| 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. Rick Valle
Arenvy Laboratories, Inc.
1212-H El Camino Real #413
San Bruno, CA 94066
Dear Mr. Valle:
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.immuneglory.com. The FDA has determined your firm’s marketing of the ImmuneGlory products (ImmuneGlory), 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 under sections 502 and 502(f)(1) of the Act [21 U.S.C §§ 352 and 352(f)(1)]. Your ImmuneGlory 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 its labeling.
Labeling statements for the ImmuneGlory products (“Part 1” is a liquid; “Part 2” is a capsule) on your website include, but are not limited to, the following:
ImmuneGlory
• “Discover How You Can Finally Stop Herpes Outbreaks In Their Tracks . . .”
• “Oral and Genital Herpes”
• “Stop current outbreaks and eliminate future ones”
• “More than just preventing outbreaks, ImmuneGlory makes sure they never come back.”
• “[S]trengthens your immune system so that herpes or cold sores has [sic] nowhere to hide!”
• “It’s a breakthrough . . . that gives your immune system a super-human boost of herpes-fighting strength.”
• “Now, thanks to the breakthrough science behind ImmuneGlory, you can equip your body with what it needs to stop outbreaks once and for all.”
• “When a C1O2 ion comes in contact with the invading pathogen (like the herpes virus) it acts like a heat-seeking anti-viral missile…“blowing it up” on contact.”
• “Each dose of ImmuneGlory . . . is more then enough to say good-bye to your herpes or cold sore outbreaks forever.”
• “ImmuneGlory: Nature’s Answer to Eliminating Herpes or Cold Sore Outbreaks Once and For All!”
• “Live Outbreak-Free with ImmuneGlory”
• “It’s the ONLY Outbreak Elimination Kit that’s Guaranteed to Give You Relief from Herpes or Cold Sore Flare-Ups.”
• “ImmuneGlory helps strengthen your immune system to ward off invading pathogens like herpes and cold sores.”
• It’s the ultimate all-natural anti-herpes outbreak solution that will give you relief from herpes or cold sore outbreaks…guaranteed!”
• “I was desperate to find a ‘cure’ . . . Now I have found the perfect solution to my herpes . . . and it’s called ImmuneGlory.”
• “ImmuneGlory . . . arrived when I was having prodrome symptoms so I immediately mixed my first dose. Two days later the symptoms went away completely.”
• “By the fourth day when I woke up, the blisters on my genitals had totally vanished…”
These claims are supplemented by the metatags that you use to bring consumers to your website. These include “genital herpes,” “herpes virus,” “herpes cure,” “herpes,” “herpes treatment,” “cold sores,” “cold sore remedies,” and “The Best Cold Sore Treatment.”
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, 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 the ImmuneGlory products 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 so that a layperson can use your product 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 the ImmuneGlory products 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. The 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 ImmuneGlory products 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
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. Any OTC drug product for oral administration, including your ImmuneGlory products, that is labeled, represented, or promoted to treat or relieve the symptoms or discomfort of cold sores is regarded as a new drug and requires an approved NDA in order to be legally marketed. 21 CFR § 310.537(a) and (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 issues and violations cited in this letter are not intended to be an all-inclusive statement of violations that exist in connection with your product. 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: Carl Lee, Compliance Officer, 1431 Harbor Bay Parkway, Alameda, CA 94502. You may reach Mr. Lee at (510) 337-6737 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/
Barbara cassen
District Director
San Francisco District Office
U.S. Food and Drug Administration
Deborah M. Autor, Esq.
Director
Office of Compliance
Center for Drug Evaluation and Research
U.S. Food and Drug Administration
Mary K. Eagle
Associate Director
Division of Advertising Practices
Federal Trade Commission
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