| 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
Mr. John Fields
Derma Remedies
247 Calvert Circle
Bunker Hill, WVA 25413
Derma Remedies
788 Foxcroft Avenue Suite #201
Martinsburg, WVA 25401
Dear Mr. Fields:
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 website at the Internet address www.dermaremedies.com. The FDA has determined your firm's marketing of the products H-Stop Dx, H-Guard Dx, Molluscum Dx, and Wart Dx, 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 misbranded under sections 502 and 502(f)(1) of the Act [21 U.S.C §§ 352 and 352(f)(1)]. Your H-Stop Dx and H-Guard Dx products are further misbranded under section 502(j) of the Act 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:
H-Stop Dx and H-Guard Dx
• "Herpes Treatment, Natural Genital Herpes Medication -Guaranteed!"
• "Complete Oral and Genital Herpes Remedy and Prevention"
• "Guaranteed Herpes Treatment with H-Stop Dx"
• "Instant Relief from intense Herpes Symptoms"
• "Effective on Genital Herpes and Cold Sores"
• "Herpes Prevention with H-Guard Dx"
• "Get rid of Herpes Outbreaks -Guaranteed!"
• "Derma Remedies has a proven effective formula which is guaranteed to get rid of your herpes outbreak completely!"
• "H-Stop Dx is a unique remedy that specifically targets both the herpes simplex virus 1 and 2. The formula will treat the outbreak -the blisters and sores. It will also provide relief from the discomfort due to the formula's anti viral and healing properties."
• "Years of research and testing have enabled us to perfect a formula which has proven results and will eliminate your herpes outbreaks effectively."
• "Melaleuca alternifolia -... Renowned for its broad spectrum action from anti microbial to anti viral."
• "Palmarosa -Effective antiviral and antibacterial agent ...."
• "Geranium Antiseptic and [sic] pain reliever."
• "Aloe barbadensis -Has excellent anti-viral, anti-bacterial, anti-fungal and anti-inflammatory properties."
• "Melissa officinalis -Powerful antiviral agent."
Molluscum Dx
• "Molluscum Treatment, Naturally Eliminate Molluscum Contagiosum -Guaranteed!"
• "Derma Remedies is different and has a proven effective formula which is guaranteed to get rid of molluscum contagiosum completely!"
• "Breakthrough Molluscum Treatment -Molluscum Dx!"
• "Molluscum Dx is unique in that the formula eliminates the papules and lesions as well as treats the virus in the surrounding skin.. This prevents the spreading of the condition."
• "Melaleuca alternifolia ... Renowned for its broad spectrum action from anti microbial to anti viral."
• "Thuja occidentalis -Excellent anti viral and therapeutic properties."
• "Cupressus sempervirens -Antibiotic qualities."
• "Clove -Anti viral, antiseptic ... properties."
• "A cost effective, easy way to quickly eliminate molluscum contagiosum guaranteed!"
• "Molluscum Dx will get rid of molluscum with no pain."
• "Will gently and effectively eliminate your molluscum."
WartDx
• "Wart Treatment Genital Warts Removal"
• "Wart Removal, Natural Warts Treatment, Remove Genital Warts -Guaranteed!"
• "Derma Remedies is different and has proven effective formula which is guaranteed to get rid of warts completely!"
• "Wart Dx is unique in that the surface of the wart is treated and, most importantly, the root structure is attacked and eliminated. As a result there is no re-growth."
• "Melaleuca alternifolia ... Renowned for its broad spectrum action from anti microbial to anti viral."
• "Aloe barbadensis -Has excellent anti-viral, anti-bacterial, anti-fungal and anti-inflammatory properties"
• "Thuja occidentalis -Excellent anti viral and therapeutic properties."
• "Cupressus sempervirens -Antibiotic qualities"
• "Melissa officinalis -Powerful antiviral agent"
• "Wart Dx will get rid of warts with no pain or aggravation."
• "Will gently and effectively eliminate your warts."
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.
We note that your products are offered over-the-counter (OTC) for the treatment of genital herpes, molluscum contagiosum, and genital warts. These indications are 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 ineligible for inclusion in the OTC Drug Review.
The 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 H-Stop Dx, H-Guard Dx, Molluscum Dx, and Wart Dx without approved NDAs violates these provisions of the Act.
Moreover, genital herpes, molluscum contagiosum, and genital warts are 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 these conditions require 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 H-Stop Dx and II-Guard Dx 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)].
H-Stop Dx and H-Guard Dx
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 H-Stop Dx and H-Guard Dx products are intended for indications covered by the TFM for fever blister and cold sore treatment drug products, they are also inconsistent with the OTC Drug Review for such products in other respects. For example, according to your website, their active ingredients are "Melaleuca alternifolia," "Palmarosa," "Lavandula angustifolia," "Geranium Antiseptic," "Aloe barbadensis," "Melissa officinalis," and "Corylus avellana." These active ingredients have not been evaluated under the OTC Drug Review for fever blister and cold sore products.
WartDx
FDA has issued a final monograph for OTC drug products intended for the topical treatment of common and plantar warts. 21 CFR part 358 Subpart B. In order to be lawfully marketed under the final common and plantar wart remover monograph, a product must meet the requirements of the final monograph. We note that the active ingredients in Wart Dx are not included in that final monograph. Indeed, the final monograph lists salicylic acid as the only acceptable active ingredient for the topical treatment of common and plantar warts, and your product does not appear to contain salicylic acid.
Additionally, we note that the monograph requires that the labeling for OTC wart remover drugs contain the warning: "Do not use on ... genital warts[.]" 21 CFR § 358.150(c)(1)(iv). Wart Dx is not labeled with this warning; rather, as noted above, it is specifically labeled for the treatment and removal of genital warts.
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 the FDA 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 the FDA of 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: Randy Pack, Director, Compliance Branch, 6000 Metro Drive, Suite 101, Baltimore, MD 21215. You may reach Mr. Pack at (410)779-5454 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), aff'd, 624 F.3d 1 (1 st 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 V.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).
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 Of 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/
Evelyn Bonnin
District Director
Baltimore 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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