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U.S. Department of Health and Human Services

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Enforcement Actions

True Renewal 1/06/09

   

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

Public Health Service
Food and Drug Administration
  Southwest Region
Denver District Office
Bldg. 20-Denver Federal Center
P.O. Box 25087
6th Avenue & Kipling Street
Denver, Colorado 80225-0087
Telephone: 303-236-3000
FAX: 303-236-3100


January 06, 2009

WARNING LETTER

CERTIFIED MAIL
RETURN RECEIPT REQUESTED

Ms. Jenine M. Cohoon
True Renewal
4618 Windsor Dr.
Provo, UT 84604

3214 N. University Ave. #223
Provo, UT 84604.

DEN-09-04-CIWL

Dear Ms. Cohoon,

This is to advise you that the Food and Drug Administration (FDA) has reviewed your websites at the Internet addresses www.truerenewal.com, www.healthwithmms.com, www.drjenine.com, and www.oxypowdercleanse.com and has determined that the products "Miracle Mineral Supplement," "Dr Ohhira Essential Formulas Probiotics 12 Plus Original Formula," "Graviola," "Graviola Max," and "Livatrex" are promoted for conditions that cause the products to be drugs under section 201(g)(1)(B) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 321(g)(1)(B)]. The therapeutic claims on your website establish that the products are drugs because they are intended for use in the cure, mitigation, treatment, or prevention of disease. The marketing of these products with these claims violates the Act.

Examples of some of the claims observed on your websites include:

Miracle Mineral Supplement (www.healthwithmms.com)

• "The Miracle Mineral Supplement -- Chlorine Dioxide Ion -- The most powerful killer of disease ever known"

• "Hundreds of lives have been saved. Reports of overcoming incurable diseases are happening every day."

• "MMS has been used to Supercharge the Immune System into erradicating [sic] disease-causing parasites: Virus, Bacteria, Fungi, Yeast, Slime Molds, Mildew, Spirochetes, Mycoplasmas, Nanobacteria; Flukes, Round Worms, Tongue. Worms, Tapeworms, Pinworms, Protozoa, and, MORE!"

• "Eliminate the cause, reverse the dis-ease!"

• Numerous statements made in the text of the book posted on your website entitled, Breakthrough: The Miracle Mineral Supplement of the 21st Century (3rd Edition) by Jim Humble, including:

o "This Miracle Mineral supplement works in a few hours. The #1 killer of mankind in the world today is malaria, a disease that is usually overcome by this supplement in only four hours in most cases. This has been proven through clinical trials in Malawi, a country in eastern Africa. In killing the malaria parasite in the body, there was not a single failure. More than 75,000 malaria victims have taken the Miracle Mineral Supplement and are now back to work and living productive lives."

o "After taking the Miracle Mineral Supplement AIDS patients are often disease free in three days and other diseases and conditions simply disappear. If patients in the nearest hospital were treated with this Miracle supplement, over 50% of them would be back home within a week."

o "Amazing as it might seem, when used correctly, the immune system can use this killer to only attack those germs, bacteria and viruses that are harmful to the body, and does not affect the friendly bacteria in the body nor any of the healthy cells."

Dr. Ohhira's Essential Formulas Probiotics 12 Plus Original Formula (www.healthwithmms.com)

• "[H]as been proven effective in vitro against the most virulent pathogens including the MRSA (Methicillin-resistant Staphylococcus aureus) superbug, E coli-157, H. pylori (the cause of peptic ulcers)."
• "Benefits of Dr. Ohhira OMX 12-Plus Probiotic Formula . . . decreases incidence of digestive ailments like crohns disease . . .decreases incidence of certain infections . . .decreases incidence of oral cavity infections"
• "probiotics help to normalize cholesterol"

Miracle Mineral Supplement (www.truerenewal.com)

• "Chlorine dioxide is more effective than chlorine against viruses, bacteria and protozoa-including the cysts of Giardia and the oocysts of Cryptosporidium (parasites)."

• "Chlorine dioxide is the topic of author, scientist, chemist and humanitarian, Jim Humble's book entitled, 'Breakthrough, The Miracle Mineral Supplement of the 21st Century'. In Breakthrough, Humble describes how he discovered the use of chlorine dioxide as an alternative treatment for Malaria, which has since led to over 75,000 documented successful treatments of the disease in Africa. Humble's research aims to establish MMS as a powerful alternative treatment to many pathogen borne diseases."

• "Chlorine dioxide can be used to kill 'disease-bearing bacteria, yeasts, molds, fungi and algae', including MRSA and other deadly pathogens."

Graviola (www.truerenewal.com and www.drjenine.com)

• "Main Actions (in order): anticancerous, antitumorous, antimicrobial, antiparasitic, hypotensive (lowers blood pressure)"

• "Main Uses:
1. for cancer (all types)
2. as a broad-spectrum internal and external antimicrobial to treat bacterial and fungal infections
3. for internal parasites and worms
4. for high blood pressure
5. for depression"

• "Properties/Actions Documented by Research: anticonvulsant, antidepressant, antifungal,antimalarial, antimutagenic . . . , antiparasitic, antitumorous . . . hypotensive (lowers blood pressure) . . . sedative . . ."

• "Other Properties/Actions Documented by Traditional Use ; antiviral . . . febrifuge (reduces fever), . . . pediculicide (kills lice), vermifuge (expels worms)"

• Numerous statements made within the article, "Cancer Cell 'Smart Bombs"' which is posted in the "Health Articles" section of your web sites and accompanied by a link to a page where consumers can order "Graviola." These statements include:

o "The tree is called Graviola. The compounds contained therein are 10,000 times stronger than chemotherapy and act only on cancer cells, not healthy cells! . . .[E]xtensive research that proves the cancer killing properties of Graviola were conducted by extensive independent research including research by one of today's leading drug companies. The National Cancer Institute confirms that the tree's chemical extracts attack and destroy cancer cells with lethal precision!"
o "About Graviola: Graviola conquers cancer safely and effectively with an all-natural therapy that doesn't cause extreme nausea, weight loss, and hair loss. Graviola protects your immune system from deadly infections. . . . Graviola effectively targets and kills malignant cells in 12 different types of cancer, including colon, breast, prostate, lung, and pancreatic cancer. Graviola is 10,000 times stronger in killing colon cancer cells than Adriamycin, a commonly used chemotherapeutic drug. Graviola selectively hunts down and kills cancer cells without harming healthy cells, unlike chemotherapy."

o "Through a series of confidential communications involving the researcher from the pharmaceutical company, this ancient tree's anti-cancerous properties are now known."

Graviola Max (www.truerenewal and www.drjenine.com)

• "Main Actions (in order): anticancerous, antitumorous, antimicrobial, antiparasitic, hypotensive (lowers blood pressure)"

• "Main Uses:
1. for cancer (all types)
2. as a broad-spectrum internal and external antimicrobial to treat bacterial and fungal infections
3. for internal parasites and worms
4. for high blood pressure
5. for depression . . ."

• Properties/Actions Documented by Research: antibacterial, anticancerous, anticonvulsant, antidepressant, antifungal, antimalarial, . . . antiparasitic, . . . antitumerous . . .
• Other Properties/Actions Documented by Traditional Use: antiviral . . . febrifuge (reduces fever) . . . pediculicide (kills lice), vermifuge (expels worms)"

Livatrex (www.oxypowdercleanse.com)

• "Aids in breaking down gallstones and kidney stones that can result from an overburdened liver."
• "Ingredients: . . . Chanca Piedra translates to 'stone breaker' in reference to its action upon gallstones"

These claims are supplemented by the metatags used to bring consumers to your websites through Internet searches. The metatags include:

• www.truerenewal.com: "fungal infections," "fungal diseases," "chronic fungal infection," "fungi cancer link." "True Renewal offers products to help with a fungus infection"

• www.healthwithmms.com: "Miracle Mineral Supplement has long been known as a malaria cure, taken to Afria [sic] by Jim Humble"

The unlawful disease treatment and prevention claims observed for these and other products on your websites are too numerous to mention in this letter. It is your responsibility to ensure that products marketed by your firm comply with the Act and its implementing regulations. We advise you to review your websites, product labels, and other labeling and promotional materials for your products to ensure that the claims you make for your products do not cause them to violate the Act.

Your products are not generally recognized as safe and effective for the above referenced uses and therefore, the products are also "new drugs" 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. Your products "Miracle Mineral Supplement," "Graviola," "Graviola Max," "Dr Ohhira Essential Formulas Probiotics 12 Plus Original Formula" and "Livatrex" are also misbranded within the meaning of section 502(f)(1) of the Act in that labeling for these drugs fail to bear adequate directions for use [21 U.S.C. § 352(f)(1)]

You should take prompt action to correct the violations described above and prevent their future recurrence. Failure to do so may result in enforcement action without further notice. The Act authorizes the seizure of illegal products and injunctions against manufacturers and distributors of those products for causing violations of the Act [21 U.S.C. §§ 332 and 334].

Please notify this office, in writing, within fifteen (15) working days of the 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. Include any documentation necessary to show that correction has been achieved. If corrective actions cannot be completed within fifteen working days, state the reason for the delay and the time within which the corrections will be completed.

Your response should be directed to Nancy G. Schmidt, Compliance Officer, Denver District at the address noted above.

Sincerely,

/S/

H. Thomas Warwick,
District Director, Denver