Inspections, Compliance, Enforcement, and Criminal Investigations
IMULUX, LLC 04-Mar-08
Department of Health and Human Services
Public Health Service
March 4, 2008
VIA FEDERAL EXPRESS
RETURN RECEIPT REQUESTED
Attention: Jon F. Stoneburner, O.D.
7221 Free Ferry Road
Fort Smith, AR 72903
Dear Dr. Stoneburner:
This letter concerns your firm’s marketing of the product “IMULUX” on your website, www.imulux.com. Based on claims made on your website, this product is promoted as intended to prevent, treat, or cure disease conditions, or to affect the structure or function of the body. Statements on your website that document these intended uses include, but are not limited to, the following:
• “Treat Once For Life Today”
• “Imulux Treatment Kills all Herpes Viruses WITHOUT having to use conventional drugs or medications”
• “Genital Herpes (Genital Herpes, STD) Treat Now”
• “Effective against all forms of herpes, including shingles”
• "IMULUX is my first line of defense and the only effective treatment for Herpes."
• “Immediately ends outbreaks of Oral Herpes”
• “Frees you from further outbreaks for life – Guaranteed!”
• “But only IMULUX is truly effective because it doesn’t simply end an outbreak: it actually kills any strain of herpes virus that caused it.”
• “So not only is a current outbreak ended; you will remain outbreak-free from that herpes strain for life – Guaranteed”
• “Kills all Genital Warts Virus Strains”
• “IMULUX is a new scientific breakthrough -- proven safe and effective -- that is uniquely able to actually kill all strains of the Shingles (Herpes Zoster) virus.”
• “Even better, the virus dies in one infected cell after another throughout the body. As this occurs, the dead viruses cause the body to form antibodies -- protecting you from future outbreaks.”
• “The treatment, now named IMULUX, is effective and safe for oral and genital herpes, genital warts, and shingles. Over the years, thousands of clinical trial patients have benefited from the IMULUX procedure.”
• “I considered modern medicine a complete failure in the war against viruses until the addition of Imulux. It has allowed me to treat herpes patients with renewed confidence.”
• “In less than 30 minutes the treatment will be complete and your Genital Herpes virus killed. The IMULUX treatment will enhance most patients’ ability to fight future symptoms: another outbreak will never occur.”
• “Other remedies may offer temporary relief, but IMULUX also suppresses future outbreaks.”
• “Prior to the advent of IMULUX, there was no medical option that could both stop an outbreak of Oral Herpes and prevent subsequent outbreaks.”
• “The product is so effective, in fact, that 93% of those infected with oral or genital herpes or shingles will be treated successfully with IMULUX.”
• “Even better, IMULUX actually helps to teach your body to eliminate the virus internally, and helps stop future outbreaks.”
• “IMULUX works effectively on any of the eight human herpes types, provided there is a skin outbreak. This includes oral, genital and shingles (herpes zoster). IMULUX also works effectively on Condyloma (a general class of viruses known to be responsible for genital warts). It has even been found in clinical studies to be an effective treatment for non-genital warts.”
These claims are further supplemented by the metatags that you use to bring consumers to your website. The metatags include “herpes,” “herpes simplex,” “genital herpes,” “herpes shingles,” “genital herpes symptoms,” “herpes virus,” “herpes treatment,” “herpes outbreaks,” “genital warts,” “STD,” “HPV,” “HPVI,” “HPVII,” “HPVIII,” “herpes solution,” “herpes cure,” and “herpes zoster.”
IMULUX is a drug/device combination product. The product meets the definition of a drug, under section 201(g)(1) of the Federal Food, Drug, and Cosmetic Act (Act), 21 U.S.C. § 321(g)(1), because it is intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in humans, or to affect the structure or any function of the body of man or other animals, and acts through chemical or metabolic action within or on the body. Moreover, this product is a new drug, as defined by section 201(p) of the Act, 21 U.S.C. § 321(p), because it is not generally recognized as safe and effective for its labeled uses. Under sections 301(d) and 505(a) of the Act, 21 U.S.C. §§ 331(d) and 355(a), a new drug may not be introduced or delivered for introduction into interstate commerce unless an FDA-approved application is in effect for it. Your sale of IMULUX without such an approved application violates these provisions of the Act.
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, IMULUX’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).
Additionally, FDA is concerned that the promotional statement on your website “IMULUX is a patented system composed of two US FDA approved class I medical devices” misleadingly implies that FDA has approved the combination of these products for this intended use.
The label or labeling of an investigational new drug may not bear any statement that is false or misleading and may not represent that the investigational new drug is safe or effective for the purpose for which it is being investigated. See 21 CFR § 312.6. Additionally, pursuant to 21 CFR § 312.7, a sponsor or investigator, or any person acting on their behalf, may not represent in a promotional context that an investigational new drug is safe or effective for the purposes for which it is under investigation, or otherwise promote the drug. Furthermore, a sponsor or investigator may not commercially distribute or test market an investigational new drug. See 21 CFR § 312.7. Your marketing of IMULUX violates these provisions.
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 and FDA 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. If you no longer manufacture or market IMULUX, your response should so indicate, including the reasons that, and the date on which, you ceased production. Additionally, if another firm manufactures the product identified above, your reply should include the name and address of the manufacturer. If the firm from which you receive the product is not the manufacturer, please include the name of your supplier in addition to the manufacturer. Address your reply to the U.S. Food and Drug Administration, 4040 N. Central Expressway, Suite 300, Dallas, Texas 75204, Attention: Edwin Ramos, Compliance Officer.
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 (HFD 240), Center for Drug Evaluation and Research, 5600 Fishers Lane, Rockville, Maryland 20857.
Reynaldo R. Rodriguez, Jr.
U.S. Food and Drug Administration
Attention: Jon F. Stoneburner, O.D.
25 Hubbells Drive
Mount Kisco, NY 10549
Attention: Charles S. Campbell
Executive Director, Arkansas Board of Pharmacy
101 E Capitol, Suite 218
Little Rock, AR 72201
Attention: Trent P. Pierce, M.D.
Chairman, Arkansas State Medical Board
2100 Riverfront Drive
Little Rock, AR 72202