| 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. Guy Lyman
Flor Nutraceuticals, LLC
PO Box 720264
Dallas, TX 75372
Dear Mr. Lyman:
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.herpaflor.com. The FDA has determined your firm's marketing of the products Herpaflor Outbreak Response Topical Liquid, Herpaflor Outbreak Response Tablets, and Herpaflor Daily Formula Tablets, 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)]. These 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:
General Claims for all Herpaflor products:
• "Put an end to Herpes Outbreaks!"
• "Finally, there's a real solution for the millions who suffer from genital herpes and oral herpes (cold sores)."
• "We've combined SEVENTEEN of the most researched and proven herpes killers in a single formula ...."
• "Some Herpaflor® ingredients have proven to penetrate and destroy the herpes virus in vitro. Others inhibit replication and spreading. Still others have even shown an ability to suppress future outbreaks."
• "In addition to attacking the virus, several of the natural ingredients in Herpaflor® immediately begin reducing pain and inflammation - without chemicals! Others accelerate the healing process. Unlike some prescription medications, Herpaflor® is designed to be more than a virucide; it mitigates pain and inflammation as well!"
• "Though the formulation of Herpaflor® is quite complex, the idea behind it is simple: take all the compounds best known to inhibit or destroy the herpes virus, concentrate them in their most potent form, and combine them in a single bottle."
Herpaflor Outbreak Response Topical Liquid
• "Applied directly to the skin, Herpaflor Topical is guaranteed to prevent or dramatically shorten outbreaks, and to immediately reduce pain!"
Herpaflor Outbreak Response Tablets
• "Herpaflor Tablets taken at the first signs of an outbreak will prevent or greatly shorten duration of sores."
Herpaflor Outbreak Response Combo Pack (contains Outbreak Response Topical Liquid and Outbreak Response Tablets)
• "Together, Herpaflor Topical and Herpaflor Tablets give you the ULTIMATE solution for fighting outbreaks."
Herpaflor Daily Formula Tablets (also described as "Herpaflor Daily Program")
• "Herpaflor Daily is a scientifically-balanced formula designed to be taken every day, to reduce the number of outbreaks you experience, and shorten their duration should they
occur."
• "We use pharmaceutical-grade L-Lysine in the potency and amount used in the best-known clinical trials for the daily suppression of herpes ...."
• "Licorice Root ... A potent natural herpes killer."
• "Prunella Vulgaris ... Another powerful natural anti-viral."
• "Vitamin C ... and rose hips... Inhibits reproduction of the herpes virus and formation of sores."
• "Zinc ... inhibits reproduction of the herpes virus."
The Herpaflor Complete Package (contains Outbreak Response Topical Liquid, Herpaflor Daily Formula Tablets, and Outbreak Response Tablets)
• "Youll [sic] reduce the frequency and intensity of your outbreaks, AND be fully prepared to kill off an outbreak with the Outbreak Response Tablets and Topical if you do feel one starting! This is the most powerful, all-natural outbreak control program available ANYWHERE, at ANY price!"
Based on these claims, your products are drugs as defined by sections 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 Herpaflor Outbreak Response Topical Liquid, Herpaflor Outbreak Response Tablets, and Herpaflor Daily Formula Tablets (a.k.a. Herpaflor Daily Program) 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 this use. 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 Herpaflor Outbreak Response Topical Liquid, Herpaflor Outbreak Response Tablets, and Herpaflor Daily Formula Tablets 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 5020) of the Act [21 U.S.C. § 352(j)].
Genital Herpes and Cold Sores
Claims Regarding Treatment of Genital Herpes
We note that your Herpaflor Outbreak Response Topical Liquid, Herpaflor Outbreak Response Tablets, and Herpaflor Daily Formula Tablets are offered over-the-counter (OTC) for the treatment of genital herpes. This indication 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 Outbreak Response Topical Liquid product is intended for indications covered by the TFM for fever blister and cold sore treatment drug products, this product is also inconsistent with the OTC Drug Review for such products in other respects. For example, according to your website, the active ingredients are "RMA Polysaccharides," "Zinc Sulfate," "Prunella Vulgaris," "L-Lysine," "Opuntia Streptacantha," "Glycyrrhiza(from Licorice Root)" "Sage," "Lemon Balm (Melissa Officinalis," "Reishi Mushroom,"" Tea Tree Essential Oil," "Spirulina," "Oregano Essential Oil," "Rosemary Essential Oil," "Peppermint Essential Oil," " Chaparral (Larrea tridentate)," "Aloe Vera," ""Vitamin B6," "Licorice Root," "Prunella Vulgaris," "Vitamin C and rose hips," and "Zinc." These active ingredients have not been evaluated under the OTC Drug Review for fever blister and cold sore products.
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 Herpaflor Outbreak Response Tablets and Herpaflor Daily Formula Tablets, 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 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.
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: Shari Shambaugh, Director, Compliance Branch, 4040 North Central Expressway, Suite 300, Dallas, TX 75204. You may reach Ms. Shambaugh at (214) 253-5215 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 Fed 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 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).
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/
Reynaldo Rodriguez
District Director
Dallas 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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