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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Frad 35, Inc 19-Jul-06

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

Public Health Service
Food and Drug Administration

 

Dallas District
4040 North Central Expressway
Dallas, Texas 75204-3145




July 19, 2006

Re: 2006-DAL-WL-27

WARNING LETTER

VIA FEDERAL EXPRESS

Mr. Donald Worden
Frad 35, Inc.
8050 PR 2543
Clyde, TX 79510

Dear Mr. Worden:

This letter concerns your marketing of the product 35% Food Grade Hydrogen Peroxide on your website, www.h2o2-4u.com. According to information on your website, 35% Food Grade Hydrogen Peroxide is intended to prevent, treat, or cure disease conditions or to affect the structure or function of the body. The statement noted below is on your website and documents these intended uses:

35% Food Grade Hvdrocren Peroxide

  • "Bio-oxidative therapies are small amounts of diluted ozone and or hydrogen peroxide used in the body for the prevention and treatment of disease."

In addition, your website provides the link "Hydrogen Peroxide :[sic] Medical Miracle (Paperback, 1996)." This link takes consumers to the website, http://www.healthysecrets.com. Statements on this website also demonstrate that hydrogen peroxide is intended to prevent, treat, or cure disease conditions or to affect the structure or function of the body. Statements on this website that document these intended uses include, but are not limited to, the following:

  • "Intravenous hydrogen peroxide rapidly relieves allergic reactions, influenza symptoms, and acute viral infections."

  • "Tumor cells, bacteria, and other unwanted foreign elements in the blood can usually be destroyed with hydrogen peroxide treatment. Peroxide has a definite destructive effect on tumors, and, in fact, cancer therapy may prove to be the most dramatic and useful place for peroxide therapy. . . ."

Furthermore, your website provides the link "Forbidden Cures." This link takes consumers to the website, http://educate-yourself.org Statements on this website further demonstrate that hydrogen peroxide is intended to prevent, treat, or cure disease conditions or to affect the structure or any function of the body. The following is an example that documents these intended uses:

  • "Hydrogen peroxide can also be applied either internally as injections (directly into a cancerous tumor for example) or intravenously into the blood stream."

35% Food Grade Hydrogen Peroxide is a drug, as defined by Section 201(g)(1) of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. § 321(g)(1), because it is intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease, or to affect the structure or any function of the body of man or other animals. 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 35% Food Grade Hydrogen Peroxide without 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, 35% Food Grade Hydrogen Peroxide'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, 35% Food Grade Hydrogen Peroxide is dangerous to health when used in the dosage or manner; or with the frequency or duration prescribed, recommended, or suggested in the product's labeling . For example, hydrogen peroxide taken orally can cause severe gastrointestinal irritation leading to ulceration, and IV administration may result in vaculitis and potentially life-threatening allergic reactions. Therefore, your product is misbranded under Section 502(j) of the Act, 21 U.S.C. § 352(j).

The above violations are not. intended to be an all-inclusive list of deficiencies . It is your responsibility to ensure that the drug products that you manufacture, or distribute, meet all of the requirements of the Act and its implementing regulations. Federal agencies are advised of the issuance of all warning letters about drugs and devices so that they may take this information into account when considering the award of contracts.

You must immediately correct these violations. If you do not immediately correct them, you may be subject to enforcement action against you without further notice. The Act provides for the seizure of illegal products and for an injunction against the manufacturer and distributors of illegal products. Individuals and businesses that violate the Act may also be subject to criminal prosecution.

You must notify this office in writing within 15 working days of receipt of this letter as to the steps that you have taken to correct the above-listed violations and to assure that similar violations will not recur. If corrective action cannot be completed within 15 working days, state the reason for the delay and the time within which the corrections will be made. Additionally, if your firm does not manufacture 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 North Central Expressway, Suite 300, Dallas, TX 75204, Attention: Sherrie L. Krolczyk, Compliance Officer.

A description of the new drug approval process can be found on FDA's internet website at http:/lwww.fda.gov/cder/regulatory/applications/default.htm. 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.

Sincerely,

/s/
Michael A. Chappell
District Director