- Eidon Incorporated
- Issuing Office:
- Los Angeles District Office
| || |
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
Los Angeles District
Irvine, CA 92612-2506
VIA UNITED PARCEL SERVICE
November 5, 2015
President and CEO
12330 Stowe Drive
Poway, CA 92064
Dear Mr. Wagner:
The United States Food and Drug Administration (FDA) conducted an inspection of your dietary supplement manufacturing facility, Eidon Inc., located at 12330 Stowe Drive, Poway, California on February 19, 2015 to March 5, 2015. The inspection revealed serious violations of the FDA’s regulations for Current Good Manufacturing Practice (CGMP) in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements, under Title 21, Code of Federal Regulations (CFR), Part 111 (21 CFR Part 111). These violations cause the dietary supplement products Eidon® Ionic Minerals Immune Support and Eidon® Ionic Minerals Magnesium to be adulterated within the meaning of section 402(g)(1) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 342(g)(1)] in that they have been prepared, packed, or held under conditions that do not meet CGMP requirements for dietary supplements.
We have received your written responses dated March 20 and July 7, 2015, concerning our investigator’s observations noted on the Form FDA 483, Inspectional Observations, which was issued to you on March 5, 2015. Our comments regarding the adequacy of the actions you took to correct the objectionable conditions and practices observed during the inspection are detailed after the applicable violations, noted below.
In addition, FDA reviewed your product labeling collected during our inspection and your website at the internet address http://www.eidon.com on April 22 and October 7, 2015, and has determined that you take orders for your various Eidon® products that are being promoted for conditions that cause the products to be drugs under section 201(g)(1)(B) of the Act [21 U.S.C. § 321(g)(1)(B)]. The therapeutic claims on your websites and in your product labeling establish that the products are drugs because they are intended for use in the cure, mitigation, treatment, or prevention of disease. As explained further below, introducing or delivering these products for introduction into interstate commerce for such uses violates the Act.
The significant violations documented during the inspection include, but are not limited to, the following:
Unapproved New Drugs
Examples of some of the claims that provide evidence that your Eidon® products, including Eidon® Ionic Minerals Immune Support, Eidon® Ionic Minerals Immune Support Liquid Concentrate, Eidon® Ionic Minerals Sulfur, Eidon® Ionic Minerals Sulfur Liquid Concentrate, Eidon® Ionic Minerals Silica, and Eidon® Ionic Minerals BSE Brown Seaweed Extract, are intended for uses as drugs include:
- For Eidon® Ionic Minerals Immune Support and Eidon® Ionic Minerals Immune Support Liquid Concentrate, you claim, “Eidon Immune Support…[t]he blend of zinc, selenium, sulfur and silver is a combination optimized to give your body the essential nutrients required to effectively and naturally deal with the cold and flu season. Also, wounds and infections respond well to both internal and topical applications of Eidon Immune Support.” “SELENIUM – Inhibits viral mutation. SULFUR – Calms the body’s inflammatory response. SILVER - Provides a natural defense against bacteria.”
- For Eidon® Ionic Minerals Sulfur and Eidon® Ionic Minerals Sulfur Liquid Concentrate, you claim, “Sulfur is a natural detoxifier for lead…reduces pain and inflammation and promotes healing.” “Sulfur’s anti-inflammatory properties and ability to repair scar tissue around damaged areas explains its power to alleviate rheumatoid arthritis.” “Sulfur alleviates the pain associated with osteoarthritis by acting as an anti-inflammatory. Sulfur is also known for its ability to help with digestive disorders, such as heartburn, indigestion, and gastritis.”
- For Eidon® Ionic Minerals Silica and Eidon® Ionic Minerals Silica Liquid Concentrate, you claim, “Supplementation with this essential element may improve or alleviate many of the following diverse symptoms: Teeth and gum disease, and structural failure…Gastrointestinal products such as acid reflux, and Crohn’s disease. Arthritis symptoms primarily associated with osteoarthritis…Arteriosclerosis…Skin, hair and nail disorders.”
- For Eidon® Ionic Minerals BSE Brown Seaweed Extract, you claim, “Brown seaweeds also contain polysaccharides such as alginates. Alginates have been shown to chemically bind toxic metals and radioactive isotopes and aid in their elimination from the body. Alginates proved to be so functionally effective at this task that they were used to treat radiation sickness in Chernobyl disaster victims.” “Helps to decrease high blood sugar and to normalize cholesterol levels.”
Your products are not generally recognized as safe and effective for the above referenced uses and, therefore, your Eidon® products are new drugs under section 201(p) of the Act [21 U.S.C. § 321(p)]. New drugs may not be legally introduced or delivered for introduction into interstate commerce without prior approval from FDA, as described in section 505(a) of the Act [21 U.S.C. § 355(a)]; see also section 301(d) of the Act [21 U.S.C. § 331(d)]. 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.
Furthermore, your Eidon® products are offered for conditions that are not amenable to self-diagnosis and treatment by individuals who are not medical practitioners; therefore, adequate directions for use cannot be written so that a layperson can use these drugs safely for their intended purposes. Thus, these drugs aremisbranded within the meaning of section 502(f)(1) of the Act, in that their labeling fails to bear adequate directions for use [21 U.S.C. § 352(f)(1)]. The introduction of a misbranded drug into interstate commerce is a violation of section 301(a) of the Act [21 U.S.C. § 331(a)].
Adulterated Dietary Supplements
Even if your “Eidon® Ionic Minerals Immune Support and Eidon® Ionic Minerals Magnesium” products did not have therapeutic claims which make them unapproved drugs, these dietary supplement products are adulterated under section 402(g)(1) of the Act [21 U.S.C. § 342(g)(1)] in that they have been prepared, packed, or held under conditions that do not meet the Current Good Manufacturing Practice (CGMP) requirements for dietary supplements, Title 21, Code of Federal Regulations, Part 111 (21 CFR Part 111).
The inspection revealed the following significant violations of the CGMP requirements for dietary supplements. These violations cause your dietary supplement products to be adulterated under section 402(g)(l) of the Act [21 U.S.C. § 342(g)(l)] in that they have been prepared, packed, or held under conditions which do not meet the CGMP regulations for dietary supplements.
Specifically, during the inspection, our investigator observed the following violations:
1. You failed to identify and use an appropriate scientifically valid method for each established specification for which testing or examination is required to determine whether the specification is met, as required by 21 CFR 111.320(b). Specifically, your component and specification factors for the component Zinc Sulfate Heptahydrate states that the ID test is confirmed by HPLC, by a third party lab. However, HPLC for this material is not possible.
2. You failed to establish and follow written procedures for fulfilling the requirements for packaging of dietary supplements as required by 21 CFR 111.153. Specifically, during the inspection, you were unable to provide written procedures related to packaging examination and identification of immediate containers and closures, as required by 21 CFR 111.160.
We have reviewed your responses dated March 20 and July 7, 2015. You indicated in your responses that written procedures for container and closure systems were being created to ensure that specifications are met, tested, and incorporated into quality control. However, we have not received written procedures for handling packaging received, including procedures for packaging examination and identification of immediate containers and closures.
3. You failed to identify each unique lot within each unique shipment of labels in a manner that allows you to trace the lot to the supplier, the date received, the name of the label, the status of the label (e.g. quarantined, approved, or rejected); and to the dietary supplement that you distributed, as required by 21 CFR 111.160(d)(1). Specifically, you told our investigator that for labels received, you write the date received on the outer plastic wrapping, compare them to the previous lot, and use the rolls in a first in first out (FIFO) basis; however you do not assign a unique lot number to the labels you receive for the labeling of dietary supplement.
We have reviewed your responses dated March 20 and July 7, 2015. Your SOP No.14.1, Rev No: 03, Issued: June 3, 2015 suggests that unique identifiers will be assigned to labels you receive from your supplier. You also indicated in your responses that your employees were retrained to assign unique lot numbers to labels in the future. Your responses are inadequate in that you did not provide documentation that shows you have implemented this requirement.
This letter is not an intended to be an all-inclusive list of violations in connection with your products. It is your responsibility to ensure that your establishment and your products comply with the Act and its implementing regulations. You should take prompt action to correct all violations noted in this letter.
Failure to promptly correct these violations may result in enforcement action without further notice, such as seizure and/or injunction.
Please respond in writing within fifteen (15) working days from your receipt of this letter. Your response should outline the specific actions you are taking to correct these violations and to prevent similar violations from occurring in the future. You should include in your response documentation and any other useful information that would assist us in evaluating your corrections. If you cannot complete all corrections before you respond, you should explain the reason for your delay and state when you will correct any remaining violations.
Section 743 of the Act [21 U.S.C. 379j-31] authorizes FDA to assess and collect fees to cover the FDA’s costs for certain activities, including reinspection-related costs. A reinspection is one or more inspections conducted subsequent to an inspection that identified noncompliance materially related to a food safety requirement of the Act, specifically to determine whether compliance has been achieved. Reinspection-related costs means all expenses, including administrative expenses, incurred in connection with FDA’s arranging, conducting, and evaluating the results of the reinspection and assessing and collecting the reinspection fees [21 U.S.C. 379j-31(a)(2)(B)]. For a domestic facility, FDA will assess and collect fees for reinspection-related costs from the responsible party for the domestic facility. The inspection noted in this letter identified noncompliance materially related to a food safety requirement of the Act. Accordingly, the FDA may assess fees to cover any reinspection-related costs.
Your response should be sent to:
Acting 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 Jessica Mu, Compliance Officer, at 949-608-4477. Include Special Identifier FEI #3004402329 on all correspondence.
LCDR Steven Porter, Acting Director
Los Angeles District
David M. Mazzera, Ph.D.
Chief, Food and Drug Branch
California Department of Public Health
1500 Capitol Avenue, MS-7602
P.O. Box 997435
Sacramento, CA 95899-7435