| Public Health Service Food and Drug Administration |
| Southwest Region Denver District Office Bldg, 20-Denver Federal Center PO, Box 25087 6th Avenue & Kipling Street Denver, Colorado 80225-0087 Telephone: 303-236-3000 FAX: 303-236-3551 |
Department of Health and Human ServicesOctober 12, 2010
Ref: DEN-11-01-WL
WARNING LETTER
VIA UPS
Mr. Jay Salmon
World Health Products, LLC
12685 South 125 East
Draper, Utah 84020
Dear Mr. Salmon:
This letter concerns your firm's marketing of its Detoxamin products, Detoxamin Oral, Detoxamin Suppositories, and the Metal Detector test kit on your website, www.detoxamin.com These products are marketed in violation of provisions of the Federal Food, Drug, and Cosmetic
Act (the Act) as described below.
According to the labeling, Detoxamin is intended to affect the structure or function of the body of man or other animals and/or intended to cure, mitigate, treat, or prevent disease conditions.1 Statements documenting these intended uses include, but are not limited to, the following:
• "Detoxamin is a smart and effective way to safely remove the toxic metals which are now clearly associated with many diseases like heart and cardiovascular disease, chronic fatigue, autism, and so many more."
• "[A] case study supports the use of chelation therapy to correct neurological damage. They used monthly intravenous injections of EDTA to remove mercury in a patient. .."
• "How can Detoxamin help you lose weight. . ."
• "Detoxamin can effectively remove heavy metal toxins, on a cellular level, where they are doing the most damage."
• "Decreases free radical damage caused by heavy metal toxins."
Your website further lists several articles/papers demonstrating the intended use of your products, including, but not limited to, the following:
• Ninety Percent Reduction in Cancer Mortality after Chelation Therapy with EDTA
• EDTA Chelation Therapy III Treatment of Peripheral Arterial Occlusion and Alternative to Amputation
• EDTA Chelation Therapy Efficacy in Arteriosclerotic Heart Disease
• Carotid Restenosis a Case for EDTA Chelation
• A Nonsurgical Approach to Obstructive Carotid Stenosis Using EDTA Chelation
• Chelation Therapy of Occlusive Arteriosclerosis in Diabetic Patients
• Disappearance of Immune Deposits with EDTA Therapy in a Case of IgA Nephropathy
• Disintegration of Retroviruses by Chelating Agents
• Lead Toxicity Chelation Therapy New Findings
• Visual Field Evidence of Macular Degeneration Reversal Using a Combination of EDTA Chelation and Multiple Vitamin and Trace Mineral Therapy
Your firm markets Detoxamin Oral as a dietary supplement. However, this product is a drug, as defined by section 201 (g)(1)(B) of the Federal Food, Drug, and Cosmetic Act ("the Act"), 21 U.S.C. § 321(g)(1)(B), because it is intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease. Detoxamin Suppositories are also drugs under section 201(g)(1) of the Act, 21 U.S.C. § 321 (g)(1), because they are intended to affect the structure or function of the body and/or intended for use tn the diagnosis, cure, mitigation, treatment or prevention of disease in man. We note that certain versions of Detoxamin Suppositories are represented as dietary supplements. To the extent that these products are not intended for ingestion, they are not dietary supplements as defined by section 201(ff) of the Act, 21 U.S.C. § 321(ff).
Moreover, Detoxamin Oral and Detoxamin Suppositories 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 use under the conditions prescribed, recommended, or suggested in their labeling. 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 Detoxamin Oral and Detoxamin Suppositories without approved applications violates these provisions of the Act.
Furthermore, Detoxamin Oral and Detoxamin Suppositories are offered for conditions such as, but not limited to, cardiovascular disease, autism, cancer, carotid stenosis, atherosclerosis, lead toxicity, and macular degeneration, which are not amenable to self-diagnosis and treatment by individuals who are not medical practitioners. Therefore, adequate directions cannot be written so that a layman can use Detoxamin Oral and/or Detoxamin Suppositories safely for their intended uses. Thus, labeling of Detoxamin Oral and Detoxamin Suppositories fail to bear adequate directions for their intended uses, causing them to be misbranded under section 502(f)(1) of the Act, 21 U.S.C. § 352(f)(1). Neither Detoxamin Oral nor Detoxamin Suppositories are exempt under 21 C.F.R. §§ 201.100(c)(2) and 201.115 from the requirement that their labeling bear adequate directions for use because the products lack approved applications.
Section 502(a) of the Act, 21 U.S.C. § 352(a), states that a drug is misbranded if its labeling is false or misleading in any particular. Your website states that Detoxamin is a "viable alternative to IV EDTA." However, the FDA-approved labeling for IV EDTA (e.g., Calcium Disodium Versenate (Edetate calcium disodium)) 2 states that "Edetate calcium disodium is poorly absorbed from the gastrointestinal tract"3 Therefore, the statement that Detoxamin is a viable alternative to IV EDTA when the suppository product requires absorption from the gastrointestinal tract in order to exert its claimed effects, renders your product's labeling false or misleading. As such, Detoxamin is misbranded under section 502(a) of the Act, 21 U.S.C. § 352(a). The introduction or delivery for introduction into interstate commerce of this misbranded drug violates section 301(a) of the Act, 21 U.S.C. §§ 331(a).
In addition to the new drug that you market and sell on your website in violation of the Act, you also market and sell the Metal Detector test kit in violation of the Act. The Metal Detector test kit is a device because it is intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals. Your website www.detoxamin.com states: "The Metal Detector test kits are designed especially to detect the presence of toxic heavy metals in the body using urine." The Metal Detector test kit, used to detect heavy metals in human urine, is adulterated under section 501(f)(1)(B) of the Act, 21 U.S.C. §351(f)(1)(B), because an approved application for premarket approval (PMA) pursuant to section 515(a) of the Act, §21 U.S.C. 360e(a) or an approved application for an investigational device exemption (IDE) under section 520(g) of the Act, 21 U.S.C. §360j(g), are not in effect for it.
The Metal Detector test kit is also misbranded under section 502(0) of the Act, 21 U.S.C. §352(0), in that it was manufactured, prepared, propagated, compounded or processed in an establishment not duly registered under section 510 of the Act, 21 U.S.C. §360; not included in a list required by 510(j), 21 U.S.C. §360(j); and notification or other information respecting the device was not provided to the FDA as required by section 510(k) of the Act, 21 U.S.C. §360(k).
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 ensure 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. Furthermore, please advise this office what actions you will take to address product that you have already distributed. 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 Food and Drug Administration, Denver District Office, Bldg. 20 - Denver Federal Center, 6th Avenue & Kipling Street, Denver, Colorado 80225-0087, Attention: Thomas R. Berry, Compliance Officer.
A description of the new drug approval process can be found on FDA's internet website at http://www.fda.gov/Drugs/DevelopmentApprovalProcess/default.htm. In addition, information regarding approval or clearance for devices is described at http://www.fda.gov/cdrh/devadvice/3122.html. 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, 10903 New Hampshire Avenue, W051-2201, Silver Spring, Maryland 20993-0002
Sincerely,
/s
H. Thomas Warwick, Jr.
Denver District Director
__________
1 These claims refer to Detoxamin generally (presumably both oral and suppository) or Detoxamin Suppositories.
2 Injectable edentate calcium disodium (commonly known as EDTA) is FDA approved under the trade name Calcium Disodium Versenale for intravenous and intramuscular administration for therapeutic use in lead poisoning and lead encephalopathy.
3 See FDA approved insert labeling for Calcium Disodium Versenate (NDA 008922) at
http:www.accessdata.fda.gov/drugsatfda_docs/label/2009/008922s016lbl.pdf
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