a layperson can use your products safely for these uses. Thus, your products’ labeling fails to bear adequate directions for use for these indications, which causes the products to be misbranded under section 502(f)(1) of the Act [21 U.S.C. § 352(f)(1)]. Because your products lack required approved applications, they are not exempt under 21 CFR §§ 201.100(c)(2) and 201.115 from the requirements of section 502(f)(1) of the Act. The introduction or delivery for introduction into interstate commerce of these products therefore violates sections 301(a) and (d) of the Act [21 U.S.C. §§ 331(a) and (d)].
The labeling for Medavir, ViraBalm, and Vyristic includes claims for the prevention, treatment, and cure of genital herpes, as noted above. A consumer who uses these products as labeled may forgo or delay appropriate treatment, which can be dangerous not only to the consumer but also to the consumer’s sexual partners. These products are therefore dangerous to health and misbranded under section 502(j) of the Act [21 U.S.C. § 352(j)].
Genital Herpes and Cold Sores
Claims Regarding Treatment of Genital Herpes
We note that your products are offered over-the-counter (OTC) for the treatment of genital herpes. This condition is not covered by any monograph or ongoing rulemaking under the OTC Drug Review. In addition, we are not aware of any evidence that similarly formulated and labeled products were marketed on or before the inception of the OTC Drug Review, nor has FDA ever proposed that such products be included in the OTC Drug Review. Your products are therefore not covered by the OTC Drug Review.
Claims Regarding Treatment of Cold Sores
OTC drug products intended for the topical treatment of fever blisters and cold sores are being evaluated under the ongoing OTC Drug Review. The Tentative Final Monograph (TFM) for this category of products was published in 1990 [External Analgesic Drug Products for Over-The-Counter Human Use; Proposed Rulemaking for Fever Blister and Cold Sore Treatment Drug Products, 55 Fed. Reg. 3370 (Jan. 31, 1990)]. However, FDA considers the use of the term “herpes” alone misleading for products marketed under the OTC Drug Review for treatment of fever blisters and cold sores, because a consumer may associate it with the genital form of herpes. 55 Fed. Reg. at 3373. As stated above, genital herpes is neither covered by any OTC monograph or ongoing rulemaking, nor is it an appropriate OTC indication.
To the extent your products are intended for indications covered by the TFM for products for the topical treatment of fever blisters and cold sores, they are also inconsistent with the OTC Drug Review for such products in other respects. For example, according to your website, Medavir contains “a special patented formulation of Stannous Fluoride (tin bifluoride) manufactured . . . to give our product its effectiveness against Herpes Simplex.” This active ingredient has not been evaluated under the OTC Drug Review for products for the topical treatment of fever blisters and cold sores.
Furthermore, FDA has determined that there is a lack of adequate data to establish general recognition of the safety and effectiveness of any orally administered ingredients for OTC use to treat or relieve the symptoms or discomfort of cold sores. 21 CFR 310.537(a). Any OTC drug product for oral administration, including your Vyristic product, that is labeled, represented, or promoted to treat or relieve the symptoms or discomfort of cold sores is regarded as a new drug under section 201(p) of the Act and requires an approved NDA in order to be legally marketed. 21 CFR 310.537(b). Additionally, per 21 CFR 310.537(b), any orally administered product that is labeled, represented, or promoted to treat or remove cold sores, and that is not the subject of an FDA-approved application, is misbranded under section 502 of the Act [21 U.S.C. §352].
The violations cited in this letter are not intended to be an all-inclusive statement of violations that exist in connection with your products. You are responsible for investigating and determining the causes of the violations identified above and for preventing their recurrence or the occurrence of other violations. It is your responsibility to assure that your firm complies with all requirements of federal law, the Act and its implementing regulations.
You should take prompt action to correct the violations cited in this letter. Failure to promptly correct these violations may result in legal action without further notice, including, without limitation, seizure and injunction. Other federal agencies may take this Warning Letter into account when considering the award of contracts.
Within fifteen working days of receipt of this letter, please notify this office in writing of the specific steps that you have taken to correct violations. Include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation. If you cannot complete corrective action within fifteen working days, state the reason for the delay and the time within which you will complete the correction. Furthermore, please advise this office what actions you will take to address product that you have already distributed.
Address your reply to the U.S. Food and Drug Administration; Attn: Winston Alejo, Compliance Officer, 555 Winderley Place, Suite 200, Maitland, FL 32751. You may reach Mr. Alejo at (407) 475-4731 if you have any questions about this matter.
A description of the new drug approval process can be found on FDA’s Internet website at http://www.fda.gov/cder/regulatory/applications/default.htm. Any questions you may have regarding this process should be directed to the Food and Drug Administration, Division of Drug Information, Center for Drug Evaluation and Research, 10001 New Hampshire Avenue, Silver Spring, MD 20993.
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.)
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 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/
Emma R. Singleton
District Director
Florida District Office
U.S. Food and Drug Administration
/S/
Deborah M. Autor, Esq.
Director
Office of Compliance
Center for Drug Evaluation and Research
U.S. Food and Drug Administration
/S/
Mary K. Engle
Associate Director
Division of Advertising Practices
Federal Trade Commission
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