Disclaimer – Informed Consent
(This document is generally constructed in conformity with):
TITLE 21–FOOD AND DRUGS Code of Federal Regulations CHAPTER I–FOOD AND DRUG ADMINISTRATION Title 21, Volume 1 DEPARTMENT OF HEALTH AND HUMAN SERVICES Revised as of April 1, 2007 SUBCHAPTER A—GENERAL CITE: 21CFR 50.25
Mitigation of Diseases, Inc., a Delaware Corporation (hereinafter referred to as “MODI” or (Company) is conducting ongoing research on ingredients of the proprietary, patent-application pending formula, also known as FROST-ZC100. The purpose of the research is to determine the effectiveness of the formula in identifying and/or eliminating certain types of non-typical or non-performing cells in humans and other animals while reinforcing healthy cells. The company believes that it is possible to also formulate a product version (using transdermal patches) that may be useful in detecting the presence or existence of non-performing or mutated cells in the body even when there are no visual or conventional manifestations or symptoms. A further goal is to confirm that the formula alerts the body’s defenses including the immune system and eliminates and/or expels the non-typical cells from the human and/or animal’s body through the skin or as bodily waste.
Further Research is Needed to Validate the Company’s Belief that many non-typical or non-performing cells are not recognized by the body as being a serious danger because the “mutated” cells contain the subject’s DNA and are masked by a protective sheath and therefore are not attacked by the immune system to an extent that it would eliminate the proliferation of these cells.
Ligands in our formulations are formed in an exothermic reaction between a strong acid and base that form a biological complex that binds with the Zinc and Copper ions and carries the minerals to the target area. The particular structure is called Zinc/Copper Ligands and becomes a highly efficient transport system since the ionic minerals are loosely-bounded and therefore are highly bio-available.
The Ligands are quickly transported across semi-permeable membranes and the free mineral ions can immediately be absorbed by diseased or healthy tissues at very low concentrations while minerals bound in salts have great difficulty reaching the target cells. The disassociation of the mineral ions in such compounds is inefficient and it takes much higher concentrations of such compounds’ without the superior results we have achieved using our system.
The Krebs cycle is a charting of the metabolic pathways that healthy plant or animal cells must follow to perform all functions supporting life. There are approximately thirty-two (32) steps in the process. The steps allow for exclusion of excessive amounts of materials including minerals and other nutrients unless totally over-whelmed (too much salt, etc.).
Mutated or non-typical cells do not follow the Krebs cycle with only about eighteen (18) steps and absorb all foods (particularly sugars). These cells will also absorb minerals such as Zinc and Copper however the high concentrations (as included in our formulation) are toxic to non-performing cells thus, causing them to die. The surrounding healthy tissues, following the Krebs cycle, take up the amounts of Zinc and Copper needed to function more efficiently and excrete the excess minerals. Following the Krebs 32 steps, versus the 18 steps that diseased cells follow, saves and replenishes minerals in normal healthy tissue while killing the mutated cells.
In summary, we believe that we are able to transport our highly available Zinc and Copper on Ligands to our target diseases (several types of non-typical, non-functioning and/or mutated cells) and kill ONLY those cells, leaving the healthy normal cells surrounding the disease, functioning without disruption.
Further, a sheath of cells (also non-Krebs cycle) often surrounds metastasized cells. The highly bio-available Zinc and Copper should penetrate and kill the cells within this shield, that has protected the diseased cells from detection by the immune system, and destroy that sheath. The mass of the diseased cells are then exposed to the immune system (hopefully a strong immune system) which will then join in to destroy the exposed mutated cells as well.
Expected Duration of Subject’s Use of Product
The use of this formula is not considered a permanent “cure” for any disease as it is possible that the removal of existing cellular tumors or other non-productive cells does not preclude the possibility of a future return of new mutated cells or tumors. Therefore, it is possible and even probable that re-use of the formula may be indicated. The initial use of the formula can be effective within a few days, but can take many months. Our research indicates that the determining time-line factors revolve around the strength of the subject’s immune system and the severity of the disease.
Description of the Procedures to be Followed
Subjects (you) are required to follow the directions issued with each dose of the FROST-ZC100 formula exactly. General instructions will require that you place a portion of the formula topically (on your skin) as close to the area of concern as possible; in cases of internal diseases or tumors, it is recommended that a larger (uncovered) area is covered. In the case of skin lesions it is suggested that you place the ingredients directly on the lesion and cover it with a non-allergenic bandage for a period of several days. It is our belief that the formula will not cause a skin reaction (other than a normal reaction to the covering bandage or Band-Aid) if there are no non-typical cells present on or under the skin surface. The subject will be encouraged to follow a refined sugar free diet and to take food supplements on a daily basis. Our experience indicates that the formula is systemic (affecting the entire body). Systemic therapies employ carrier agents that travel through the body’s fluid systems and effect cells throughout the body. Our non-clinical research has been gathered from subjects who have used the formula that have had confirmed mutated cells, manifested in areas of their body that were several inches from the application site. When the formula was used, these remote sites reacted as if they were diseased.
It is important to consider using “immune system” building vitamins and minerals with supplements including yogurt and/or probiotics as we feel that a strong immune system may be important to speed the time-line involved and to provide the highest success rate possible for this therapy; ask your doctor(s) about recommended and approved supplements.
Procedures, beliefs and theories associated with the FROST-ZC100 formula are experimental and none of the statements of expected results or ingredients of this formula have been reviewed or approved by the FDA or any other governmental agency.
Use at Own Risk – Agreement to Hold Harmless
The Subject and his or her heirs, assignees or representatives, agree that the self-application of this formula known as FROST-ZC100, is done at his or her own risk and agree to hold the Manufacturer, Distributor, Affiliates and any Officers, Directors, Employees, Investigators, Designees or Other Persons and/or any other Subjects who may have recommended or commented to the efficacy of the formula, harmless from any legal action of any description or form.
Description of Possible Risks, Reactions, Observations or Discomforts to the Subject
The risk of sickness or serious illness, due to the use of this formula, is considered minimal by the company as all ingredients are considered Generally Regarded as Safe or “GRAS”) under 40 CFR 180.1001 entitled the Exemption from the Requirements of a Tolerance; this regulation eliminates the need to establish a maximum permissible level of the ingredients. The components in the formulation are considered nutritional elements for plants and animals and can be found in the food we eat, the water we drink and/or the air we breathe.
Some of the ingredients are concentrated minerals that are readily expelled from the body when in excess of the normal daily intake through food and/or vitamin supplements. More research is required to develop a complete understanding of all of the possible benefits and consequences of the use of this formula.
There are no new experimental chemicals or ingredients in the formula that are considered “synthetic” drugs. However, the risk of discomfort or moderate pain for three (3) or more days, due to the use of the formula, is probable in the event that the subject has mutated cells present in the skin or body. Some subjects have used the formula for as long as three (3) weeks before a noticeable reaction has developed and some subjects, with advanced diseases, have continued the use of this formula for six (6) plus months. A few Subjects have experienced extreme pain however there is limited experience with all types of diseases and severe pain may be typical with certain diseases. Subjects have experienced “itchiness” for the first ten to thirty (10-30) minutes after application and have experienced ulcerations and moderate to severe pain where tumors have come through the skin to be expelled. In most cases, the tumors have left no noticeable scars. The science and observations lead to the conclusion that the dead cells are typically expelled by the body, either in urine or feces with other body waste.
In addition to the many side effects that are expected or possible with any prescription or non-prescription therapies that you are using, other temporary reactions that are possible from using the FROST-ZC100 formula may include; area redness or discolored skin, skin crusting resulting in temporary scabbing, flaking and/or peeling of the skin, small black and/or red “pinpoint” spots on the areas where the formula has been used, or other areas (some with white halos around them), skin nodules of various sizes colors, extreme or mild fatigue, bowel and/or urine incontinence, white cloudy material in urine and/or stools, itchy foot bottoms, unusual body and/or stool/urine odors, a metallic taste in the mouth, flu like symptoms and sensitivity to direct sunlight. All of these conditions should resolve themselves with no residual effect or scarring. If you are taking prescription drugs, read the information which accompanied those drugs to ensure that there are no contraindications of the ingredients to those drugs; if in doubt, ask your doctor/caregiver.
This formula or procedure may involve unknown risks to the subject (or to the embryo or fetus, if the subject is or may become pregnant) which are currently unforeseeable. It is important to advise any case worker or person following your progress of any allergies and/or reactions to any natural or unnatural substances and particularly, an adverse reaction to minerals.
Description of the Benefits that You May Expect From the Research
Subjects, with strong immune systems, that have used this formula have reported success in eliminating surface tumors and/or lesions. Anecdotal success has been reported with subsurface tumors including breast and prostate tumors as well as success with viral, bacterial and fungal conditions. The formulation is at least locally systemic and appears to be capable of affecting tumors in organs and subsurface viruses. There have been no clinical studies to support this belief to date but non-clinical studies have demonstrated positive results. Most of the successful cases have been reported verbally and are not well documented by physicians but, some are extremely well documented by the subjects and care-takers including several that are sequenced with film evidence.
Appropriate Alternative Procedures or Courses of Treatment
The Subject understands that use of the formula is experimental and that they are not being encouraged to abandon any other traditional treatment avenues or advice by competent medical personnel. Subjects are encouraged to discuss use of this formula and any possible adverse interaction between minerals and prescribed medicines with their Doctors. Remain under the care of your Doctor. Use of the FROST-ZC100 formula should not in any way be considered a substitute for the medical care as recommended or provided by your Doctor.
These statements have not been evaluated by the Food and Drug Administration. Biominix Products are not intended to diagnose, treat, cure, or prevent any disease.
This disclaimer – informed consent is not intended to preempt any applicable Federal, State, or local laws which require additional information to be disclosed for informed consent to be legally effective. Nothing in this document is intended to limit the authority of a physician to provide emergency medical care to the extent the physician is permitted to do so under applicable Federal, State, or local law.
5.2.2. Canadians importing by means other than on their person (via mail, courier, etc.),
A Canadian who chooses to obtain a health product from outside Canada which may or may not have been reviewed and market authorized by Health Canada is allowed to import:
A single course of treatment or a 90-day supply based on the directions for use, whichever is less, of a health product as long as the product does not contain a substance listed in Schedule F of the Food and Drug Regulations.
The health product must be for their own personal use, the use of a person for whom they are responsible or for use on an animal for which they are responsible.
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