Department of Health and Human Services' logo Department of Health and Human Services

Public Health Service
Food and Drug Administration
  Dallas District
4040 North Central Expressway
Dallas, Texas 75204-3128

March 4, 2008


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, 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:


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 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.
Dallas District
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


This page was posted on July 19, 2010.

Links to Recommended Companies

  • Compare drug prices and save money at verified online pharmacies.
  • Evaluates the quality of dietary supplement and herbal products.
  • Discount prices, huge inventory, and superb customer service.
  • OnlyMyEmail: Award-winning anti-spam services.
  • 10 Types: Website design, development, and hosting with superb technical support.