Inspections, Compliance, Enforcement, and Criminal Investigations
Eidon Incorporated 4/8/11
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
Los Angeles District
RETURN RECEIPT REQUESTED
April 8, 2011
Richard M. Wagner
12330 Stowe Dr.
Poway, CA 92064
Dear Mr. Wagner:
This is to advise you that the Food and Drug Administration (FDA) has reviewed your web site at the Internet address http://www.eidon.com in March 2011 and has determined that your product, “Liquid Iodine,” is promoted for conditions that cause the product to be a drug under section 201(g)(1) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 321(g)(1)(B)]. The therapeutic claims on your web site establish that this product is a drug because it is intended for use in the cure, mitigation, treatment, or prevention of disease. The marketing of this product with these claims violates the Act.
Examples of some of the claims observed on your website include:
Under the heading, “A Short Note on Iodine Supplementation” on your home page:
■ “Due to the earthquake disaster in Japan and the associated damage to one or more nuclear reactors, awareness for the need for iodine as thyroid protection is widespread on all news media. Eidon manufactures a liquid iodine supplement perfectly suited for protection of not only the thyroid, but also the tissues of the breast, and prostrate [sic] from the impact of radioactive iodine-131 absorption. If your thyroid is replete with elemental iodine the radioactive iodine-131 will not be absorbed into this organ. The same holds true for breast and prostate tissues.”
Under the heading, “Iodine Supplementation” on the webpage titled, “Iodine as Thyroid Protection”:
■ “Due to the earthquake disaster in Japan and the associated damage to one or more nuclear reactors, awareness for the need for iodine as thyroid protection is widespread on all news media…. The recommendation of 130mgs per dose is seen a lot in the media surrounding radioactive exposure….We recommend anyone taking our iodine start out with the suggested dose of 2 drops daily (.225mgs) and work up to between 5 and 10 drops daily. This level of dosing should be adequate for most individuals to achieve iodine replete thyroid tissue. If you desire to take more, increase your dosing slowly up to a maximum of 30 drops daily (3.4mgs).”
Your product is not generally recognized as safe and effective for the above referenced uses and, therefore, the product is a “new drug” under section 201(p) of the Act [21 U.S.C. § 321(p)]. New drugs may not be legally marketed in the U.S. without prior approval from FDA as described in section 505(a) of the Act [21 U.S.C. § 355(a)]. FDA approves a new drug on the basis of scientific data submitted by a drug sponsor to demonstrate that the drug is safe and effective.
The above violation is not meant to be an all-inclusive list of deficiencies in your product and their labeling. It is your responsibility to ensure that all of your products and labeling are in compliance with the laws and regulations enforced by FDA. You should take prompt action to correct the violations. Failure to promptly correct these violations may result in regulatory action without further notice, such as seizure and/or injunction.
Please notify this office in writing within fifteen (15) working days from your receipt of this letter as to the specific steps you have taken to correct the violations noted above and to assure that similar violations do not occur. Your response should include any documentation necessary to show that correction has been achieved. If you cannot complete all corrections before you respond, please explain the reason for the delay and state the date by which the corrections will be completed.
Your response should be sent to:
Director, Compliance Branch
Food and Drug Administration
Los Angeles District Office
Irvine, CA 92612
If you have any questions about the content of this letter, please contact Mei-Chen (Jessica) Mu, Compliance Officer, at 949-608-4477.
Alonza E. Cruse