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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Hormonal Health, LLC 10/12/10

  

Department of Health and Human Services' logoDepartment of Health and Human Services

Public Health Service
Food and Drug Administration
 Los Angeles District
Pacific Region
1970I Fairchild
Irvine, CA 92612-2506
Telephone: 949-608-2900
FAX: 949-608-44154

WARNING LETTER


VIA UPS NEXT DAY

 

October 12, 2010

W/L 04-11

Mr. Richard D. Brooks
Ms. Joan R. Campbell
Hormonal Health, LLC
357 West 2nd Street Suite 1A
San Bernardino, California  92401

Mr. Richard D. Brooks
Ms. Joan R. Campbell
Hormonal Health, LLC
1213 Goldfield Avenue
Carson City, Nevada  89701

Dear Mr. Brooks and Ms. Campbell:

This letter concerns your firm’s marketing of its Kelatox suppository product and its METALDETECTOR Instant Toxic Metals Test, on your websites, www.kelatox.com, www.kelatoxpro.com, and www.chelationhealthproducts.com.  This product is marketed in violation of provisions of the Federal Food, Drug, and Cosmetic Act (the Act) as described below.

According the labeling, Kelatox 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.  Statements documenting these intended uses include, but are not limited to, the following:

• “Kelatox . . . removes a wide range of toxic metals including Mercury, Lead and Aluminum from the body.”

• “Kelatox® uses Calcium Disodium EDTA . . . recommended . . . for lead poisoning and other toxic heavy metal conditions . . . as far ranging as decreased circulation, degenerative diseases such as Alzheimer’s, diabetes, decreased adrenal gland function and Autism. ”

• “The primary cause of endothelial dysfunction is the build up of heavy metals in this [endothelial] lining . . . .  The EDTA in Kelatox will remove heavy metals from the endothelium helping it to produce nitric oxide thereby allowing the blood vessels to relax increasing the blood flow.”

• “We have seen changes in patients with chronic fatigue, fibromyalgia, neurological diseases, depression, skin problems, headaches, and many more conditions.  This product is beneficial to help your patients heal.”

• “My husband was diagnosed with Parkinson’s Disease recently. . . .  Kelatox was ordered and started.  Within weeks, he was feeling better.  In eight weeks his massage therapist noticed a difference in his overall body . . . She was giving him massages for years and was never able to work “deep in his muscles” until he took Kelatox.”

• “I . . . have been taking IV EDTA since 1998 for macular degeneration.  I’ve recently switched to EDTA chelation suppositories. . . .  Because they are working so well, I am planning on dropping IV EDTA and solely using the chelation suppositories.”

• “I suffer from Peripheral Neuropathy and had lost all feeling in my legs. . . .  One month after I started Kelatox, I regained the sense of feeling completely in my right leg and partially in the left.”

Your firm markets Kelatox as a dietary supplement.  Because this product is a suppository and not intended for ingestion, it is not a dietary supplement as defined by section 201(ff) of the Act, 21 U.S.C. § 321(ff).  Rather, this product is a drug, as defined by section 201(g)(1) of the Act, 21 U.S.C. § 321(g)(1), because it is intended to affect the structure or function of the body and/or intended for use in the diagnosis, cure, mitigation, treatment or prevention of disease in man.

Moreover, Kelatox 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 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 Kelatox suppositories without an approved application violates these provisions of the Act.

Furthermore, Kelatox is offered for conditions such as, but not limited to, lead poisoning, Alzheimer’s disease, autism, endothelial dysfunction, Parkinson’s disease, macular degeneration, and peripheral neuropathy, which are not amendable to self-diagnoses and treatment by individuals who are not medical practitioners.  Therefore, adequate directions cannot be written so that a layman can use Kelatox safely for its intended uses.  Thus, the labeling of Kelatox suppositories 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).  Kelatox is not exempt, under 21 C.F.R. §§ 201.100(c)(2) and 201.115, from the requirement that its labeling bear adequate directions for use because Kelatox lacks an approved application.  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 websites in violation of the Act, you also market and sell the METALDETECTOR Instant Toxic Metals Test in violation of the Act.  The METALDETECTOR Instant Toxic Metals Test 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.kelatox.com states the following regarding the METALDETECTOR Instant Toxic Metals Test:

• “Test for the presence of toxic metals in urine or water, with this quick and convenient in-home test.”

• “The METALDECTOR™ Instant Toxic Metals Test readily detects free, electrically-active heavy metal ions.”

• “For anyone who is serious about avoiding degenerative diseases facing the human race, getting tested for heavy metals is more important than ever before.”

The METALDETECTOR Instant Toxic Metals Test, 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 METALDETECTOR Instant Toxic Metals Test is also misbranded under section 502(o) of the Act, 21 U.S.C. §352(o), 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. 

Your response should be sent to:

 Blake Bevill
 Director, Compliance Branch
 Food and Drug Administration
 19701 Fairchld
 Irvine, CA  92612-2506

If you have any questions regarding any issues in this letter, please contact Marco Esteves, Compliance Officer at (949) 608-4439

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, WO51-2201, Silver Spring, Maryland  20993.

Sincerely,

/S/


Alonza E. Cruse
District Director

 

 

cc: Jay Salmon
World Health Products, LLC
12685 South 125 East
Draper, Utah  84020

Marv Bateman
1189 E. Pinion St.
Washington, Utah  84780

Zayin of Utah Corporation
1022 W Smithsonian
Apple Valley, Utah  84737